Obesity
Conditions
Keywords
Obesity, Diabetes, Internet, Obesity with high cardiovascular risk
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
Interventions
BEHAVIORALVirtual Lifestyle Management (VLM)
16 weekly lessons followed by monthly maintenance lessons
Sponsors
U.S. Air Force Office of the Surgeon General
University of Pittsburgh
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Weight | Baseline and 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Lipid | 1 year |
| A1C (if Applicable) | 1 year |
| Blood Pressure | 1 year |
| Health Related Quality of Life | 1 year |
| Physical Activity | 1 year |
| Fat Consumption | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VLM Online Lifestyle Counseling Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | VLM Online Lifestyle Counseling |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants |
| Age Continuous | 51.94 years STANDARD_DEVIATION 10.82 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Change in Weight
Time frame: Baseline and 1 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Change in Weight | -4.79 kg |
Secondary
A1C (if Applicable)
Time frame: 1 year
Secondary
Blood Pressure
Time frame: 1 year
Secondary
Fat Consumption
Time frame: 1 year
Secondary
Health Related Quality of Life
Time frame: 1 year
Secondary
Lipid
Time frame: 1 year
Secondary
Physical Activity
Time frame: 1 year