- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318877
Sports to Prevent Obesity
Sports to Prevent Obesity Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is an urgent need for feasible, effective, and cost-efficient programs to help overweight children control their weight. To start to address this unmet need, we are evaluating after school team sports as an intervention for reducing weight gain among low-income and at-risk of being overweight, and overweight children. 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 1 year randomized controlled trial comparing weight changes among low-income, overweight children randomized to participate in an after school team sports program versus a traditional weight control/health education program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Stanford Prevention Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- In the participating school district
- 8-11.9 years old
- BMI >= 85th percentile for age and sex on the 2000 Centers for Disease Control (CDC) growth charts
- Clearance to participate from medical care provider
- Willing, able, and available to attend an after school program
- Not planning to move from school district within the next 12 months
- Speaks and reads English or Spanish
- Child has not repeated more than one grade in school
- Completion of signed active informed consent (parent or guardian) and assent (child) to participate, which includes a description of the two interventions and requires their willingness to be randomized.
Exclusion Criteria:
The investigators' goal is to be as 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)
- 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 affecting their growth and/or weight [e.g. methylphenidate hydrochloride (HCL)]
- Are pregnant
- Are unable to complete the informed consent process
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: After school sports
After school team sports
|
|
|
Active Comparator: Health and Nutrition Education
Health and Nutrition Education Active Placebo Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body mass index (BMI)
Time Frame: baseline to follow-up
|
baseline to follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Waist circumference
Time Frame: baseline to follow-up
|
baseline to follow-up
|
|
Triceps skinfold thickness
Time Frame: baseline to follow-up
|
baseline to follow-up
|
|
Resting heart rate
Time Frame: baseline to follow-up
|
baseline to follow-up
|
|
Blood pressure
Time Frame: baseline to follow-up
|
baseline to follow-up
|
|
Physical activity monitoring
Time Frame: baseline to follow-up
|
baseline to follow-up
|
|
Sedentary behaviors
Time Frame: baseline to follow-up
|
baseline to follow-up
|
|
Psychosocial measures
Time Frame: baseline to follow-up
|
baseline to follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas N Robinson, MD, MPH, Stanford University
- Study Director: Dana L Weintraub, MD, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31487
- 1R03DK070580-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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