Newswise — PHILADELPHIA -- Diabetes affects over 30 million people worldwide. Effective management of diabetes often requires substantial changes in diet and lifestyle. Many people have difficulty making these changes because of various life barriers, and thus do not achieve optimal control of their blood sugar levels. This lack of blood sugar control can result in ongoing damage to the heart, eyes, blood vessels and kidneys -- complications that often land patients in the emergency room. Overall, the cost of care for diabetes in the U.S. accounts for over $325 billion according to the American Diabetes Association.
“In our prior work, patients with diabetes identified needing access to healthy food and nutrition counseling as primary barriers to diabetes management,” explains lead researcher of the project, Kristin Rising, MD, an emergency medicine physician at Jefferson Health.
In response, researchers led by Dr. Rising, who is also an associate professor at Thomas Jefferson University, will be launching a 5-year $3.2 million clinical trial to test whether the delivery to patients’ homes of medically tailored meals (meals designed to meet each individual’s medical needs), paired with individual nutrition counseling given via telehealth (video visit), can improve blood sugar control. They will also test whether the interventions are cost-effective and reduce future emergency department visits and hospital admissions.
“Medication and basic education aren’t enough to empower many patients to control their diabetes – we need to address the daily barriers to self-care,” says Dr. Rising. “The issue isn’t just access to food. Many patients identify significant fear around eating. In health care, we are much better about telling patients what not to do than giving guidance about how to do something well.”
Dr. Rising is partnering with Philadelphia-based nonprofit MANNA, a national leader in providing medically tailored meals and nutrition education. The organization currently provides 3-meals a day 7-days a week to eligible patients with a variety of medical conditions who benefit from a nutritious but curated diet.
The trial will enroll patients while they are in the hospital. “These are some of our highest risk patients because they are in a state of acute health decline,” says Dr. Rising. The patients will be randomized into one of three groups. One group will receive standard of care treatment, which consists of regular visits with a primary care provider or diabetes specialist as well as occasional in-person visits with a nutritionist. Another group will receive medically tailored meals delivered to their homes for 12 weeks. The third group will also receive 12 weeks of home-delivered medically tailored meals and counseling as well as 6 months of individual medical nutrition therapy provided by video visit with Jefferson practitioners. The addition of the intensive medical nutrition therapy is to change the short-term solution (healthy food) into a long-term practice.
“People are often confused by all of the diet information available online,” says clinical dietician Cheryl Marco, RD, in the Jefferson Division of Endocrinology, Diabetes & Metabolic Diseases, who will lead the nutrition-counseling component of the study. “Should I eat less carbohydrates, or less fat? Should I eat a vegetarian diet or Paleo? The fact is that there is credible evidence supporting all of these eating patterns.”
Medical nutrition therapy, a combination of nutrition education and lifestyle counseling, takes into account specific medical requirements of each patient as well their lifestyle, preferences, and culture. The goal in this study is to guide each participant to an eating pattern that improves their diabetes control and simultaneously is sustainable for life, not just during the study period.
“We suspect that ensuring patients have access to medically nutritious food as they recover from an acute complication, and then provide the support they need to change their diet in a way that fits into their life, will be more effective than our current system of treatment,” says co-investigator on the study Anna Marie Chang, an emergency medicine physician at Jefferson.
“We have seen time and time again on an individual basis the profound effect that our food delivery service has for patients, and are convinced that our food truly is medicine for these patients,” says MANNA’s CEO, Sue Daugherty, RD, LDN. “Yet to date, we have not had the resources or necessary partnerships to perform a rigorous assessment of the effects of our medically tailored meals on patient medical and personal outcomes. We are especially interested in longer-term impacts, which are particularly difficult to study.”
The study draws on a body of literature, including a groundbreaking study from MANNA published in 2013 that suggests that both medically tailored meals and medical nutrition therapy have an impact. Dr. Rising’s work will be a significant addition to these previous studies in part because of its size and its scope. The researchers plan to enroll 600 patients, the largest randomized trial conducted for this question to date. The study is also designed to compare the cost-effectiveness of the three arms of the study.
“If our clinical trial demonstrates that medically tailored meals and telehealth-delivered nutrition counseling can improve a patient’s diabetes control long-term, and reduce overall medical costs, there will be a strong argument for making these services covered by insurance,” says Dr. Rising. “No study to date has ever been designed to look at this question and enroll enough patients to drive changes in policy. Our study is powered to do just that.”
The research is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Number R18DK118590. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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