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Enhanced Lifestyles for Metabolic Syndrome (ELM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04036006
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : November 27, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
Geisinger Clinic
Rochester Institute of Technology
University of Missouri, Kansas City
Information provided by (Responsible Party):
Lynda Powell, PhD, MEd, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Group-Based Program Behavioral: Self-Directed Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A National Trial of the ELM Lifestyle Program and Remission of the Metabolic Syndrome
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group-Based Behavioral: Group-Based Program
The Group-based Program uses an ecologically valid setting in which participants exercise, prepare foods, and eat together to facilitate the emergence of old habits and replace them with healthy alternatives. The intervention team consists of a health psychologist, registered dietitian, and health coach. They co-facilitate group meetings for 15 participants that are held weekly for 3 months, bi-weekly for 3 months, and then monthly in participant-led maintenance meetings. Each session includes: weigh-in and physical activity (20 min), cooking demonstration (20 min), and a shared vegetable dish with discussion (50 min). The maintenance phase (months 7 to 24 post randomization) consists of support and health-related topics of the participants' own choosing. Progress reports with lab results are sent to participants and primary care physicians.

Active Comparator: Self-Directed Behavioral: Self-Directed Program
The Self-Directed lifestyle program represents enhanced usual care based upon what is currently offered in primary care in the United States for lifestyle treatments for adults with metabolic syndrome. Usual care is enhanced by: 1) lifestyle education for management of metabolic syndrome provided in evidence-based tip sheets from nationally recognized organizations; 2) provision of a Fitbit for self-monitoring physical activity; 3) access to a website containing all education materials; and 4) progress report letters with lab results sent to participants and primary care physicians after completion of each assessment.




Primary Outcome Measures :
  1. Remission of Metabolic Syndrome [ Time Frame: Measured at 24 months following treatment assignment. ]

    Compare the Group-Based and Self-Directed arms on the proportion of participants who are in remission of the metabolic syndrome (MetS) at 2 years. 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.

    Analysis will be performed on pre-determined subgroups: education, sex, site, weight, BMI, MetS severity, race, income # of comorbidities, self-efficacy, and age.



Secondary Outcome Measures :
  1. Vegetable consumption [ Time Frame: Measured at 6, 15, and 24 months following treatment assignment ]
    Compare the Group-Based and Self-Directed arms on 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.

  2. Physical activity [ Time Frame: Measured at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on the proportion of participants who achieve 150 minutes of at least moderate intensity physical activity per week. Activity is measured using an accelerometer (Actigraph wGT3X-BT) worn on the right hip for 7 days and for at least 10 hours/day.

  3. Facets of Mindfulness [ Time Frame: Measuring change from baseline mindfulness at 6, 15, and 24 months following treatment assignment. ]
    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. Group-Based and Self-Directed arms will be compared on the proportion of participants who improve in a 3-facet mindfulness score of greater than or equal to 1 standard deviation of baseline distribution. 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.

  4. Habit formation [ Time Frame: Measuring at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on 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. A 5-point Likert scale will be used with a scale range from 0 to 20. A lower score reflects a weaker habit.

  5. Cost-effectiveness [ Time Frame: Measured over the 24 month patient participant follow-up period ]
    Calculate the cost-effectiveness of the Group-Based relative to the Self-Directed programs. Cost-effectiveness will be be quantified by using the Incremental Cost-Effectiveness Ratio and will reflect the additional cost of the Group-Based program relative to the Self-Directed Program in its efficacy at promoting a sustained remission of metabolic syndrome.

  6. Healthcare utilization [ Time Frame: Measured over the 24 month patient participant follow-up period ]
    Compare the Group-Based and Self-Directed programs on health care utilization (primary care visits, specialty care visits, ER visits, hospital admissions). Participants are queried quarterly concerning use of health care services.

  7. Cost of Medications [ Time Frame: Measured at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed programs on the cost of prescribed medications. This will include collecting data on the number of prescribed medications including data on the number of medications and dosage (mg) of each medication.

  8. Number of Prescribed Medications [ Time Frame: Measured at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed programs on the number of prescribed medications self-reported by participants.

  9. Severity of Metabolic Syndrome [ Time Frame: Measured at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on the severity of the Metabolic Syndrome (MetS). MetS components will be assessed as a continuous sex- and race/ethnicity-specific score (Gurka MJ, Lilly CL, Oliver MN, DeBoer MD. An examination of sex and racial/ethnic differences in the metabolic syndrome among adults: a confirmatory factor analysis and a resulting continuous severity score. Metabolism. 2014;63:218-25).

  10. Weight Loss [ Time Frame: Measuring change from baseline at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on average weight loss (kg). Weight is recorded in kilograms to the nearest 0.1 kg using a flat scale.

  11. ≥ 5% body weight loss [ Time Frame: Measuring change from baseline at 6,15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on the proportion of participants with ≥ 5% loss of baseline weight (kg). Weight is recorded in kilograms to the nearest 0.1 kg using a flat scale.

  12. Body Mass Index [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on Body Mass Index (BMI). Height will be recorded in cm to nearest 0.25 cm and weight recorded in kg to nearest 0.1 kg. BMI = weight (kg) / height squared (m)

  13. Blood Pressure (metabolic syndrome component) [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]

    Compare the Group-Based and Self-Directed arms on the blood pressure component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for blood pressure is met when systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or self-reported treatment for hypertension.

    Average of 3 seated resting blood pressure measurements using NHANES protocol and cuff sizes based on arm circumference. Device is OMRON HEM-907XL

    Cuff sizes:

    Small (17.0-22.0 cm) Medium/Adult (22.1-32.0 cm) Large (32.1-42.0 cm) Extra Large (42.0-50.0 cm)


  14. Waist Circumference (metabolic syndrome component) [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]

    Compare the Group-Based and Self-Directed arms on the waist circumference component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria is based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women.

