ObesityBeE-schoolNCT05395364
A Health Promotion Intervention for Vulnerable School
A study testing Intervention program BeE-school in people with Obesity and Health Promotion, run by University of Minho at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obesity, Health Promotion, Noncommunicable Diseases
- What is being tested?
- Intervention program BeE-school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 735 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from TEIP schools
- Ages between 5 to 12 years old
Who cannot join
- Children/families who don't speak/understand Portuguese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Health Promotion Intervention for Vulnerable School - Children and Families: a Cluster-randomized Trial
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.
- Being tested
- Intervention program BeE-school
- Medical subject headings
- Obesity, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention program BeE-schoolBehavioural
The intervention program will be co-developed and directed to school professionals. It will be based on the promotion of health literacy and lifestyles.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention will occur. |
| Intervention | Experimental | 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. Receives: Behavioral: Intervention program BeE-school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overweight and obesity
Anthropometry (weight and height will be combined to report BMI in kg/m^2)
Measured: 6 months
Risk of high blood pressure
Blood pressure monitoring (systolic and diastolic blood pressure)
Measured: 6 months
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).
Measured: 6 months
Dietary intake
Dietary intake (24h dietary recall) - recall the intake of foods in the previous day.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Mar 2022
- Primary completion2 Feb 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 735 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Rafaela Vieira do Rosario, University of Minho
- Investigators
- Rafaela D Rosário, PhD, Principal investigator, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395364
- Sponsor's protocol ID
- UMinho
- Acronym
- BeE-school
- Status last verified
- May 2024
- First submitted
- 16 May 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duarte A, Martins J, Silva MJ, Augusto C, Rosario R. Screen Exposure and Childhood Adiposity in Socially Vulnerable Settings: Cross-Sectional Study. JMIR Pediatr Parent. 2026 Jul 8;9:e77431. doi: 10.2196/77431.
PubMed 42418266Leite N, Tadiotto MC, Tozo TAA, Duarte A, Augusto C, Silva MJ, Brand C, Mota J, Pereira B, Rosario R. Positive changes in 24-hour movement behaviors and blood pressure in socioeconomically vulnerable schoolchildren after a 16-week health promotion intervention. Sci Rep. 2026 Jun 26. doi: 10.1038/s41598-026-58919-8. Online ahead of print.
PubMed 42362675Martins J, Augusto C, Silva MJ, Duarte A, Martins SP, Antunes H, Novais P, Pereira B, Veiga P, Rosario R. Effectiveness of a health promotion program on overweight in vulnerable children from primary schools (BeE-school): A cluster-randomized controlled trial. Int J Obes (Lond). 2025 Feb;49(2):332-339. doi: 10.1038/s41366-024-01672-7. Epub 2024 Nov 9.
PubMed 39521923
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health Promotion Intervention for Vulnerable School - Children and Families: a Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT05395364
- Acronym / sponsor ID
- BeE-school / UMinho
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention will occur. |
| Intervention | Experimental | Behavioral: Intervention program BeE-schoolAn 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children from TEIP schools
- Ages between 5 to 12 years old
Key exclusion criteria (1 listed)
- Children/families who don't speak/understand Portuguese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention program BeE-schoolThe intervention program will be co-developed and directed to school professionals. It will be based on the promotion of health literacy and lifestyles. | Behavioural | Intervention |
Primary outcome
Overweight and obesity
Time frame: 6 months
Anthropometry (weight and height will be combined to report BMI in kg/m^2)
Risk of high blood pressure
Time frame: 6 months
Blood pressure monitoring (systolic and diastolic blood pressure)
Health literacy
Time frame: 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).
Dietary intake
Time frame: 6 months
Dietary intake (24h dietary recall) - recall the intake of foods in the previous day.
Physical activity
Time frame: 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.
Sedentary behavior
Time frame: 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.
Sleep time
Time frame: 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.
Sleep quality
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 42418266Duarte A, Martins J, Silva MJ, Augusto C, Rosario R. Screen Exposure and Childhood Adiposity in Socially Vulnerable Settings: Cross-Sectional Study. JMIR Pediatr Parent. 2026 Jul 8;9:e77431. doi: 10.2196/77431.
- Derived from this study: PubMed 42362675Leite N, Tadiotto MC, Tozo TAA, Duarte A, Augusto C, Silva MJ, Brand C, Mota J, Pereira B, Rosario R. Positive changes in 24-hour movement behaviors and blood pressure in socioeconomically vulnerable schoolchildren after a 16-week health promotion intervention. Sci Rep. 2026 Jun 26. doi: 10.1038/s41598-026-58919-8. Online ahead of print.
- Derived from this study: PubMed 39521923Martins J, Augusto C, Silva MJ, Duarte A, Martins SP, Antunes H, Novais P, Pereira B, Veiga P, Rosario R. Effectiveness of a health promotion program on overweight in vulnerable children from primary schools (BeE-school): A cluster-randomized controlled trial. Int J Obes (Lond). 2025 Feb;49(2):332-339. doi: 10.1038/s41366-024-01672-7. Epub 2024 Nov 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafaela D Rosário, PhD principal investigator
University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention program BeE-school in people with Obesity and Health Promotion, run by University of Minho at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overweight and obesity (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05395364, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.