Reducing Pediatric Obesity Through After-school Programs

This study has been completed.
Sponsor:
Collaborators:
San Francisco Unified School District
America SCORES, Bay Area
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
  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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in BMI z-score [ Time Frame: Baseline (0 months) and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156103

Sponsors and Collaborators
University of California, San Francisco
San Francisco Unified School District
America SCORES, Bay Area
Investigators
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
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014