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Lifestyle Interventions for Metabolic Syndrome (ELM Trial)
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Waitlist Available
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 6, 15, and 24 months following treatment assignment.
Awards & highlights
ELM Trial Summary
This trial is comparing two different lifestyle interventions to see which is more effective in helping people with the metabolic syndrome achieve remission.
Who is the study for?
Adults with metabolic syndrome, which means having at least three of these: large waist size, high triglycerides or treatment for it, low HDL cholesterol or treatment for it, high blood pressure or treatment for hypertension, and fasting glucose levels that are higher than normal but not yet diabetes. Participants must be able to walk and ready to change their lifestyle but can't join if they have serious health issues like heart disease, severe mental illness, recent major surgery or cancer treatment.Check my eligibility
What is being tested?
The trial is testing two ways to improve lifestyles in people with metabolic syndrome over a period of 2 years. One group will participate in a program with others (group-based), while the other group will follow a program on their own (self-directed). The goal is to see which method helps better in reducing symptoms of metabolic syndrome.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include muscle soreness from increased physical activity or discomfort from dietary changes. Emotional stress due to new routines could also occur.
ELM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 6, 15, and 24 months following treatment assignment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 6, 15, and 24 months following treatment assignment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Remission of Metabolic Syndrome
Secondary outcome measures
Blood Pressure (metabolic syndrome component)
Body Mass Index
Cost of Medications
+24 moreOther outcome measures
Pre-specified outcomes
ELM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group-BasedExperimental Treatment1 Intervention
The Group-based Program uses an ecologically valid setting in which participants exercise, prepare foods, and eat together to facilitate the emergence of old habits and replace them with healthy alternatives. The intervention team consists of a health psychologist, registered dietitian, and health coach. They co-facilitate group meetings for 15 participants that are held weekly for 3 months, bi-weekly for 3 months, and then monthly in participant-led maintenance meetings. Each session includes: weigh-in and physical activity (20 min), cooking demonstration (20 min), and a shared vegetable dish with discussion (50 min). The maintenance phase (months 7 to 24 post randomization) consists of support and health-related topics of the participants' own choosing. Progress reports with lab results are sent to participants and primary care physicians.
Group II: Self-DirectedActive Control1 Intervention
The Self-Directed lifestyle program represents enhanced usual care based upon what is currently offered in primary care in the United States for lifestyle treatments for adults with metabolic syndrome. Usual care is enhanced by: 1) lifestyle education for management of metabolic syndrome provided in evidence-based tip sheets from nationally recognized organizations; 2) provision of a Fitbit for self-monitoring physical activity; 3) access to a website containing all education materials; and 4) progress report letters with lab results sent to participants and primary care physicians after completion of each assessment
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
162,913 Total Patients Enrolled
3 Trials studying Metabolic Syndrome
308 Patients Enrolled for Metabolic Syndrome
University of Colorado, DenverOTHER
1,734 Previous Clinical Trials
2,148,265 Total Patients Enrolled
7 Trials studying Metabolic Syndrome
239 Patients Enrolled for Metabolic Syndrome
Rochester Institute of TechnologyOTHER
9 Previous Clinical Trials
4,201 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
10 Patients Enrolled for Metabolic Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not open to being randomly assigned to a treatment group in the study.I have been diagnosed with metabolic syndrome.You have a history of an eating disorder like binging and purging within the last 5 years.I am not ready or able to follow the lifestyle changes in the ELM program.I have diabetes or take diabetes medication, but not metformin.You are currently taking or planning to take specific medications, or have had recent cancer treatment or participated in certain clinical trials.I meet at least 3 criteria for metabolic syndrome and am over 18.I don't have any health issues that could affect my metabolic syndrome.I have a visual or hearing impairment.I have not been hospitalized for mental health issues in the last 6 months and do not have schizophrenia or a similar condition.I haven't taken weight loss drugs or supplements in the last 3 months and am willing to avoid them during the study.You have a high score on a screening tool that shows you may have a problem with using alcohol or recreational drugs.I cannot walk two blocks by myself.I am not fluent in English.I have severe food allergies or intolerances that prevent me from joining the ELM program.You have trouble with memory and thinking, as measured by a test called the Montreal Cognitive Assessment (MoCA), and score 25 or lower on the test.I do not have a history of serious heart problems.I have used oral steroids for over 30 days in the past year, or I have had an organ or stem cell transplant.I have had surgery on my intestines or weight loss surgery.You are likely to have major depression based on a score of 10 or higher on the PHQ-8 assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Group-Based
- Group 2: Self-Directed
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative being conducted in various healthcare settings across the US?
"Five separate institutions are working on this research project, namely the Department of Preventive Medicine, Rush University Medical Center in Chicago, Rochester Institute of Technology in Rochester and University of Missouri-Kansas City in Kansas City. In addition to these four primary sites there are 5 other locations also involved."
Answered by AI
Is registration for this experiment available at present?
"According to the clinicaltrials.gov website, this medical study is not currently accepting new patients; its most recent update was made on February 7th, 2022. Nonetheless, there are 1,470 alternative trials that remain active and have open registration periods at present."
Answered by AI
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