Mediterranean DietNCT05620303
24-h Movement Behaviors and Adherence to the Mediterranean Diet in Children
A study testing Exercise in people with Mediterranean Diet and Physical Activity, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The purpose of this study is to determine the effects of the Archena Infancia Saludable project on adherence to MD and 24-h movement behaviors in schoolchildren Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediterranean Diet, Physical Activity, Sedentary Time
- What is being tested?
- Exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2022to 30 Sep 2023
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schoolchildren aged 6-13 years will be eligible
Who cannot join
- Participants with any pathology that contraindicate exercise or that request special attention.
- Participants under pharmacological treatment that prevent them from receiving the contents of the activities of the program.
- Participants or parents/legal guardians presenting Spanish learning difficulties.
- Participants do not authorized by the parents/guardians to be included in the research project.
- Participants do not agree to take part in the research project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Healthy Lifestyle-based Randomized Controlled Trial on 24-h Movement Behaviors and Adherence to the Mediterranean Diet in Schoolchildren - The Archena Infancia Saludable Project: A Protocol Study
The purpose of this study is to determine the effects of the Archena Infancia Saludable project on adherence to MD and 24-h movement behaviors in schoolchildren
- Conditions
- Mediterranean Diet, Physical Activity, Sedentary Time, Sleep
- Being tested
- Exercise
- Keywords
- Physical activity, Sedentary behavior, Screen time, Sleep duration, Movement guidelines
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Parents/guardians will receive three different contents weekly (i.e., infographics, video recipes, information pills, or videos) each week related to 24-h movement behaviors (i.e., PA, sedentary behavior, sleep duration) or Mediterranean Diet for 36 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Other: Exercise |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Mediterranean diet
To assess the adherence to the Mediterranean Diet, the Mediterranean Diet Quality Index for Children and Teenagers (KIDMED) index will be used.
Measured: From baseline to 36 weeks later
24-h movement behaviors (accelerometers) sedentary time
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sedentary time over seven consecutive days.
Measured: From baseline to 36 weeks later
24-h movement behaviors (self-reported)
Self-report of physical activity levels and sedentary behaviors in youth will assessed by the Youth Activity Profile - Spain. In this questionnaire, a rating scale is used with a score from 1 to 5 in which, in the first two sections, "1" indicates low intensity and frequency of physical activity and "5" indicates high intensity and frequency of physical activity; while, in the third section, "1" indicates a low amount of sedentary behaviors and "5" an excess of them.
Measured: From baseline to 36 weeks later
24-h movement behaviors (accelerometers) physical activity
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess physical activity over seven consecutive days.
Measured: From baseline to 36 weeks later
24-h movement behaviors (accelerometers) sleep duration
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sleep duration over seven consecutive days.
Measured: From baseline to 36 weeks later.
Secondary outcomes (8)
Anthropometrics measurements
The body weight of the schoolchildren will be measured using an electronic scale (with an accuracy of 0.1 kg) (Tanita BC-545, Tokyo, Japan), while height will be determined by a portable height rod with an accuracy of 0.1 cm (Leicester Tanita HR 001, Tokyo, Japan). Body mass index (BMI) will be calculated by dividing body weight (in kg) by the height (in squared meters). Furthermore, BMI z-score will be computed by the WHO age-specific and sex-specific thresholds.
Measured: From baseline to 36 weeks later
Active transportation
Active transportation to and from school is evaluated by a self-reported questionnaire (Mode and Frequency of Commuting To and From School Questionnaire). Participants were categorized as "active" if reported: ≥2 active travel days out of 5 school days (questions #1 and #2) and ≥ 4 active travel trips out of 10 school trips per week (question #3). The usual mode of commuting to/from school was categorized as active when participants reported ≥ 1 active travel per day out of 2 daily school trips (question #4). Those who were not categorized as "active commuting" were categorized as "passive commuting" users.
Measured: From baseline to 36 weeks later
Resting blood pressure
Resting blood pressure will be measured using an automated blood pressure monitor with a fittingly sized cuff (Omrom® EVOLV HEM-7600T-E, Health-care Co, Kyoto, Japan). First, schoolchildren will be seated in a quiet room for 10 min with their feet on the ground and their back supported. Two readings will be taken, with the second blood pressure reading taken five min after the first. The average of the two measurements for systolic blood pressure and diastolic blood pressure will be retained. Subsequently, mean arterial pressure will be computed by the following formula: diastolic blood pressure + [0.333 × (systolic blood pressure - diastolic blood pressure)].
Measured: From baseline to 36 weeks later
Sleep disorders
Sleep disorders will be evaluated by the BEARS (B = Bedtime Issues, E = Excessive Daytime Sleepiness, A = Night Awakenings, R = Regularity and Duration of Sleep, S = Snoring) scale. Any questions that are answered positively indicate a sleep problem.
