The clinical trial across 3 sites in California and Washington state will involve 300 participants and report results in 2017.
Omada Health, based in San Francisco, California, today launched a version of its digitally based behavioral counseling program aimed at undeserved groups, and also announced a clinical trial at 3 sites to include both English and Spanish speakers.
Known as Prevent, Omada’s smart technology program aims to reduce participants’ risk of type 2 diabetes (T2D) and heart disease through 24-hour access to a personal coach, peer support, and a proprietary curriculum.
The trial will include up to 300 participants across 3 sites: The Wellness Center at LAC+USC Medical Center in Los Angeles, California; Northeast Valley Health Corporation in San Fernando; and Providence Health & Services in Monroe, Washington. Omada Director of Medical Affairs Cynthia Castro Sweet, PhD, and Director of Medicaid and Safety Net Commercial Development, Eliza Gibson, LCSW, will oversee the clinical trial, with results expected in 2017.
Those enrolled in the trial will be Medicaid beneficiaries, Medicaid eligible, or uninsured. The trial will track clinical outcomes for 12 months using independent evaluators, funded by the California Health Care Foundation and the Kresge Foundation, according to statement from Omada. Besides clinical outcomes, the trial will assess:
· Participant engagement
· Hospital and health system utilization
· Qualitative feedback
“This trial is the culmination of more than a year of work by our team,” said Sean Duffy, Omada co-founder and CEO, in a statement. “Omada’s mission is to inspire and enable people everywhere to live free of chronic disease; this is another step in making that mission a reality.”
Chronic conditions including diabetes have been shown to be more common among underserved populations, which creates fiscal concerns for the federal government and the states as Medicaid has enrolled 11 million new recipients due to expansion under the Affordable Care Act.
A 2013 study in JAMA found that while new Medicaid enrollees as a group were less likely to be obese or have chronic conditions like diabetes, those who did come to Medicaid with a chronic condition were in bad shape: 80% who had 1 of 3 chronic conditions (hypertension, hypercholesterolemia, or diabetes) were uncontrolled, and many were unaware of their diagnosis.1
Finding scalable solutions to help underserved populations to combat chronic conditions related to obesity, including T2D, is essential to hold down healthcare costs for both Medicaid and commercial plans.
Digital solutions may offer an answer, since smartphone technology appears to have crossed all economic boundaries. A study just published in Diabetes Care found that adding a daily, standardized text message to the National Diabetes Prevention Program curriculum helped participants lose 17% more weight, with even better results among Spanish speakers.2
Elements of the Prevent program tailored to underserved populations include:
· Recommended recipes will take into account access to food and the cost of ingredients.
· Recommended activities will acknowledge neighborhood safety concerns.
· Bilingual health coaches will be available.
· The curriculum will be adapted for those with limited literacy skills, as well as those who speak English as a second language.
Said Duffy, “Medicaid and uninsured populations live with disproportionate rates of chronic disease; it’s time to bring this type of life-changing intervention to anyone and everyone who needs it.”
1. Decker SL, Kostova D, Kenney GM, Long SK. Health status, risk factors, and medical conditions among persons enrolled in Medicaid vs uninsured low-income adults potentially eligible for Medicaid under the Affordable Care Act. JAMA. 2013;309(24):2579-2586. doi: 10.1001/jama.2013.7106.
2. Fischer HH, Fischer IP, Pereira RI, et al. Text message support for weight loss in patients with prediabetes: a randomized clinical trial [published online February 9, 2016]. Diabetes Care. 2016; doi:10.2337/dc15-2137.