Clinical trial NCT04036006: Enhanced Lifestyles for Metabolic Syndrome
Official title: A National Trial of the ELM Lifestyle Program and Remission of the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Behavioral intervention
Lifestyle
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Geisinger Clinic
name: Rochester Institute of Technology
name: University of Missouri, Kansas City
First posted: 2019-07-29
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 over 2 years of follow-up.

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 trial will be conducted on 600 patients with the metabolic syndrome (MetS) by five national sites, each of which will randomize 120 patients to the Group-Based or Self-Directed programs. The Group-Based program targets healthy eating, physical activity, and stress reduction and is based upon neuroscience studies showing that mindful habits provide resilience against the power of emotions to subvert intention, and social science studies showing that sustainability is enhanced by support from a health network. The Self-Directed program represents enhanced usual care based upon what is currently offered in medicine and wearable technology for treatment of adults with MetS and its components. The primary outcome is remission of MetS at 2 years. Secondary outcomes include cost-effectiveness, vegetable intake, physical activity, and mindful awareness.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. Greater than 18 years of age

Exclusion Criteria:

1. Unable to walk 2 consecutive blocks without assistance, based on patient report.
2. Unwilling, unable, or not ready to make the lifestyle changes prescribed in ELM
3. Unwilling to be randomized to either arm of the trial
4. 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)
5. Does not have reliable access to the internet via a computer or mobile device
6. Not fluent in English
7. Current diagnosis of type 1 or type 2 diabetes, or on any diabetes medications except metformin
8. Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness
9. Probable major depression, defined as a PHQ-8 score ≥10
10. Pregnant women, planning a pregnancy in the next 24 months, given birth in the last 6 months, or currently breastfeeding
11. ≥ 30 total days of oral corticosteroid use within the last year, history of solid organ transplant, or history of stem cell transplant
12. Problematic use of alcohol and/or recreational drugs based on the ASSIST screening tool (score of ≥27).
13. Self-reported or known history of an eating disorder (e.g., binging and purging) in the past 5 years
14. 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
15. History of bowel resection surgery or bariatric surgery
16. Participant does not have, or is unwilling to seek care from, a primary care physician at the time of enrollment
17. Any medical condition known to influence the etiology of MetS as judged by the study physician (e.g., uncontrolled hypothyroidism, endocrine hypertension, etc)
18. 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.
19. Behavioral/logistical barriers to trial participation or engagement, e.g., a scheduled major surgery, scheduling difficulties, travel plans, moving outside the study area
20. Cognitive impairment, defined by a Montreal Cognitive Assessment (MoCA) score of ≤25. The MoCA will be administered only when research staff suspect cognitive impairment
21. Visual or hearing impairment
22. Severe food allergies or food intolerances/preferences that preclude participation in the ELM program
23. Currently taking or expecting to take any of the following exclusionary medications:

    1. Antiretroviral therapy (e.g., HAART)
    2. Weight loss medications (as in #14)
    3. Medications known to significantly influence weight or metabolic outcomes
    4. Diabetes drugs other than metformin (as in #7)
24. 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.
25. Cancer treatment within the last 6 months, excluding chemoprophylaxis or treatment for non-melanoma skin cancer.
26. Previous participation in an ELM program or currently living with ELM participant.

Primary outcomes:
measure: Remission of Metabolic Syndrome
timeFrame: Measured at 24 months following treatment assignment.
Secondary outcomes:
measure: Vegetable consumption
timeFrame: Measured at 6, 15, and 24 months following treatment assignment
measure: Physical activity
timeFrame: Measured at 6, 15, and 24 months following treatment assignment.
measure: Facets of Mindfulness
timeFrame: Measuring change from baseline mindfulness at 6, 15, and 24 months following treatment assignment.
measure: Habit formation
timeFrame: Measuring at 6, 15, and 24 months following treatment assignment.
measure: Cost-effectiveness
timeFrame: Measured over the 24 month patient participant follow-up period
measure: Healthcare utilization
timeFrame: Measured over the 24 month patient participant follow-up period
measure: Cost of Medications
timeFrame: Measured at 6, 15, and 24 months following treatment assignment.
measure: Number of Prescribed Medications
timeFrame: Measured at 6, 15, and 24 months following treatment assignment.
measure: Severity of Metabolic Syndrome
timeFrame: Measured at 6, 15, and 24 months following treatment assignment.
measure: Weight Loss
timeFrame: Measuring change from baseline at 6, 15, and 24 months following treatment assignment.
measure: ≥ 5% body weight loss
timeFrame: Measuring change from baseline at 6,15, and 24 months following treatment assignment.
measure: Body Mass Index
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: Blood Pressure (metabolic syndrome component)
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: Waist Circumference (metabolic syndrome component)
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: Triglycerides (metabolic syndrome component)
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: High-Density Lipoproteins (HDL) Cholesterol (metabolic syndrome component)
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: Fasting Plasma Glucose (metabolic syndrome component)
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: Frequency of Contacts within Health network
timeFrame: Measuring change from baseline at 6, 15, and 24 months following treatment assignment.
measure: Energy and vitality Index
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: Perceived stress
timeFrame: Measuring change from baseline at 6, 15, and 24 months following treatment assignment.
measure: Depressive symptoms
timeFrame: Measuring change from baseline at 6, 15, and 24 months following treatment assignment.
measure: Social support for diet
timeFrame: Measured at 6, 15, and 24 months following treatment assignment.
measure: Social support for exercise
timeFrame: Measured at 6, 15, and 24 months following treatment assignment.
measure: Hemoglobin A1c levels
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: Sugar-sweetened beverages
timeFrame: Assessed during in-person participant assessments conducted at baseline and 6, 15, and 24 months following treatment assignment.
measure: Eating competence
timeFrame: Measured at baseline and 6, 15, and 24 months following treatment assignment.
measure: Impact of pandemic
timeFrame: Measured at 24 months following treatment assignment.
Other outcomes:
measure: Pre-specified outcomes
timeFrame: Measured at 24 months after treatment assignment.
Locations:
city: Aurora
country: United States
facility: CU Anschutz Health and Wellness Center
state: Colorado
city: Chicago
country: United States
facility: Department of Family and Preventive Medicine, Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Missouri-Kansas City
state: Missouri
city: Rochester
country: United States
facility: Rochester Institute of Technology
state: New York
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Rush University Medical Center
name: Lynda Powell, PhD
role: STUDY_CHAIR
affiliation: Rush University Medical Center
name: Sumihiro Suzuki, PhD
role: STUDY_DIRECTOR
References: