September 15, 2021 - Many families across the country struggle with affordable housing, social isolation, low wages, health problems, high medical costs, and other issues that can cause food insecurity. Individuals or households that are food insecure have insufficient or uncertain access to enough food for an active, healthy life. Food insecurity affects more than 35 million people in the United States, including more than 10 million children. In North Carolina, 1.6 million people are food insecure, including one-in-five children.
To help address this problem, Blue Cross and Blue Shield of North Carolina (Blue Cross NC) has dedicated $3.2 million for a new, large clinical study to address food insecurity among its at-risk members who also have hypertension. The study will measure how to best help people who are food insecure achieve better health through nutrition. UNC-Chapel Hill researchers are leading the study, in conjunction with the UNC Health Alliance, UNC Health's statewide, clinically integrated physician network and population health services organization. Blue Cross NC, utilizing support of its data scientists and analysts, is collaborating as a co-principal investigator of the study.
"Our immediate goal is to find the best interventions to help Blue Cross NC members who are food insecure and have high blood pressure, a common condition related to many other health issues," said study co-leader Darren DeWalt, MD, MPH, a practicing primary care doctor with UNC Health and director of the UNC Institute for Healthcare Quality Improvement at the UNC School of Medicine. "Our overall goal is to create and sustain research-backed, nutrition-based interventions for anyone dealing with food insecurity."
Study co-leaders are Alice Ammerman, DrPH, the Mildred Kaufman Distinguished Professor of Nutrition at the UNC Gillings School of Global Public Health and director of the UNC Center for Health Promotion and Disease Prevention, and Seth Berkowitz, MD, MPH, assistant professor in the UNC Department of Medicine and member of the UNC Cecil G. Sheps Center for Health Services Research. DeWalt is also the John R. and Helen B. Chambliss Distinguished Professor of Medicine and division chief of General Medicine and Clinical Epidemiology.
"This collaboration with UNC Health is the latest step in our ongoing commitment to improve health outcomes by addressing non-medical drivers of health, which include access to food, transportation, shelter, and social connection, among other things," said John Lumpkin, MD, MPH, vice president of Drivers of Health Strategy at Blue Cross NC. "Our hope is that the findings from this study are instrumental in advancing the use of nutritious food as medicine to treat chronic conditions and improve overall health."
How will the study work?
The research team will enroll 1,400 eligible Blue Cross NC members with hypertension, who are also experiencing food insecurity. Recruitment for the study is set to begin in the fall of this year through the end of 2023, with results expected in 2024.
Based on screening questions around access to nutritious, sufficient food, each participant in the study will receive an intervention. One group of individuals will receive a $40 grocery store voucher each month to use towards fresh, frozen or shelf stable produce. A second group will receive a box of healthful, affordable foods delivered to them twice a month, with foods such as seasonal vegetables from North Carolina farms, grains, healthful oils, nuts, etc.
To test how lifestyle support helps individuals develop healthy habits, half of the participants from each group will also receive educational materials, including samples, demonstrations, and video instruction on how to prepare delicious meals, and they will receive direct assistance from UNC Health Alliance community health workers and registered dietitians, who will help participants understand dietary guidelines, prepare healthy meals, find affordable nutritious foods near them and identify resources to aid them in other aspects of life that contribute to food insecurity. Lifestyle support from the UNC Health Alliance staff will be offered for six months for one set of participants, and 12 months for the other set. These trained staff members and other providers will continue to help participants after the study is complete.
"We are very interested to understand and address the core drivers of health outcomes, which are often rooted in social factors like food insecurity," said Mark Gwynne, DO, president of UNC Health Alliance. "If we understand more deeply, and invest resources more wisely, we can help patients overcome these barriers and hopefully improve their health and well-being."
"We've designed the study to help provide healthy, inexpensive, and easy-to-make meals based on the Mediterranean Diet adapted for southeastern taste preferences," Ammerman said. "Our aim is long-term sustainability for everyone enrolled in the study and to translate our findings to inform health care providers and insurance companies how to best care for people who are at risk for chronic disease and who experience food insecurity."
Who's eligible to participate in the study?
Blue Cross NC members who receive care from practices affiliated with UNC Health are eligible for the study. The research team will be enrolling only individuals with a diagnosis of high blood pressure and who have screened positive for food insecurity.
"We want to measure how each intervention might be associated with better health outcomes," Berkowitz said. "High blood pressure is one of the most common health issues, and we know that lowering it is associated with fewer heart attacks, decreased burden from strokes, and generally better health."
DeWalt added, "It's the broadest condition to choose. It's such a large study, and so we're confident it will detect a statistical signal, one way or the other, whether one intervention is better than the other to help people achieve better health outcomes."
Extensive research has already revealed that food insecurity is a complex problem for many people who face significant challenges and lack the means to meet their basic needs. Food insecurity is associated with poverty, but not all people living below the poverty line experience food insecurity; likewise, people living above the poverty line can experience food insecurity.
"In our practice, we already have a food pantry, and we're working hard across UNC Health to identify which patients are food insecure and to help them as best we can," DeWalt said. "This study will help us develop best practices and work toward a model for having health providers and health insurance companies across the country adopt affordable, nutrition-based ways to improve health for people who are food insecure."
