Primary Care Obesity Prevention and Treatment

This study has been completed.
Sponsor:
Collaborators:
Group Health
Fred Hutchinson Cancer Research Center
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00944164
First received: July 9, 2009
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

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 Intervention
Obesity
Behavioral: Healthy eating and physical activity
Behavioral: Safety and injury prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Test the Feasibility of Primary Care Obesity Prevention and Treatment - Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Feasibility of recruiting and retaining families [ Time Frame: Enrollment to 3-month followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child weight (BMI) [ Time Frame: Baseline and 3-months post ] [ Designated as safety issue: No ]
  • Parental perceptions of child weight [ Time Frame: Baseline and 3-months post intervention ] [ Designated as safety issue: No ]
  • Satisfaction with intervention [ Time Frame: 3-months post intervention ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: September 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 9 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Rona Levy, University of Washington
ClinicalTrials.gov Identifier: NCT00944164     History of Changes
Other Study ID Numbers: HS-06-C40
Study First Received: July 9, 2009
Last Updated: July 21, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014