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

Primary Purpose

Obesity

Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nudge
Primary prevention
Primary prevention + nudge
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

9 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

pregnant girls

Sites / Locations

  • 18 Schools of Metropolitan Area

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Nudge

Primary prevention

Primary prevention + nudge

Control

Arm Description

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.

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.

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

without any activity

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

body fat percentage
Body fat percentage will be measured by a portable electronic scale with a segmental body composition monitor (Tanita BC-558).

Full Information

First Posted
October 4, 2016
Last Updated
October 25, 2022
Sponsor
Rio de Janeiro State University
Collaborators
Oswaldo Cruz Foundation, University of Copenhagen, Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT03128775
Brief Title
Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity
Acronym
PAAPASNudge
Official Title
School Randomized Factorial Trial for Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity: a Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
no fundng was provided by the financial agency
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University
Collaborators
Oswaldo Cruz Foundation, University of Copenhagen, Universidade Federal do Rio de Janeiro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nudge
Arm Type
Experimental
Arm Description
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.
Arm Title
Primary prevention
Arm Type
Experimental
Arm Description
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.
Arm Title
Primary prevention + nudge
Arm Type
Experimental
Arm Description
This group will receive educational activities and in the classroomchanges in the school environment (nudge).
Arm Title
Control
Arm Type
No Intervention
Arm Description
without any activity
Intervention Type
Behavioral
Intervention Name(s)
Nudge
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Primary prevention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Primary prevention + nudge
Intervention Description
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 Outcome Measure Information:
Title
Body mass Index (BMI)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
body fat percentage
Description
Body fat percentage will be measured by a portable electronic scale with a segmental body composition monitor (Tanita BC-558).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 5th and 6th grades students consent form signed by parents/tutors Exclusion Criteria: pregnant girls
Facility Information:
Facility Name
18 Schools of Metropolitan Area
City
Duque de Caxias
State/Province
Rio De Janeiro
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity

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