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

Overview

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.

Full Title of Study: “LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2011

Interventions

  • 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.
  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in BMI z score
    • Time Frame: Change from Baseline to 6 months
    • Body mass index z score

Secondary Measures

  • Change in Parent weight loss
    • Time Frame: Change from baseline to 6 months
  • Change in Child caloric intake
    • Time Frame: Change from baseline to 6 months
  • Change in Home food and activity environment
    • Time Frame: Change from baseline to 6 months
  • Change in Child physical activity
    • Time Frame: Change from baseline to 6 months
  • Change in Parent-child mealtime interactions
    • Time Frame: Change from baseline to 6 months
  • Change in Health related quality of life
    • Time Frame: Change from baseline to 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Children’s Hospital Medical Center, Cincinnati
  • Collaborator
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lori J Stark, Ph.D., Principal Investigator, Children’s Hospital Medical Center, Cincinnati

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