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| Name | Class |
|---|---|
| PeaceHealth Laboratories | UNKNOWN |
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This is a six month lifestyle management study to compare the effects of iWell; a dynamic online interactive technology to a self-directed program in overweight or obese individuals.
The primary aim is to test the hypothesis that dynamic online interactive technology intervention is more effective than self-directed program in obtaining and maintaining weight loss and other biometric improvements.
Optimal health behavior is difficult to sustain over extended periods. This study seeks to demonstrate that technology can be a low cost scaleable solution that will provide the user with sufficient customization and personalization through social networking approaches such that sustainability of optimal health behavior is realized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self directed | No Intervention |
| |
| Technology assisted health behavior | Active Comparator | The intervention arm will have access to a dynamic online environment with social networking and device data uploads that include activity data, weight data and laboratory data at frequent intervals to nudge optimal health behavior. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology assisted health behavior | Behavioral | Web-based interactive program using an hpod sensor that tracks physical activity as well as biometric parameters into the iWell server and is transmitted to the internet site via the users PC. Also serves as a social networking site. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss from baseline | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure change from baseline | Systolic blood pressure and diastolic blood pressure | at 3 months |
| Triglyceride level change from baseline | Participants will have a venous draw to determine Triglyceride levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Piniewski, MD | PeaceHealth Laboratories | Principal Investigator |
| David Kil | SKTelecom Americas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PeaceHealth Laboratories | Springfield | Oregon | 97477 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
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| Self directed | Behavioral | Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations. |
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| at 3 months |
| High density lipoprotein level change from baseline | Venous draw to determine high density lipoprotein levels | at 3 months |
| Physical activity adjustment from baseline | Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm | at 3 months |
| Blood pressure change from baseline | at 6 months |
| Triglyceride level change from baseline | at 6 months |
| High density lipoprotein level change from baseline | at 6 months |
| Physical activity adjustment from baseline | Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm | at 6months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |