School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,326
- 试验地点
- 6
- 主要终点
- Changes in the composite ICH score of adolescents from baseline to year 2 and 4
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.
排除标准
- •No exclusion criteria.
结局指标
主要结局
Changes in the composite ICH score of adolescents from baseline to year 2 and 4
时间窗: 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.
次要结局
- 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)
研究者
Rosa M Lamuela-Raventós
Associate Professor
University of Barcelona