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The EMPOWER diabetes program is a year-long, community-based program designed to enhance diabetes management in rural African American women with uncontrolled diabetes. The treatment is delivered by community peers and follows a relative Small Changes approach.
East Carolina University, along with established community partners, is implementing a community-based and culturally-tailored intervention to reduce diabetes disparities in 200 rural African American women with uncontrolled diabetes using our unique behaviorally-centered small changes approach to diabetes self-management, delivered by community health workers. The focus is on moderation and patient-selected small changes in eating, activity, and care management that decrease feelings of deprivation and failure and increase feelings of confidence and success. The intervention is specifically tailored to overcome psychosocial and environmental barriers to behavioral change through a strong focus on emotional, cultural, and social factors related to eating, activity, and medications. Objectives for the proposed project are to: 1) implement and evaluate the effectiveness of this tailored small changes intervention; 2) examine the impact of this approach on psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a business-sustainable care model. The study will be a randomized prospective trial comparing the small changes intervention, delivered in 16 sessions by community health workers, to a control group receiving 16 mailings of diabetes educational materials. We hypothesize that there will be a greater improvement in behavioral choices and glycemic control in the intervention group compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational control arm | Active Comparator | Control group receives 16 mailings of diabetes educational materials but no regular contact with community health workers |
|
| Lifestyle counseling | Experimental | Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Counseling | Behavioral | Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Glycosylated hemoglobin | 6 months |
| Change in Hemoglobin A1c | Glycosylated hemoglobin | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Body weight | 6 Months |
| Change in Weight | Body Weight | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Blood pressure | 6 months |
| Blood Pressure | Blood pressure | 12 Months |
Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Doyle M. Cummings, Pharm.D. | East Carolina University | Principal Investigator |
| Lesley Lutes, Ph.D. | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23792133 | Background | Cummings DM, Lutes LD, Littlewood K, Dinatale E, Hambidge B, Schulman K. EMPOWER: a randomized trial using community health workers to deliver a lifestyle intervention program in African American women with Type 2 diabetes: design, rationale, and baseline characteristics. Contemp Clin Trials. 2013 Sep;36(1):147-53. doi: 10.1016/j.cct.2013.06.006. Epub 2013 Jun 19. | |
| 24904183 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Educational Control Arm | Behavioral | 16 mailings of diabetes educational materials but no regular contact with community health workers |
|
| Cummings DM, Lutes L, Littlewood K, DiNatale E, Hambidge B, Schulman K, Morisky DE. Regimen-Related Distress, Medication Adherence, and Glycemic Control in Rural African American Women With Type 2 Diabetes Mellitus. Ann Pharmacother. 2014 Aug;48(8):970-977. doi: 10.1177/1060028014536532. Epub 2014 Jun 5. |
| 28660719 | Derived | Lutes LD, Cummings DM, Littlewood K, Dinatale E, Hambidge B. A Community Health Worker-Delivered Intervention in African American Women with Type 2 Diabetes: A 12-Month Randomized Trial. Obesity (Silver Spring). 2017 Aug;25(8):1329-1335. doi: 10.1002/oby.21883. Epub 2017 Jun 29. |
| D004700 | Endocrine System Diseases |