NCT03504059.

Study name	School‐based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents
Methods	Type of trial: efficacy Allocation: cluster randomised Intervention model: parallel assignment Masking: none (open‐label)
Participants	Estimated number of schools: − Estimated number of students: 1366 Inclusion criteria (schools): − Exclusion criteria (schools): − Inclusion criteria (students): any student in the first academic year of secondary school  Exclusion criteria (‐students): none
Interventions	Intervention: comprehensive educational school‐based intervention for adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention and complementary intervention in the family setting, at school, and by teachers Comparator: usual educational programme
Outcomes	Primary outcomes: changes in composite ICH score of adolescents from baseline to Years 2 and 4. ICH score measures cardiovascular health and includes 7 components: No smoking Being physically active Good nutritional habits Normal weight ‐ health factors Normal blood pressure Normal cholesterol level 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: body mass index, waist circumference, percentage of body fat, distribution of body fat, dietary habits, attitudes about eating, polyphenol consumption, carotenoid consumption, energy and nutrition, metabolomics, physical activity, sedentary habits, attitudes towards abuse substances, smoking habits, self‐image, self‐esteem, emotional eating, mood, educational effectiveness, cardiovascular score Other outcomes: −
Starting date	Trial start date: 1 June 2017 Trial completion date: 30 June 2021 (anticipated)
Contact information	Responsible Party/Principal Investigator: Rosa M Lamuela‐Raventós, PhD, Gloria Santos‐Beneit, PhD, Juan M Fernández Alvira, PhD, Valentín Fuster, PhD, MD
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