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Primary Care Obesity Prevention and Treatment

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ClinicalTrials.gov Identifier: NCT00944164
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : July 23, 2009
Sponsor:
Collaborators:
Group Health
Fred Hutchinson Cancer Research Center
Information provided by:
University of Washington

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?


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Healthy eating and physical activity Behavioral: Safety and injury prevention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Test the Feasibility of Primary Care Obesity Prevention and Treatment - Pilot Study
Study Start Date : September 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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




Primary Outcome Measures :
  1. Feasibility of recruiting and retaining families [ Time Frame: Enrollment to 3-month followup ]

Secondary Outcome Measures :
  1. Child weight (BMI) [ Time Frame: Baseline and 3-months post ]
  2. Parental perceptions of child weight [ Time Frame: Baseline and 3-months post intervention ]
  3. Satisfaction with intervention [ Time Frame: 3-months post intervention ]


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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944164


Locations
United States, Minnesota
Health Partners Research Foundation
Minneapolis, Minnesota, United States, 55440
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Group Health
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Rona L Levy, MSW, PhD, MPH University of Washington
Principal Investigator: Nancy Sherwood, PhD Health Partners Research Foundation

Responsible Party: Rona Levy, University of Washington
ClinicalTrials.gov Identifier: NCT00944164     History of Changes
Other Study ID Numbers: HS-06-C40
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: July 23, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms