Behavioral Rx & Nutrition in Pediatric Chronic Disease

Phase 1

Completed

• Conditions: Pediatric Obesity
• Interventions: Behavioral: LAUNCH; Other: Pediatrician Counseling

• Registration Number: NCT01018121
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-11
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-20
• Last Update Submitted: 2009-11-20
• Study First Posted: 2009-11-23
• Last Update Posted: 2009-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. child age between 2- 5 years;
2. child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
3. medical clearance from pediatrician; and
4. at least one parent with a BMI > 25. -

Exclusion Criteria

1. non-English speaking;
2. living more than 50 miles from the medical center;
3. a disability/illness that would preclude engagement in at least moderate physical activity;
4. medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinic and Home Behavioral Intervention	LAUNCH	-
Pediatrician Counseling	Pediatrician Counseling	-

Primary Outcome Measures

Name	Time	Method
BMI z score	Baseline, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States