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| Name | Class |
|---|---|
| University of Virginia | OTHER |
| University of Colorado, Denver | OTHER |
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The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels, reduce diabetes distress, and increase empowerment and confidence in managing diabetes.
The purpose of the study is to test the feasibility, acceptability, and initial efficacy of the tailored GEM intervention among adult Black patients with type 2 diabetes, who are not on insulin or secretagogues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEM Intervention | Experimental | A lifestyle coach will deliver the GEM intervention over 4 weeks in person and/or virtually (synchronously) to permit interaction with participants. A pocket-sized manual will be provided with 4 units corresponding to session topics, and diary pages to record glucose responses to food and physical activity (PA). Session 1: Introduce GEM, identify personal motivation, learn about foods that cause glucose to go high (high glycemic load (GL) foods) and those that do not (low GL foods), learn how physical activity affects glucose, and begin monitoring how these choices affect glucose. Session 2: Replacement, substitution, and portion control to reduce consumption of high GL foods. Session 3: Increasing PA and reducing sedentary behavior, esp. after a meal. Session 4: Ways to continue lifestyle changes over a lifetime, handle relapses, and thank loved ones for their support. Text message reminders may be sent to participants between sessions to prompt diary entries and for encouragement. |
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| Waitlist | No Intervention | Participants will be invited to receive the GEM intervention after they posttest, the next time it is offered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEM Intervention | Behavioral | Lifestyle coaching |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on percent time in range from continuous glucose monitor at post-intervention | Difference in percent of time in range (70-180 mg/dL) from continuous glucose monitor data. Change = post intervention week minus baseline week. | Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine L Davis, PhD | Contact | 706-721-4534 | katie.davis@augusta.edu |
| Name | Affiliation | Role |
|---|---|---|
| Catherine L Davis, PhD | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Prevention Institute | Recruiting | Augusta | Georgia | 30912 | United States |
The small number of expected participants means there is too great a risk of loss of confidentiality. Group level data will be shared upon request to qualified researchers.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized controlled trial, intervention vs. waitlist
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| D004700 | Endocrine System Diseases |
| D001519 | Behavior |