Nudging, Healthy Diet and Physical Activity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136016
• Other study ID #: nudgingpaappas
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: September 2019
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 15, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

pregnant girls

Related Conditions & MeSH terms

• Obesity

Intervention

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
• nudging
In group 3, changes in the environment will be included that will facilitate both physical activity and healthy food choices
• nudging + educational activities
Group 4 will receive both interventions

Locations

Country	Name	City	State
Brazil	10 Schools of Metropolitan Area	Duque de Caxias	Rio De Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Oswaldo Cruz Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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