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Nudging, Healthy Diet and Physical Activity

Sponsor
Rio de Janeiro State University (Other)
Overall Status
Completed
CT.gov ID
NCT03136016
Collaborator
Oswaldo Cruz Foundation (Other)
1,000
Enrollment
1
Location
4
Arms
9.5
Actual Duration (Months)
105.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: educational activities
  • Behavioral: nudging
  • Behavioral: nudging + educational activities
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Design of a School Randomized Trial for Nudging Students Towards Healthy Diet and Physical Activity
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Nov 15, 2017
Actual Study Completion Date :
Dec 15, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

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

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

Exclusion Criteria:

pregnant girls

Contacts and Locations

Locations

Site City State Country Postal Code
1 10 Schools of Metropolitan Area Duque de Caxias Rio De Janeiro Brazil

Sponsors and Collaborators

  • Rio de Janeiro State University
  • Oswaldo Cruz Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rosely Sichieri, Full professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT03136016
Other Study ID Numbers:
  • nudgingpaappas
First Posted:
May 2, 2017
Last Update Posted:
Sep 17, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 17, 2019