A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes.

Background Depression and antidepressant medications are associated with increased risk for type 2 diabetes. It is not known if diabetes can be prevented in the setting of depression. Cambodian Americans have high rates of both depression and diabetes. This paper reports intervention development, experimental design, baseline characteristics, and process outcomes of diabetes prevention interventions Cambodian Americans with depression, "Diabetes Risk Reduction through Eat, Walk, Sleep and Medication Therapy Management" (DREAM). Methods Participants were aged 35-75, Khmer speaking, at high risk for developing diabetes, and met criteria for likely depression by either a) antidepressant medication and/or b) elevated depressive symptoms at two timepoints during a study eligibility period. Treatment arms were: 1) community health educator (CHE) delivered lifestyle intervention called Eat, Walk, Sleep (EWS), 2) EWS plus pharmacist/CHE-delivered medication therapy management (EWS + MTM), and, 3) social services (SS; control). Results 188 participants were randomized. Treatment fidelity was high (98% checklist adherence) and on a scale from 0 to 3, participants reported high EWS treatment satisfaction (M = 2.9, SD = 0.2), group cohesion (M = 2.9, SD = 0.3), and therapeutic alliance to CHEs (M = 2.9, SD = 0.2) and pharmacists (2.9, SD = 0.3). Attendance was challenging but highly successful; in EWS, 99% attended ≥ one session and 86% completed ≥ 24 sessions, M = 27.3 (SD = 3.7) sessions. Of those randomized to EWS + MTM, 98% attended at least one MTM session and 77%) completed ≥ 4 sessions. Retention was high, 95% at 12-month and 96% at 15-month assessments. Conclusions The interventions were successfully implemented. Lessons learned and suggestions for future trials are offered. ClinicalTrials.gov identifier: NCT02502929.