NCT03136016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

April 27, 2017

Last Update Submit

September 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Fruit consumption

    6 months

  • Vegetable consumption

    6 months

  • Water consumption

    6 months

  • Physical activity

    6 months

Study Arms (4)

control

NO INTERVENTION

without any activity

educational activities

EXPERIMENTAL

The students will receive educational activities in the classroom.

Behavioral: educational activities

nudging

EXPERIMENTAL

The students will receive changes in the school environment (nudge strategies);

Behavioral: nudging

nudging + educational activities

EXPERIMENTAL

The students will receive educational activities and changes in the school environment.

Behavioral: nudging + educational activities

Interventions

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

educational activities
nudgingBEHAVIORAL

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

nudging

Group 4 will receive both interventions

nudging + educational activities

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • pregnant girls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

10 Schools of Metropolitan Area

Duque de Caxias, Rio de Janeiro, Brazil

Location

Related Publications (1)

  • Antunes ABS, Hassan BK, Pinto RL, Sichieri R, Cunha DB. A choice architecture intervention targeting school meals and water frequency intake: A school-based randomized trial. Appetite. 2024 Feb 1;193:107118. doi: 10.1016/j.appet.2023.107118. Epub 2023 Nov 17.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 2, 2017

Study Start

March 1, 2017

Primary Completion

November 15, 2017

Study Completion

December 15, 2017

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations