Behavioral Rx & Nutrition in Pediatric Chronic Disease (LAUNCH)

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pediatric Obesity

Treatments: Behavioral: LAUNCH; Other: Pediatrician Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01018121

103254

K24DK059492 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Clinic and Home Behavioral Intervention

Experimental group

Treatment:

Behavioral: LAUNCH

Pediatrician Counseling

Active Comparator group

Treatment:

Other: Pediatrician Counseling