Enhanced Lifestyles for Metabolic Syndrome

Completed · Not applicable

Conditions studied: Metabolic Syndrome

In brief

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 over 2 years of follow-up.

Key facts

Study ID

NCT04036006

Run by

Rush University Medical Center

People needed

618

Starts

2019-07-01

Expected to finish

2024-03-29

Last updated by the study team

2024-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• CU Anschutz Health and Wellness Center — Aurora, Colorado, United States
• Department of Family and Preventive Medicine, Rush University Medical Center — Chicago, Illinois, United States
• University of Missouri-Kansas City — Kansas City, Missouri, United States
• Rochester Institute of Technology — Rochester, New York, United States
• Geisinger — Danville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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