EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
This is a pragmatic, 24 month, single-center, randomized, open-label, parallel-group trial
comparing an obesity-centric approach with a medically-supervised and comprehensive weight
loss program (Cleveland Clinic's Endocrinology and Metabolism Institute's Integrated Weight
Management Program) augmented by AOMs, vs. an obesity-centric approach with a
medically-supervised and comprehensive weight loss program without AOMs, vs. the current
usual care approach to general health management.
Informed consent will be obtained. IRB approval of the study will be obtained. 300 subjects
(employees or spouses covered by our EHP) will be randomized 1:1:1 to receive either an
obesity-centric approach with AOM therapy (N=100), an obesity-centric approach without AOM
therapy (N=100), or the current usual care approach to general health management (N=100).