BeE-school: A Health Promotion Intervention for Vulnerable School

Sponsor
University of Minho (Other)
Overall Status
Recruiting
CT.gov ID
NCT05395364
Collaborator
(none)
478
1
2
17
28.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention program BeE-school
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
478 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Health Promotion Intervention for Vulnerable School - Children and Families: a Cluster-randomized Trial
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

No intervention will occur.

Experimental: Intervention

An intervention program based on the promotion of health literacy and lifestyles, specifically on children's: 1-health literacy and infodemic resilience; 2- lifestyles (e.g. dietary intake, 24h-movement behaviour); 3-overweight and obesity; 4-blood pressure.

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.

Outcome Measures

Primary Outcome Measures

  1. Overweight and obesity [6 months]

    Anthropometry (weight and height will be combined to report BMI in kg/m^2)

  2. Risk of high blood pressure [6 months]

    Blood pressure monitoring (systolic and diastolic blood pressure)

  3. Health literacy [6 months]

    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).

  4. Dietary intake [6 months]

    Dietary intake (24h dietary recall) - recall the intake of foods in the previous day.

  5. Physical activity [6 months]

    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. Sedentary behavior [6 months]

    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.

  7. Sleep time [6 months]

    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.

  8. Sleep quality [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children from TEIP schools

  • Ages between 5 to 12 years old

Exclusion Criteria:
  • Children/families who don't speak/understand Portuguese

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ana Duarte Braga Portugal 4704

Sponsors and Collaborators

  • University of Minho

Investigators

  • Principal Investigator: Rafaela D Rosário, PhD, University of Minho

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helena Rafaela Vieira do Rosario, Principal Investigator, PhD, University of Minho
ClinicalTrials.gov Identifier:
NCT05395364
Other Study ID Numbers:
  • UMinho
First Posted:
May 27, 2022
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022