Reducing Pediatric Obesity Through After-school Programs
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
America SCORES, Bay Area
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, minority, child, physical fitness, school, physical activity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SCORES
Usual care
Arm Description
America SCORES, Bay Area, after-school program
Standard after-school programming
Outcomes
Primary Outcome Measures
Change in BMI z-score
Secondary Outcome Measures
Change in Aerobic capacity
Full Information
NCT ID
NCT01156103
First Posted
February 17, 2009
Last Updated
May 7, 2015
Sponsor
University of California, San Francisco
Collaborators
San Francisco Unified School District, America SCORES, Bay Area, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01156103
Brief Title
Reducing Pediatric Obesity Through After-school Programs
Official Title
Reducing Pediatric Obesity Through After-school Programs
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Unified School District, America SCORES, Bay Area, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, minority, child, physical fitness, school, physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCORES
Arm Type
Experimental
Arm Description
America SCORES, Bay Area, after-school program
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Standard after-school programming
Intervention Type
Behavioral
Intervention Name(s)
America SCORES, Bay Area
Intervention Description
After-school program promoting physical activity via soccer 3 days/week
Primary Outcome Measure Information:
Title
Change in BMI z-score
Time Frame
Baseline (0 months) and 9 months
Secondary Outcome Measure Information:
Title
Change in Aerobic capacity
Time Frame
Baseline and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine A Madsen, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23440308
Citation
Madsen K, Thompson H, Adkins A, Crawford Y. School-community partnerships: a cluster-randomized trial of an after-school soccer program. JAMA Pediatr. 2013 Apr;167(4):321-6. doi: 10.1001/jamapediatrics.2013.1071.
Results Reference
derived
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Reducing Pediatric Obesity Through After-school Programs
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