ObesityCFNCT05420116
"Program "Cerdanya on Fitness" to Improve the Lifestyle of People With Obesity in Cerdanya (CF).
A study testing Cerdanya on Fitness in people with Obesity, run by University of Barcelona at 1 site in Spain.
Trial summary
To evaluate the effectiveness of an intervention program called "Cerdanya on fitness" based on the prescription of physical activity, healthy nutritional habits and the promotion of positive mental health, adapted to people with obesity to improve their lifestyle and psychoemotional wellbeing Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Cerdanya on Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2020to 10 Jan 2021
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years
- Body Mass Index 30-40
Who cannot join
- Serious cognitive impairment
- Serious mental disorder
- Impossibility of performing physical activity for medical diagnosis (IAM < 3 months, hemorrhagic stroke < 3 months, major surgery < 3 months)
- Severe mobility difficulties (people with use of devices such as cane, walker, wheelchair..)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the " Cerdanya on Fitness" Program to Promote the Physical Exercise, Healthy Nutritional Habits and Psycho-emotional Well-being of Obese People in Cerdanya. Pilot Study of the "Cerdanya on Fitness" Program to Promote Physical Exercise, Healthy Nutritional Habits and Psychoemotional Well-being of People With Obesity in Cerdanya.
To evaluate the effectiveness of an intervention program called "Cerdanya on fitness" based on the prescription of physical activity, healthy nutritional habits and the promotion of positive mental health, adapted to people with obesity to improve their lifestyle and psychoemotional wellbeing
Read the detailed description
Previous phase:Presentation of the protocol to doctors and nurses of the primary health care center.
Phase 1: After being informed about the study and the possible risks, all patients who give their written informed consent will undergo.
-1) 4 weeks of screening to determine eligibility to enter the study. Referral of patients who meet the inclusion/exclusion criteria to enter the Cerdanya on fitness program by the nursing consultation.
Phase I protocol data collection (physical activity scale, positive mental health scale, Mediterranean diet scale, sociodemographic variables will also be collected week 0) Patients who meet the eligibility requirements will be randomized in a non-blinded fashion. (control group and research group) (5 weeks)
weeks 1-2: Initial assessment of physical fitness and dietary habits in the intervention group (blood test- stress test- anthropometry)
week 3-39: Implementation of the intervention (nutritional, physical activity and psychosocial) to the intervention group. The control group will continue with the usual nursing controls in the primary care center.
40-41 week: Final evaluation of the physical condition and eating habits of the intervention group (blood test, stress test, anthropometry): Final data collection of the control and intervention group (physical activity scale, positive mental health scale, Mediterranean diet scale).
Translated with www.DeepL.com/Translator (free version)
- Conditions
- Obesity
- Being tested
- Cerdanya on Fitness
- Keywords
- physical activity,, healthy lifestyle, Mental Health
- Medical subject headings
- Obesity, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerdanya on FitnessBehavioural
The intervention lasts 9 months. The participants will carry out group activities and will be followed individually by the different interdisciplinary professionals. Goals will be set for each visit. Before and after the training there will be an assessment of physical exercise, nutritional and positive mental health habits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Physical Activity: Prescription in physical activity include to perform 1 session a week of exercice led by a sports professional, and 2 sessions of authonomus exercice at 60-80% of participants maximum heart rate.
Nutritional: Visits and checks every 2 months with a nutritionist with the aim of improving healthy eating habits.
Positive Mental Health: There are 4 group psycho-emotional sessions based on improving self-esteem, self-control, proactive social attitude and conflict resolution Receives: Behavioral: Cerdanya on Fitness |
| Control group | No intervention | Participants follow the habitual controls in nursing consultation. Recomendations of physical activity and diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of frecuency and intensity of pysical activity
CLASS AF is a rapid classification scale for physical activity. It is measured based on physical activity at work and physical activity in leisure time, taking into account minutes and frequency. From the formula: 2 x L + Ll x frq 2, the person is classified as sedentary, minimally active, mildly active, moderately active or very active.
Measured: 9 months
Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.
The scale of adherence to the Mediterranean diet, is a scale based on 14 items where you ask about 7 groups of foods and portions characteristic of this diet. each item must score with a 1 or 0 depending on the fulfilled or not. The sum of the points if it is less than 9 indicates a bad grip if it is equal to or greater than 9 , a good grip
Measured: 9 months
Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale
The SMP multifactorial scale consists of 39 items that are distributed among 6 factors: Personal Satisfaction, Prosocial Attitude, Self-Control, Autonomy, Problem Solving and Self-Update, and Interpersonal Relationship Skills. The evaluation of each item is done with a scale scale ranging from 1 to 4. Being 1, always or almost always, 2, quite often, 3 often and 4, never or almost never. Finally, a score between 39 and 156 is obtained, the higher the score the more positive mental health.
Measured: 9 months
Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2
Weigh will be mesured with a analogic weighing machine in Kilograms. Participants are mesured only with underwear clouths. Height will be mesured in m^2.
Measured: 2 months
Change from baseline of watter percentage with a bioimpedance scale
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
Measured: 2 months
Change from baseline of fat mass percentage with a bioimpedance scale
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
Measured: 2 months
Change from baseline of fat free mass percentage with a bioimpedance scale
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
Measured: 2 months
change in the baseline of the caryovascular risk index with the waist-hip measurement
The waist-hip ratio (IC-C) is a specific anthropometric measurement to measure the levels of intra-abdominal fat, it relates the perimeter of the waist to that of the hip (in centimeters) and depending on the result it is estimated if there is a certain cardiovascular risk.
The WHO establishes normal levels of 0.8 in women and 1 in men; higher values would indicate
Measured: 9 months
Change from baseline of fat percentage and fat Kg on anthropometric measurements
The specific anthropometric measurements for people with obesity according to ISAK are 3 skin folds mesured in mm 3 diameters and 2 perimeters (.Waist circumference 1: at rib height, waist circumference 2: 2 cm above the navel.
The percentage of fat is determined from specific formula. (F Weltman) Mesured in kg and percentage
Measured: 9 months
Change from baseline of muscle percentage and muscle kg on anthropometric measurements
The specific anthropometric measurements for people with obesity according to ISAK are 3 perimeters (triceps muscles, calf muscles, quadriceps muscles) . The percentage of muscle is determined from specific formulas.( F Lee) mesured in kg and percentage
Measured: 9 months
Change from baseline of bone percentage on anthropometric measurements
The specific anthropometric measurements for people with obesity according to ISAK are 3 diameters. The percentage of bone is determined from specific formulas.(F Rocha) Mesured in kg and percentage
Measured: 9 months
Change from baseline of glucose and cholesterol on blood test
Test levels of HDL, LDL, Triglicerids, Cholesterol Total. Mesured in mg/dL
Measured: 9 months
Change from baseline of glucose and cholesterol on blood test
Test levels of glucose. Mesured in mg/dL
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start10 Jan 2020
- Primary completion1 Sep 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model pre-post test in intervention group and pre-post usual follow up in control group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Cerdanya, Spain
- Responsible party
- Principal investigator, Marta Prats Arimon, University of Barcelona
- Investigators
- Marta Prats-Arimon, PHD, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420116
- Sponsor's protocol ID
- 2038
- Acronym
- CF
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD when the periode of collecting data is finished.
Publications
Prats-Arimon M, Puig-Llobet M, Barcelo-Peiro O, Ribot-Domenech I, Vilalta-Sererols C, Fontecha-Valero B, Heras-Ojeda M, Aguera Z, Lluch-Canut T, Moreno-Poyato A, Moreno-Arroyo MC. An Interdisciplinary Intervention Based on Prescription of Physical Activity, Diet, and Positive Mental Health to Promote Healthy Lifestyle in Patients with Obesity: A Randomized Control Trial. Nutrients. 2024 Aug 20;16(16):2776. doi: 10.3390/nu16162776.
