Reducing Pediatric Obesity Through After-school Programs

Obesity Clinical Trial

Official title:

Reducing Pediatric Obesity Through After-school Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156103
• Other study ID #: H48814-32411-0
• Secondary ID: 1K23HD054470-01A
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: May 7, 2015
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• America SCORES, Bay Area
After-school program promoting physical activity via soccer 3 days/week

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	America SCORES, Bay Area, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), San Francisco Unified School District

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI z-score		Baseline (0 months) and 9 months	No
Secondary	Change in Aerobic capacity		Baseline and 9 months	No