Nudging, Healthy Diet and Physical Activity

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: educational activities; Behavioral: nudging + educational activities; Behavioral: nudging

• Registration Number: NCT03136016
• Lead Sponsor: Rio de Janeiro State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Primary Completion: 2017-11-15
• Study Completion: 2017-12-15
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

pregnant girls

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
educational activities	educational activities	The students will receive educational activities in the classroom.
nudging + educational activities	nudging + educational activities	The students will receive educational activities and changes in the school environment.
nudging	nudging	The students will receive changes in the school environment (nudge strategies);

Primary Outcome Measures

Name	Time	Method
Body Mass Index	6 months	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).

Secondary Outcome Measures

Name	Time	Method
Vegetable consumption	6 months	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
Fruit consumption	6 months	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.
Physical activity	6 months	Physical activity levels will be measured through a validated questionnaire including six questions about frequency and time of different physical activities domains.
Water consumption	6 months	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.

Trial Locations

Locations (1)

10 Schools of Metropolitan Area; 🇧🇷 Duque de Caxias, Rio De Janeiro, Brazil