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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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, minority, child, physical fitness, school, physical activity

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

    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)
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    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

    Learn more about this trial

    Reducing Pediatric Obesity Through After-school Programs

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