It’s estimated that 86 million Americans now have prediabetes – that’s one out of three adults – and nine out of 10 are unaware they are at risk.
Without intervention, many people with prediabetes could develop type 2 diabetes within five years.
Now Wake Forest University has begun a digital diabetes prevention clinical trial that features a virtual interactive program that provides personalized guidance and weekly interactive lessons to encourage healthy habits. It is the largest-ever single-blind, randomized control trial of a digital diabetes prevention program (DDP).
And, the program is accessible through personal electronic devices – computer, laptop, smartphone and tablet – and it can link to a Fitbit or other fitness wearable devices. It combines proven behavioral science and the power of social networking with cutting-edge technology and world-class design.
The trial, called PREDICTS (Preventing diabetes with digital health and coaching for translation and scalability), is a collaboration between Omada Health, University of Nebraska Medical Center (UNMC) and Wake Forest.
Jeffrey Katula, associate professor of Health and Exercise Science, is co-investigator of the three-year study. Katula co-led the “Healthy Living to Prevent Diabetes” project, along with researchers at the Wake Forest School of Medicine, intended to translate clinical literature on DPP into community practice. His research involving the study of human behavior as it relates to the prevention and management of chronic diseases and disability has been widely published and recognized internationally.
“I’ve been working in the diabetes prevention community for years,” said Katula, whose research the Society of Behavioral Medicine Public Policy Leadership Group described as the “gold standard” for diabetes prevention translation.
“The goal has always been to find ways to translate the academic work on this intervention into clinical and community practice while maintaining outcomes and reducing costs,” he said.
“The PREDICTS trial will test a method that will vastly enhance the access to diabetes prevention programs that transcends physical proximity and will allow us to reach underserved populations.” Jeffrey Katula, associate professor of Health and Exercise Science
Omada Health, based in San Francisco, is a leading provider of digitally-enabled intensive behavioral counseling that enables individuals at elevated risk of chronic conditions, like type 2 diabetes, to change habits that put them most at risk.
UNMC is in the process of enrolling approximately 500 participants who will be randomly assigned to either the digital Omada Program or a comparison group through UNMC’s current clinical practice that features a single two-hour in-person diabetes prevention class.
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 health care use, among other measures. This will be the first time many of these measures are tracked in a randomized controlled trial of a digitally-delivered DPP.
Through the Omada platform, participants will have access to a personal coach, support group and weekly interactive lessons that provide information on healthy eating, nutrition, physical activity, stress and locking in healthier habits. The platform also provides ways to share information and chat with group members.
The Omada study is patterned after a study originally conducted by the Diabetes Prevention Program Research Group with funding from the National Institutes of Health (NIH). Results were published in 2002.
In the National Institutes of Health study, 3,234 participants from 27 clinical centers around the U.S. were divided into three groups. Each person in the first group was assigned a health counselor and to a health center or YMCA where they met for a one-hour class each week where they received behavior modification information. The second group received metformin, the first-line medication for the treatment of type 2 diabetes, and the third a placebo.
In the lifestyle intervention group, those receiving intensive individual counseling and motivational support on effective diet, exercise, and behavior modification, reduced their risk of developing diabetes by 58 percent. Lifestyle changes worked particularly well for participants aged 60 and older, reducing their risk by 71 percent. About 5 percent of the lifestyle intervention group developed diabetes each year during the study period, compared with 11 percent of those in the placebo group.