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Sports to Prevent Obesity: Feasibility and Pilot RCT

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ClinicalTrials.gov Identifier: NCT00186173
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 13, 2012
Association of American Medical Colleges
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: After school sports program Behavioral: After school health education Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sports to Prevent Obesity: Feasibility and Pilot RCT
Study Start Date : November 2004
Actual Primary Completion Date : February 2006

Arm Intervention/treatment
Experimental: After school sports
After school team sports intervention designed specifically for overweight and obese children
Behavioral: After school sports program
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
Behavioral: After school health education
After school health and nutrition education program

Primary Outcome Measures :
  1. Body mass index [ Time Frame: Baseline, 3 and 6 months ]

Secondary Outcome Measures :
  1. Waist circumference [ Time Frame: Baseline, 3 and 6 months ]
  2. Triceps skinfold thickness [ Time Frame: baseline, 3 and 6 months ]
  3. Resting heart rate [ Time Frame: baseline, 3 and 6 months ]
  4. Physical activity monitoring [ Time Frame: baseline, 3 and 6 months ]
  5. Sedentary behaviors [ Time Frame: baseline, 3 and 6 months ]
  6. Psychosocial measures [ Time Frame: baseline, 3 and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186173

Sponsors and Collaborators
Stanford University
Association of American Medical Colleges
Centers for Disease Control and Prevention
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Principal Investigator: Thomas N Robinson, MD, MPH Stanford University
Study Director: Dana L Weintraub, MD Stanford University
Publications of Results:
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00186173    
Other Study ID Numbers: MM-0851-05/05
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012
Keywords provided by Stanford University:
Physical activity
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight