ExerciseSONRIENCT05849792
Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project
A study testing Exercise and psychological intervention in people with Exercise and Physical Fitness, run by University of Cadiz at 1 site in Spain.
Trial summary
The goal of this randomized controlled trial is to determine the effect of an intervention program with physical activity for 12 weeks on depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Exercise, Physical Fitness, Depression
- What is being tested?
- Exercise and psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants between 25-65 years.
- Mild and / or moderate depression diagnosed by Beck Scale.
- Do not have other severe somatic or psychiatric disorders or other diseases that prevents physical activity.
- To be able to communicate with any problem.
- To be able to read and understand the main purpose of the study.
- Informed consent: must be capable and willing to provide consent.
Who cannot join
- Major depression diagnosed.
- Acute or terminal illness.
- History of cerebral infarction, epilepsy, brain tumor.
- Unstable cardiovascular disease, or other medical conditions.
- Upper or lower extremity fracture in the past 3 months.
- Severe visual or auditory problems.
- Unwillingness to either complete the study requirements or to be randomized into control or training group.
- To be a participant in another research study that may influence the present project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Physical Activities Randomized Controlled Trial in Patients With Mild/Moderate Depression: Effects on Psychological and Social Well-being: SONRIE Project
The goal of this randomized controlled trial is to determine the effect of an intervention program with physical activity for 12 weeks on depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression. The main questions it aims to answer are:
- - To determine the association of physical activity levels, sedentary behavior, sleep patterns, physical condition, diet, and general health status with mental and social well-being, and quality of life in a large sample of adult patients diagnosed with mild or moderate depression.
- - To examine the predictive capacity of physical activity, sedentary behaviors, and physical condition on mild and moderate depressive disorder.
- - To study the effect of a period without an intervention program with physical activity (8 weeks without exercise intervention) on the variables studied.
- - To examine the role of the endocannabinoid system on depression as well as its behavior after an intervention program of physical activity.
Read more
Participants will be involved in a physical activity intervention program for 12 weeks.
Researchers will compare intervention group and control group to see if an intervention program with physical activity for 12 weeks improve depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression.
Read the detailed description
One hundred and six eligible participants between 25-65 years old (Spanish higher prevalence of depression in adulthood) diagnosed with mild or moderate depression will be the sample of this project. Participants will be recruited from the Mental Health Unit (UGC Salud Mental), covering different areas of the province of Cadiz (Spain) such as Puerto Real, Chiclana de la Frontera and Vejer de la Frontera. The Mental Health Unit Director from Puerto Real Hospital is a researcher associated with this project who has specific experience with clinical experience. He will be the person in charge for the clinical depression diagnosis. Moreover, participants will perform specific depression tests at the time of recruitment to confirm their clinical status. Individuals who meet the criteria to participate in this study will sign the informed consent previously to their inclusion in this project (see inclusion / exclusion criteria section).
Sample size and statistical power
Sample size determination will be estimated with a 5% type I error (α) and 95% confidence interval establishing a level of precision (d = 0.095) for the hypothesis test to comparing two proportions. The desired sample size will be n = 96 participants and it will be increased by 10% (n = 106) to compensate the possible dropout of participants during the evaluation process of the study. Sample size for the hypothesis test to comparing two means for the intervention study will consider with a significance level alpha of 0.05 and a power of 0.95 (beta = 0.05) and considering the standard deviation for depression variable as 9.36 (Bouldering psychotherapy reduces depressive symptoms even when general physical activity is controlled for: A randomized controlled trial, Heylon, 2018; Mar; 4 (3): e00580). In this way, to detect a minimum mean difference of 8.26 between control and experimental groups for the depression variable, it is estimated that the sample size of each group should be 30 patients. Therefore, a total of 60 participants will be randomly recruited to each group balanced by sex, age and depression clinical severity. It should be taking into account that several simulations to estimate the sample size based on previous studies were performed by STATA statistical software vs. 14.0.
- Conditions
- Exercise, Physical Fitness, Depression, Adult ALL, Psychological
- Being tested
- Exercise and psychological intervention
- Keywords
- depression, physical activity, exercise, physical fitness, psychological, Endocannabinoids system
- Medical subject headings
- Motor Activity, Depression, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and psychological interventionBehavioural
Physical Exercise Intervention
Sixty-minute sessions were delivered via internet, three times per week (1 supervised) over the first four weeks of the COVID-19 home confinement. The intervention was a multicomponent exercise program lead by a specialist in fitness composed of aerobic, resistance, balance, coordination, mobility and stretching exercises. Each multicomponent exercise session consisted of a 10 min warm-up, 40 min of moderate to vigorous intensity physical activity, and 10 min cool down.
Psychological intervention
The internet-based-psychological intervention provided to different component of Cognitive Behavioral Therapy (CBT) guided and recorded by a sport neuro-psychologist specialist. The iCBT is based on the protocol for face-to-face CBT for depression. The program consisted of 4 weeks composed of 2 weekly video-guided sessions, with a maximum duration of 30 minutes. iCBT was focused on 4 main axes of action physiological, emotional, behavioral and cognitive.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Group where the participants realize an intervention based on exercise and psychology. Receives: Behavioral: Exercise and psychological intervention |
| Control | No intervention | Group where the subjects do not realize the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression PRE
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured before the intervention program.
Measured: month 11-12
Depression POST
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Depression RET
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Anxiety disorders and stress PRE
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured before the intervention program.
Measured: month 11-12
Anxiety disorders and stress POST
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Anxiety disorders and stress RET
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Light physical activity PRE
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Measured: month 11-12
Light physical activity POST
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Light physical activity RET
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Moderate physical activity PRE
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Measured: month 11-12
Moderate physical activity POST
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Moderate physical activity RET
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Vigorous physical activity PRE
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Measured: month 11-12
Vigorous physical activity POST
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Vigorous physical activity RET
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Moderate-Vigorous physical activity PRE
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Measured: month 11-12
Moderate-Vigorous physical activity POST
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Moderate-Vigorous physical activity RET
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Cardiorespiratory fitness PRE
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured before the intervention program.
Measured: month 11-12
Cardiorespiratory fitness POST
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Cardiorespiratory fitness RET
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
30-s chair stand PRE
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured before the intervention program.
Measured: month 11-12
30-s chair stand POST
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
30-s chair stand RET
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Chair sit and reach PRE
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured before the intervention program.
Measured: month 11-12
Chair sit and reach POST
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Chair sit and reach RET
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Back scratch PRE
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured before the intervention program.
Measured: month 11-12
Back scratch POST
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Back scratch RET
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Blind flamingo PRE
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.
Measured: month 11-12
Blind flamingo POST
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Blind flamingo RET
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
8 ft. up and go PRE
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.
Measured: month 11-12
8 ft. up and go POST
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
8 ft. up and go RET
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Handgrip strength PRE
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured before the intervention program.
Measured: month 11-12
Handgrip strength POST
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Handgrip strength RET
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Anandamine (AEA) PRE
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Measured: month 11-12
Anandamine (AEA) POST
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Anandamine (AEA) RET
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
2-araquinodilglicerol (2-AG) PRE
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Measured: month 11-12
2-araquinodilglicerol (2-AG) POST
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Measured: month 18-19
2-araquinodilglicerol (2-AG) RET
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
N-palmitoylethanolamide (PEA) PRE
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Measured: month 11-12
N-palmitoylethanolamide (PEA) POST
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Measured: month 18-19
N-palmitoylethanolamide (PEA) RET
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
N-oleylethanolamine (OEA) PRE
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Measured: month 11-12
N-oleylethanolamine (OEA) POST
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Measured: month 18-19
N-oleylethanolamine (OEA) RET
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Brain-derived neurotrophic factor PRE
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured before the intervention program.
Measured: month 11-12
Brain-derived neurotrophic factor POST
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Brain-derived neurotrophic factor RET
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Secondary outcomes (36)
Ryff's Psychological Well-Being Scale (42-item) PRE
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294. That measurements will be measured before the intervention program.
Measured: month 11-12
Ryff's Psychological Well-Being Scale (42-item) POST
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Ryff's Psychological Well-Being Scale (42-item) RET
Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294, being 42 the worst score. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
The SF-36 Health Questionnaire PRE
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured before the intervention program.
Measured: month 11-12
The SF-36 Health Questionnaire POST
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
The SF-36 Health Questionnaire RET
The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Blood pressure PRE
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured before the intervention program.
Measured: month 11-12
Blood pressure POST
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Blood pressure RET
Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Heart rate PRE
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured before the intervention program.
Measured: month 11-12
Heart rate POST
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Heart rate RET
Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Weight PRE
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured before the intervention program.
Measured: month 11-12
Weight POST
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Weight RET
Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Height PRE
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured before the intervention program.
Measured: month 11-12
Height POST
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Height RET
Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Waist circumference PRE
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured before the intervention program.
Measured: month 11-12
Waist circumference POST
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Waist circumference RET
Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Fat mass PRE
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured before the intervention program.
Measured: month 11-12
Fat mass POST
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Fat mass RET
Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Sociodemographic characteristics questionnaire PRE
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured before the intervention program.
Measured: month 11-12
Sociodemographic characteristics questionnaire POST
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Sociodemographic characteristics questionnaire RET
Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Food Frequency Questionnaire (FFQ) PRE
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured before the intervention program.
Measured: month 11-12
Food Frequency Questionnaire (FFQ) POST
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Food Frequency Questionnaire (FFQ) RET
food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Sleep time PRE
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Measured: month 11-12
Sleep time POST
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
Sleep time RET
Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
The Pittsburg Sleep Quality Index PRE
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured before the intervention program.
Measured: month 11-12
The Pittsburg Sleep Quality Index POST
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured immediately after the intervention program.
Measured: month 18-19
The Pittsburg Sleep Quality Index RET
The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured 4 weeks after the intervention program.
Measured: month 22-23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Sep 2019
- Primary completion28 Feb 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia, Instituto de investigación e innovación biomédica de Cádiz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849792
- Sponsor's protocol ID
- PI/0068/2018
- Acronym
- SONRIE
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8. doi: 10.1159/000066239.
PubMed 9636945BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Spielberger CD, Gorsuch RL, L. R. State-trait anxiety inventory. Palo Alto Consult. Psychol. Press 1-23 (1970)
Ryff, C. D. Happiness is everything, or is it? Explorations on the meaning of psychological well-being. J. Pers. Soc. Psychol. 57, 1069-1081 (1989)
Diaz D, Rodriguez-Carvajal R, Blanco A, Moreno-Jimenez B, Gallardo I, Valle C, van Dierendonck D. [Spanish adaptation of the Psychological Well-Being Scales (PWBS)]. Psicothema. 2006 Aug;18(3):572-7. Spanish.
PubMed 17296089Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish.
PubMed 15860162Pietrobelli A, Rubiano F, St-Onge MP, Heymsfield SB. New bioimpedance analysis system: improved phenotyping with whole-body analysis. Eur J Clin Nutr. 2004 Nov;58(11):1479-84. doi: 10.1038/sj.ejcn.1601993.
PubMed 15138459Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. doi: 10.1038/nn1457.
PubMed 15856067Kroes R, Muller D, Lambe J, Lowik MR, van Klaveren J, Kleiner J, Massey R, Mayer S, Urieta I, Verger P, Visconti A. Assessment of intake from the diet. Food Chem Toxicol. 2002 Feb-Mar;40(2-3):327-85. doi: 10.1016/s0278-6915(01)00113-2.
PubMed 11893401Martinez-Gonzalez MA, Fernandez-Jarne E, Serrano-Martinez M, Wright M, Gomez-Gracia E. Development of a short dietary intake questionnaire for the quantitative estimation of adherence to a cardioprotective Mediterranean diet. Eur J Clin Nutr. 2004 Nov;58(11):1550-2. doi: 10.1038/sj.ejcn.1602004.
PubMed 15162136Gonzalez Carrascosa R, Bayo Monto JL, Meneu Barreira T, Garcia Segovia P, Martinez-Monzo J. Design of a self-administered online food frequency questionnaire (FFQ) to assess dietary intake among university population. Nutr Hosp. 2011 Nov-Dec;26(6):1440-6. doi: 10.1590/S0212-16112011000600035.
PubMed 22411394Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Ruiz-Munoz M, Jimenez-Pavon D, Garrido-Palomino I, Escudier-Vazquez JM, Gomez de Lara EJV, Espana-Romero V. Effects of an internet-based combined exercise and cognitive-behavioral therapy intervention on endocannabinoid system biomarkers and physical fitness in adults with mild-to-moderate depression: a SONRIE randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2026 Aug 4. doi: 10.1007/s00406-026-02330-x. Online ahead of print.
