Behavioral Rx & Nutrition in Pediatric Chronic Disease

Study Overview
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Brief Summary
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The objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is: H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 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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Pediatric Obesity

Intervention / Treatment
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* Behavioral: LAUNCH
* Other: Pediatrician Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child age between 2- 5 years; child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI; medical clearance from pediatrician; and at least one parent with a BMI > 25. - Exclusion Criteria: non-English speaking; living more than 50 miles from the medical center; a disability/illness that would preclude engagement in at least moderate physical activity; medical condition/medication associated with weight gain; or 5) enrolled in another weight control 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 |
| --- | --- |
| Experimental: Clinic and Home Behavioral Intervention<br> | Behavioral: LAUNCH<br>* A 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions. Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity.<br>|
| Active Comparator: Pediatrician Counseling<br> | Other: Pediatrician Counseling<br>* A one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z score |  | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent weight loss |  | baseline, 24 weeks, 48 weeks | 
| Child caloric intake |  | baseline, 6 months, 12 months | 
| Home food and activity environment |  | baseline, 6 months, 12 months | 
| Child physical activity |  | baseline, 6 motnhs, 12 months | 
| Parent-child mealtime interactions |  | baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Treatment, Preschool Children, Obesity Treatment