Nudging, Healthy Diet and Physical Activity

Design of a School Randomized Trial for Nudging Students Towards Healthy Diet and Physical Activity

The present study is a randomized school-based trial of a sample of 5th and 6th grade students from 10 public schools in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. The aim is to investigate whether adding nudging actions to the intervention group of PAAPPAS trial (PAAPAS Study, NCT02711488) increase fruits, vegetables and water consumption and daily energy expenditure, in a factorial design.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: educational activities; Behavioral: nudging; Behavioral: nudging + educational activities

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

pregnant girls

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; without any activity
Experimental: educational activities; The students will receive educational activities in the classroom.	Behavioral: educational activities; Group 2 will receive 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
Experimental: nudging; The students will receive changes in the school environment (nudge strategies);	Behavioral: nudging; In group 3, changes in the environment will be included that will facilitate both physical activity and healthy food choices
Experimental: nudging + educational activities; The students will receive educational activities and changes in the school environment.	Behavioral: nudging + educational activities; Group 4 will receive both interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Sample size of PAAPPAS Nudge was calculated based on a minimum effect of 0.15 in BMI variation and considering intra and intergroup comparisons. Body mass index (BMI) will be determined as a ratio between body weight (kg) and squared height (m).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit consumption	Food intake will be assessed by a food frequency questionnaire validated for teenagers in Rio de Janeiro and one 24-hour recall (Rec24h). Netbooks containing a computer program developed for school use, based on a technique called "Multiple Pass Method" will be used.	6 months
Vegetable consumption	Vegetable consumption will be assessed by one 24-hour recall (Rec24h). The food items in the Rec24h will be transformed into daily consumption and grouped according to similary in nutritional containing	6 months
Water consumption	Water consumption will be assessed by a question regarding the number of glasses of water consumed during a day. Glasses of water consumed during a day will be assessed by a question at baseline and at the end of the study.	6 months
Physical activity	Physical activity levels will be measured through a validated questionnaire including six questions about frequency and time of different physical activities domains.	6 months

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Collaborators: Oswaldo Cruz Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): November 15, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: nudgingpaappas

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