Sports to Prevent Obesity: Feasibility and Pilot RCT

This study has been completed.
Sponsor:
Collaborators:
Association of American Medical Colleges
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00186173
First received: September 13, 2005
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Obesity
Behavioral: After school sports program
Behavioral: After school health education
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sports to Prevent Obesity: Feasibility and Pilot RCT

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Body mass index [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist circumference [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Triceps skinfold thickness [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Resting heart rate [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Physical activity monitoring [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Sedentary behaviors [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Psychosocial measures [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: November 2004
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT00186173

Sponsors and Collaborators
Stanford University
Association of American Medical Colleges
Investigators
Principal Investigator: Thomas N Robinson, MD, MPH Stanford University
Study Director: Dana L Weintraub, MD Stanford University
  More Information

Publications:
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00186173     History of Changes
Other Study ID Numbers: MM-0851-05/05, SPO#31174
Study First Received: September 13, 2005
Last Updated: July 11, 2012
Health Authority: United States: Federal Government

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