Sports to Prevent Obesity

NCT00318877 | Completed

• 2 other identifiers: 314871R03DK070580-01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; Physical activity

Outcome Measures

Primary Outcomes (1)

• Body mass index (BMI)

  baseline to follow-up

Secondary Outcomes (7)

• Waist circumference

  baseline to follow-up

• Triceps skinfold thickness

  baseline to follow-up

• Resting heart rate

  baseline to follow-up

• Blood pressure

  baseline to follow-up

• Physical activity monitoring

  baseline to follow-up

Study Arms (2)

After school sports

EXPERIMENTAL

After school team sports

Behavioral: After school team sports program

Health and Nutrition Education

ACTIVE COMPARATOR

Health and Nutrition Education Active Placebo Control

Behavioral: After school health education program

Interventions

After school team sports program BEHAVIORAL

After school sports

After school health education program BEHAVIORAL

Health and Nutrition Education

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• In the participating school district
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford Prevention Research Center

Palo Alto, California, 94305, United States

Location

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: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: May 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (1)