Behavioral Rx & Nutrition in Pediatric Chronic Disease

Completed · Phase 1/Phase 2

Conditions studied: Pediatric Obesity

In brief

The objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is: H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 months post-treatment.

Key facts

Study ID

NCT01018121

Run by

Children's Hospital Medical Center, Cincinnati

People needed

18

Starts

2007-11-01

Expected to finish

2009-09-01

Last updated by the study team

2009-11-23

Who can join

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

You may qualify if…

• child age between 2- 5 years;
• child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
• medical clearance from pediatrician; and
• at least one parent with a BMI > 25. -

You may not qualify if…

• non-English speaking;
• living more than 50 miles from the medical center;
• a disability/illness that would preclude engagement in at least moderate physical activity;
• medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.

Where it is running

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

Full record on ClinicalTrials.gov

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