A Health Promotion Intervention for Vulnerable School (BeE-school)
Primary Purpose
Obesity, Health Promotion, Noncommunicable Diseases
Status
Active
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Intervention program BeE-school
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
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
Sites / Locations
- Ana Duarte
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
No intervention will occur.
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.
Outcomes
Primary Outcome Measures
Overweight and obesity
Anthropometry (weight and height will be combined to report BMI in kg/m^2)
Risk of high blood pressure
Blood pressure monitoring (systolic and diastolic blood pressure)
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).
Dietary intake
Dietary intake (24h dietary recall) - recall the intake of foods in the previous day.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05395364
Brief Title
A Health Promotion Intervention for Vulnerable School
Acronym
BeE-school
Official Title
A Health Promotion Intervention for Vulnerable School - Children and Families: a Cluster-randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Health Promotion, Noncommunicable Diseases, Child Development, Life Style
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
478 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will occur.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention program BeE-school
Intervention Description
The intervention program will be co-developed and directed to school professionals. It will be based on the promotion of health literacy and lifestyles.
Primary Outcome Measure Information:
Title
Overweight and obesity
Description
Anthropometry (weight and height will be combined to report BMI in kg/m^2)
Time Frame
6 months
Title
Risk of high blood pressure
Description
Blood pressure monitoring (systolic and diastolic blood pressure)
Time Frame
6 months
Title
Health literacy
Description
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).
Time Frame
6 months
Title
Dietary intake
Description
Dietary intake (24h dietary recall) - recall the intake of foods in the previous day.
Time Frame
6 months
Title
Physical activity
Description
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.
Time Frame
6 months
Title
Sedentary behavior
Description
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.
Time Frame
6 months
Title
Sleep time
Description
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.
Time Frame
6 months
Title
Sleep quality
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafaela D Rosário, PhD
Organizational Affiliation
University of Minho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ana Duarte
City
Braga
ZIP/Postal Code
4704
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Health Promotion Intervention for Vulnerable School
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