Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity (PAAPASNudge)

November 16, 2023 updated by: Rosely Sichieri, Rio de Janeiro State University

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio De Janeiro
      • Duque de Caxias, Rio De Janeiro, Brazil
        • 18 Schools of Metropolitan Area

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

5th and 6th grades students consent form signed by parents/tutors

Exclusion Criteria:

pregnant girls

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nudge
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

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.
Experimental: Primary prevention
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
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.
Experimental: Primary prevention + nudge
This group will receive educational activities and in the classroomchanges in the school environment (nudge).
Behavioral: Primary prevention + nudge
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.
No Intervention: Control
without any activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body fat percentage
Time Frame: 1 year
Body fat percentage will be measured by a portable electronic scale with a segmental body composition monitor (Tanita BC-558).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Collaborators

University of Copenhagen
Oswaldo Cruz Foundation
Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nudgepaappas

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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