PubMed 42550192
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Physical Activities Randomized Controlled Trial in Patients With Mild/Moderate Depression: Effects on Psychological and Social Well-being: SONRIE Project
- ClinicalTrials.gov ID
- NCT05849792
- Acronym / sponsor ID
- SONRIE / PI/0068/2018
- Conditions
- Exercise, Physical Fitness, Depression, Adult ALL, Psychological
- Keywords
- depression, physical activity, exercise, physical fitness, psychological, Endocannabinoids system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Junta de Andalucia, Instituto de investigación e innovación biomédica de Cádiz
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to determine the effect of an intervention program with physical activity for 12 weeks on depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression. The main questions it aims to answer are:
- - To determine the association of physical activity levels, sedentary behavior, sleep patterns, physical condition, diet, and general health status with mental and social well-being, and quality of life in a large sample of adult patients diagnosed with mild or moderate depression.
- - To examine the predictive capacity of physical activity, sedentary behaviors, and physical condition on mild and moderate depressive disorder.
- - To study the effect of a period without an intervention program with physical activity (8 weeks without exercise intervention) on the variables studied.
- - To examine the role of the endocannabinoid system on depression as well as its behavior after an intervention program of physical activity.
Participants will be involved in a physical activity intervention program for 12 weeks.
Researchers will compare intervention group and control group to see if an intervention program with physical activity for 12 weeks improve depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression.
Detailed description
One hundred and six eligible participants between 25-65 years old (Spanish higher prevalence of depression in adulthood) diagnosed with mild or moderate depression will be the sample of this project. Participants will be recruited from the Mental Health Unit (UGC Salud Mental), covering different areas of the province of Cadiz (Spain) such as Puerto Real, Chiclana de la Frontera and Vejer de la Frontera. The Mental Health Unit Director from Puerto Real Hospital is a researcher associated with this project who has specific experience with clinical experience. He will be the person in charge for the clinical depression diagnosis. Moreover, participants will perform specific depression tests at the time of recruitment to confirm their clinical status. Individuals who meet the criteria to participate in this study will sign the informed consent previously to their inclusion in this project (see inclusion / exclusion criteria section).
Sample size and statistical power
Sample size determination will be estimated with a 5% type I error (α) and 95% confidence interval establishing a level of precision (d = 0.095) for the hypothesis test to comparing two proportions. The desired sample size will be n = 96 participants and it will be increased by 10% (n = 106) to compensate the possible dropout of participants during the evaluation process of the study. Sample size for the hypothesis test to comparing two means for the intervention study will consider with a significance level alpha of 0.05 and a power of 0.95 (beta = 0.05) and considering the standard deviation for depression variable as 9.36 (Bouldering psychotherapy reduces depressive symptoms even when general physical activity is controlled for: A randomized controlled trial, Heylon, 2018; Mar; 4 (3): e00580). In this way, to detect a minimum mean difference of 8.26 between control and experimental groups for the depression variable, it is estimated that the sample size of each group should be 30 patients. Therefore, a total of 60 participants will be randomly recruited to each group balanced by sex, age and depression clinical severity. It should be taking into account that several simulations to estimate the sample size based on previous studies were performed by STATA statistical software vs. 14.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise and psychological interventionGroup where the participants realize an intervention based on exercise and psychology. |
| Control | No intervention | –Group where the subjects do not realize the intervention. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female participants between 25-65 years.
- Mild and / or moderate depression diagnosed by Beck Scale.
- Do not have other severe somatic or psychiatric disorders or other diseases that prevents physical activity.
- To be able to communicate with any problem.
- To be able to read and understand the main purpose of the study.
Key exclusion criteria (8 listed)
- Major depression diagnosed.
- Acute or terminal illness.
- History of cerebral infarction, epilepsy, brain tumor.
- Unstable cardiovascular disease, or other medical conditions.
- Upper or lower extremity fracture in the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and psychological interventionPhysical Exercise Intervention Sixty-minute sessions were delivered via internet, three times per week (1 supervised) over the first four weeks of the COVID-19 home confinement. The intervention was a multicomponent exercise program lead by a specialist in fitness composed of aerobic, resistance, balance, coordination, mobility and stretching exercises. Each multicomponent exercise session consisted of a 10 min warm-up, 40 min of moderate to vigorous intensity physical activity, and 10 min cool down. Psychological intervention The internet-based-psychological intervention provided to different component of Cognitive Behavioral Therapy (CBT) guided and recorded by a sport neuro-psychologist specialist. The iCBT is based on the protocol for face-to-face CBT for depression. The program consisted of 4 weeks composed of 2 weekly video-guided sessions, with a maximum duration of 30 minutes. iCBT was focused on 4 main axes of action physiological, emotional, behavioral and cognitive. | Behavioural | Exercise group |
Primary outcome
Depression PRE
Time frame: month 11-12
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured before the intervention program.