    Waist circumference will be measured using a tape measure, following the National Heart, Lung, and Blood Institute waist circumference assessment guidelines.


  15. Triglycerides (metabolic syndrome component) [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]

    Compare the Group-Based and Self-Directed arms on the triglyceride component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for elevated triglyceride levels are fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides.

    A fasting blood sample will be sent to Quest diagnostics for analysis.


  16. High-Density Lipoproteins (HDL) Cholesterol (metabolic syndrome component) [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]

    Compare the Group-Based and Self-Directed arms on the HDL cholesterol component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for low HDL are fasting HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or treatment for low HDL.

    A fasting blood sample will be sent to Quest diagnostics for analysis.


  17. Fasting Plasma Glucose (metabolic syndrome component) [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on each of the five components of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. Fasting plasma glucose 100-125 mg/dL (range inclusive) is considered a component of the metabolic syndrome. A fasting blood sample will be sent to Quest diagnostics for analysis.

  18. Frequency of Contacts within Health network [ Time Frame: Measuring change from baseline at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on the frequency of contacts within participants' health network.

  19. Energy and vitality Index [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on the energy and vitality subscale from the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) version 1. The scale range is 0 to 100 with a low score reflecting a lower energy and vitality.

  20. Perceived stress [ Time Frame: Measuring change from baseline at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on change of perceived stress score from baseline using the 10-item Perceived Stress Scale. The scale range is from 0 to 40. A lower score reflects lower levels of stress.

  21. Depressive symptoms [ Time Frame: Measuring change from baseline at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on change of depressive symptoms from baseline using the 8-item self-report Patient Health Questionnaire Depression Scale (PHQ-8). This scale ranges from 0 to 24 with a lower score reflecting less (or no) depressive symptoms.

  22. Social support for diet [ Time Frame: Measured at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on social support for diet. The Social Support for Diet Survey assesses the level of support individuals making health-behavior changes (eating habits) feel they receive from family and friends. This scale is divided into two subscales: 1) encouragement from family and friends and 2) discouragement from family and friends. The Encouragement subscale ranges from 5 to 25 with a lower score reflecting less encouragement (negative outcome). The Discouragement subscale ranges from 5 to 25 with a lower score reflecting less discouragement (positive outcome).

  23. Social support for exercise [ Time Frame: Measured at 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on social support for exercise. The Social Support for Exercise Survey assesses the level of support individuals making health-behavior changes (exercise) feel they receive from family and friends. This questionnaire includes two subscales: 1) Participation and 2) Family Rewards and Punishment. The Participation subscale ranges from 10-50 with a low score reflecting less participation of family and friends (negative outcome). The Family Rewards and Punishment subscale ranges from 3 to 15 with a lower score reflecting increased family rewards (positive outcome).

  24. Hemoglobin A1c levels [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on Hemoglobin A1c levels. A blood assay will be analyzed by Quest Diagnostics. Standard safety procedures are used in performing the participant blood draw required for this measure.

  25. Sugar-sweetened beverages [ Time Frame: Assessed during in-person participant assessments conducted at baseline and 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on frequency of consumption of sugar-sweetened beverages using the Behavioral Risk Factor Surveillance System - Beverage Items.

  26. Eating competence [ Time Frame: Measured at baseline and 6, 15, and 24 months following treatment assignment. ]
    Compare the Group-Based and Self-Directed arms on eating competence using the 16-item Eating Competence Survey. The scale ranges from 0 to 48 with a higher score reflecting a better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036006


Contacts
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Contact: Rebecca Dawar, MPH (312) 942-8571 rebecca_dawar@rush.edu
Contact: Lynda Powell, PhD (312) 942-2013 lynda_powell@rush.edu

Locations
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United States, Colorado
CU Anschutz Health and Wellness Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Jeanne Anne Breen, MS    303-724-9015    jeanneanne.breen@cuanschutzwellness.com   
Principal Investigator: Kevin Masters, PhD         
United States, Illinois
Department of Preventive Medicine, Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Joselyn Williams, MPH    312-563-2233    Joselyn_L_Williams@rush.edu   
Principal Investigator: Brad Appelhans, PhD         
United States, Missouri
University of Missouri-Kansas City Recruiting
Kansas City, Missouri, United States, 64108
Contact: Alex Lyon, BA    816-404-4418    alex.lyon@tmcmed.org   
Principal Investigator: Betty Drees, MD         
United States, New York
Rochester Institute of Technology Not yet recruiting
Rochester, New York, United States, 14623
Contact: Jill Scheltz, RN    585-475-5716    jlshst@rit.edu   
Principal Investigator: Barbara Lohse, PhD         
United States, Pennsylvania
Geisinger Not yet recruiting
Danville, Pennsylvania, United States, 17822
Contact: Jacob Mowrey    570-214-5330    jwmowery@geisinger.edu   
Principal Investigator: Lisa Bailey-Davis, DEd         
Sponsors and Collaborators
Rush University Medical Center
University of Colorado, Denver
Geisinger Clinic
Rochester Institute of Technology
University of Missouri, Kansas City
Investigators
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Study Chair: Lynda Powell, PhD Rush University Medical Center
Study Director: DeJuran Richardson, PhD Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Lynda Powell, PhD, MEd, Rush University Medical Center:
Informed Consent Form  [PDF] January 30, 2020

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Responsible Party: Lynda Powell, PhD, MEd, Professor and Chair of Preventive Medicine, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04036006    
Other Study ID Numbers: 18092408
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lynda Powell, PhD, MEd, Rush University Medical Center:
Behavioral intervention
Lifestyle
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases