NCT03128775

Brief 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.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

October 4, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
8.2 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

October 4, 2016

Last Update Submit

April 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • body fat percentage

    1 year

Study Arms (4)

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.

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.

Behavioral: Primary prevention

Primary prevention + nudge

EXPERIMENTAL

This group will receive educational activities and in the classroomchanges in the school environment (nudge).

Behavioral: Primary prevention + nudge

Control

NO INTERVENTION

without any activity

Interventions

NudgeBEHAVIORAL

School 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.

Nudge

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

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.

Primary prevention + nudge

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th and 6th grades students consent form signed by parents/tutors

You may not qualify if:

  • pregnant girls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

18 Schools of Metropolitan Area

Duque de Caxias, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Obesity

Interventions

Primary Prevention

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Preventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

October 4, 2016

First Posted

April 25, 2017

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations