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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
NameTimeMethod
Change in BMI z scoreChange from Baseline to 6 months

Body mass index z score

Secondary Outcome Measures
NameTimeMethod
Change in Parent weight lossChange from baseline to 6 months
Change in Child caloric intakeChange from baseline to 6 months
Change in Home food and activity environmentChange from baseline to 6 months
Change in Child physical activityChange from baseline to 6 months
Change in Parent-child mealtime interactionsChange from baseline to 6 months
Change in Health related quality of lifeChange 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

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