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ObesityNCT03504059

School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents

A study testing Long-term educational program and Short-term educational program in people with Obesity and Cardiovascular Health, run by University of Barcelona at 3 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background and objective: There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue threatens to have a highly negative health and socioeconomic impact in the near future. Read more about this study

Who is it for?
Ages 11 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Cardiovascular Health, Diabetes Mellitus
What is being tested?
Long-term educational program and Short-term educational program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,326 participants
Where
3 sitesSpain
Study dates
1 Jun 2017to 30 Jun 2025
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 11 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • • Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.

Who cannot join

  • No exclusion criteria.

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • School of Pharmacy. University of Barcelona.

    Barcelona, Barcelona, 08028

  • Fundación SHE

    Barcelona, Barcelona, 08037

  • Centro Nacional de Investigaciones Cardiovasculares Carlos III

    Madrid, Madrid, 28029

Other trials in Spain

About this study

Official title: School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial

Background and objective:

There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue threatens to have a highly negative health and socioeconomic impact in the near future. The only way to tackle this epidemic is to implement effective preventive strategies able to positively impact on youth lifestyle behaviours. The school is the most appropriate environment for such an intervention. The main objective of this study is to evaluate the efficacy of a comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles. The project consortium constitutes a unique framework of research groups at the forefront of novel and successful approaches aiming to healthier behaviours and dietary habits.

Read more

Methodology:

A cluster-randomized controlled trial involving 24 secondary schools in Spain will be carried out. Schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term (4-year) comprehensive educational program, or to receive the usual curriculum (control). Participants will be evaluated at baseline, and after 2 and 4 years with the following: weight scale, circumference measuring tape, bioelectrical impedance, dual energy X-ray absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers, and questionnaires. The primary outcome is the change in obesity and other health parameters from baseline to year 2 and 4, as assessed by the Ideal Cardiovascular Health score. Secondary outcomes include the change in adiposity, anthropometry and body composition parameters, physical activity and dietary habits, polyphenol and carotenoid intake, metabolomics and attitudes. Participants will be measured again when they reach 20 years old.

Expected results:

The investigators expects to show that a school-based educational intervention induces favorable lifestyle changes and improves cardiovascular health among Spanish adolescents, including obesity/adiposity and metabolic profiles. If successful, this strategy could be widely adopted having a meaningful effect on obesity and cardiovascular health promotion. Additionally, associations between health parameters and bioactive dietary compounds intake and metabolic profiles will be stablished.

Being tested
Long-term educational program, Short-term educational program
Keywords
Obesity, Cardiovascular Health, Diabetes, Adolescents, Physical Activity, Diet, School-Based
Medical subject headings
Obesity, Diabetes Mellitus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Long-term educational programBehavioural

    Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.

  • Short-term educational programBehavioural

    Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.

Study groups in NCT03504059
Study groupRoleWhat they receive
ControlNo interventionThe usual educational program is applied
Short InterventionActive comparatorA two-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.
Receives: Behavioral: Short-term educational program
Long InterventionActive comparatorA four-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.
Receives: Behavioral: Long-term educational program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the composite ICH score of adolescents from baseline to year 2 and 4

    The ICH score measures cardiovascular health and includes 7 components:

    • Behaviors factors:
    1. No smoking
    2. Being physically active
    3. Good nutritional habits
    4. Normal weight
    • Health factors:
    1. Normal blood pressure
    2. Normal cholesterol level
    3. Normal glucose levels To meet the complete definition of ideal cardiovascular health, an individual would need to meet the ideal levels of all 7 components.

    Measured: 2 and 4 years

Secondary outcomes (21)

  1. Changes in body mass index from baseline to year 2 and 4

    Change in body mass index (kg/m^2), calculated after measure weight (kg) and height (meter).

    Measured: 2 and 4 years

  2. Changes in waist circumference from baseline to year 2 and 4

    Change in waist circumference (cm) measured in triplicate

    Measured: 2 and 4 years

  3. Changes in percentage of body fat from baseline to year 2 and 4

    Change in total adiposity measured by bioelectrical impedance (percentage of fat).

    Measured: 2 and 4 years

  4. Changes in distribution of body fat from baseline to year 2 and 4

    Change in adiposity distribution measured by dual energy X-ray absorptiometry, that calculate total body fat, regional fat, including android, gynoid, visceral and lean mass.

