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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03128775
Other study ID # Nudgepaappas
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date December 2024

Study information

Verified date November 2023
Source Rio de Janeiro State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the present study is to estimate the effect of nudging proposals on the students' Body Mass Index, based on changes made in the school environment. This is a factorial randomized community trial, which will be conducted in 18 public schools in the city of Duque de Caxias, RJ.


Recruitment information / eligibility

Status Suspended
Enrollment 1300
Est. completion date December 2024
Est. primary completion date December 2024
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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nudge
School lunchrooms are the central place of modifications regarding food consumption, where the following strategies will be conducted: arrange the fruits served in the school lunch in a prominent position, in containers of bright and contrasting colors to serve them; Create creative names for food served at meals will be created by the students used on displays at canteen tables, posters on the way of the cafeteria and at a menu outside the cafeteria. To encourage water consumption, footprints that lead to them to water fountains will be painted on the floor. To stimulate physical activity, several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) will be available for use in the school sports court. The courts will be renovated and footsteps painted in order to nudging students to the sports equipment.
Primary prevention
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. Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
Primary prevention + nudge
This group will receive both primary prevention and nudge activities. At school lunchrooms, the fruits served in the school lunch will be put in a prominent position, in containers of bright and contrasting colors to serve them; create creative names for food served at meals will be created by the studentes, footprints that lead to them to water fountains will be painted on the floor. Several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) will be available for use in the schools sport court. Also, classroom-based educational activities based on an earlier study, called PAPPAS, will be held. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.

Locations

Country Name City State
Brazil 18 Schools of Metropolitan Area Duque de Caxias Rio De Janeiro

Sponsors (4)

Lead Sponsor Collaborator
Rio de Janeiro State University Oswaldo Cruz Foundation, Universidade Federal do Rio de Janeiro, University of Copenhagen

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body mass Index (BMI) The body weight will be measured by a portable electronic scale with a segmental body composition monitor (Tanita BC-558). The height will be measure by a portable stadiometer (brand: "AlturaExata"). BMI will be calculated as weight/stature*stature. 1 year
Secondary body fat percentage Body fat percentage will be measured by a portable electronic scale with a segmental body composition monitor (Tanita BC-558). 1 year
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