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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 13, 2005 | ||||||||
| Last Updated Date | July 19, 2007 | ||||||||
| Start Date ICMJE | November 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Body mass index | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00186173 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sports to Prevent Obesity: Feasibility and Pilot RCT | ||||||||
| Official Title ICMJE | Sports to Prevent Obesity: Feasibility and Pilot RCT | ||||||||
| 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. |
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| 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 Phase | Phase I, Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Obesity | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Our goal is to be inclusive as possible, however, children will not be eligible to participate if they:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00186173 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | MM-0851-05/05, SPO#31174 | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | July 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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