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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK103663 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Khmer Health Advocates | UNKNOWN |
| Penn State University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The primary aim of the study is to compare the effect of three different interventions on lifestyle risk factors and biological risk factors for type 2 diabetes in depressed Cambodians. The three different interventions are lifestyle, lifestyle plus medication therapy management, and social services.
Cambodian Americans have high risk for major depressive disorder and for type 2 diabetes. Depression is a known risk factor for diabetes. Some antidepressants can also increase risk of diabetes by causing weight gain. DREAM will test the effect of lifestyle and medication therapy management (MTM) compared to social services (control) on diabetes risk among depressed Cambodian Americans. Community health workers (CHWs) will deliver the lifestyle intervention and assist pharmacists with MTM. Lifestyle and biological risk factors for diabetes, such as depressive symptoms, HbA1c and insulin sensitivity, will be measured before and after the interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Services | Active Comparator | Participants in this arm will receive referrals for social services as indicated. |
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| Lifestyle | Experimental | Participants in this arm will receive lifestyle modification from community health workers using the manualized lifestyle intervention called "Eat, Walk, Sleep". They will receive individual home visits, health activity group sessions, and supportive phone calls. |
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| Lifestyle plus Medication Therapy Management | Experimental | Participants in this arm will receive everything in the Lifestyle arm, plus Medication Therapy Management (MTM). Participants will receive MTM from a pharmacist via telemedicine with the assistance of a community health worker. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Services | Behavioral |
| ||
| Lifestyle |
| Measure | Description | Time Frame |
|---|---|---|
| Lifestyle risk for type 2 diabetes | Change from baseline in depressive symptoms according to the Hopkins Symptom Checklist | 12 months and 15 months |
| Biological risk for type 2 diabetes | Change from baseline in HbA1c and insulin resistance according to logHOMA-IR | 12 months and 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Wagner, PhD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uconn Health | Farmington | Connecticut | 06030 | United States | ||
| Khmer Health Advocates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37700288 | Derived | Wagner JA, Bermudez-Millan A, Buckley TE, Buxton OM, Feinn RS, Kong S, Kuoch T, Master L, Scully MF. Secondary analysis of a randomized trial testing community health educator interventions for diabetes prevention among refugees with depression: effects on nutrition, physical activity and sleep. Int J Behav Nutr Phys Act. 2023 Sep 12;20(1):107. doi: 10.1186/s12966-023-01509-y. | |
| 36307274 | Derived | Wagner J, Bermudez-Millan A, Buckley T, Buxton OM, Feinn R, Kong S, Kuoch T, Nye LM, Scully M. Self-reported outcomes of a randomized trial comparing three community health worker interventions for diabetes prevention among Cambodian Americans with depression. Patient Educ Couns. 2022 Dec;105(12):3501-3508. doi: 10.1016/j.pec.2022.09.011. Epub 2022 Oct 6. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003863 | Depression |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D012947 | Social Work |
| D054539 | Medication Therapy Management |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D010593 | Pharmaceutical Services |
| D054524 | Medicare Part D |
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|
| Lifestyle Plus Medication Therapy Management | Behavioral |
|
| West Hartford |
| Connecticut |
| 06110 |
| United States |
| Center for Southeast Asians | Providence | Rhode Island | 02907 | United States |
| 35087696 | Derived | Wagner JA, Bermudez-Millan A, Berthold SM, Buckley T, Buxton OM, Feinn R, Kuoch T, Kong S, Lim M, Polomoff C, Scully M. Risk factors for drug therapy problems among Cambodian Americans with complex needs: a cross-sectional, observational study. Health Psychol Behav Med. 2022 Jan 24;10(1):145-159. doi: 10.1080/21642850.2021.2021917. eCollection 2022. |
| 33957272 | Derived | Wagner J, Bermudez-Millan A, Buckley T, Buxton OM, Feinn R, Kong S, Kuoch T, Nahmod NG, Scully M. A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes. Contemp Clin Trials. 2021 Jul;106:106427. doi: 10.1016/j.cct.2021.106427. Epub 2021 May 3. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |