Reducing Pediatric Obesity Through After-school Programs
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: America SCORES, Bay Area |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Reducing Pediatric Obesity Through After-school Programs |
- Change in BMI z-score [ Time Frame: Baseline (0 months) and 9 months ] [ Designated as safety issue: No ]
- Change in Aerobic capacity [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]
| Enrollment: | 158 |
| Study Start Date: | August 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SCORES
America SCORES, Bay Area, after-school program
|
Behavioral: America SCORES, Bay Area
After-school program promoting physical activity via soccer 3 days/week
|
|
No Intervention: Usual care
Standard after-school programming
|
Behavioral: America SCORES, Bay Area
After-school program promoting physical activity via soccer 3 days/week
|
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.
Eligibility| Ages Eligible for Study: | 8 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Principal Investigator: | Kristine A Madsen, MD, MPH | University of California, San Francisco |
More Information
No publications provided by University of California, San Francisco
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kristine A. Madsen, The Regents of the University of California |
| ClinicalTrials.gov Identifier: | NCT01156103 History of Changes |
| Other Study ID Numbers: | H48814-32411-0, 1K23HD054470-01A1 |
| Study First Received: | February 17, 2009 |
| Last Updated: | April 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
obesity minority child |
physical fitness school physical activity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013