Sports to Prevent Obesity: Feasibility and Pilot RCT
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: After school sports
After school team sports intervention designed specifically for overweight and obese children
|
After school team sports intervention designed specifically for overweight and obese children
|
|
Active Comparator: After school health education
After school heath and nutrition education program
|
After school health and nutrition education program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body mass index
Time Frame: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Waist circumference
Time Frame: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
|
Triceps skinfold thickness
Time Frame: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
|
Resting heart rate
Time Frame: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
|
Physical activity monitoring
Time Frame: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
|
Sedentary behaviors
Time Frame: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
|
Psychosocial measures
Time Frame: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas N Robinson, MD, MPH, Stanford University
- Study Director: Dana L Weintraub, MD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary 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
- MM-0851-05/05
- SPO#31174
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.