Researchers from the University of Nebraska Medical Center and Wake Forest University are collaborating with San Francisco-based Omada Health to explore the effectiveness of a virtual diabetes prevention program.
The PREDICTS (“Preventing Diabetes with Digital Health and Coaching for Translation and Scalability”) randomized control trial will include approximately 500 participants with verified clinical eligibility for Omada’s CDC-recognized diabetes prevention program, according to an announcement. Omada Health is best known for its digitally-enabled intensive behavioral counseling, enabling individuals at elevated risk of chronic conditions like type 2 diabetes and heart disease to change the habits that put them most at risk, the organization’s officials attest.
Participants will be recruited at UNMC, then randomly assigned to either the Omada program or UNMC’s current clinical practice. During the trial, UNMC will lead data collection and study the implementation process, while researchers at Wake Forest will be responsible for data system management, quality operational reports, evaluation, and analysis. Omada will run the experimental arm of the trial and provide engagement and outcome data for analysis.
In addition to tracking weight loss and reduction in A1c blood sugar levels, the PREDICTS trial also will track the impact of the Omada program on participants’ quality of life, stress levels, and healthcare utilization, among other measures. This will be the first time many of these measures are tracked in a randomized controlled trial of a digitally-delivered diabetes prevention program, officials noted.
“Our goal at Omada has been to continually set new standards for what the industry should expect when it comes to the effectiveness of digital healthcare interventions,” Omada co-founder and CEO Sean Duffy, said in a statement. “The PREDICTS trial is the next step in that evolution—it will track a range of healthcare and other outcomes, while establishing the highest level of clinical evidence for the effectiveness of a digitally-delivered intensive behavioral counseling program.”
Leading the PREDICTS trial will be academic leaders with deep experience in diabetes prevention, including: Paul A. Estabrooks, Ph.D., the Harold M. Maurer distinguished chair for health promotion in the Social and Behavioral Health Department at the University of Nebraska Medical Center; and Jeffrey Katula, Ph.D. associate professor in the Department of Health and Exercise Science at Wake Forest University. Katula previously led the “Healthy Living to Prevent Diabetes” (HELP PD) project at Wake Forest.
Estabrooks stated, “What’s really exciting about this clinical trial is that we also are studying how best to integrate effective, scalable preventive services, especially digitally-enabled ones, into typical clinical practice. In fact, we’ll be able to shed some light on strategies that will really speed the translation of high-quality, research-tested diabetes prevention interventions into sustained clinical practice.”