Sports to Prevent Obesity: Feasibility and Pilot RCT

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

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 16, 2005
• Last Update Posted Date: July 13, 2012
• Study Start Date: November 2004
• Actual Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 11, 2012): Body mass index [ Time Frame: Baseline, 3 and 6 months ]
• Original Primary Outcome Measures (submitted: September 13, 2005): Body mass index

Current Secondary Outcome Measures (submitted: July 11, 2012)

• Waist circumference [ Time Frame: Baseline, 3 and 6 months ]
• Triceps skinfold thickness [ Time Frame: baseline, 3 and 6 months ]
• Resting heart rate [ Time Frame: baseline, 3 and 6 months ]
• Physical activity monitoring [ Time Frame: baseline, 3 and 6 months ]
• Sedentary behaviors [ Time Frame: baseline, 3 and 6 months ]
• Psychosocial measures [ Time Frame: baseline, 3 and 6 months ]

Original Secondary Outcome Measures (submitted: September 13, 2005)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sports to Prevent Obesity: Feasibility and Pilot RCT
• Official Title: 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.

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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• Behavioral: After school sports program
  After school team sports intervention designed specifically for overweight and obese children
• Behavioral: After school health education
  After school health and nutrition education program

Study Arms

• Experimental: After school sports
  After school team sports intervention designed specifically for overweight and obese children
  Intervention: Behavioral: After school sports program
• Active Comparator: After school health education
  After school heath and nutrition education program
  Intervention: Behavioral: After school health education

• 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. doi: 10.1001/archpediatrics.2007.43.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2012): 21
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00186173
• Other Study ID Numbers: MM-0851-05/05; SPO#31174
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stanford University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current

Collaborators

• Association of American Medical Colleges
• Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Thomas N Robinson, MD, MPH; Stanford University
• Study Director: Dana L Weintraub, MD; Stanford University

• PRS Account: Stanford University
• Verification Date: July 2012