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

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ClinicalTrials.gov Identifier: NCT02034994
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Universidade Federal do Rio de Janeiro
Information provided by (Responsible Party):
Rosely Sichieri, Rio de Janeiro State University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Eating behavior and physical activity change Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Actual Study Start Date : February 15, 2014
Actual Primary Completion Date : November 15, 2014
Actual Study Completion Date : December 15, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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.
No Intervention: Control group
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean [ Time Frame: One year ]

Other Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   9 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034994


Locations
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Brazil
Public Schools
Niterói, Rio De Janeiro, Brazil
Sponsors and Collaborators
Rio de Janeiro State University
Universidade Federal do Rio de Janeiro
More Information
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Responsible Party: Rosely Sichieri, MD, PhD. Full Professor of Epidemiology, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT02034994    
Other Study ID Numbers: IMS-PAPPAS2-project
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Rosely Sichieri, Rio de Janeiro State University:
school-based intervention
after school physical activity
sugar sweetened beverages
sedentary behavior
schoolchildren
Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight