search
Back to results

Sports to Prevent Obesity: Feasibility and Pilot RCT

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
After school sports program
After school health education
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Physical activity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: In 4th or 5th grade of a participating school at time of enrollment BMI greater than or equal to the 85th percentile on the 2000 CDC growth charts Medical clearance obtained from primary care provider Exclusion Criteria: Our goal is to be inclusive as possible, however, children will not be eligible to participate if they: have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g. significant structural heart disease) are pregnant have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease) have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year are taking other medications potentially affecting their growth and/or weight (e.g. methylphenidate HCL) are unable to complete the informed consent process

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    After school sports

    After school health education

    Arm Description

    After school team sports intervention designed specifically for overweight and obese children

    After school heath and nutrition education program

    Outcomes

    Primary Outcome Measures

    Body mass index

    Secondary Outcome Measures

    Waist circumference
    Triceps skinfold thickness
    Resting heart rate
    Physical activity monitoring
    Sedentary behaviors
    Psychosocial measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    July 11, 2012
    Sponsor
    Stanford University
    Collaborators
    Association of American Medical Colleges, Centers for Disease Control and Prevention
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00186173
    Brief Title
    Sports to Prevent Obesity: Feasibility and Pilot RCT
    Official Title
    Sports to Prevent Obesity: Feasibility and Pilot RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    February 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stanford University
    Collaborators
    Association of American Medical Colleges, Centers for Disease Control and Prevention

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to learn whether overweight children who participate in an after school sports program improve their health as much as overweight children in a more traditional health education program.
    Detailed Description
    After school sports programs may be generalizable, motivating and cost-efficient interventions for long-term weight control among at-risk and overweight children. The infrastructure needed to provide such programs already exists in most communities. In contrast, more traditional, medically- and behaviorally-oriented treatment programs are expensive, generally not very effective, often inconvenient, and not available in most communities. While children involved in team sports tend to be more physically fit than their uninvolved peers, team sports has not yet been tested as a method to increase involvement of at-risk and overweight children in regular physical activity. As an added bonus, these sports programs can displace typical after school television viewing and snacking. Team sports is a potentially innovative and high impact approach for intervening with at-risk and overweight children, as it may provide an opportunity to reduce weight gain while increasing social interaction and self-esteem. If our proposed research finds that team sports are an efficacious intervention for reducing weight gain among low-income at-risk and overweight children, it is an intervention approach that could be rapidly diffused and tested for effectiveness. The policy implications of these findings would be great, encouraging expanded access to team sports programs to a population that has not been previously targeted or included. We propose a two-phase project in East Palo Alto, California, a low-income, primarily Latino, African-American and Pacific Islander community. The first phase will be a 3-month feasibility trial of an after school team sports program for overweight children to examine several theory-driven approaches to program design and implementation, including assessments of liking and participation and barriers and facilitators of participation. The second phase will be a 6-month randomized controlled pilot trial (RCT) comparing weight changes among overweight children randomized to participate in the after school team sports program versus a traditional weight control/health education program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Obesity, Physical activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    After school sports
    Arm Type
    Experimental
    Arm Description
    After school team sports intervention designed specifically for overweight and obese children
    Arm Title
    After school health education
    Arm Type
    Active Comparator
    Arm Description
    After school heath and nutrition education program
    Intervention Type
    Behavioral
    Intervention Name(s)
    After school sports program
    Intervention Description
    After school team sports intervention designed specifically for overweight and obese children
    Intervention Type
    Behavioral
    Intervention Name(s)
    After school health education
    Intervention Description
    After school health and nutrition education program
    Primary Outcome Measure Information:
    Title
    Body mass index
    Time Frame
    Baseline, 3 and 6 months
    Secondary Outcome Measure Information:
    Title
    Waist circumference
    Time Frame
    Baseline, 3 and 6 months
    Title
    Triceps skinfold thickness
    Time Frame
    baseline, 3 and 6 months
    Title
    Resting heart rate
    Time Frame
    baseline, 3 and 6 months
    Title
    Physical activity monitoring
    Time Frame
    baseline, 3 and 6 months
    Title
    Sedentary behaviors
    Time Frame
    baseline, 3 and 6 months
    Title
    Psychosocial measures
    Time Frame
    baseline, 3 and 6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: In 4th or 5th grade of a participating school at time of enrollment BMI greater than or equal to the 85th percentile on the 2000 CDC growth charts Medical clearance obtained from primary care provider Exclusion Criteria: Our goal is to be inclusive as possible, however, children will not be eligible to participate if they: have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g. significant structural heart disease) are pregnant have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease) have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year are taking other medications potentially affecting their growth and/or weight (e.g. methylphenidate HCL) are unable to complete the informed consent process
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas N Robinson, MD, MPH
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Dana L Weintraub, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18316660
    Citation
    Weintraub DL, Tirumalai EC, Haydel KF, Fujimoto M, Fulton JE, Robinson TN. Team sports for overweight children: the Stanford Sports to Prevent Obesity Randomized Trial (SPORT). Arch Pediatr Adolesc Med. 2008 Mar;162(3):232-7. doi: 10.1001/archpediatrics.2007.43.
    Results Reference
    result

    Learn more about this trial

    Sports to Prevent Obesity: Feasibility and Pilot RCT

    We'll reach out to this number within 24 hrs