Depression POST
Time frame: month 18-19
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured immediately after the intervention program.
Depression RET
Time frame: month 22-23
Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured 4 weeks after the intervention program.
Anxiety disorders and stress PRE
Time frame: month 11-12
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured before the intervention program.
Anxiety disorders and stress POST
Time frame: month 18-19
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured immediately after the intervention program.
Anxiety disorders and stress RET
Time frame: month 22-23
State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured 4 weeks after the intervention program.
Light physical activity PRE
Time frame: month 11-12
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Light physical activity POST
Time frame: month 18-19
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Light physical activity RET
Time frame: month 22-23
Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Moderate physical activity PRE
Time frame: month 11-12
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Moderate physical activity POST
Time frame: month 18-19
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Moderate physical activity RET
Time frame: month 22-23
Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Vigorous physical activity PRE
Time frame: month 11-12
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Vigorous physical activity POST
Time frame: month 18-19
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Vigorous physical activity RET
Time frame: month 22-23
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Moderate-Vigorous physical activity PRE
Time frame: month 11-12
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.
Moderate-Vigorous physical activity POST
Time frame: month 18-19
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.
Moderate-Vigorous physical activity RET
Time frame: month 22-23
Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.
Cardiorespiratory fitness PRE
Time frame: month 11-12
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured before the intervention program.
Cardiorespiratory fitness POST
Time frame: month 18-19
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured immediately after the intervention program.
Cardiorespiratory fitness RET
Time frame: month 22-23
Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured 4 weeks after the intervention program.
30-s chair stand PRE
Time frame: month 11-12
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured before the intervention program.
30-s chair stand POST
Time frame: month 18-19
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured immediately after the intervention program.
30-s chair stand RET
Time frame: month 22-23
This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured 4 weeks after the intervention program.
Chair sit and reach PRE
Time frame: month 11-12
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured before the intervention program.
Chair sit and reach POST
Time frame: month 18-19
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured immediately after the intervention program.
Chair sit and reach RET
Time frame: month 22-23
The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured 4 weeks after the intervention program.
Back scratch PRE
Time frame: month 11-12
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured before the intervention program.
Back scratch POST
Time frame: month 18-19
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured immediately after the intervention program.
Back scratch RET
Time frame: month 22-23
The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured 4 weeks after the intervention program.
Blind flamingo PRE
Time frame: month 11-12
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.
Blind flamingo POST
Time frame: month 18-19
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.
Blind flamingo RET
Time frame: month 22-23
Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.
8 ft. up and go PRE
Time frame: month 11-12
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.
8 ft. up and go POST
Time frame: month 18-19
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.
8 ft. up and go RET
Time frame: month 22-23
It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.
Handgrip strength PRE
Time frame: month 11-12
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured before the intervention program.
Handgrip strength POST
Time frame: month 18-19
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured immediately after the intervention program.
Handgrip strength RET
Time frame: month 22-23
This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured 4 weeks after the intervention program.
Anandamine (AEA) PRE
Time frame: month 11-12
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
Anandamine (AEA) POST
Time frame: month 18-19
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
Anandamine (AEA) RET
Time frame: month 22-23
Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
2-araquinodilglicerol (2-AG) PRE
Time frame: month 11-12
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
2-araquinodilglicerol (2-AG) POST
Time frame: month 18-19
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
2-araquinodilglicerol (2-AG) RET
Time frame: month 22-23
2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
N-palmitoylethanolamide (PEA) PRE
Time frame: month 11-12
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
N-palmitoylethanolamide (PEA) POST
Time frame: month 18-19
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
N-palmitoylethanolamide (PEA) RET
Time frame: month 22-23
N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
N-oleylethanolamine (OEA) PRE
Time frame: month 11-12
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.
N-oleylethanolamine (OEA) POST
Time frame: month 18-19
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.
N-oleylethanolamine (OEA) RET
Time frame: month 22-23
N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.
Brain-derived neurotrophic factor PRE
Time frame: month 11-12
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured before the intervention program.
Brain-derived neurotrophic factor POST
Time frame: month 18-19
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured immediately after the intervention program.
Brain-derived neurotrophic factor RET
Time frame: month 22-23
It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured 4 weeks after the intervention program.
