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
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 obesity
Started May 2009
Longer than P75 for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 22, 2014
October 1, 2014
2.4 years
August 5, 2011
October 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in BMI z score
Body mass index z score
Change from Baseline to 6 months
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
Clinic Only Behavioral Intervention
ACTIVE COMPARATORA 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.
Pediatrician Counseling
ACTIVE COMPARATORA 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.
Clinic + Home Behavioral Intervention
EXPERIMENTALA 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori J Stark, Ph.D.
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 18, 2011
Study Start
May 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2014
Last Updated
October 22, 2014
Record last verified: 2014-10