Preventing Diabetes With Digital Health and Coaching for Translation and Scalability (PREDICTS)

Preventing Diabetes With Digital Health and Coaching

Sponsors

Lead sponsor: Omada Health, Inc.

Collaborator: University of Nebraska
Wake Forest University Health Sciences

Source Omada Health, Inc.
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 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.

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 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.

Overall Status Active, not recruiting
Start Date November 1, 2017
Completion Date May 31, 2020
Primary Completion Date March 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
HbA1c reduction Baseline and 12 months
Secondary Outcome
Measure Time Frame
Weight loss Baseline, 4 months, and 12 months
Decreased cardiovascular risk Baseline, 4 months, and 12 months
Enrollment 600
Condition
Intervention

Intervention type: Behavioral

Intervention name: Online diabetes prevention program

Description: Digital delivery of Intensive behavioral counseling for diabetes prevention and healthy lifestyle management. Recipients have access to online curriculum, a live health coach, group-based communication forums, and connected technology to track weight and physical activity.

Arm group label: Online Diabetes Prevention Program

Intervention type: Behavioral

Intervention name: Standard Care

Description: One-on-one or small group sessions with a dietitian or a trained health professional to advise on physical activity, healthful nutrition and risk reduction for diabetes.

Arm group label: Enhanced Standard Care

Eligibility

Criteria:

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

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Paul Estabrooks, PhD Principal Investigator University of Nebraska
Location
facility University of Nebraska Medical Center
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Online Diabetes Prevention Program

Arm group type: Experimental

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.

Arm group label: Enhanced Standard Care

Arm group type: Active Comparator

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.

Acronym PREDICTS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants are randomly allocated to one of two groups for the duration of the study.

Primary purpose: Prevention

Masking: Double (Investigator, Outcomes Assessor)

Masking description: All study investigators that collect data or analyze the data are prevented from knowing the interventions assigned to individual participants.

Source: ClinicalTrials.gov