36 secondary outcomes
Ryff's Psychological Well-Being Scale (42-item) PRE
Time frame: month 11-12
Ryff's Psychological Well-Being Scale (42-item) POST
Time frame: month 18-19
Ryff's Psychological Well-Being Scale (42-item) RET
Time frame: month 22-23
The SF-36 Health Questionnaire PRE
Time frame: month 11-12
The SF-36 Health Questionnaire POST
Time frame: month 18-19
The SF-36 Health Questionnaire RET
Time frame: month 22-23
Blood pressure PRE
Time frame: month 11-12
Blood pressure POST
Time frame: month 18-19
Blood pressure RET
Time frame: month 22-23
Heart rate PRE
Time frame: month 11-12
Heart rate POST
Time frame: month 18-19
Heart rate RET
Time frame: month 22-23
Weight PRE
Time frame: month 11-12
Weight POST
Time frame: month 18-19
Weight RET
Time frame: month 22-23
Height PRE
Time frame: month 11-12
Height POST
Time frame: month 18-19
Height RET
Time frame: month 22-23
Waist circumference PRE
Time frame: month 11-12
Waist circumference POST
Time frame: month 18-19
Waist circumference RET
Time frame: month 22-23
Fat mass PRE
Time frame: month 11-12
Fat mass POST
Time frame: month 18-19
Fat mass RET
Time frame: month 22-23
Sociodemographic characteristics questionnaire PRE
Time frame: month 11-12
Sociodemographic characteristics questionnaire POST
Time frame: month 18-19
Sociodemographic characteristics questionnaire RET
Time frame: month 22-23
Food Frequency Questionnaire (FFQ) PRE
Time frame: month 11-12
Food Frequency Questionnaire (FFQ) POST
Time frame: month 18-19
Food Frequency Questionnaire (FFQ) RET
Time frame: month 22-23
Sleep time PRE
Time frame: month 11-12
Sleep time POST
Time frame: month 18-19
Sleep time RET
Time frame: month 22-23
The Pittsburg Sleep Quality Index PRE
Time frame: month 11-12
The Pittsburg Sleep Quality Index POST
Time frame: month 18-19
The Pittsburg Sleep Quality Index RET
Time frame: month 22-23
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 9636945Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8. doi: 10.1159/000066239.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- BackgroundSpielberger CD, Gorsuch RL, L. R. State-trait anxiety inventory. Palo Alto Consult. Psychol. Press 1-23 (1970)
- BackgroundRyff, C. D. Happiness is everything, or is it? Explorations on the meaning of psychological well-being. J. Pers. Soc. Psychol. 57, 1069-1081 (1989)
- Background: PubMed 17296089Diaz D, Rodriguez-Carvajal R, Blanco A, Moreno-Jimenez B, Gallardo I, Valle C, van Dierendonck D. [Spanish adaptation of the Psychological Well-Being Scales (PWBS)]. Psicothema. 2006 Aug;18(3):572-7. Spanish.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 15860162Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish.
- Background: PubMed 15138459Pietrobelli A, Rubiano F, St-Onge MP, Heymsfield SB. New bioimpedance analysis system: improved phenotyping with whole-body analysis. Eur J Clin Nutr. 2004 Nov;58(11):1479-84. doi: 10.1038/sj.ejcn.1601993.
- Background: PubMed 15856067Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. doi: 10.1038/nn1457.
- Background: PubMed 11893401Kroes R, Muller D, Lambe J, Lowik MR, van Klaveren J, Kleiner J, Massey R, Mayer S, Urieta I, Verger P, Visconti A. Assessment of intake from the diet. Food Chem Toxicol. 2002 Feb-Mar;40(2-3):327-85. doi: 10.1016/s0278-6915(01)00113-2.
- Background: PubMed 15162136Martinez-Gonzalez MA, Fernandez-Jarne E, Serrano-Martinez M, Wright M, Gomez-Gracia E. Development of a short dietary intake questionnaire for the quantitative estimation of adherence to a cardioprotective Mediterranean diet. Eur J Clin Nutr. 2004 Nov;58(11):1550-2. doi: 10.1038/sj.ejcn.1602004.
- Background: PubMed 22411394Gonzalez Carrascosa R, Bayo Monto JL, Meneu Barreira T, Garcia Segovia P, Martinez-Monzo J. Design of a self-administered online food frequency questionnaire (FFQ) to assess dietary intake among university population. Nutr Hosp. 2011 Nov-Dec;26(6):1440-6. doi: 10.1590/S0212-16112011000600035.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and psychological intervention in people with Exercise and Physical Fitness, run by University of Cadiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression PRE (time frame: month 11-12). The study lists 54 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05849792, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.