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

NCT04637477 | Completed

• 1 other identifier: 20061108
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Syndrome; Obesity

Keywords

Lifestyle

Outcome Measures

Primary Outcomes (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.

  3 months after baseline assessment

Secondary Outcomes (5)

• Remission of components of metabolic syndrome

  Measured at 3 months from baseline

• Vegetable consumption

  Measured at 3 months from baseline

• Physical activity

  Measured at 3 months from baseline

• Facets of Mindfulness

  Measuring change from baseline mindfulness at 3 months

• Habit formation

  Measured at 3 months after baseline

Other Outcomes (19)

• Metabolic syndrome severity score

  Measured at 3 months after baseline

• Weight loss

  Measuring change from baseline to 3 months

• Blood pressure (metabolic syndrome component)

  Measured at baseline and 3 months

Study Arms (1)

Virtual ELM

EXPERIMENTAL

Behavioral: Virtual ELM

Interventions

Virtual ELM BEHAVIORAL

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.

Virtual ELM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of Missouri, Kansas City: collaborator
• University of Colorado, Denver: collaborator
• Geisinger Clinic: collaborator
• Rochester Institute of Technology: collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Missouri-Kansas City School of Medicine

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lynda Powell, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 19, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: August 25, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (2)