Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity
Phase 1
Completed
- Conditions
- Obesity
- Registration Number
- NCT01419951
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in BMI z score Change from Baseline to 6 months Body mass index z score
- Secondary Outcome Measures
Name Time Method Change in Parent weight loss Change from baseline to 6 months Change in Child caloric intake Change from baseline to 6 months Change in Home food and activity environment Change from baseline to 6 months Change in Child physical activity Change from baseline to 6 months Change in Parent-child mealtime interactions Change from baseline to 6 months Change in Health related quality of life Change from baseline to 6 months
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center🇺🇸Cincinnati, Ohio, United States