School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents

School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Diabetes Mellitus; Cardiovascular Health
• Intervention / Treatment: Behavioral: Short-term educational program; Behavioral: Long-term educational program

• Study Type: Interventional
• Enrollment (Actual): 1326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • School of Pharmacy. University of Barcelona.
  • Barcelona, Spain, 08037
    • Fundación SHE
  • Madrid, Spain, 28029
    • Centro Nacional de Investigaciones Cardiovasculares Carlos III

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The usual educational program is applied
Active Comparator: Short Intervention; A two-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.	Behavioral: Short-term educational program; Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.
Active Comparator: Long Intervention; A four-year specially designed educational program is applied. This program aims to encourage a healthy lifestyle through gamification, including diet education, physical activity and self esteem.	Behavioral: Long-term educational program; Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the composite ICH score of adolescents from baseline to year 2 and 4	The ICH score measures cardiovascular health and includes 7 components: - Behaviors factors: 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.	2 and 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body mass index from baseline to year 2 and 4	Change in body mass index (kg/m^2), calculated after measure weight (kg) and height (meter).	2 and 4 years
Changes in waist circumference from baseline to year 2 and 4	Change in waist circumference (cm) measured in triplicate	2 and 4 years
Changes in percentage of body fat from baseline to year 2 and 4	Change in total adiposity measured by bioelectrical impedance (percentage of fat).	2 and 4 years
Changes in distribution of body fat from baseline to year 2 and 4	Change in adiposity distribution measured by dual energy X-ray absorptiometry, that calculate total body fat, regional fat, including android, gynoid, visceral and lean mass.	2 and 4 years
Changes in dietary habits from baseline to year 2 and 4	To evaluate the association between food and nutrient intake and changes in adiposity parameters. To assess changes in diet and adherence to the Mediterranean diet a validated Food Frequency Questionnaire (FFQ) (Tresserra-Rimbau et al., 2013) will be used. A shorter FFQ (Children's Eating Habits Questionnaire - Food Frequency Questionnaire (CEHQ-FFQ) (Lanfer et al., 2011; Bel-Serrat et al. 2014)) will also be used to analyze dietary patterns.	2 and 4 years
Changes in attitudes about eating from baseline to year 2 and 4 [ Time Frame: 2 and 4 years	To evaluate the relationship between changes in attitudes and changes in adiposity parameters. A validated questionnaire will be used to assess attitudes about eating (Lima-Serrano et al., 2012).	2 and 4 years
Changes in polyphenol consumption from baseline to year 2 and 4	Dietary polyphenol (PP) intake will be estimated from FFQ and data from the PP content in foods, obtained from the Phenol-explorer data base. With this methodology, it can obtain an estimation of total PP intake by each individual and different PP classes. For the determination of phenolics and their metabolites in human urine, will be used solid-phase extraction and ultra-HPLC coupled to mass spectrometry (Martinez-Huelamo et al., 2015).	2 and 4 years
Changes in carotenoids consumption from baseline to year 2 and 4	Carotenoids and retinol consumption will be also estimated from the longer FFQ. Total energy and micronutrient intake will be obtained using the Food Processor Nutrition and Fitness Software (ESHA Research, Salem, OR).	2 and 4 years
Changes in energy and nutrients consumption from baseline to year 2 and 4	Total energy and micronutrient intake will be obtained from a validated Food Frequency Questionnaire (Tresserra-Rimbau et al., 2013) using the Food Processor Nutrition and Fitness Software.	2 and 4 years
Changes in metabolomics from baseline to year 2 and 4	To evaluate the effect of the intervention on metabolism through a metabolomic approach. Urine and salivary samples will be collected to perform a metabolomics analysis in order to evaluate metabolic changes due to educational intervention on dietary and physical activity habits. Liquid chromatography coupled to quadrupole time of-flight mass spectrometry (HPLC-q-TOF) will be used for such analysis which is able to measure thousands of metabolites simultaneously from only minimal amounts of sample. Data mining analysis will be performed using XCMS-R package. The preprocessed data obtained by XCMS in negative and positive ionization will be separately exported to SIMCA 13.0.3 software (Umetrics) to perform unsupervised and supervised multivariate analysis to detect metabolic changes among groups.	2 and 4 years
Changes in physical activity from baseline to year 2 and 4	To study the association between changes in physical activity and changes in adiposity parameters . Actigraph wGT3X-BT accelerometers that allow the registration of the amount and intensity of physical activity will be used during 7 days per evaluation time-point. To complete this information a diary with questions about the type of physical activity performed during the 7 days will be collected. A validated questionnaire will be also used to assess physical activity habits (Barbosa et al., 2007).	2 and 4 years
Changes in sedentary habits from baseline to year 2 and 4	To study the association between changes in sedentary habits and changes in adiposity parameters. Information on sedentary time from Actigraph wGT3X-BT accelerometers will be taken into account. In addition, we will measure sedentary leisure time spent with the computer/console/TV /mobile (ENSE 2012).	2 and 4 years
Changes in attitudes towards abuse substances from baseline to year 2 and 4	The attitudes towards abuse substances will be assessed by a validated questionnaire (Lima-Serrano et al., 2013). An additional questionnaire will be used to assess self-efficacy (Markham et al., 2009).	2 and 4 years
Changes in smoking habits from baseline to year 2 and 4	Validated questionnaires will be used to assess smoking status itself, and in its immediate environment (Moreno et al., 2012 Lana, 2010).	2 and 4 years
Changes in perception of the self-image from baseline to year 2 and 4	A questionnaire to assess the perception of the self-image will be used to obtain a pattern of individual acceptance with his/her figure (Stunkard et al., 1990).	2 and 4 years
Changes in self-esteem from baseline to year 2 and 4	Self-esteem will be assessed using validated questionnaire (Rajmil et al., 2003).	2 and 4 years
Changes in emotional eating from baseline to year 2 and 4	Emotional eating will be assessed using validated questionnaire (Jauregui-Lobera et al., 2014)	2 and 4 years
Changes in mood from baseline to year 2 and 4	Self-efficacy will be assessed using a validated questionnaire (Vázquez Fernández et al., 2013).	2 and 4 years
Evaluation of the shorter vs. longer educational intervention effectiveness by comparison of 2 and 4 year results on all outcomes	The effectiveness of a shorter vs. longer educational intervention program (2 and 4 year) will be assessed by comparison of final (4 year) results on all proposed outcomes.	4 years
Cardiovascular score validation	The BEWAT score, which includes the assessment of Blood pressure, Exercise, Weight, Alimentation (fruit and vegetables) and Tobacco consumption, will be also derived. This simple and non-invasive score (score from 0 to 15 points) will be validated against the ICH score, and will serve for future studies in adolescents.	4 years
Changes in the composite ICH score of adolescents from baseline to adulthood		8 years

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: Fundació La Marató de TV3; SHE Foundation; Centro Nacional de Investigaciones Cardiovasculares Carlos III; Obra social La Caixa
• Investigators: Principal Investigator: Rosa M Lamuela-Raventós, PhD, University of Barcelona; Principal Investigator: Gloria Santos-Beneit, PhD, SHE Foundation; Principal Investigator: Juan M Fernández Alvira, PhD, Centro Nacional de Investigaciones Cardiovasculares Carlos III; Principal Investigator: Valentín Fuster, PhD, MD, Centro Nacional de Investigaciones Cardiovasculares Carlos III

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 30, 2021
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Diabetes; Physical Activity; Obesity; Diet; Cardiovascular Health; School-Based
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 369/C/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No