During last week's mHealth Summit, MobiHealthNews wrote about the relative slowness of rigorous efficacy data collection, compared to the speed of mobile development. One way to sidestep this problem is to work the other way around - to start with existing, reputable data, and build an online service that leverages it.
That's the process that led to Omada Health's diabetes prevention program, Prevent. Prevent is an online, soon-to-be-mobile implementation of a 2002 NIH Diabetes Prevention Program (DPP) intervention that produced significant results for prediabetics. The landmark study found that the lifestyle intervention group, who participated in a 16-week course of intensive training in diet, physical activity, and behavior modification, reduced their risk of diabetes by 58 percent compared to the control group. A third subject group, taking weight loss drug metaformin, reduced their risk by 31 percent.
“If that trial had been a pill, it probably would have become a billion-dollar drug and the gold standard in care. But the DPP was a behavior change program — challenging and expensive to roll out," Sean Duffy, CEO of Omada, said in a statement. He told MobiHealthNews that the ecosystem to turn effective trials into scalable interventions is just now taking shape, with help from groups like the CDC and UnitedHealth Group.
Duffy discovered the NIH study while interning at design and innovation consulting firm IDEO during a leave from Harvard Medical School.
"Where would you want to intervene if you were looking to build a business that was both economically viable and clinically relevant?" Duffy asjed. "If you look at the literature, one study stands above all the others, which is the DPP. It started to feel like there was this really rich opportunity to expand the access to this program by launching a web translation."
With Prevent, Omada hopes to offer the success of the NIH study without the high cost. Users will receive a Bodytrace wireless scale in the mail as part of a "welcome kit." The scale will automatically transmit readings to a private server via cellular, no setup required. Then, via the online portal, users will be matched up with a support group. A coach will guide users through 16 lessons based on the original Diabetes Prevention Program, which the CDC has offered up as an open source curriculum. At week five, users get a pedometer in the mail to start tracking their movement.
Initially, Duffy said, the portal is web-based and the pedometer is not connected; users enter their steps into the system manually. But he said native mobile apps are coming soon, and he hopes to be able to integrate the system with any activity tracker users might already have.
A key question for Omada is how much of the success of the original program was content, and how much was form? Can a remote implementation drive the same level of engagement and lead to the same results?
"The content is maybe 30 percent of the battle," said Duffy. "If we put the PDFs of the curriculum online, we would have no results. It's how you use the content." He said the approach emphasizes multiple contact points: sending things through the mail, providing a support group via a message board, and providing a coach who communicates via both phone calls and messaging.
"The challenge for us is to design an experience that feels like 'all hands on deck' but at a cost that makes sense," he said. "It's a very human-based program. To create an ecosystem online where the program feels real and it feels like you're getting a very high level of attention."
And a 230-person pilot study conducted by Omada posted results not too far from the NIH intervention: Participants lost an average of 6.5 percent of their weight, compared to about 7 percent in the original study. Now that the product is developed, Omada plans to do more rigorous studies to prove the strength of the platform.
The program costs $120 per month for the first 4 months, then it drops to $12 per month. But in terms of cost, the timing is good for the company and prospective users: Senator Al Franken recently proposed a bill that would allow diabetes prevention programs, specifically, to be fully covered under Medicare. So, many prediabetic patients (the CDC estimates there are 79 million in the United States) might not have to pay anything for the service.
"It's not necessary to have that bill come through for us to build a business, but it would be a wonderfully catalyzing thing," Duffy said. "Because we're a virtual model, we would need to show year-end weight loss in a peer-reviewed journal [in order to be covered], so we're creating trials right now to do so. We could be the first virtual model certified. If the bill passed and the data was convincing enough to the CDC that they would certify us, you can imagine that would be quite catalyzing."
Omada is part of Rock Health's 2011 class and has so far raised $800,000 in seed funding. Prevent is their flagship product, but Duffy says they plan to leverage the platform for other weight loss cases, including weight loss for people who have already been diagnosed with Type 2 diabetes and adults seeking to lose weight for general wellness purposes.