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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

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE January 14, 2014
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE February 15, 2014
Actual Primary Completion Date November 15, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Body Mass Index [ Time Frame: One Year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2014)
  • Sedentary activities [ Time Frame: One year ]
  • Sugar sweetened beverages intake [ Time Frame: one year ]
  • cookies intake [ Time Frame: one year ]
  • fruits intake [ Time Frame: one year ]
  • physical activity [ Time Frame: one year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Official Title  ICMJE Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention group
    Reduction of sugar sweetened beverages. cookies, sedentary activities and increasing physical activity
    Intervention: Behavioral: Eating behavior and physical activity change
  • No Intervention: Control group
    No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
1200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2014
Actual Primary Completion Date November 15, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034994
Other Study ID Numbers  ICMJE IMS-PAPPAS2-project
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rosely Sichieri, Rio de Janeiro State University
Study Sponsor  ICMJE Rio de Janeiro State University
Collaborators  ICMJE Universidade Federal do Rio de Janeiro
Investigators  ICMJE Not Provided
PRS Account Rio de Janeiro State University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP