Clinical trial NCT03312764: Preventing Diabetes With Digital Health and Coaching
Official title: Preventing Diabetes With Digital Health and Coaching for Translation and Scalability (PREDICTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: Prediabetes
Obesity
Intensive behavioral counseling
Type 2 Diabetes
Lead sponsor: Omada Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Nebraska
name: Wake Forest University Health Sciences
First posted: 2017-10-18
Enrollment: 598
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly allocated to one of two groups for the duration of the study.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: HbA1c reduction
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Weight loss
timeFrame: Baseline, 4 months, and 12 months
measure: Decreased cardiovascular risk
timeFrame: Baseline, 4 months, and 12 months
Other outcomes:
measure: Implementation Context
timeFrame: 12 months
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Paul Estabrooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katula JA, Dressler EV, Kittel CA, Harvin LN, Almeida FA, Wilson KE, Michaud TL, Porter GC, Brito FA, Goessl CL, Jasik CB, Sweet CMC, Schwab R, Estabrooks PA. Effects of a Digital Diabetes Prevention Program: An RCT. Am J Prev Med. 2022 Apr;62(4):567-577. doi: 10.1016/j.amepre.2021.10.023. Epub 2022 Feb 10.