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Nudging, Healthy Diet and Physical Activity

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ClinicalTrials.gov Identifier: NCT03136016
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Oswaldo Cruz Foundation
Information provided by (Responsible Party):
Rosely Sichieri, 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: educational activities Behavioral: nudging Behavioral: nudging + educational activities Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : December 15, 2017

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




Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    Physical activity levels will be measured through a validated questionnaire including six questions about frequency and time of different physical activities domains.



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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): NCT03136016


Locations
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Brazil
10 Schools of Metropolitan Area
Duque de Caxias, Rio De Janeiro, Brazil
Sponsors and Collaborators
Rio de Janeiro State University
Oswaldo Cruz Foundation
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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    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
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