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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-04-2-0030 |
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| Name | Class |
|---|---|
| U.S. Air Force Office of the Surgeon General | FED |
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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Lifestyle Management (VLM) | Behavioral | 16 weekly lessons followed by monthly maintenance lessons |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | 1 year | |
| Lipid | 1 year | |
| A1C (if Applicable) |
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Inclusion Criteria:
Hypertension, Diabetes, glucose intolerance, dyslipidemia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Hess, MD, MSc | University of Pittsburgh Medical Center | Principal Investigator |
| Kathleen McTigue, MD, MSc | University of Pittsburgh Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11832527 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VLM Online Lifestyle Counseling | Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | VLM Online Lifestyle Counseling | Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight | Of the original 50 participants, 12 month data was collected for 45 (90%) of them. Analysis was conducted on those participants with 12 month data. | Posted | Mean | 95% Confidence Interval | kg | Baseline and 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VLM Online Lifestyle Counseling | Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen McTigue | University of Pittsburgh | 412-692-2940 | mctiguekm@upmc.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 1 year |
| Fat Consumption | 1 year |
| Health Related Quality of Life | 1 year |
| Physical Activity | 1 year |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Blood Pressure | Not Posted | 1 year |
| Secondary | Lipid | Not Posted | 1 year |
| Secondary | A1C (if Applicable) | Not Posted | 1 year |
| Secondary | Fat Consumption | Not Posted | 1 year |
| Secondary | Health Related Quality of Life | Not Posted | 1 year |
| Secondary | Physical Activity | Not Posted | 1 year |
| 0 |
| 50 |
| 0 |
| 50 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |