Enhanced Lifestyles for Metabolic Syndrome trial will test group vs. self-directed approaches
UMKC is looking for participants.
Metabolic syndrome is a bundle of risk factors caused by common lifestyle choices that can lead to serious conditions such as diabetes, stroke, heart disease and cancer. Currently, one-third of Americans have metabolic syndrome, up from one-fourth a decade ago.
Over the next two years, with funding from the William G. McGowan Charitable Fund, the Enhanced Lifestyles for Metabolic Syndrome (ELM) Trial, developed at Rush University Medical Center in Chicago, aims to enroll 600 people who are at high-risk chronic disease and are interested in managing this risk by optimizing their lifestyle. In addition to UMKC at Truman Medical Centers in Kansas City, the other sites are Rush in Chicago; University of Colorado Denver; Geisinger Health System in Wilkes-Barre and Scranton, Pennsylvania; and Rochester Institute of Technology in New York.
The Kansas City study site is overseen by a prestigious UMKC School of Medicine team of principal investigators: endocrinologist Betty Drees, M.D., dean emeritus of the school and Jannette Berkley-Patton, Ph.D., director of the Health Equity Institute; and Matthew Lindquist, D.O.
“Metabolic syndrome is a serious condition because it is so common, and it can silently increase risk of heart disease and stroke without early warning symptoms,” Drees said. “Research into how to stop it early and keep it controlled is very important in preventing heart disease in individuals and in the population as a whole.”
Starting in January, participants will engage in the program for six months, and then will be followed for an additional 18 months, to allow for an assessment of how well they have been able to sustain the good habits they developed and the health benefits they received.
“We know that making these small lifestyle changes can have a big impact on people who have health issues that indicate they may have metabolic syndrome. Plus, everyone who participates will receive a free Fitbit. Other lifestyle-change programs can cost upwards of $500, but ELM will be free to our participants, which is awesome.” – Jannette Berkley-Patton
The ELM program provides tools, methods and support for healthier eating, increased physical activity and stress management. Guidelines include making vegetables half of every lunch and dinner, exercising for at least 30 minutes on most days, and learning to be less reactive to stressors.
The Rush team has been studying a group-based version of ELM for nearly a decade. The group approach, which has been shown to be effective, requires participants to attend meetings. While those can be helpful, they’re time-consuming and may be inconvenient; from a public-health standpoint, groups are expensive and labor-intensive. So researchers want to know: Can we simplify this treatment? Can participants get the same or better health results under their own direction, with only minimal contact with the program?
“Metabolic syndrome is a serious condition because it is so common, and it can silently increase risk of heart disease and stroke without early warning symptoms. Research into how to stop it early and keep it controlled is very important in preventing heart disease in individuals and in the population as a whole.” – Betty Drees
For this study, a “self-directed” program will be compared to a group-based program, with the best lifestyle information available in clinical practice today provided in both..
Everyone in the self-directed arm will be assigned to a coordinator, and will receive a Fitbit activity tracker, access to the program’s website and monthly tip sheets for six months.
In the group-based program, participants will get most of those things, too. But instead of the tip sheet, group members will meet for an hour and a half weekly for three months, biweekly for an additional three months, and monthly for 18 months after that. They will also have access to the ELM website. They will learn, for example, to distinguish when they are eating because they are hungry from when they turn to food because it is available or they are bored or sad.
Participants in both arms of the program will report for three follow-up visits so their progress can be assessed. They will receive lab results and physical measures after each visit.
“We are hoping we can learn how self-guided and group support programs can help people eat healthier and move more,” Berkley-Patton said. “We know that making these small lifestyle changes can have a big impact on people who have health issues that indicate they may have metabolic syndrome. Plus, everyone who participates will receive a free Fitbit. Other lifestyle-change programs can cost upwards of $500, but ELM will be free to our participants, which is awesome.”
How to participate
Participants in the study must be ages 18 years or older, not have diabetes, speak English, be willing to commit to a healthy lifestyle and have at least three of metabolic syndrome’s five risk factors:
- Central fat (waist circumference of 40 inches or more for men, 35 inches or more for women)
- High blood pressure
- High blood sugar
- Low HDL cholesterol
- Elevated triglycerides
A condition of enrollment is a willingness to participate in either arm of the trial. Participants will not get to choose. To participate in the Kansas City area, email ELMtrial@tmcmed.org or call Alex Lyon at (816) 404-4418.