PubMed 39203911
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the " Cerdanya on Fitness" Program to Promote the Physical Exercise, Healthy Nutritional Habits and Psycho-emotional Well-being of Obese People in Cerdanya. Pilot Study of the "Cerdanya on Fitness" Program to Promote Physical Exercise, Healthy Nutritional Habits and Psychoemotional Well-being of People With Obesity in Cerdanya.
- ClinicalTrials.gov ID
- NCT05420116
- Acronym / sponsor ID
- CF / 2038
- Conditions
- Obesity
- Keywords
- physical activity,, healthy lifestyle, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital of Cerdanya, Spain
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 15 Jun 2022 (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.
To evaluate the effectiveness of an intervention program called "Cerdanya on fitness" based on the prescription of physical activity, healthy nutritional habits and the promotion of positive mental health, adapted to people with obesity to improve their lifestyle and psychoemotional wellbeing
Detailed description
Previous phase:Presentation of the protocol to doctors and nurses of the primary health care center.
Phase 1: After being informed about the study and the possible risks, all patients who give their written informed consent will undergo.
-1) 4 weeks of screening to determine eligibility to enter the study. Referral of patients who meet the inclusion/exclusion criteria to enter the Cerdanya on fitness program by the nursing consultation.
Phase I protocol data collection (physical activity scale, positive mental health scale, Mediterranean diet scale, sociodemographic variables will also be collected week 0) Patients who meet the eligibility requirements will be randomized in a non-blinded fashion. (control group and research group) (5 weeks)
weeks 1-2: Initial assessment of physical fitness and dietary habits in the intervention group (blood test- stress test- anthropometry)
week 3-39: Implementation of the intervention (nutritional, physical activity and psychosocial) to the intervention group. The control group will continue with the usual nursing controls in the primary care center.
40-41 week: Final evaluation of the physical condition and eating habits of the intervention group (blood test, stress test, anthropometry): Final data collection of the control and intervention group (physical activity scale, positive mental health scale, Mediterranean diet scale).
Translated with www.DeepL.com/Translator (free version)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model pre-post test in intervention group and pre-post usual follow up in control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cerdanya on FitnessPhysical Activity: Prescription in physical activity include to perform 1 session a week of exercice led by a sports professional, and 2 sessions of authonomus exercice at 60-80% of participants maximum heart rate. Nutritional: Visits and checks every 2 months with a nutritionist with the aim of improving healthy eating habits. Positive Mental Health: There are 4 group psycho-emotional sessions based on improving self-esteem, self-control, proactive social attitude and conflict resolution |
| Control group | No intervention | –Participants follow the habitual controls in nursing consultation. Recomendations of physical activity and diet. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years
- Body Mass Index 30-40
Key exclusion criteria (4 listed)
- Serious cognitive impairment
- Serious mental disorder
- Impossibility of performing physical activity for medical diagnosis (IAM < 3 months, hemorrhagic stroke < 3 months, major surgery < 3 months)
- Severe mobility difficulties (people with use of devices such as cane, walker, wheelchair..)
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 |
|---|---|---|
| Cerdanya on FitnessThe intervention lasts 9 months. The participants will carry out group activities and will be followed individually by the different interdisciplinary professionals. Goals will be set for each visit. Before and after the training there will be an assessment of physical exercise, nutritional and positive mental health habits. | Behavioural | Intervention group |
Primary outcome
Change from baseline of frecuency and intensity of pysical activity
Time frame: 9 months
CLASS AF is a rapid classification scale for physical activity. It is measured based on physical activity at work and physical activity in leisure time, taking into account minutes and frequency. From the formula: 2 x L + Ll x frq 2, the person is classified as sedentary, minimally active, mildly active, moderately active or very active.
Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.
