Clinical trial NCT03504059: School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents
Official title: School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Cardiovascular Health
Diabetes Mellitus
Keywords: Obesity
Cardiovascular Health
Diabetes
Adolescents
Physical Activity
Diet
School-Based
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: SHE Foundation
name: Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Fundació La Marató de TV3
name: Obra social La Caixa
First posted: 2018-04-20
Enrollment: 1326
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Changes in the composite ICH score of adolescents from baseline to year 2 and 4
timeFrame: 2 and 4 years
Secondary outcomes:
measure: Changes in body mass index from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in waist circumference from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in percentage of body fat from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in distribution of body fat from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in dietary habits from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in attitudes about eating from baseline to year 2 and 4 [ Time Frame: 2 and 4 years
timeFrame: 2 and 4 years
measure: Changes in polyphenol consumption from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in carotenoids consumption from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in energy and nutrients consumption from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in metabolomics from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in physical activity from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in sedentary habits from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in attitudes towards abuse substances from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in smoking habits from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in perception of the self-image from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in self-esteem from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in emotional eating from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Changes in mood from baseline to year 2 and 4
timeFrame: 2 and 4 years
measure: Evaluation of the shorter vs. longer educational intervention effectiveness by comparison of 2 and 4 year results on all outcomes
timeFrame: 4 years
measure: Cardiovascular score validation
timeFrame: 4 years
measure: Changes in the composite ICH score of adolescents from baseline to adulthood
timeFrame: 8 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: School of Pharmacy. University of Barcelona.
city: Barcelona
country: Spain
facility: Fundación SHE
city: Madrid
country: Spain
facility: Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study officials:
affiliation: University of Barcelona
name: Rosa M Lamuela-Raventós, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SHE Foundation
name: Gloria Santos-Beneit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Juan M Fernández Alvira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Nacional de Investigaciones Cardiovasculares Carlos III
name: Valentín Fuster, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.