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ABSTRACT: 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 for 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 to 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.
SUBMITTER: Wagner J
PROVIDER: S-EPMC8312406 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature
Wagner Julie J Bermudez-Millan Angela A Buckley Thomas T Buxton Orfeu M OM Feinn Richard R Kong Sengly S Kuoch Theanvy T Nahmod Nicole G NG Scully Mary M
Contemporary clinical trials 20210503
<h4>Background</h4>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 for Cambodian Americans with depression, "Diabetes Risk Reduction through Eat, Walk, Slee ...[more]