Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
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.


Options:
A: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Short Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Short-term educational program | Arm Label: Long Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Long-term educational program | Intervention Type: BEHAVIORAL; Name: Long-term educational program; Assigned to Arm(s): Long Intervention | Intervention Type: BEHAVIORAL; Name: Short-term educational program; Assigned to Arm(s): Short Intervention
B: Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Face-to-face family mentoring and education sessions, Behavioral: Telephone follow-up | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Face-to-face family mentoring and education sessions; Assigned to Arm(s): Intervention Group | Intervention Type: BEHAVIORAL; Name: Telephone follow-up; Assigned to Arm(s): Intervention Group
C: Intervention Type: BEHAVIORAL; Name: FLOW; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: SelfHelp; Assigned to Arm(s): N/A
D: Arm Label: Group 1:; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard care management | Arm Label: Group 2; Type: EXPERIMENTAL; Interventions: Behavioral: Standard care management | Arm Label: Group 3; Type: EXPERIMENTAL; Interventions: Behavioral: The strengthened care management | Intervention Type: BEHAVIORAL; Name: Standard care management; Assigned to Arm(s): Group 1:, Group 2 | Intervention Type: BEHAVIORAL; Name: The strengthened care management; Assigned to Arm(s): Group 3

Answer: A