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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01419951
First received: August 5, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Obesity
Behavioral: Clinic + Home Behavioral Intervention
Other: Pediatrician Counseling
Behavioral: Clinic Only Behavioral Intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Change in BMI z score [ Time Frame: Change from Baseline to 6 months ] [ Designated as safety issue: Yes ]
    Body mass index z score


Secondary Outcome Measures:
  • Change in Parent weight loss [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Child caloric intake [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: Yes ]
  • Change in Home food and activity environment [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Child physical activity [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Parent-child mealtime interactions [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Health related quality of life [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419951

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Lori J Stark, Ph.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01419951     History of Changes
Other Study ID Numbers: 2008-0666, K24DK059492
Study First Received: August 5, 2011
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Behavioral treatment
Preschool aged children
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014