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

NCT03504059 | Active Not Recruiting

• 1 other identifier: 369/C/2016
• Study Type: interventional
• Target: 1,326
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Obesity; Cardiovascular Health; Diabetes Mellitus

Keywords

Obesity; Cardiovascular Health; Diabetes; Adolescents; Physical Activity; Diet; School-Based

Outcome Measures

Primary Outcomes (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: 5. Normal blood pressure 6. Normal cholesterol level 7. 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.

  2 and 4 years

Secondary Outcomes (21)

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

  2 and 4 years

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

  2 and 4 years

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

  2 and 4 years

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

  2 and 4 years

• Changes in dietary habits from baseline to year 2 and 4

  2 and 4 years

Study Arms (3)

Control

NO INTERVENTION

The usual educational program is applied

Short Intervention

ACTIVE COMPARATOR

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.

Behavioral: Short-term educational program

Long Intervention

ACTIVE COMPARATOR

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.

Behavioral: Long-term educational program

Interventions

Long-term educational program BEHAVIORAL

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

Short-term educational program BEHAVIORAL

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 Intervention

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• University of Barcelona: lead
• SHE Foundation: collaborator
• Centro Nacional de Investigaciones Cardiovasculares Carlos III: collaborator
• Fundació La Marató de TV3: collaborator
• Obra social La Caixa: collaborator

Study Sites (3)

School of Pharmacy. University of Barcelona.

Barcelona, Barcelona, 08028, Spain

Location

Fundación SHE

Barcelona, Barcelona, 08037, Spain

Location

Centro Nacional de Investigaciones Cardiovasculares Carlos III

Madrid, Madrid, 28029, Spain

Location

Related Publications (6)

• 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.

  PMID: 40055723 DERIVED

• 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.

  PMID: 38964203 DERIVED

• 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.

  PMID: 37568128 DERIVED

• 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.

  PMID: 37531100 DERIVED

• 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.

  PMID: 34555181 DERIVED

• 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.

  PMID: 31277052 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Rosa M Lamuela-Raventós, PhD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

• Gloria Santos-Beneit, PhD

  SHE Foundation

  PRINCIPAL INVESTIGATOR

• Juan M Fernández Alvira, PhD

  Centro Nacional de Investigaciones Cardiovasculares Carlos III

  PRINCIPAL INVESTIGATOR

• Valentín Fuster, PhD, MD

  Centro Nacional de Investigaciones Cardiovasculares Carlos III

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: April 20, 2018
• Study Start: June 1, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-05

Locations

ES (3)