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Completed

NCT Number: NCT03136016

Nudging, 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

10 Schools of Metropolitan Area

Duque de Caxias, Rio de Janeiro, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

pregnant girls

Treatment and study plan

Educational activities

Behavioral

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

nudging

Behavioral

In group 3, changes in the environment will be included that will facilitate both physical activity and healthy food choices

nudging + educational activities

Behavioral

Group 4 will receive both interventions

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Collaborators

  • Oswaldo Cruz Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 2, 2017
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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