School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Barcelona
- Enrollment
- 1326
- Locations
- 3
- Primary Endpoint
- Changes in the composite ICH score of adolescents from baseline to year 2 and 4
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Rosa M Lamuela-Raventós
Associate Professor
University of Barcelona
Eligibility Criteria
Inclusion Criteria
- •• Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.
Exclusion Criteria
- •No exclusion criteria.
Outcomes
Primary Outcomes
Changes in the composite ICH score of adolescents from baseline to year 2 and 4
Time Frame: 2 and 4 years
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.
Secondary Outcomes
- Changes in carotenoids consumption from baseline to year 2 and 4(2 and 4 years)
- Changes in metabolomics from baseline to year 2 and 4(2 and 4 years)
- Changes in attitudes towards abuse substances from baseline to year 2 and 4(2 and 4 years)
- Changes in emotional eating from baseline to year 2 and 4(2 and 4 years)
- Evaluation of the shorter vs. longer educational intervention effectiveness by comparison of 2 and 4 year results on all outcomes(4 years)
- Changes in body mass index 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 attitudes about eating from baseline to year 2 and 4 [ Time Frame: 2 and 4 years(2 and 4 years)
- Changes in waist circumference 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)
- Changes in polyphenol consumption from baseline to year 2 and 4(2 and 4 years)
- Changes in perception of the self-image from baseline to year 2 and 4(2 and 4 years)
- Changes in sedentary habits from baseline to year 2 and 4(2 and 4 years)
- Changes in energy and nutrients consumption from baseline to year 2 and 4(2 and 4 years)
- Changes in physical activity from baseline to year 2 and 4(2 and 4 years)
- Changes in smoking habits from baseline to year 2 and 4(2 and 4 years)
- Changes in mood from baseline to year 2 and 4(2 and 4 years)
- Changes in self-esteem from baseline to year 2 and 4(2 and 4 years)
- Cardiovascular score validation(4 years)
- Changes in the composite ICH score of adolescents from baseline to adulthood(8 years)