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Behavioral Treatment for Obese Preschoolers

NCT01546727 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2016-12-28

No results posted yet for this study

Summary

This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic and home family behavioral intervention (LAUNCH) against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the criteria for obesity (\>95th percentile for body mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary end-point will be change in BMI z-score at the end of treatment. The investigators will also assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in factors thought to be mechanisms for change in weight (food intake and activity level), changes in the obesiogenic environment (parent weight, food intake and activity, and changes in the home food environment) and factors that could be negatively impacted (parent and child eating and feeding interactions).

Conditions

Interventions

BEHAVIORAL

Behavioral Family Intervention

Three months of weekly treatment delivered via alternating group based clinic visits and individual home visits followed by three months of every other week treatment alternating between clinic and home.

BEHAVIORAL

Motivational Interviewing

Motivational interviewing will be delivered at the same frequency at the behavioral intervention with 4 in-person visits spaced at the first visit, month 3 and month 5. Phone calls will be conducted weekly during the first 3 months and every other week during months 4 through 6.

Sponsors & Collaborators

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

    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
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01546727 on ClinicalTrials.gov