Enhanced Lifestyles for Metabolic Syndrome (ELM)

Rush

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Behavioral: Self-Directed Program; Behavioral: Group-Based Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04036006

18092408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 618 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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618 participants in 2 patient groups

Group-Based

Experimental group

Description:

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.

Treatment:

Behavioral: Group-Based Program

Self-Directed

Active Comparator group

Description:

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

Treatment:

Behavioral: Self-Directed Program