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OpenTrials
Completed

NCT Number: NCT02034994

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

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.

Completed

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Key information

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Schools

Niterói, Rio de Janeiro, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eating behavior and physical activity change

Behavioral

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.

Primary outcomes

  1. Body Mass Index

    Time frame: One Year

Secondary outcomes

  1. Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean

    Time frame: One year

Other outcomes

  1. Sedentary activities

    Time frame: One year

  2. Sugar sweetened beverages intake

    Time frame: one year

  3. cookies intake

    Time frame: one year

  4. fruits intake

    Time frame: one year

  5. physical activity

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Collaborators

  • Universidade Federal do Rio de Janeiro

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2014
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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