EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

What this study is testing ClinicalTrials.gov NCT04531176 ↗

Description as written by the study sponsor.

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).

Treatments tested

• Weight Management Program (WMP) Other

  Weight Management Program (WMP)

• Traditional care Other

  Traditional care

• Phentermine / Topiramate Extended Release Oral Capsule Drug

  Medication for chronic weight management (Rx)

• naltrexone/bupropion extended-release Drug

  Medication for chronic weight management (Rx)

• liraglutide 3.0 mg Drug

  Medication for chronic weight management (Rx)

• Orlistat Drug

  Medication for chronic weight management (Rx)