Clinical trial NCT00409786: Virtual Lifestyle Management: Prevention Through the UPMC Patient Portal
Official title: Virtual Lifestyle Management: Prevention Through the UPMC Patient Portal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Diabetes
Internet
Obesity with high cardiovascular risk
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: U.S. Air Force Office of the Surgeon General
First posted: 2006-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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 University of Pittsburgh Medical Center (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.

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 University of Pittsburgh Medical Center (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 criteria: Inclusion Criteria:

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

Hypertension, Diabetes, glucose intolerance, dyslipidemia

* Age 18-80
* Agrees to participate in the Virtual Lifestyle Management (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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Blood Pressure
timeFrame: 1 year
measure: Lipid
timeFrame: 1 year
measure: A1C (if Applicable)
timeFrame: 1 year
measure: Fat Consumption
timeFrame: 1 year
measure: Health Related Quality of Life
timeFrame: 1 year
measure: Physical Activity
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Rachel Hess, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Kathleen McTigue, MD, MSc
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1056/NEJMoa012512.