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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01419951
First received: August 5, 2011
Last updated: October 20, 2014
Last verified: October 2014
  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
Study Completion Date: October 2014
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 20, 2014
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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014