Primary Care Obesity Prevention and Treatment

July 21, 2009 updated by: University of Washington

Test the Feasibility of Primary Care Obesity Prevention and Treatment - Pilot Study

The overall objective of this pilot is to demonstrate the feasibility of a low-cost intervention targeting obesity prevention among children in a primary care setting.

Specifically, the investigators aim to answer the following questions:

Can the investigators recruit and retain patients using the methods proposed, and how easy or difficult will this process be?

Can physicians deliver the proposed intervention messages in the time the investigators have proposed?

Can the phone counselor reach participants and accomplish the goals outlined for these calls?

Can the investigators obtain the data proposed and within the proposed time frame?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55440
        • Health Partners Research Foundation
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • child BMI ≥ 70th percentile for age and sex according to CDC Growth Tables
  • child scheduled for an upcoming well child visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy eating/physical activity
Behavioral: Healthy eating and physical activity
Parent counseling and coaching regarding healthy eating and physical activity habits for their child
Active Comparator: Safety/Injury prevention
Behavioral: Safety and injury prevention
Parent counseling and coaching regarding general personal and household safety

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of recruiting and retaining families
Time Frame: Enrollment to 3-month followup
Enrollment to 3-month followup

Secondary Outcome Measures

Outcome Measure
Time Frame
Child weight (BMI)
Time Frame: Baseline and 3-months post
Baseline and 3-months post
Parental perceptions of child weight
Time Frame: Baseline and 3-months post intervention
Baseline and 3-months post intervention
Satisfaction with intervention
Time Frame: 3-months post intervention
3-months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Fred Hutchinson Cancer Center
Group Health

Investigators

  • Principal Investigator: Rona L Levy, MSW, PhD, MPH, University of Washington
  • Principal Investigator: Nancy Sherwood, PhD, Health Partners Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

July 23, 2009

Last Update Submitted That Met QC Criteria

July 21, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-06-C40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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