NCT03504059

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

Active, enrolled NA Last updated 9 December 2024

What this trial tests

NA trial testing Long-term educational program in Obesity in 1,326 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2017

Primary endpoint
30 June 2021

30 June 2025

Quick facts

Lead sponsor	University of Barcelona
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,326
Start date	1 June 2017
Primary completion	30 June 2021
Estimated completion	30 June 2025
Sites	3 locations across Spain

Drugs / interventions tested

• Long-term educational program
• Short-term educational program

Conditions studied

• Obesity — all drugs for Obesity →
• Cardiovascular Health — all drugs for Cardiovascular Health →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

University of Barcelona

Who can join

Adults 11 to 16, any sex, with Obesity or Cardiovascular Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18.
   Neil-Sztramko SE, Caldwell H, Dobbins M. · · 2021 · cited 182× · PMID 34555181 · DOI 10.1002/14651858.cd007651.pub3
2. Strategies for enhancing the implementation of school-based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use.
   Wolfenden L, McCrabb S, Barnes C, O'Brien KM, et al · · 2022 · cited 35× · PMID 36036664 · DOI 10.1002/14651858.cd011677.pub3
3. Interventions to prevent obesity in children aged 12 to 18 years old.
   Spiga F, Tomlinson E, Davies AL, Moore TH, et al · · 2024 · cited 30× · PMID 38763518 · DOI 10.1002/14651858.cd015330.pub2
4. School-Based Cardiovascular Health Promotion in Adolescents: A Cluster Randomized Clinical Trial.
   Santos-Beneit G, Fernández-Alvira JM, Tresserra-Rimbau A, Bodega P, et al · · 2023 · cited 21× · PMID 37531100 · DOI 10.1001/jamacardio.2023.2231
5. Identification and Quantification of Urinary Microbial Phenolic Metabolites by HPLC-ESI-LTQ-Orbitrap-HRMS and Their Relationship with Dietary Polyphenols in Adolescents.
   Laveriano-Santos EP, Marhuenda-Muñoz M, Vallverdú-Queralt A, Martínez-Huélamo M, et al · · 2022 · cited 15× · PMID 35740067 · DOI 10.3390/antiox11061167
6. Dietary Patterns and Cardiovascular Risk Factors in Spanish Adolescents: A Cross-Sectional Analysis of the SI! Program for Health Promotion in Secondary Schools.
   Bodega P, Fernández-Alvira JM, Santos-Beneit G, de Cos-Gandoy A, et al · · 2019 · cited 15× · PMID 31561533 · DOI 10.3390/nu11102297
7. Strategies for enhancing the implementation of school-based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use.
   Lee DC, O'Brien KM, McCrabb S, Wolfenden L, et al · · 2024 · cited 11× · PMID 39665378 · DOI 10.1002/14651858.cd011677.pub4
8. Preventing and treating childhood obesity by sleeping better: a systematic review.
   Porri D, Luppino G, Aversa T, Corica D, et al · · 2024 · cited 10× · PMID 39363896 · DOI 10.3389/fendo.2024.1426021