A Health Promotion Intervention for Vulnerable School

Obesity Clinical Trial

— BeE-school  

Official title:

A Health Promotion Intervention for Vulnerable School - Children and Families: a Cluster-randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395364
• Other study ID #: UMinho
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2024
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 735
• Est. completion date: July 31, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children from TEIP schools

• Ages between 5 to 12 years old

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Child Development
• Health Promotion
• Life Style
• Noncommunicable Diseases
• Obesity

Intervention

Behavioral:
• Intervention program BeE-school
The intervention program will be co-developed and directed to school professionals. It will be based on the promotion of health literacy and lifestyles.

Locations

Country	Name	City	State
Portugal	Ana Duarte	Braga

Sponsors (1)

Lead Sponsor	Collaborator
University of Minho

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overweight and obesity	Anthropometry (weight and height will be combined to report BMI in kg/m^2)	6 months
Primary	Risk of high blood pressure	Blood pressure monitoring (systolic and diastolic blood pressure)	6 months
Primary	Health literacy	European health literacy questionnaire (HLS19-Q12-PT) - range between 0 and 100. The cut-offs for categorizing health literacy were based on the following positions: below 50; between 50 and 66.66; between 66.67 and 83.33; above 83.34. These cut-offs allowed the definition of the same categories as in the HLS-EU study: "inadequate" and "problematic" (low health literacy), "adequate" and "excellent" (high health literacy).	6 months
Primary	Dietary intake	Dietary intake (24h dietary recall) - recall the intake of foods in the previous day.	6 months
Primary	Physical activity	Physical activity will be assessed using Actigraph GT3X+ accelerometers (ActiGraph, Pensacola, Florida, USA) over a usual week (24 h/day over 7 days - except for water activities). These devices are small, light and unobtrusive, worn on the wrist, and their validity and utility have previously been established in children. For this study, one count per minute will be converted into light, moderate or vigorous activity. Parents will be asked to fill in an activity monitor log with the times that the accelerometers were removed and put back onto the child.	6 months
Primary	Sedentary behavior	Sedentary behavior will be assessed using Actigraph GT3X+ accelerometers (ActiGraph, Pensacola, Florida, USA) over a usual week (24 h/day over 7 days - except for water activities). These devices are small, light and unobtrusive, worn on a belt around the waist, and their validity and utility have previously been established in children. For this study values below 100 counts/min will be considered as sedentary behaviour. Parents will be asked to fill in an activity monitor log with the times that the accelerometers were removed and put back onto the child.	6 months
Primary	Sleep time	Sleep time will be assessed using Actigraph GT3X+ accelerometers (ActiGraph, Pensacola, Florida, USA) over a usual week (24 h/day over 7 days - except for water activities). These devices are small, light and unobtrusive, worn on a belt around the waist, and their validity and utility have previously been established in children. Parents will be asked to fill in an activity monitor log with the times that the accelerometers were removed and put back onto the child.	6 months
Primary	Sleep quality	Sleep quality will be assessed with the Portuguese Children's Sleep Habits Questionnaire, which along with Actigraph seems to better inform clinical practice and research on a child's sleep. The Children's Sleep Habits Questionnaire has the following dimensions: bedtime behavior and sleep onset; sleep duration; anxiety around sleep; behavior occurring during sleep and night wakings; sleep-disordered breathing; parasomnias; and morning waking/daytime sleepiness. Parents are asked to recall sleep behaviors occurring over a "typical" recent week. Items are rated on a three-point scale: "usually" if the sleep behavior occurred five to seven times/week; "sometimes" for two to four times/week; and "rarely" for zero to one time/week.	6 months