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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Clinic + Home Behavioral Intervention
* Other: Pediatrician Counseling
* Behavioral: Clinic Only Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinic Only Behavioral Intervention<br>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<br>* 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.<br>|
| Active Comparator: Pediatrician Counseling<br>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<br>* 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.<br>|
| Experimental: Clinic + Home Behavioral Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI z score | Body mass index z score | Change from Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral treatment, Preschool aged children, Obesity