Sports to Prevent Obesity: Feasibility and Pilot RCT

NCT00186173 | Completed Phase 1

• 2 other identifiers: MM-0851-05/05SPO#31174
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Obesity; Physical activity

Outcome Measures

Primary Outcomes (1)

• Body mass index

  Baseline, 3 and 6 months

Secondary Outcomes (6)

• Waist circumference

  Baseline, 3 and 6 months

• Triceps skinfold thickness

  baseline, 3 and 6 months

• Resting heart rate

  baseline, 3 and 6 months

• Physical activity monitoring

  baseline, 3 and 6 months

• Sedentary behaviors

  baseline, 3 and 6 months

Study Arms (2)

After school sports

EXPERIMENTAL

After school team sports intervention designed specifically for overweight and obese children

Behavioral: After school sports program

After school health education

ACTIVE COMPARATOR

After school heath and nutrition education program

Behavioral: After school health education

Interventions

After school sports program BEHAVIORAL

After school team sports intervention designed specifically for overweight and obese children

After school sports

After school health education BEHAVIORAL

After school health and nutrition education program

After school health education

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Association of American Medical Colleges: collaborator
• Centers for Disease Control and Prevention: collaborator

Related Publications (1)

• 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.

  PMID: 18316660 RESULT

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Thomas N Robinson, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Dana L Weintraub, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2004
• Primary Completion: February 1, 2006
• Last Updated: July 13, 2012

Record last verified: 2012-07