Preventing Diabetes With Digital Health and Coaching (PREDICTS)

Omada Health

Status: Completed

Conditions: PreDiabetes

Treatments: Behavioral: Standard Care; Behavioral: Online diabetes prevention program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03312764

2017-03-06-001

Details and patient eligibility

About

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.

Full 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 lifestyle interventions targeting changes in diet, physical activity, sleep, and stress can reduce the risk of progressing from prediabetes to Type 2 diabetes. The Diabetes Prevention Recognition Program (DPRP) currently recognizes both in-person and online programs that meet requirements to deliver approved curriculum, provide health coaching and group support, and equip participants with behavioral skills and self-monitoring tools to support behavior change. While non-randomized trial data demonstrate that an online digital program was successful for producing meaningful weight loss and improved glucose control, the goal of this randomized, controlled trial is to definitively evaluate the efficacy of the program for improving weight, glucose control and secondary risk factors compared to current standard care for prediabetes. In addition, few trials have examined the implementation factors that could speed the uptake of efficacious diabetes prevention interventions for delivery in regular clinical practice. Qualitative information on key organizational stakeholders (e.g., physicians, office managers) will be gathered to provide information on perceptions of the online program characteristics, outcomes, and resources concurrently with strategies to promote adoption and implementation in health care settings.

Enrollment: 598 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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598 participants in 2 patient groups

Online Diabetes Prevention Program

Experimental group

Description:

Participants will receive access to a 12-month online diabetes prevention program modeled after the CDC DPP curriculum. Participants in the online program receive paced curriculum, access to a live health coach, interactive group message forums, and connected weight scale and activity monitoring devices.

Treatment:

Behavioral: Online diabetes prevention program

Enhanced Standard Care

Active Comparator group

Description:

All participants randomized to the standard-care/control group (SC) will be offered the opportunity to attend a single 90-minute diabetes prevention class with a trained health professional (MPH, RD, or related advanced degree). The class will focus on healthful eating based on the current MyPlate recommendations, guidance on gradual increases in moderate intensity physical activity, and action planning to be shared with friends and/or family. Control participants will also be given the opportunity to participate in the online digital intervention upon completion of the 12-month follow-up assessment.

Treatment:

Behavioral: Standard Care