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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03128775
Recruitment Status : Unknown
Verified June 2017 by Rosely Sichieri, Rio de Janeiro State University.
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : June 21, 2017
Sponsor:
Collaborators:
Oswaldo Cruz Foundation
University of Copenhagen
Universidade Federal do Rio de Janeiro
Information provided by (Responsible Party):
Rosely Sichieri, Rio de Janeiro State University

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Nudge Behavioral: Primary prevention Behavioral: Primary prevention + nudge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: School Randomized Factorial Trial for Nudging Students Towards Healthy Diet and Physical Activity to Prevent Obesity: a Study Protocol
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnant girls


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128775


Locations
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Brazil
18 Schools of Metropolitan Area
Duque de Caxias, Rio de Janeiro, Brazil
Sponsors and Collaborators
Rio de Janeiro State University
Oswaldo Cruz Foundation
University of Copenhagen
Universidade Federal do Rio de Janeiro
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Responsible Party: Rosely Sichieri, Full professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT03128775    
Other Study ID Numbers: Nudgepaappas
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight