Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
1 other identifier
interventional
1,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Feb 2014
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedStudy Start
First participant enrolled
February 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2014
CompletedSeptember 19, 2019
September 1, 2019
9 months
January 10, 2014
September 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Mass Index
One Year
Secondary Outcomes (1)
Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean
One year
Other Outcomes (5)
Sedentary activities
One year
Sugar sweetened beverages intake
one year
cookies intake
one year
- +2 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALReduction of sugar sweetened beverages. cookies, sedentary activities and increasing physical activity
Control group
NO INTERVENTIONNo intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- Both prevention programs:
- th and 7th grades students
- consent form signed by parents / tutors
- Secondary prevention program:
- \- overweight and obese children
You may not qualify if:
- pregnant girls
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Public Schools
Niterói, Rio de Janeiro, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD. Full Professor of Epidemiology
Study Record Dates
First Submitted
January 10, 2014
First Posted
January 14, 2014
Study Start
February 15, 2014
Primary Completion
November 15, 2014
Study Completion
December 15, 2014
Last Updated
September 19, 2019
Record last verified: 2019-09