Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School

September 16, 2019 updated by: Rosely Sichieri, Rio de Janeiro State University
The main objective is to evaluate the effects of a multicomponent, school-based intervention combining change in nutritional behaviors with after school physical activity activities in reducing the excessive weight gain in schoolchildren.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific objectives are:

- evaluate the effect of the program on: change in nutritional behaviors, such as reducing sugar sweetened beverages and cookies intake reduction of time spent in sedentary activities gains in school performance and cognition outcomes the amount of daily physical activity on the percentage of body fat, changes in biochemical markers and blood pressure.

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio De Janeiro
      • Niterói, Rio De Janeiro, Brazil
        • Public schools

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:

  • 6th and 7th 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
Reduction of sugar sweetened beverages. cookies, sedentary activities and increasing physical activity
Behavioral: Eating behavior and physical activity change
A combination of two prevention school based programs will be addressed to schoolchildren over one year. Primary prevention will be developed monthly in order to reduce cookies and sugar sweetened beverages consumption, reduction of sedentary activities, increase meal consumption frequency and quality etc, in all children from 6th and 7th grades. Overweight and obese children will be invited to participate on a secondary prevention program in which daily physical activity classes will be performed by physical education teachers in school facilities.

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
Time Frame
Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean
Time Frame: One year
One year

Other Outcome Measures

Outcome Measure
Time Frame
Sedentary activities
Time Frame: One year
One year
Sugar sweetened beverages intake
Time Frame: one year
one year
cookies intake
Time Frame: one year
one year
fruits intake
Time Frame: one year
one year
physical activity
Time Frame: one year
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

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)

February 15, 2014

Primary Completion (Actual)

November 15, 2014

Study Completion (Actual)

December 15, 2014

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

September 19, 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-PAPPAS2-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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