Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity

Completed · Phase 1

Conditions studied: Obesity

In brief

The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial. H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.

Key facts

Study ID

NCT01419951

Run by

Children's Hospital Medical Center, Cincinnati

People needed

60

Starts

2009-05-01

Expected to finish

2014-10-01

Last updated by the study team

2014-10-22

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 2 years 0 months to 5 years 11 months of age
• at or above the 95th percentile BMI for age and sex
• have at least one parent with a BMI at or greater than 25
• medical clearance from pediatrician

You may not qualify if…

• non-English speaking
• living greater than 50 miles from medical center
• a disability or illness that would preclude engagement in moderate activity
• medical condition/medication associated with weight
• enrolled in another weight management program

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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