Status:
COMPLETED
Enhanced Lifestyles for Metabolic Syndrome
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
University of Colorado, Denver
Geisinger Clinic
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a multi-center behavioral randomized trial with the aim of comparing a group-based lifestyle intervention with a self-directed lifestyle intervention on remission of the metabolic syndrome ove...
Detailed Description
The purpose of this trial is to determine the efficacy and cost-effectiveness of the Group-Based and Self-Directed ELM lifestyle programs when offered on a national level. A multi-site randomized tria...
Eligibility Criteria
Inclusion
- Men and women with metabolic syndrome, defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO (Alberti, 2009). Note that hemoglobin A1c will be measured as a marker of impaired glucose metabolism, but will not be considered in determining metabolic syndrome status. To meet metabolic syndrome criteria the participant should have ≥ 3 of the following five criteria:
- Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women
- Fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides
- Fasting HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women, or treatment for low HDL
- Systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or treatment for hypertension
- Fasting plasma glucose 100-125 mg/dL (range inclusive)
- Greater than 18 years of age
Exclusion
- Unable to walk 2 consecutive blocks without assistance, based on patient report.
- Unwilling, unable, or not ready to make the lifestyle changes prescribed in ELM
- Unwilling to be randomized to either arm of the trial
- Unable or unwilling to give an informed consent, communicate with study staff, or complete the study run-in period. The run-in period requires attending an information session, completing two assessment visits within the scheduled time (potential participant is allowed to reschedule once), wearing an accelerometer, and completing lifestyle logs (see protocol)
- Does not have reliable access to the internet via a computer or mobile device
- Not fluent in English
- Current diagnosis of type 1 or type 2 diabetes, or on any diabetes medications except metformin
- Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness
- Probable major depression, defined as a PHQ-8 score ≥10
- Pregnant women, planning a pregnancy in the next 24 months, given birth in the last 6 months, or currently breastfeeding
- ≥ 30 total days of oral corticosteroid use within the last year, history of solid organ transplant, or history of stem cell transplant
- Problematic use of alcohol and/or recreational drugs based on the ASSIST screening tool (score of ≥27).
- Self-reported or known history of an eating disorder (e.g., binging and purging) in the past 5 years
- Use of weight loss medications (Qsymia, phentermine, etc.) or supplements in the last 3 months, or unwilling to abstain from taking weight loss medications or supplements during the study
- History of bowel resection surgery or bariatric surgery
- Participant does not have, or is unwilling to seek care from, a primary care physician at the time of enrollment
- Any medical condition known to influence the etiology of MetS as judged by the study physician (e.g., uncontrolled hypothyroidism, endocrine hypertension, etc)
- History of major cardiovascular illness, including a) stroke; b) myocardial infarction; c) congestive heart failure requiring hospitalization, or greater than NYHA heart failure class I; d) uncontrolled hypertension (SBP\>180 or DBP \> 105); e) unstable angina; or f) other major cardiovascular illness which the site PI determines could limit ability to participate in the trial.
- Behavioral/logistical barriers to trial participation or engagement, e.g., a scheduled major surgery, scheduling difficulties, travel plans, moving outside the study area
- Cognitive impairment, defined by a Montreal Cognitive Assessment (MoCA) score of ≤25. The MoCA will be administered only when research staff suspect cognitive impairment
- Visual or hearing impairment
- Severe food allergies or food intolerances/preferences that preclude participation in the ELM program
- Currently taking or expecting to take any of the following exclusionary medications:
- Antiretroviral therapy (e.g., HAART)
- Weight loss medications (as in #14)
- Medications known to significantly influence weight or metabolic outcomes
- Diabetes drugs other than metformin (as in #7)
- Participation in any clinical trial, until at least six months following the end of the intervention phase. Individuals in long-term follow-up (over 6 months post intervention) may be enrolled in ELM.
- Cancer treatment within the last 6 months, excluding chemoprophylaxis or treatment for non-melanoma skin cancer.
- Previous participation in an ELM program or currently living with ELM participant.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2024
Estimated Enrollment :
618 Patients enrolled
Trial Details
Trial ID
NCT04036006
Start Date
July 1 2019
End Date
March 29 2024
Last Update
June 11 2024
Active Locations (5)
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1
CU Anschutz Health and Wellness Center
Aurora, Colorado, United States, 80045
2
Department of Family and Preventive Medicine, Rush University Medical Center
Chicago, Illinois, United States, 60612
3
University of Missouri-Kansas City
Kansas City, Missouri, United States, 64108
4
Rochester Institute of Technology
Rochester, New York, United States, 14623