Reducing Pediatric Obesity Through After-school Programs
May 7, 2015 updated by: University of California, San Francisco
This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children.
The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants.
The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program.
Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test).
Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference.
The investigators will also measure academic outcomes.
Study Overview
Detailed Description
Baseline measures were collected in September 2009; midpoint measures were collected in January 2010; and final measures were collected in May 2010.
Repeated measures analyses will compare trajectories for BMI, physical activity, and fitness between students in the SCORES and the usual care arms.
Study Type
Interventional
Enrollment (Actual)
158
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 3rd-5th grade student enrolled in after-school program in San Francisco Unified School District
Exclusion Criteria:
- Uncontrolled asthma
- Unable to participate in moderate physical activity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SCORES
America SCORES, Bay Area, after-school program
|
After-school program promoting physical activity via soccer 3 days/week
|
|
No Intervention: Usual care
Standard after-school programming
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in BMI z-score
Time Frame: Baseline (0 months) and 9 months
|
Baseline (0 months) and 9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Aerobic capacity
Time Frame: Baseline and 9 months
|
Baseline and 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kristine A Madsen, MD, MPH, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
July 1, 2010
First Posted (Estimate)
July 2, 2010
Study Record Updates
Last Update Posted (Estimate)
May 8, 2015
Last Update Submitted That Met QC Criteria
May 7, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H48814-32411-0
- 1K23HD054470-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.