Preventing Diabetes With Digital Health and Coaching



Status:Enrolling by invitation
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:19 - Any
Updated:8/23/2018
Start Date:November 1, 2017
End Date:January 1, 2020

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

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.

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.

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
We found this trial at
1
site
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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