Time frame: 9 months
The scale of adherence to the Mediterranean diet, is a scale based on 14 items where you ask about 7 groups of foods and portions characteristic of this diet. each item must score with a 1 or 0 depending on the fulfilled or not. The sum of the points if it is less than 9 indicates a bad grip if it is equal to or greater than 9 , a good grip
Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale
Time frame: 9 months
The SMP multifactorial scale consists of 39 items that are distributed among 6 factors: Personal Satisfaction, Prosocial Attitude, Self-Control, Autonomy, Problem Solving and Self-Update, and Interpersonal Relationship Skills. The evaluation of each item is done with a scale scale ranging from 1 to 4. Being 1, always or almost always, 2, quite often, 3 often and 4, never or almost never. Finally, a score between 39 and 156 is obtained, the higher the score the more positive mental health.
Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2
Time frame: 2 months
Weigh will be mesured with a analogic weighing machine in Kilograms. Participants are mesured only with underwear clouths. Height will be mesured in m^2.
Change from baseline of watter percentage with a bioimpedance scale
Time frame: 2 months
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
Change from baseline of fat mass percentage with a bioimpedance scale
Time frame: 2 months
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
Change from baseline of fat free mass percentage with a bioimpedance scale
Time frame: 2 months
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
change in the baseline of the caryovascular risk index with the waist-hip measurement
Time frame: 9 months
The waist-hip ratio (IC-C) is a specific anthropometric measurement to measure the levels of intra-abdominal fat, it relates the perimeter of the waist to that of the hip (in centimeters) and depending on the result it is estimated if there is a certain cardiovascular risk. The WHO establishes normal levels of 0.8 in women and 1 in men; higher values would indicate
Change from baseline of fat percentage and fat Kg on anthropometric measurements
Time frame: 9 months
The specific anthropometric measurements for people with obesity according to ISAK are 3 skin folds mesured in mm 3 diameters and 2 perimeters (.Waist circumference 1: at rib height, waist circumference 2: 2 cm above the navel. The percentage of fat is determined from specific formula. (F Weltman) Mesured in kg and percentage
Change from baseline of muscle percentage and muscle kg on anthropometric measurements
Time frame: 9 months
The specific anthropometric measurements for people with obesity according to ISAK are 3 perimeters (triceps muscles, calf muscles, quadriceps muscles) . The percentage of muscle is determined from specific formulas.( F Lee) mesured in kg and percentage
Change from baseline of bone percentage on anthropometric measurements
Time frame: 9 months
The specific anthropometric measurements for people with obesity according to ISAK are 3 diameters. The percentage of bone is determined from specific formulas.(F Rocha) Mesured in kg and percentage
Change from baseline of glucose and cholesterol on blood test
Time frame: 9 months
Test levels of HDL, LDL, Triglicerids, Cholesterol Total. Mesured in mg/dL
Change from baseline of glucose and cholesterol on blood test
Time frame: 9 months
Test levels of glucose. Mesured in mg/dL
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 15 Jun 2022.
- Background: PubMed 39203911Prats-Arimon M, Puig-Llobet M, Barcelo-Peiro O, Ribot-Domenech I, Vilalta-Sererols C, Fontecha-Valero B, Heras-Ojeda M, Aguera Z, Lluch-Canut T, Moreno-Poyato A, Moreno-Arroyo MC. An Interdisciplinary Intervention Based on Prescription of Physical Activity, Diet, and Positive Mental Health to Promote Healthy Lifestyle in Patients with Obesity: A Randomized Control Trial. Nutrients. 2024 Aug 20;16(16):2776. doi: 10.3390/nu16162776.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD when the periode of collecting data is finished.
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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.
Marta Prats-Arimon, PHD principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerdanya on Fitness in people with Obesity, run by University of Barcelona 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 2 inclusion and 4 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 15 Jun 2022. 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?
Change from baseline of frecuency and intensity of pysical activity (time frame: 9 months). The study lists 13 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 NCT05420116, which also lists 1 linked publication.
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 15 Jun 2022.