Clinical trial NCT05395364: A Health Promotion Intervention for Vulnerable School
Official title: A Health Promotion Intervention for Vulnerable School - Children and Families: a Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Health Promotion
Noncommunicable Diseases
Child Development
Life Style
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 735
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Children from TEIP schools
* Ages between 5 to 12 years old

Exclusion Criteria:

* Children/families who don't speak/understand Portuguese

Primary outcomes:
measure: Overweight and obesity
timeFrame: 6 months
measure: Risk of high blood pressure
timeFrame: 6 months
measure: Health literacy
timeFrame: 6 months
measure: Dietary intake
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Sedentary behavior
timeFrame: 6 months
measure: Sleep time
timeFrame: 6 months
measure: Sleep quality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Ana Duarte
Study officials:
affiliation: University of Minho
name: Rafaela D Rosário, PhD
role: PRINCIPAL_INVESTIGATOR
References: