NCT01156103

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

9 months

First QC Date

February 17, 2009

Last Update Submit

May 7, 2015

Conditions

Keywords

obesityminoritychildphysical fitnessschoolphysical activity

Outcome Measures

Primary Outcomes (1)

  • Change in BMI z-score

    Baseline (0 months) and 9 months

Secondary Outcomes (1)

  • Change in Aerobic capacity

    Baseline and 9 months

Study Arms (2)

SCORES

EXPERIMENTAL

America SCORES, Bay Area, after-school program

Behavioral: America SCORES, Bay Area

Usual care

NO INTERVENTION

Standard after-school programming

Interventions

After-school program promoting physical activity via soccer 3 days/week

SCORES

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • rd-5th grade student enrolled in after-school program in San Francisco Unified School District

You may not qualify if:

  • Uncontrolled asthma
  • Unable to participate in moderate physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Kristine A Madsen, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2009

First Posted

July 2, 2010

Study Start

August 1, 2009

Primary Completion

May 1, 2010

Study Completion

December 1, 2010

Last Updated

May 8, 2015

Record last verified: 2015-05