Back to resultsCombining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Eating behavior and physical activity change
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring school-based intervention, after school physical activity, sugar sweetened beverages, sedentary behavior, schoolchildren
Eligibility 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
Sites / Locations
- Public Schools
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Reduction of sugar sweetened beverages. cookies, sedentary activities and increasing physical activity
No intervention
Outcomes
Primary Outcome Measures
Body Mass Index
Secondary Outcome Measures
Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean
Full Information
NCT ID
NCT02034994
First Posted
January 10, 2014
Last Updated
September 16, 2019
Sponsor
Rio de Janeiro State University
Collaborators
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT02034994
Brief Title
Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Official Title
Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2014 (Actual)
Primary Completion Date
November 15, 2014 (Actual)
Study Completion Date
December 15, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University
Collaborators
Universidade Federal do Rio de Janeiro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
school-based intervention, after school physical activity, sugar sweetened beverages, sedentary behavior, schoolchildren
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Reduction of sugar sweetened beverages. cookies, sedentary activities and increasing physical activity
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Eating behavior and physical activity change
Intervention Description
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 Outcome Measure Information:
Title
Body Mass Index
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Sedentary activities
Time Frame
One year
Title
Sugar sweetened beverages intake
Time Frame
one year
Title
cookies intake
Time Frame
one year
Title
fruits intake
Time Frame
one year
Title
physical activity
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Public Schools
City
Niterói
State/Province
Rio De Janeiro
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
We'll reach out to this number within 24 hrs