Status:
COMPLETED
Preventing Diabetes With Digital Health and Coaching
Lead Sponsor:
Omada Health, Inc.
Collaborating Sponsors:
University of Nebraska
Wake Forest University Health Sciences
Conditions:
PreDiabetes
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The goal of this randomized controlled trial is to determine the efficacy of a digital diabetes prevention program for improving weight, glucose control, and secondary risk factors among people with p...
Detailed Description
Prediabetes is an increasingly prevalent condition, characterized by glucose levels that are above normal but below the threshold for diabetes. Previous studies have demonstrated that intensive lifest...
Eligibility Criteria
Inclusion
- Receives care at University of Nebraska Medical Center or Nebraska Medicine
- Age 19 years or older
- HbA1c 5.7%-6.4%
- Overweight (BMI 25+ or 22+ if Asian)
- Planning to reside in recruitment area for next 12 months
- Able to engage in moderate aerobic physical activity
- Medically stable
- Able to provide informed consent
- Willing to accept random assignment to treatment
Exclusion
- Not meeting all inclusion criteria
- Diagnosed with Type I or II diabetes
- Diagnosed with congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, pulmonary hypertension
- Diagnosed with dementia or probable Alzheimer's disease
- Taking oral hypoglycemic agents
- Participating in a concurrent weight management program or interventional research protocol
- Unable to engage in physical activity
- On a prescribed medical diet
- Had bariatric surgery within the past 3 years or planning surgery within the next 12 months
- Anti-obesity or diabetes therapy within the preceding 4 months
- Any mental health condition, including eating disorders or alcohol/substance use, which would preclude full participation
- Self-report as currently pregnant or within 6 weeks of having given birth (or planning to become pregnant in the next 12 months)
- Unstable cardiac disease (i.e. heart attack/failure or stroke in the last 6 months, or in cardiac rehabilitation)
- On dialysis or an active organ transplant list
- Chronic kidney disease
- Untreated thyroid disease
- Cancer within the last 5 years unless skin cancer (i.e. currently or within the last 5 years in chemotherapy or radiation treatment)
- Unwilling to accept random assignment
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
598 Patients enrolled
Trial Details
Trial ID
NCT03312764
Start Date
November 1 2017
End Date
August 31 2020
Last Update
February 23 2021
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-4365