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Clinical Trials/NCT01419951
NCT01419951CompletedPhase 1

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

Children's Hospital Medical Center, Cincinnati2 sites in 1 country60 target enrollmentStarted: May 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Change in BMI z score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Change in BMI z score

Time Frame: Change from Baseline to 6 months

Body mass index z score

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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