Sports to Prevent Obesity

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00318877
First received: April 25, 2006
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to learn whether overweight children who participate in an after school team sports program improve their health as much as overweight children in a more traditional health education program.


Condition Intervention
Obesity
Behavioral: After school team sports program
Behavioral: After school health education program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sports to Prevent Obesity Randomized Trial

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Body mass index (BMI) [ Time Frame: baseline to follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist circumference [ Time Frame: baseline to follow-up ] [ Designated as safety issue: No ]
  • Triceps skinfold thickness [ Time Frame: baseline to follow-up ] [ Designated as safety issue: No ]
  • Resting heart rate [ Time Frame: baseline to follow-up ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: baseline to follow-up ] [ Designated as safety issue: No ]
  • Physical activity monitoring [ Time Frame: baseline to follow-up ] [ Designated as safety issue: No ]
  • Sedentary behaviors [ Time Frame: baseline to follow-up ] [ Designated as safety issue: No ]
  • Psychosocial measures [ Time Frame: baseline to follow-up ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: May 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: After school sports
After school team sports
Behavioral: After school team sports program
Active Comparator: Health and Nutrition Education
Health and Nutrition Education Active Placebo Control
Behavioral: After school health education program

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.

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318877

Locations
United States, California
Stanford Prevention Research Center
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Thomas N Robinson, MD, MPH Stanford University
Study Director: Dana L Weintraub, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00318877     History of Changes
Other Study ID Numbers: 31487, 1 R03 DK70580-01
Study First Received: April 25, 2006
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Obesity
Physical activity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014