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

LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Clinic Only Behavioral Intervention; Other: Pediatrician Counseling; Behavioral: Clinic + Home Behavioral Intervention

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
Active Comparator: 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.	Other: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI z score	Body mass index z score	Change from Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Lori J Stark, Ph.D., Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: August 17, 2011
• First Posted (Estimate): August 18, 2011

Study Record Updates

• Last Update Posted (Estimate): October 22, 2014
• Last Update Submitted That Met QC Criteria: October 20, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; Behavioral treatment; Preschool aged children
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2008-0666; K24DK059492 (U.S. NIH Grant/Contract)