    Measured: 2 and 4 years

  5. Changes in dietary habits from baseline to year 2 and 4

    To evaluate the association between food and nutrient intake and changes in adiposity parameters. To assess changes in diet and adherence to the Mediterranean diet a validated Food Frequency Questionnaire (FFQ) (Tresserra-Rimbau et al., 2013) will be used. A shorter FFQ (Children's Eating Habits Questionnaire - Food Frequency Questionnaire (CEHQ-FFQ) (Lanfer et al., 2011; Bel-Serrat et al. 2014)) will also be used to analyze dietary patterns.

    Measured: 2 and 4 years

  6. Changes in attitudes about eating from baseline to year 2 and 4 [ Time Frame: 2 and 4 years

    To evaluate the relationship between changes in attitudes and changes in adiposity parameters. A validated questionnaire will be used to assess attitudes about eating (Lima-Serrano et al., 2012).

    Measured: 2 and 4 years

  7. Changes in polyphenol consumption from baseline to year 2 and 4

    Dietary polyphenol (PP) intake will be estimated from FFQ and data from the PP content in foods, obtained from the Phenol-explorer data base. With this methodology, it can obtain an estimation of total PP intake by each individual and different PP classes. For the determination of phenolics and their metabolites in human urine, will be used solid-phase extraction and ultra-HPLC coupled to mass spectrometry (Martinez-Huelamo et al., 2015).

    Measured: 2 and 4 years

  8. Changes in carotenoids consumption from baseline to year 2 and 4

    Carotenoids and retinol consumption will be also estimated from the longer FFQ. Total energy and micronutrient intake will be obtained using the Food Processor Nutrition and Fitness Software (ESHA Research, Salem, OR).

    Measured: 2 and 4 years

  9. Changes in energy and nutrients consumption from baseline to year 2 and 4

    Total energy and micronutrient intake will be obtained from a validated Food Frequency Questionnaire (Tresserra-Rimbau et al., 2013) using the Food Processor Nutrition and Fitness Software.

    Measured: 2 and 4 years

  10. Changes in metabolomics from baseline to year 2 and 4

    To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine and salivary samples will be collected to perform a metabolomics analysis in order to evaluate metabolic changes due to educational intervention on dietary and physical activity habits. Liquid chromatography coupled to quadrupole time of-flight mass spectrometry (HPLC-q-TOF) will be used for such analysis which is able to measure thousands of metabolites simultaneously from only minimal amounts of sample. Data mining analysis will be performed using XCMS-R package. The preprocessed data obtained by XCMS in negative and positive ionization will be separately exported to SIMCA 13.0.3 software (Umetrics) to perform unsupervised and supervised multivariate analysis to detect metabolic changes among groups.

    Measured: 2 and 4 years

  11. Changes in physical activity from baseline to year 2 and 4

    To study the association between changes in physical activity and changes in adiposity parameters . Actigraph wGT3X-BT accelerometers that allow the registration of the amount and intensity of physical activity will be used during 7 days per evaluation time-point. To complete this information a diary with questions about the type of physical activity performed during the 7 days will be collected. A validated questionnaire will be also used to assess physical activity habits (Barbosa et al., 2007).

    Measured: 2 and 4 years

  12. Changes in sedentary habits from baseline to year 2 and 4

    To study the association between changes in sedentary habits and changes in adiposity parameters. Information on sedentary time from Actigraph wGT3X-BT accelerometers will be taken into account. In addition, we will measure sedentary leisure time spent with the computer/console/TV /mobile (ENSE 2012).

    Measured: 2 and 4 years

  13. Changes in attitudes towards abuse substances from baseline to year 2 and 4

    The attitudes towards abuse substances will be assessed by a validated questionnaire (Lima-Serrano et al., 2013). An additional questionnaire will be used to assess self-efficacy (Markham et al., 2009).

    Measured: 2 and 4 years

  14. Changes in smoking habits from baseline to year 2 and 4

    Validated questionnaires will be used to assess smoking status itself, and in its immediate environment (Moreno et al., 2012 Lana, 2010).

    Measured: 2 and 4 years

  15. Changes in perception of the self-image from baseline to year 2 and 4

    A questionnaire to assess the perception of the self-image will be used to obtain a pattern of individual acceptance with his/her figure (Stunkard et al., 1990).

    Measured: 2 and 4 years

  16. Changes in self-esteem from baseline to year 2 and 4

    Self-esteem will be assessed using validated questionnaire (Rajmil et al., 2003).

    Measured: 2 and 4 years

  17. Changes in emotional eating from baseline to year 2 and 4

    Emotional eating will be assessed using validated questionnaire (Jauregui-Lobera et al., 2014)

    Measured: 2 and 4 years

  18. Changes in mood from baseline to year 2 and 4

    Self-efficacy will be assessed using a validated questionnaire (Vázquez Fernández et al., 2013).

    Measured: 2 and 4 years

  19. Evaluation of the shorter vs. longer educational intervention effectiveness by comparison of 2 and 4 year results on all outcomes

    The effectiveness of a shorter vs. longer educational intervention program (2 and 4 year) will be assessed by comparison of final (4 year) results on all proposed outcomes.

    Measured: 4 years

  20. Cardiovascular score validation

    The BEWAT score, which includes the assessment of Blood pressure, Exercise, Weight, Alimentation (fruit and vegetables) and Tobacco consumption, will be also derived. This simple and non-invasive score (score from 0 to 15 points) will be validated against the ICH score, and will serve for future studies in adolescents.

    Measured: 4 years

  21. Changes in the composite ICH score of adolescents from baseline to adulthood

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study start1 Jun 2017
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2025 (estimated)

Resources

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
Masking
None (open label)
Enrolment
1,326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504059
Sponsor's protocol ID
369/C/2016
Status last verified
May 2024
First submitted
9 Jan 2018
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Martinez-Gomez J, Bodega P, Santos-Beneit G, de Cos-Gandoy A, Beneito-Dura M, de Miguel M, Tresserra-Rimbau A, Ruiz-Leon AM, Estruch R, Lamuela-Raventos RM, Moreno LA, Fernandez-Alvira JM, Fernandez-Jimenez R. Trajectories of adherence to an obesogenic dietary pattern and changes in diet quality, food intake, and adiposity during adolescence. Nutr J. 2025 Mar 7;24(1):35. doi: 10.1186/s12937-025-01102-y.

    PubMed 40055723

  • Arancibia-Riveros C, Dominguez-Lopez I, Laveriano-Santos EP, Parilli-Moser I, Tresserra-Rimbau A, Ruiz-Leon AM, Sacanella E, Casas R, Estruch R, Bodega P, de Miguel M, de Cos-Gandoy A, Martinez-Gomez J, Santos-Beneit G, Fernandez-Alvira JM, Fernandez-Jimenez R, Lamuela-Raventos RM. Unlocking the power of polyphenols: A promising biomarker of improved metabolic health and anti-inflammatory diet in adolescents. Clin Nutr. 2024 Aug;43(8):1865-1871. doi: 10.1016/j.clnu.2024.06.023. Epub 2024 Jun 25.

    PubMed 38964203

  • Bodega P, Santos-Beneit G, de Cos-Gandoy A, Moreno LA, de Miguel M, Orrit X, Tresserra-Rimbau A, Martinez-Gomez J, Ramirez-Garza SL, Laveriano-Santos EP, Arancibia-Riveros C, Estruch R, Lamuela-Raventos RM, Fernandez-Jimenez R, Fernandez-Alvira JM. Clustering of lifestyle behaviors and adiposity in early adolescents in Spain: findings from the SI! Program for Secondary Schools. BMC Public Health. 2023 Aug 12;23(1):1535. doi: 10.1186/s12889-023-16461-6.

    PubMed 37568128

  • Santos-Beneit G, Fernandez-Alvira JM, Tresserra-Rimbau A, Bodega P, de Cos-Gandoy A, de Miguel M, Ramirez-Garza SL, Laveriano-Santos EP, Arancibia-Riveros C, Carral V, Orrit X, Rodriguez C, Carvajal I, Haro D, Peyra C, Martinez-Gomez J, Alvarez-Benavides A, Estruch R, Lamuela-Raventos RM, Fernandez-Jimenez R, Fuster V. School-Based Cardiovascular Health Promotion in Adolescents: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2023 Sep 1;8(9):816-824. doi: 10.1001/jamacardio.2023.2231.

    PubMed 37531100

  • Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.

    PubMed 34555181

  • Fernandez-Jimenez R, Santos-Beneit G, Tresserra-Rimbau A, Bodega P, de Miguel M, de Cos-Gandoy A, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, Ibanez B, Storniolo C, Domenech M, Estruch R, Fernandez-Alvira JM, Lamuela-Raventos RM, Fuster V. Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial. Am Heart J. 2019 Sep;215:27-40. doi: 10.1016/j.ahj.2019.03.014. Epub 2019 Apr 10.

    PubMed 31277052

Questions about this trial

What is this clinical trial studying?

A study testing Long-term educational program and Short-term educational program in people with Obesity and Cardiovascular Health, run by University of Barcelona at 3 sites 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 1 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (time frame: 2 and 4 years). 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 NCT03504059, which also lists 6 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 Dec 2024.

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