ObesityPAAPASNudgeNCT03128775
Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity
A study testing Nudge, Primary prevention and Primary prevention + nudge in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The objective of the present study is to estimate the effect of nudging proposals on the students' Body Mass Index, based on changes made in the school environment. This is a factorial randomized community trial, which will be conducted in 18 public schools in the city of Duque de Caxias, RJ. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nudge, Primary prevention and Primary prevention + nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2025to Dec 2026
- 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 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5th and 6th grades students consent form signed by parents/tutors
Who cannot join
- pregnant girls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: School Randomized Factorial Trial for Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity: a Study Protocol
The objective of the present study is to estimate the effect of nudging proposals on the students' Body Mass Index, based on changes made in the school environment. This is a factorial randomized community trial, which will be conducted in 18 public schools in the city of Duque de Caxias, RJ.
- Conditions
- Obesity
- Being tested
- Nudge, Primary prevention, Primary prevention + nudge
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
School lunchrooms are the central place of modifications regarding food consumption, where the following strategies will be conducted:
- arrange the fruits served in the school lunch in a prominent position, in containers of bright and contrasting colors to serve them;
- Create creative names for food served at meals will be created by the students used on displays at canteen tables, posters on the way of the cafeteria and at a menu outside the cafeteria.
To encourage water consumption, footprints that lead to them to water fountains will be painted on the floor. To stimulate physical activity, several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) will be available for use in the school sports court. The courts will be renovated and footsteps painted in order to nudging students to the sports equipment.
Primary preventionBehavioural
Classroom-based educational activities based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans. Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
Primary prevention + nudgeBehavioural
This group will receive both primary prevention and nudge activities. At school lunchrooms, the fruits served in the school lunch will be put in a prominent position, in containers of bright and contrasting colors to serve them; create creative names for food served at meals will be created by the studentes, footprints that lead to them to water fountains will be painted on the floor. Several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) will be available for use in the schools sport court. Also, classroom-based educational activities based on an earlier study, called PAPPAS, will be held. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
| Study group | Role | What they receive |
|---|---|---|
| Nudge | Experimental | This group will receive changes in the school environment (nudge strategies). Interventions regarding food consumption were based on nudge strategies to led students to eat more fruits and vegetables. To stimulate physical activity, several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) are available for use in the school sports court. Receives: Behavioral: Nudge |
| Primary prevention | Experimental | This group will receive educational activities in the classroom. Classroom-based educational activities will be based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans. Receives: Behavioral: Primary prevention |
| Primary prevention + nudge | Experimental | This group will receive educational activities and in the classroomchanges in the school environment (nudge). Receives: Behavioral: Primary prevention + nudge |
| Control | No intervention | without any activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass Index (BMI)
The body weight will be measured by a portable electronic scale with a segmental body composition monitor (Tanita BC-558). The height will be measure by a portable stadiometer (brand: "AlturaExata"). BMI will be calculated as weight/stature*stature.
Measured: 1 year
Secondary outcomes (1)
body fat percentage
Body fat percentage will be measured by a portable electronic scale with a segmental body composition monitor (Tanita BC-558).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: no funding was provided by the financial agency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- PAAPPAS Nudge is a randomized community-based, school-based trial designed to promote healthful choices in a low-income scenario, with will be held in 2018 school-year in 18 municipal public schools in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil (http://duquedecaxias.rj.gov.br/portal/). All students from the 5th and 6th grade from the 18 selected schools will be invited to participate to the study. The study design will be of the factorial type, with 4 group arms: A) Group 1: control (without any activity); B) Group 2: will receive educational activities in the classroom; C) Group 3: will receive changes in the school environment (nudge strategies); D) Group 4: will receive educational activities and changes in the school environment.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, University of Copenhagen, Universidade Federal do Rio de Janeiro
- Responsible party
- Principal investigator, Rosely Sichieri, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128775
- Sponsor's protocol ID
- Nudgepaappas
- Acronym
- PAAPASNudge
- Status last verified
- Apr 2025
- First submitted
- 4 Oct 2016
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Randomized Factorial Trial for Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity: a Study Protocol
- ClinicalTrials.gov ID
- NCT03128775
- Acronym / sponsor ID
- PAAPASNudge / Nudgepaappas
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding was provided by the financial agency
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, University of Copenhagen, Universidade Federal do Rio de Janeiro
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Apr 2017 (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 objective of the present study is to estimate the effect of nudging proposals on the students' Body Mass Index, based on changes made in the school environment. This is a factorial randomized community trial, which will be conducted in 18 public schools in the city of Duque de Caxias, RJ.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- PAAPPAS Nudge is a randomized community-based, school-based trial designed to promote healthful choices in a low-income scenario, with will be held in 2018 school-year in 18 municipal public schools in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil (http://duquedecaxias.rj.gov.br/portal/). All students from the 5th and 6th grade from the 18 selected schools will be invited to participate to the study. The study design will be of the factorial type, with 4 group arms: A) Group 1: control (without any activity); B) Group 2: will receive educational activities in the classroom; C) Group 3: will receive changes in the school environment (nudge strategies); D) Group 4: will receive educational activities and changes in the school environment.
| Arm | Type | Receives |
|---|---|---|
| Nudge | Experimental | Behavioral: NudgeThis group will receive changes in the school environment (nudge strategies). Interventions regarding food consumption were based on nudge strategies to led students to eat more fruits and vegetables. To stimulate physical activity, several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) are available for use in the school sports court. |
| Primary prevention | Experimental | Behavioral: Primary preventionThis group will receive educational activities in the classroom. Classroom-based educational activities will be based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans. |
| Primary prevention + nudge | Experimental | Behavioral: Primary prevention + nudgeThis group will receive educational activities and in the classroomchanges in the school environment (nudge). |
| Control | No intervention | –without any activity |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 5th and 6th grades students consent form signed by parents/tutors
Key exclusion criteria (1 listed)
- pregnant girls
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 |
|---|---|---|
| NudgeSchool lunchrooms are the central place of modifications regarding food consumption, where the following strategies will be conducted: 1. arrange the fruits served in the school lunch in a prominent position, in containers of bright and contrasting colors to serve them; 2. Create creative names for food served at meals will be created by the students used on displays at canteen tables, posters on the way of the cafeteria and at a menu outside the cafeteria. To encourage water consumption, footprints that lead to them to water fountains will be painted on the floor. To stimulate physical activity, several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) will be available for use in the school sports court. The courts will be renovated and footsteps painted in order to nudging students to the sports equipment. | Behavioural | Nudge |
| Primary preventionClassroom-based educational activities based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans. Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class. | Behavioural | Primary prevention |
| Primary prevention + nudgeThis group will receive both primary prevention and nudge activities. At school lunchrooms, the fruits served in the school lunch will be put in a prominent position, in containers of bright and contrasting colors to serve them; create creative names for food served at meals will be created by the studentes, footprints that lead to them to water fountains will be painted on the floor. Several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) will be available for use in the schools sport court. Also, classroom-based educational activities based on an earlier study, called PAPPAS, will be held. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class. | Behavioural | Primary prevention + nudge |
Primary outcome
Body mass Index (BMI)
Time frame: 1 year
The body weight will be measured by a portable electronic scale with a segmental body composition monitor (Tanita BC-558). The height will be measure by a portable stadiometer (brand: "AlturaExata"). BMI will be calculated as weight/stature*stature.
1 secondary outcome
body fat percentage
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge, Primary prevention and Primary prevention + nudge in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
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 1 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: withdrawn, as of the sponsor's last update on 6 Apr 2025. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Body mass Index (BMI) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.