Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention (PAAPAS-DC)

September 16, 2019 updated by: Rosely Sichieri, Rio de Janeiro State University
The objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will combine primary prevention activities at the school level with secondary prevention at the household level, both focusing on behavior strategies such as mindfulness, reduction of eating rate; eating with others at a dinning table; healthy eating, increasing physical activity and reducing sedentary lifestyle habits.

Study Type

Interventional

Enrollment (Actual)

3000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both prevention programs
  • 5th and 6th grades students
  • consent form signed by parents/tutors
  • Secondary prevention program
  • Overweight and obese children

Exclusion Criteria:

  • pregnant girls

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention
Experimental: Intervention group
Combine primary prevention activities at the school level with secondary prevention at the household level
Behavioral: Intervention group

The proposed intervention will focus on encouraging students to change their eating habits and food consumption over 9 months (from March to November). Monthly 1-h sessions in the classroom will be given by the class teacher, and includes playing games, staging theater sketches, watching movies and puppet shows, and writing and drawing contests. The activities were designed to discourage students from consuming sugar-sweetened beverages as well as getting them to replace snacks, particularly processed foods (especially cookies) with fresh fruit or healthy homemade food. To reinforce the messages of the in-class nutritional sessions, a set of messages will be sent to the families in the form of illustrated booklets and recipes.

The secondary prevention strategy at households will be developed for those with excessive weight. The family will receive additional motivation to change these behaviors, using the community health agents as the encourager.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: one year
body composition will be estimated by bioelectrical impedance, using the leg=to=leg method with Tanita scales
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence to the protocol at household level
Time Frame: one year
will be measured by questionnaire
one year
physical activity
Time Frame: one year
will be measured by questionnaire
one year
physical activity
Time Frame: one year
In a subgroup will be measured by accelerometer (GT3X Actigraph).
one year
food intake
Time Frame: one year
Will be assessed by 24-hour recall
one year
food intake
Time Frame: one year
Will be assessed by a short (23 items) food frequency questionnaire (FFQ), reduced from a validated FFQ for Brazilian adolescents.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Collaborators

Universidade Federal do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

November 15, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMS-PAAPAS-project

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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