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Clinical Trials: Diabetes
IRB No. 15-164S-3 (Dr. Julie Wagner, PI): Diabetes Risk Reduction through Eat,Walk,Sleep And Medication Therapy Management for Depressed Cambodians (DREAM)
Diabetes Risk Reduction through Eat, Walk, Sleep And Medication Therapy Management for Depressed Cambodians (DREAM) This project is designed to reduce risk for diabetes in Cambodian Americans with depression. 210 Cambodian Americans in southern New England will be screened for their diabetes risk as well as depression; those at risk for diabetes with depression will be enrolled. This study will determine the effect of Lifestyle Modification vs Lifestyle + Medication Therapy Management (MTM) vs Supportive Services Control. Assessments gather data such as sleep, activity, anthropometrics, mental health symptoms, and medications at baseline, 1year and 2years. Blood tests will be performed on the same schedule for glucose, insulin, and inflammation. Hair samples will be obtained on the same schedule for levels of cortisol Cambodian Americans have been previously studied by these Investigators who found that found 50% of this group (over age 35) have 5 or more chronic diseases including heart attack, chronic depression and/ or PTSD. Their rates of diseases like diabetes, hypertension and high cholesterol are twice those of national averages. Overall Cambodian health status in the US is worse than other Asian refugee groups resettled in the US from their refugee camps. The Diabetes Prevention Program (DPP) has shown that disease onset can be delayed or even prevented by lifestyle modification programs such as that to be provided here. The KHA agency is a partner with the National Diabetes Education Program and committed to overcoming care barriers which underserved communities face. Such programs help mitigate depression by activating and engaging their clients. This PI & Team will utilize Community Health Workers (CHW) to conduct the research and deliver the lifestyle program called Eat, Walk, Sleep. 1/3 of the subjects will receive EWS which has been specifically tailored for the unique language and cultural considerations in this group.The PI has previously done a similar diabetes education intervention with non english speaking Latinos with low literacy- delivered in an ethnic agency setting by CHWs, including home and group participation. For 1/3, EWS is combined with secure pharmacist (Medication Therapy Management-MTM) videoconferencing interactions at home. 1/3 (70 subjects) 1/3 will receive control/Supportive Services Group- will receive Enhanced Standard CHW support/services referral, while undergoing the same initial evaluation assessments . The researchers seek to determine that lifestyle intervention will produce greater improvement in risk factiors and that biologic factors-waist size,blood pressure, diabetes marker- HgBA1c, and others are improved.