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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Other: Pediatrician Counseling; Behavioral: Clinic Only Behavioral Intervention; Behavioral: Clinic + Home Behavioral Intervention

• 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

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Primary Completion: 2011-10
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-20
• Last Update Posted: 2014-10-22

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

Arm && Interventions

Group	Intervention	Description
Pediatrician Counseling	Pediatrician Counseling	A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.
Clinic Only Behavioral Intervention	Clinic Only Behavioral Intervention	A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
Clinic + Home Behavioral Intervention	Clinic + Home Behavioral Intervention	A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.

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