NCT05395364: BeE-school

A Health Promotion Intervention for Vulnerable School

Completed NA Last updated 8 May 2024

What this trial tests

NA trial testing Intervention program BeE-school in Obesity in 735 participants. Completed in 31 July 2023.

Timeline

1 March 2022

Primary endpoint
2 February 2023

31 July 2023

Quick facts

Lead sponsor	University of Minho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	735
Start date	1 March 2022
Primary completion	2 February 2023
Estimated completion	31 July 2023
Sites	1 location across Portugal

Drugs / interventions tested

• Intervention program BeE-school

Conditions studied

• Obesity — all drugs for Obesity →
• Health Promotion — all drugs for Health Promotion →
• Noncommunicable Diseases — all drugs for Noncommunicable Diseases →
• Child Development — all drugs for Child Development →

Sponsor

University of Minho

Who can join

Adults 5 to 12, any sex, with Obesity or Health Promotion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The BeE-school (Be Empowered in school) is a cluster-randomised trial that addresses the complexity of the social challenge (vulnerable school-age children). It aims to analyse the effectiveness of the intervention program, based on the promotion of health literacy and lifestyles, specifically on children's: 1-health literacy and infodemic resilience (Aim 1); 2- lifestyles (e.g. dietary intake, 24hmovement behaviour) (Aim 2); 3-overweight and obesity (Aim 3); 4-blood pressure (Aim 4). The project converges multiple disciplines (e.g. public health, informatics, law) and researchers with proven expertise in these fields to provide comprehensive and innovative answers. 478 children (6 schools) aged 6-12years old will participate in this cluster-randomised trial, having schools as the unit of randomisation, assigned into intervention (239-3schools) and the control arm (239 - 3 schools). This project will perform a social listening (online and offline) and bottom-up approach to tackling NCDs, focusing on health literacy and health promotion and recognising children's systems in daily life (e.g. family, teachers). Stakeholders' involvement goes far beyond a merely consultative approach; the researchers are committed to a genuine codevelopment process. Data collection includes sociodemographics, health literacy and infodemic resilience, dietary intake and children's 24-h movement behaviour (e.g. accelerometry), anthropometry (e.g. weight, height and waist circumference) and blood pressure. Data collection will occur at baseline and after the intervention (follow-up, 6 months after the beginning of the intervention). Expected outputs and outcomes include the creation of a model for characterising NCDs and health topics based on artificial intelligence techniques (e.g. deep learning, and social network analysis methods); improved health literacy and infodemic resilience of children, families and teachers; enhanced children's lifestyles (e.g. dietary intake, 24-h movement behaviour); reduction of NCDs' physical risk factors (e.g. overweight, raised blood pressure); feasible intervention program about health promotion and NCDs' prevention for school-aged children with vulnerabilities, and advocacy- policies about health promotion and NCDs' prevention.

Publications & conference data

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

1. Interventions to prevent obesity in children aged 5 to 11 years old.
   Spiga F, Davies AL, Tomlinson E, Moore TH, et al · · 2024 · cited 40× · PMID 38763517 · DOI 10.1002/14651858.cd015328.pub2
2. 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
3. Health Literacy and Its Association with the Adoption of the Mediterranean Diet: A Cross-Sectional Study.
   Duarte A, Martins J, Lopes C, Silva MJ, et al · · 2024 · cited 3× · PMID 39064620 · DOI 10.3390/nu16142176
4. The Role of Parental Adherence to the Mediterranean Diet and Family Time Together in Children's Weight Status: The BeE-School Project.
   Duarte A, Martins J, Silva MJ, Augusto C, et al · · 2024 · cited 3× · PMID 38612950 · DOI 10.3390/nu16070916
5. Precision nutrition-based interventions for the management of obesity in children and adolescents up to the age of 19 years.
   Huey SL, Mehta NH, Steinhouse RS, Jin Y, et al · · 2025 · cited 2× · PMID 39882755 · DOI 10.1002/14651858.cd015877
6. Development of an Instrument to Measure Resilience to Misinformation on Social Media: Measurement Properties and Validation.
   Rosário R, Martins S, Purnat TD, Wilhelm E, et al · · 2025 · cited 1× · PMID 40928836 · DOI 10.2196/72449
7. Sex differences in blood pressure and physical activity among socioeconomically vulnerable Portuguese schoolchildren aged 6 to 10 years: insights from the BeE-school Project.
   Leite N, Tadiotto MC, Duarte A, Augusto C, et al · · 2026 · PMID 41792664 · DOI 10.1186/s12887-026-06704-x