Clinical trial NCT04637477: Virtual Enhanced Lifestyle for Metabolic Syndrome (ELM) Proof-of-Concept Study
Official title: Rush Coronavirus Disease Virtual Lifestyle Program to Boost Host Resistance in Patients With Elevated Cardiometabolic Risk: A Proof-of-Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Keywords: Lifestyle
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Missouri, Kansas City
name: University of Colorado, Denver
name: Geisinger Clinic
name: Rochester Institute of Technology
First posted: 2020-11-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a proof-of-concept study of a virtual version of a lifestyle intervention aimed at reducing cardiometabolic risk in patients with the Metabolic Syndrome (MetS). The aim is to recruit 12 patients at high risk for coronavirus infection based upon a diagnosis of obesity and the MetS, conduct a 12-week virtual version of the in-person intervention, and explore efficacy using clinically significant pre-specified targets for weight, diet, physical activity, stress, and markers of inflammation. In addition, the investigators will explore safety, fidelity, feasibility, and acceptability.


Eligibility criteria: Inclusion Criteria:

1. Men and women with components of the metabolic syndrome, defined by an adapted version of the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO (Alberti, 2009). Surrogates for waist circumference and fasting glucose were selected to help identify prospective participants using medical records. Participants must have ≥ 2 of the following five criteria to participate in the study:

   * Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women or BMI≥30
   * Triglycerides ≥150 mg/dL or treatment for elevated triglycerides
   * 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), or on metformin, or HbA1c between 5.7 and 6.4.
2. Age 18 years or older
3. Highly motivated to make lifestyle changes as a way to manage the MetS.

Exclusion Criteria:

1. Individuals who report being unable to walk 2 consecutive blocks without assistance are ineligible. Additionally, individuals who endorse pain, tightness, or pressure in their chest during physical activity (on question 1 of the EASY screener) or current dizziness or lightheadedness (on question 2 of the EASY screener) may not be randomized without providing documentation in writing from their physician indicating that they have been cleared for participation in the trial.
2. Unwilling, unable, or not ready to make the lifestyle changes prescribed in ELM
3. BMI \<27 or \> 40
4. Weight \> 397 lbs. The Fitbit Aria scale, utilized in the intervention, measures up to 397 lbs.
5. Unable to consistently attend group classes at the anticipated time due to schedule conflicts or other reasons.
6. Unable or unwilling to give an informed consent or communicate with study staff.
7. Unable or unwilling to complete accelerometer data collection.
8. Does not have reliable access to the internet.
9. Does not have a smart phone. Must be willing to download the Fitbit app on their smart phone.
10. Not fluent in English
11. Current diagnosis of type 1 or type 2 diabetes, on any diabetes medications except metformin, or has a screening A1c ≥6.5
12. Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness
13. Probable major depression, defined as a PHQ-8 score ≥10
14. Pregnant women, planning a pregnancy in the next 2 months, given birth in the last 6 months, or currently breastfeeding
15. ≥ 30 total days of oral corticosteroid use within the last year, history of solid organ transplant, or history of stem cell transplant
16. Problematic use of alcohol and/or recreational drugs, defined as ASSIST screening score of ≥27.
17. Self-reported or known history of an eating disorder (e.g., binging and purging) in the past 5 years
18. Use of weight loss medications (Qsymia, orlistat, phentermine, Saxenda, etc.) in the last 3 months, or unwilling to abstain from taking weight loss medications or supplements during the trial
19. History of bowel resection surgery or bariatric surgery
20. Any medical condition known to influence the etiology of MetS as judged by the study physician (e.g., uncontrolled hypothyroidism, endocrine hypertension, etc)
21. 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 \> 109); e) unstable angina or an active prescription for sublingual nitroglycerin; or f) other major cardiovascular illness which the site PI determines could limit ability to participate in the trial. Individuals screened for participation, whose screening systolic blood pressure is ≥160 and ≤179, or whose screening diastolic blood pressure is ≥100 and ≤109 are considered to have MODERATE, or Stage 3 Hypertension. If they otherwise qualify and wish to participate in ELM, they will be referred to their physician for clearance prior to randomization.
22. Cognitive impairment
23. Visual or hearing impairment
24. 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)
25. Receiving dialysis
26. Cancer treatment within the last 6 months, excluding chemoprophylaxis or treatment for non-melanoma skin cancer

Primary outcomes:
measure: Fifty percent of participants will lose >5% of baseline weight after completing the intervention at 3 months.
timeFrame: 3 months after baseline assessment
Secondary outcomes:
measure: Remission of components of metabolic syndrome
timeFrame: Measured at 3 months from baseline
measure: Vegetable consumption
timeFrame: Measured at 3 months from baseline
measure: Physical activity
timeFrame: Measured at 3 months from baseline
measure: Facets of Mindfulness
timeFrame: Measuring change from baseline mindfulness at 3 months
measure: Habit formation
timeFrame: Measured at 3 months after baseline
Other outcomes:
measure: Metabolic syndrome severity score
timeFrame: Measured at 3 months after baseline
measure: Weight loss
timeFrame: Measuring change from baseline to 3 months
measure: Blood pressure (metabolic syndrome component)
timeFrame: Measured at baseline and 3 months
measure: Waist circumference (metabolic syndrome component)
timeFrame: Measured at baseline and 3 months
measure: Triglycerides (metabolic syndrome component)
timeFrame: Measured at baseline and 3 months
measure: High-Density Lipoproteins (HDL) cholesterol (metabolic syndrome component)
timeFrame: Measured at baseline and 3 months
measure: Fasting plasma glucose (metabolic syndrome component)
timeFrame: Measured at baseline and 3 months
measure: Body mass index
timeFrame: Measuring change from baseline to 3 months
measure: Frequency of contacts within health network
timeFrame: Measuring change from baseline to 3 months
measure: Energy and vitality index
timeFrame: Measuring change from baseline to 3 months
measure: Perceived stress
timeFrame: Measuring change from baseline to 3 months
measure: Depressive symptoms
timeFrame: Measuring change from baseline to 3 months
measure: Hemoglobin A1c levels
timeFrame: Measuring change from baseline to 3 months
measure: Sugar-sweetened beverages
timeFrame: Measuring change from baseline to 3 months
measure: Eating competence
timeFrame: Measuring change from baseline to 3 months
measure: C-reactive protein (hs-CRP)
timeFrame: Measuring change from baseline to 3 months
measure: Interleukin 6 (IL-6)
timeFrame: Measuring change from baseline to 3 months
measure: Fidelity of intervention
timeFrame: Measuring during 3-month lifestyle program
measure: Feasibility of recruitment
timeFrame: Up to 12 weeks
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Missouri-Kansas City School of Medicine
state: Missouri
Study officials:
affiliation: Rush University Medical Center
name: Lynda Powell, PhD
role: PRINCIPAL_INVESTIGATOR
References: