Back to resultsPrimary Care Obesity Prevention and Treatment
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy eating and physical activity
Safety and injury prevention
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- child BMI ≥ 70th percentile for age and sex according to CDC Growth Tables
- child scheduled for an upcoming well child visit
Sites / Locations
- Health Partners Research Foundation
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Healthy eating/physical activity
Safety/Injury prevention
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of recruiting and retaining families
Secondary Outcome Measures
Child weight (BMI)
Parental perceptions of child weight
Satisfaction with intervention
Full Information
NCT ID
NCT00944164
First Posted
July 9, 2009
Last Updated
July 21, 2009
Sponsor
University of Washington
Collaborators
Group Health, Fred Hutchinson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00944164
Brief Title
Primary Care Obesity Prevention and Treatment
Official Title
Test the Feasibility of Primary Care Obesity Prevention and Treatment - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
Group Health, Fred Hutchinson Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy eating/physical activity
Arm Type
Experimental
Arm Title
Safety/Injury prevention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Healthy eating and physical activity
Intervention Description
Parent counseling and coaching regarding healthy eating and physical activity habits for their child
Intervention Type
Behavioral
Intervention Name(s)
Safety and injury prevention
Intervention Description
Parent counseling and coaching regarding general personal and household safety
Primary Outcome Measure Information:
Title
Feasibility of recruiting and retaining families
Time Frame
Enrollment to 3-month followup
Secondary Outcome Measure Information:
Title
Child weight (BMI)
Time Frame
Baseline and 3-months post
Title
Parental perceptions of child weight
Time Frame
Baseline and 3-months post intervention
Title
Satisfaction with intervention
Time Frame
3-months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
child BMI ≥ 70th percentile for age and sex according to CDC Growth Tables
child scheduled for an upcoming well child visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rona L Levy, MSW, PhD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Sherwood, PhD
Organizational Affiliation
Health Partners Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Partners Research Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55440
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
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Primary Care Obesity Prevention and Treatment
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