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Metabolic SyndromeNCT04637477

Virtual Enhanced Lifestyle for Metabolic Syndrome (ELM) Proof-of-Concept Study

A study testing Virtual ELM in people with Metabolic Syndrome and Obesity, run by Rush University Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome, Obesity
What is being tested?
Virtual ELM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
1 Aug 2020to 25 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Age 18 years or older
  • Highly motivated to make lifestyle changes as a way to manage the MetS.

Who cannot join

  • 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.
  • Unwilling, unable, or not ready to make the lifestyle changes prescribed in ELM
  • BMI <27 or > 40
  • Weight > 397 lbs. The Fitbit Aria scale, utilized in the intervention, measures up to 397 lbs.
  • Unable to consistently attend group classes at the anticipated time due to schedule conflicts or other reasons.
  • Unable or unwilling to give an informed consent or communicate with study staff.
Show all 30Show fewer
  • Unable or unwilling to complete accelerometer data collection.
  • Does not have reliable access to the internet.
  • Does not have a smart phone. Must be willing to download the Fitbit app on their smart phone.
  • Not fluent in English
  • Current diagnosis of type 1 or type 2 diabetes, on any diabetes medications except metformin, or has a screening A1c ≥6.5
  • 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 2 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, defined as ASSIST screening 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, orlistat, phentermine, Saxenda, etc.) in the last 3 months, or unwilling to abstain from taking weight loss medications or supplements during the trial
  • History of bowel resection surgery or bariatric surgery
  • 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 > 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.
  • Cognitive impairment
  • Visual or hearing impairment
  • 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)
  • Receiving dialysis
  • Cancer treatment within the last 6 months, excluding chemoprophylaxis or treatment for non-melanoma skin cancer

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Missouri-Kansas City School of Medicine

    Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Rush Coronavirus Disease Virtual Lifestyle Program to Boost Host Resistance in Patients With Elevated Cardiometabolic Risk: A Proof-of-Concept Study

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.

Being tested
Virtual ELM
Keywords
Lifestyle
Medical subject headings
Metabolic Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual ELMBehavioural

    Participants will attend 1.5-hour virtual group-based sessions for 12 weeks. The program includes physical activity, cooking demonstrations, and group discussions. All sessions are led by a registered dietitian and health psychologist.

Study groups in NCT04637477
Study groupRoleWhat they receive
Virtual ELMExperimentalNot described
Receives: Behavioral: Virtual ELM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fifty percent of participants will lose >5% of baseline weight after completing the intervention at 3 months.

    Weight is recorded in kilograms to the nearest 0.1 kg using a flat scale.

    Measured: 3 months after baseline assessment

Secondary outcomes (5)

  1. Remission of components of metabolic syndrome

    The proportion of participants who are in remission of the metabolic syndrome (MetS) at 3 months will be calculated. MetS is defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO as having 3 or more risk factors for cardiovascular disease. To be considered in remission of MetS the participant must have less than 3 of the following 5 criteria: 1) Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women; 2) Fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides; 3) Fasting HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or treatment for low HDL; 4) Systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or treatment for hypertension; and 5) Fasting plasma glucose 100-125 mg/dL.

    Measured: Measured at 3 months from baseline

  2. Vegetable consumption

    The proportion of participants who eat 2 cups of vegetables per day. This will be assessed using the National Cancer Institute (NCI) Fruit and Vegetable Intake Screener from the Eating at America's Table Study: All Day Screener.

    Measured: Measured at 3 months from baseline

  3. Physical activity

    The proportion of participants who achieve 150 minutes of at least moderate intensity physical activity per week will be calculated. Activity is measured using an accelerometer (Actigraph wGT3X-BT) worn on the right hip for 7 days and for at least 10 hours/day.

    Measured: Measured at 3 months from baseline

  4. Facets of Mindfulness

    Participants will complete the Five Facet Mindfulness Questionnaire. A subscale comprised of 3-facets (observe, act with awareness, and nonreact) will be utilized to measure mindfulness in ELM. The proportion of participants who improve in a 3-facet mindfulness score of greater than or equal to 1 standard deviation of baseline distribution will be calculated. The scale range for the 5-facet mindfulness questionnaire is 39-195 with a lower score reflecting less mindfulness. The 3-facet scale range is 23-115 with a lower score reflecting less mindfulness.

    Measured: Measuring change from baseline mindfulness at 3 months

  5. Habit formation

    The proportion of participants who improve in habit strength in 4 domains (diet, physical activity, emotional control, and sensory awareness), defined as a mean of ≥ 4 on the Self-Report Habit Index will be calculated. A 5-point Likert scale will be used with a scale range from 0 to 20. A lower score reflects a weaker habit.

    Measured: Measured at 3 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start1 Aug 2020
  3. Primary completion31 Dec 2020
  4. Study completion25 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04637477
Sponsor's protocol ID
20061108
Status last verified
Sep 2021
First submitted
6 Nov 2020
Last updated
16 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual ELM in people with Metabolic Syndrome and Obesity, run by Rush University Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fifty percent of participants will lose >5% of baseline weight after completing the intervention at 3 months. (time frame: 3 months after baseline assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04637477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.

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