Nudging, Healthy Diet and Physical Activity

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: educational activities
* Behavioral: nudging
* Behavioral: nudging + educational activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5th and 6th grades students consent form signed by parents/tutors Exclusion Criteria: pregnant girls

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |