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

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Behavioral: Clinic Only Behavioral Intervention; Other: Pediatrician Counseling; Behavioral: Clinic + Home Behavioral Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01419951

2008-0666

K24DK059492 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Clinic Only Behavioral Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Clinic Only Behavioral Intervention

Pediatrician Counseling

Active Comparator group

Description:

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.

Treatment:

Other: Pediatrician Counseling

Clinic + Home Behavioral Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Clinic + Home Behavioral Intervention