National trial seeks participants to test lifestyle treatments for metabolic syndrome

National trial seeks participants to test lifestyle treatments for metabolic syndrome

One-third of Americans have metabolic syndrome – up from one-quarter just ten years ago and it is underdiagnosed. Metabolic syndrome is a bundle of risk factors caused by common lifestyle choices that can lead to serious conditions like diabetes, stroke, heart disease, and some types of cancer.

People are considered to have metabolic syndrome if they have at least three of its five indicators -; 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, and elevated triglycerides.

The Enhanced Lifestyles for Metabolic Syndrome (ELM) Trial, a multisite test of two lifestyle treatments for a dangerous cluster of sub-disease indicators called the metabolic syndrome, is now accepting applicants at five medical centers around the country.

Over the next two years, with funding from the William G. McGowan Charitable Fund, the ELM Trial, developed at Rush University Medical Center in Chicago, Illinois, aims to enroll 600 people who are at high-risk for chronic disease and are interested in managing this risk by optimizing their lifestyle. The partner sites are Rush in Chicago, Illinois; University of Colorado Denver, Denver, Colorado; Geisinger Health System, Wilkes-Barre/Scranton, Pennsylvania; Rochester Institute of Technology, Rochester, New York; and University of Missouri - Kansas City, Kansas City, Missouri.

We need to see which approach is better at achieving a sustained remission in metabolic syndrome with lifestyle changes."
Lynda Powell PhD, MEd, preventive medicine chair at Rush Medical College, and the Principal Investigator of the ELM trial

Until the serious medical conditions the syndrome causes emerge, these people may not feel ill. Different drugs are available to address the syndrome's markers, like anti-hypertension medication, but none of these drugs treat the underlying lifestyle cause of the syndrome.

The good news is that better lifestyle choices, like the ones ELM teaches, have repeatedly been associated with low risk for the metabolic syndrome along with low risk for the diseases it portends.

"We know that lifestyle change works," says Jennifer Ventrelle MS, a registered nutritionist, and director of the ELM Lifestyle Program at the Rush University Prevention Center. Ventrelle, who is charged with making sure the ELM Intervention is administered consistently across all the participating centers, cites the Diabetes Prevention Program as one solid trial that showed the importance of lifestyle change on health.

The process is not always easy, though. "We know how to get people to change their behavior in the short term -; to eat better, be active, or stop smoking. The challenge is to get these changes to stick over time," Powell says.

For this trial, the first thirty eligible candidates will embark on the evidence-based ELM program at each of the five sites in January of 2020; signups will continue through the spring of 2021. 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.
The ELM program provides tools, methods, and support for healthier eating, increased physical activity and stress management. Guidelines include making vegetable 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. A "self-directed" option representing the best lifestyle information available in clinical practice today will be compared to the group-based program. Participants in both programs will receive a Fitbit to help them monitor their physical activity.

A condition of enrollment is a willingness to participate in either arm of the trial. Participants will not get to choose. 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.

"Can we simplify this treatment?" Powell asks. Can participants get the same or better health results under their own direction, with only minimal contact with the program? That's an important question investigators hope to answer. "We truly don't know which one is better," Powell says.

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.

"They'll get the best lifestyle protocols we have in medical practice today, augmented by one of the best wearables (the Fitbit)," Powell says.

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.

Not everybody with metabolic syndrome is interested in eating a healthier diet and undertaking a regular exercise program, but many people are. Powell says ELM can give those people a boost on their journey.

"We try to get people to see that living a healthy lifestyle is all about enjoying life, and having more energy and vitality," Powell says.

Anyone older than 18 who has three of the five markers for metabolic syndrome, does not have diabetes, can converse in English, and is committed to making healthy lifestyle changes, can apply to participate in the ELM Trial at one of its five sites. For more information, go to
Rush University Medical Center

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