Virtual Lifestyle Management: Prevention Through the UPMC Patient Portal - Full Text View

Sponsors and Collaborators:	University of Pittsburgh U.S. Air Force Office of the Surgeon General
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00409786

Purpose

Diabetes affects 18 million Americans and costs over $132 billion in both direct treatment and lost productivity per year. It is known that weight loss, improved diet and increased exercise can result in improvement in glucose, lipid, and blood pressure control in patients with diabetes and reduce the incidence of diabetes in individuals at high risk. Effective delivery of proven, comprehensive lifestyle programs is difficult because of associated high costs.

The internet provides a venue to deliver these lifestyle programs to large numbers of individuals while decreasing the cost per person. HealthTrak, the UPMC patient portal, provides an ideal setting to test such a program. HealthTrak provides participants with access to individual medical information while facilitating electronic communication with their physicians. Portal enhancements will allow the delivery of a comprehensive lifestyle intervention aimed at weight loss, improved diet, and increased exercise, and provide the opportunity to communicate with experts regarding concerns.

Through this project, we will evaluate the modification of a successful comprehensive lifestyle intervention for delivery through HealthTrak. We will enroll and follow 50 individuals with diabetes or at high risk for diabetes for 12 months and examine change in parameters including diet, weight, physical activity, hemoglobin A1C, glucose, blood pressure, and lipid profile.

Condition	Intervention
Obesity	Behavioral: Virtual Lifestyle Management

MedlinePlus related topics: Diabetes Diets Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Virtual Lifestyle Management: Prevention Through the UPMC Patient Portal

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Change in weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood Pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Lipid [ Time Frame: 1 year ] [ Designated as safety issue: No ]
A1C (if applicable) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Fat consumption [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Health Related Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Physical activity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2008

Intervention Details:

16 weekly lessons followed by monthly maintenance lessons

Detailed Description:

Diabetes affects 18 million Americans and costs over $132 billion in both direct treatment and lost productivity per year. It is known that weight loss, improved diet and increased exercise can result in improvement in glucose, lipid, and blood pressure control in patients with diabetes and reduce the incidence of diabetes in individuals at high risk. Effective delivery of proven, comprehensive lifestyle programs is difficult because of associated high costs.

The internet provides a venue to deliver these lifestyle programs to large numbers of individuals while decreasing the cost per person. HealthTrak, the UPMC patient portal, provides an ideal setting to test such a program. HealthTrak provides participants with access to individual medical information while facilitating electronic communication with their physicians. Portal enhancements will allow the delivery of a comprehensive lifestyle intervention aimed at weight loss, improved diet, and increased exercise, and provide the opportunity to communicate with experts regarding concerns.

Through this project, we will evaluate the modification of a successful comprehensive lifestyle intervention for delivery through HealthTrak. We will enroll and follow 50 individuals with diabetes or at high risk for diabetes for 12 months and examine change in parameters including diet, weight, physical activity, hemoglobin A1C, glucose, blood pressure, and lipid profile

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Overweight (BMI≥25) and one of the following:

HTN, Diabetes, glucose intolerance, dyslipidemia

Age 18-80
Agrees to participate in the VLM program and evaluation
Computer access to UPMC Health Trak
Regular access to a scale

Exclusion Criteria:

Pregnancy
Inability to participate in moderate exercise as determined by the primary care physician

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409786

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

U.S. Air Force Office of the Surgeon General

Investigators

Principal Investigator:	Rachel Hess, MD, MSc	University of Pittsburgh
Study Director:	Kathleen McTigue, MD, MSc	University of Pittsburgh

More Information

Publications:

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.

Responsible Party:	University of Pittsburgh ( Kathleen McTigue )
Study ID Numbers:	0606089, W81XWH-04-2-0030
Study First Received:	December 7, 2006
Last Updated:	December 16, 2007
ClinicalTrials.gov Identifier:	NCT00409786 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Obesity
Diabetes
Internet
Obesity with high cardiovascular risk

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Diabetes Mellitus

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009