EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04531176
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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).

Key Dates

Start date
Sep 1, 2020
Status verified
Aug 2024
Primary completion
Aug 15, 2022
Completion
Aug 4, 2023

Study Design

Enrollment
74 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Obesity-centric approach + AOM
    Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
  • Experimental: Obesity-centric approach without AOM
    Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
  • Active Comparator: Usual care approach (Comorbidity-centric approach)
    Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.

Primary Outcome Measure

Mean Change in Body Weight Between Baseline and 12 Months [ Time Frame: 12 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Cleveland Clinic· Cleveland, OH

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