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

Summary

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.

Conditions

• Obesity

Interventions

BEHAVIORAL

Clinic + Home Behavioral Intervention

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.

OTHER

Pediatrician Counseling

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.

BEHAVIORAL

Clinic Only Behavioral Intervention

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Center for Research Resources (NCRR)

  collaborator NIH

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Lori J Stark, Ph.D. · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

5 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-05-31

Primary Completion

2011-10-31

Completion

2014-10-31

Countries

• United States

Study Locations