Measured: From baseline to 36 weeks later
Health-related quality of life
Health-related quality of life will be measured by Child Health Utility 9D (CHU9D). The CHU9D consists of 9 dimensions: worried, sad, pain, tired, annoyed, schoolwork/homework, sleep, daily routine, ability to join in activities with five different levels representing increasing levels of severity within each dimension. Furthermore, CHU9D scores will be used in cost-utility analyses.
Measured: From baseline to 36 weeks later
Self-reported physical fitness
Self-reported physical fitness will be assessed by the International Fitness Scale (IFIS), which is composed of a 5-point Likert-scale items asking about the children' perceived global physical fitness, cardiorespiratory fitness, muscular fitness, speed-agility, and flexibility in comparison with their counterparts' physical fitness (very poor (1), poor (2), average (3), good (4), and very good (5)).
Measured: From baseline to 36 weeks later
Parents'/guardians' perception of their children's body mass index status
This outcome will be evaluated with the following question: "In relation to his/her height, which of the following options best describes your child's weight: 1) substantially above normal, 2) slightly above normal, 3) normal, 4) below normal?".
Measured: From baseline to 36 weeks later
Academic performance
Academic records will be provided at the end of the academic year by the school. Firstly, academic performance will be evaluated according to the grade obtained in Language, Mathematics, Language and Mathematics (combined), English, as well as the grade point average of these three subjects. Secondly, academic performance will be assessed by computing the grade point average of all the subjects taken by the children.
Measured: From baseline to 36 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start2 Dec 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediterranean DietStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620303
- Sponsor's protocol ID
- UCLMCFE00085
- Status last verified
- Mar 2023
- First submitted
- 9 Nov 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Healthy Lifestyle-based Randomized Controlled Trial on 24-h Movement Behaviors and Adherence to the Mediterranean Diet in Schoolchildren - The Archena Infancia Saludable Project: A Protocol Study
- ClinicalTrials.gov ID
- NCT05620303
- Acronym / sponsor ID
- UCLMCFE00085
- Conditions
- Mediterranean Diet, Physical Activity, Sedentary Time, Sleep
- Keywords
- Physical activity, Sedentary behavior, Screen time, Sleep duration, Movement guidelines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 17 Nov 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.
The purpose of this study is to determine the effects of the Archena Infancia Saludable project on adherence to MD and 24-h movement behaviors in schoolchildren
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise |
| Control group | No intervention | – |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Schoolchildren aged 6-13 years will be eligible
Key exclusion criteria (5 listed)
- Participants with any pathology that contraindicate exercise or that request special attention.
- Participants under pharmacological treatment that prevent them from receiving the contents of the activities of the program.
- Participants or parents/legal guardians presenting Spanish learning difficulties.
- Participants do not authorized by the parents/guardians to be included in the research project.
- Participants do not agree to take part in the research project.
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 |
|---|---|---|
| ExerciseParents/guardians will receive three different contents weekly (i.e., infographics, video recipes, information pills, or videos) each week related to 24-h movement behaviors (i.e., PA, sedentary behavior, sleep duration) or Mediterranean Diet for 36 weeks. | Other | Exercise group |
Primary outcome
Adherence to the Mediterranean diet
Time frame: From baseline to 36 weeks later
To assess the adherence to the Mediterranean Diet, the Mediterranean Diet Quality Index for Children and Teenagers (KIDMED) index will be used.
24-h movement behaviors (accelerometers) sedentary time
Time frame: From baseline to 36 weeks later
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sedentary time over seven consecutive days.
24-h movement behaviors (self-reported)
Time frame: From baseline to 36 weeks later
Self-report of physical activity levels and sedentary behaviors in youth will assessed by the Youth Activity Profile - Spain. In this questionnaire, a rating scale is used with a score from 1 to 5 in which, in the first two sections, "1" indicates low intensity and frequency of physical activity and "5" indicates high intensity and frequency of physical activity; while, in the third section, "1" indicates a low amount of sedentary behaviors and "5" an excess of them.
24-h movement behaviors (accelerometers) physical activity
Time frame: From baseline to 36 weeks later
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess physical activity over seven consecutive days.
24-h movement behaviors (accelerometers) sleep duration
Time frame: From baseline to 36 weeks later.
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sleep duration over seven consecutive days.
8 secondary outcomes
Anthropometrics measurements
Time frame: From baseline to 36 weeks later
Active transportation
Time frame: From baseline to 36 weeks later
Resting blood pressure
Time frame: From baseline to 36 weeks later
Sleep disorders
Time frame: From baseline to 36 weeks later
Health-related quality of life
Time frame: From baseline to 36 weeks later
Self-reported physical fitness
Time frame: From baseline to 36 weeks later
Parents'/guardians' perception of their children's body mass index status
Time frame: From baseline to 36 weeks later
Academic performance
Time frame: From baseline to 36 weeks later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Related trials for Mediterranean Diet
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Systemic Lupus Erthematosus (SLE)
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
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 in people with Mediterranean Diet and Physical Activity, run by University of Castilla-La Mancha 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Mar 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?
Results are not available in the source record.
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?
Adherence to the Mediterranean diet (time frame: From baseline to 36 weeks later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2023.