Preventing Diabetes With Digital Health and Coaching

Completed · Not applicable

Conditions studied: PreDiabetes

In brief

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 prediabetes compared to an enhanced standard care plus wait-list control. Exploratory assessments of implementation facilitators and barriers will also be completed to determine strategies for integrating external diabetes-prevention interventions within healthcare settings.

Key facts

Study ID

NCT03312764

Run by

Omada Health, Inc.

People needed

598

Starts

2017-11-01

Expected to finish

2020-08-31

Last updated by the study team

2021-02-23

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.