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Reducing Pediatric Obesity Through After-school Programs

This study has been completed.
Sponsor:
Collaborators:
San Francisco Unified School District
America SCORES, Bay Area
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01156103
First received: February 17, 2009
Last updated: April 6, 2011
Last verified: April 2011
History of Changes

February 17, 2009
April 6, 2011
August 2009
May 2010   (final data collection date for primary outcome measure)
Change in BMI z-score [ Time Frame: Baseline (0 months) and 9 months ] [ Designated as safety issue: No ]
Change in BMI z-score [ Time Frame: 1 school-year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01156103 on ClinicalTrials.gov Archive Site
Change in Aerobic capacity [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]
Change in aerobic capacity [ Time Frame: 1 school-year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Reducing Pediatric Obesity Through After-school Programs
Reducing Pediatric Obesity Through After-school Programs

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Behavioral: America SCORES, Bay Area
After-school program promoting physical activity via soccer 3 days/week
  • Experimental: SCORES
    America SCORES, Bay Area, after-school program
    Intervention: Behavioral: America SCORES, Bay Area
  • No Intervention: Usual care
    Standard after-school programming
    Intervention: Behavioral: America SCORES, Bay Area
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
December 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01156103
H48814-32411-0, 1K23HD054470-01A1
No
Kristine A. Madsen, The Regents of the University of California
University of California, San Francisco
  • San Francisco Unified School District
  • America SCORES, Bay Area
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Kristine A Madsen, MD, MPH University of California, San Francisco
University of California, San Francisco
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP