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ELM Group for Metabolic Syndrome (3ELM Trial)

N/A
Waitlist Available
Led By Rasa Kazlauskaite, MD
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 at 3 and 6 months
Awards & highlights

3ELM Trial Summary

Approximately 24% of the US adult population meet criteria for metabolic syndrome (MetS), diagnosed by a combination of abdominal obesity, elevated blood pressure, high triglyceride and low HDL-cholesterol level, and pre-diabetes. MetS quintuples the risk of diabetes, and doubles the risk of cardiovascular disease (CVD), particularly heart failure. Lifestyle modification is the initial step of treatment, but few studies have demonstrated early and sustained efficacy in remission of MetS. Our preliminary studies of a lifestyle change program for patients with MetS included a 1-year of development of an intervention by an interdisciplinary team of experts in medicine and the behavioral sciences. The investigators then tested the efficacy of the intervention in a treatment-only, proof-of-concept study. The investigators achieved our goal of 50% MetS remission after 2 years, in a sample of 26 patients. This study is the second step of a research program testing an innovative bio-behavioral intervention aimed at remitting MetS through lifestyle intervention, by focusing on eating patterns, daily activity, and stress management. The overarching objective of this research program is to determine the efficacy of the ELM lifestyle intervention to achieve remission of MetS. This purpose of the current study is to prepare for a large, randomized, clinical trial by conducting a smaller clinical trial that examines the acceptability of the ELM intervention (ELM Group) as compared to two other intervention arms (ELM Classes, ELM Individual).

Eligible Conditions
  • Metabolic Syndrome

3ELM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
metabolic syndrome remission, defined as <3 of the 5 standard diagnostic criteria.
Secondary outcome measures
A1c
Accelerometry
Continuous metabolic syndrome score
+6 more
Other outcome measures
Beliefs about medications
Brief COPE
Daily Hassles Questionnaire
+14 more

3ELM Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ELM GroupExperimental Treatment1 Intervention
A 6-month group lifestyle intervention, consisting of 12 weekly and 6 bi-weekly 2-hour sessions. The sessions consist of 30-min physical activity, 30-min meal demonstration, and 60-min group behavioral intervention, with a focus on experiential learning in naturalistic setting. Sessions are facilitated by dietitian/personal trainer and behavioral specialist.
Group II: ELM ClassesExperimental Treatment1 Intervention
A 6-month health education, consisting of 12 weekly and 6 bi-weekly 30-45 min sessions. The sessions consist of didactic classes, with a focus on health education curriculum. Sessions are facilitated by a health educator and medical providers.
Group III: ELM IndividualActive Control1 Intervention
A 6-month intervention, that consists of educational manuals on physical activity, diet and stress reduction and recommended 3 medical visits every 3 months for medical counseling and feedback using 5A (Ask, Advise, Assess, Assist, and Arrange) framework . These Metabolic syndrome care materials and provider documentation will be embedded in electronic medical record system, and will be accessible to medical providers by usual means. This enhanced usual care by participant's usual health care provider focuses on metabolic syndrome and lifestyle modifications to reduce the risk of chronic disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ELM Group
2013
N/A
~50

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,453 Total Patients Enrolled
3 Trials studying Metabolic Syndrome
878 Patients Enrolled for Metabolic Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,579 Total Patients Enrolled
34 Trials studying Metabolic Syndrome
19,502 Patients Enrolled for Metabolic Syndrome
Rasa Kazlauskaite, MDPrincipal InvestigatorRush University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Apr 2025