Enhanced Lifestyles for Metabolic Syndrome

NCT04036006 | Completed DMC

• 1 other identifier: 18092408
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 5

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.

Conditions

Metabolic Syndrome

Keywords

Behavioral intervention; Lifestyle

Outcome Measures

Primary Outcomes (1)

• Remission of Metabolic Syndrome

  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.

  Measured at 24 months following treatment assignment.

Secondary Outcomes (27)

• Vegetable consumption

  Measured at 6, 15, and 24 months following treatment assignment

• Physical activity

  Measured at 6, 15, and 24 months following treatment assignment.

• Facets of Mindfulness

  Measuring change from baseline mindfulness at 6, 15, and 24 months following treatment assignment.

• Habit formation

  Measuring at 6, 15, and 24 months following treatment assignment.

• Cost-effectiveness

  Measured over the 24 month patient participant follow-up period

Other Outcomes (1)

• Pre-specified outcomes

  Measured at 24 months after treatment assignment.

Study Arms (2)

Group-Based

EXPERIMENTAL

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.

Behavioral: Group-Based Program

Self-Directed

ACTIVE COMPARATOR

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

Behavioral: Self-Directed Program

Interventions

Group-Based Program BEHAVIORAL

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.

Group-Based

Self-Directed Program BEHAVIORAL

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.

Self-Directed

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 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)
• Greater than 18 years of age

You may not qualify if:

• Unable to walk 2 consecutive blocks without assistance, based on patient report.
• Unwilling, unable, or not ready to make the lifestyle changes prescribed in ELM
• Unwilling to be randomized to either arm of the trial
• 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)
• Does not have reliable access to the internet via a computer or mobile device
• Not fluent in English
• Current diagnosis of type 1 or type 2 diabetes, or on any diabetes medications except metformin
• 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 24 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 based on the ASSIST screening tool (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, phentermine, etc.) or supplements in the last 3 months, or unwilling to abstain from taking weight loss medications or supplements during the study
• History of bowel resection surgery or bariatric surgery

Sponsors & Collaborators

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

Study Sites (5)

CU Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

Department of Family and Preventive Medicine, Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Missouri-Kansas City

Kansas City, Missouri, 64108, United States

Location

Rochester Institute of Technology

Rochester, New York, 14623, United States

Location

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Related Publications (2)

• Powell LH, Berkley-Patton J, Drees BM, Karavolos K, Lohse B, Masters KS, Nicklas JM, Rothschild SK, Yeh C, Zimmermann LJ, Suzuki S; ELM Trial Research Group. Lifestyle Intervention for Sustained Remission of Metabolic Syndrome: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jan 1;186(1):67-77. doi: 10.1001/jamainternmed.2025.5900.

  PMID: 41207299 DERIVED

• Yeh C, Crane MM, Daniels B, Lohse B, Karavolos K, Olinger T, Nicklas J, Powell LH, Suzuki S. Factors associated with male recruitment in a multi-site randomized behavioral clinical trial targeting the metabolic syndrome: analysis of screening and recruitment data from the ELM trial. Trials. 2024 Dec 21;25(1):844. doi: 10.1186/s13063-024-08703-8.

  PMID: 39707544 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lynda Powell, PhD

  Rush University Medical Center

  STUDY CHAIR

• Sumihiro Suzuki, PhD

  Rush University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Preventive Medicine

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: July 29, 2019
• Study Start: July 1, 2019
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)