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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL118189-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to determine whether participation in virtual environment which incorporates real-time diabetes self management and support (DSMT/S) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web-based DSMT/S.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIVE Arm | Experimental | Participation in 3D virtual environment for DSMT/S for a period of 12 months. |
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| Website | Active Comparator | Participation in 2D website for DSMT/S for a period of 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIVE | Behavioral | 3-D Virtual Environment for DSMT/S |
| |
| Website |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Intake | Dietary (fat intake, fruit and vegetable intake) will be assessed at start of the study and at 3, 6, 12 and 18 months | 18 months |
| Change in Physical Activity | Changes in physical activity will be measured using the Fitbit physical activity monitoring at 3, 6, 12, and 18 months. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1C level | Metabolic control (HbA1c) levels will be measured at the start of the study and again at 6, 12, and 18 months | 18 months |
| Change in BMI | BMI will measured at the start of study and at 6, 12, and 18 months. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Constance M. Johnson, PhD | Duke University School of Nursing | Principal Investigator |
| Allison Vorderstrasse, DNSc | Duke University School of Nursing | Principal Investigator |
| Gail Melkus, EdD | New York University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University | New York | New York | 10003 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36962700 | Derived | Johnson CM, D'Eramo Melkus G, Reagan L, Pan W, Amarasekara S, Pereira K, Hassell N, Nowlin S, Vorderstrasse A. Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial. JMIR Form Res. 2023 Apr 20;7:e40359. doi: 10.2196/40359. | |
| 28600025 | Derived | Johnson CM, McIlwain S, Gray O, Willson B, Vorderstrasse A. Creating a sustainable collaborative consumer health application for chronic disease self-management. J Biomed Inform. 2017 Jul;71:198-206. doi: 10.1016/j.jbi.2017.06.004. Epub 2017 Jun 6. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Behavioral |
2-D Website participation for DSMT/S |
|
| 18 months |
| Change in Waist Circumference | Waist circumference will be measured at start of study and at 6, 12, and 18 months. | 18 months |
| Change in Blood Pressure | Blood pressure will be measured at the start of the study and again at 6, 12, and 18 months. | 18 months |
| Change in Lipid Levels | High density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol (TC) and triglyceride levels will be measured at the start of the study and again at 6, 12 and 18 months. | 18 months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| 26505161 | Derived | Vorderstrasse AA, Melkus GD, Pan W, Lewinski AA, Johnson CM. Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol). Nurs Res. 2015 Nov-Dec;64(6):485-93. doi: 10.1097/NNR.0000000000000128. |