School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents
NCT ID: NCT03504059
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1326 participants
INTERVENTIONAL
2017-06-01
2025-06-30
Brief Summary
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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.
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
The usual educational program is applied
No interventions assigned to this group
Short Intervention
A 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.
Short-term educational program
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.
Long Intervention
A 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.
Long-term educational program
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.
Interventions
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Long-term educational program
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 program
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.
Eligibility Criteria
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Inclusion Criteria
11 Years
16 Years
ALL
Yes
Sponsors
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SHE Foundation
OTHER
Centro Nacional de Investigaciones Cardiovasculares Carlos III
UNKNOWN
Fundació La Marató de TV3
OTHER
Obra social La Caixa
UNKNOWN
University of Barcelona
OTHER
Responsible Party
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Rosa M Lamuela-Raventós
Associate Professor
Principal Investigators
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Rosa M Lamuela-Raventós, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Barcelona
Gloria Santos-Beneit, PhD
Role: PRINCIPAL_INVESTIGATOR
SHE Foundation
Juan M Fernández Alvira, PhD
Role: PRINCIPAL_INVESTIGATOR
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Valentín Fuster, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Locations
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School of Pharmacy. University of Barcelona.
Barcelona, Barcelona, Spain
Fundación SHE
Barcelona, Barcelona, Spain
Centro Nacional de Investigaciones Cardiovasculares Carlos III
Madrid, Madrid, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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369/C/2016
Identifier Type: -
Identifier Source: org_study_id