A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study) (3ELM)

A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome

Approximately 24% of the US adult population meet criteria for metabolic syndrome (MetS), diagnosed by a combination of abdominal obesity, elevated blood pressure, high triglyceride and low HDL-cholesterol level, and pre-diabetes. MetS quintuples the risk of diabetes, and doubles the risk of cardiovascular disease (CVD), particularly heart failure. Lifestyle modification is the initial step of treatment, but few studies have demonstrated early and sustained efficacy in remission of MetS. Our preliminary studies of a lifestyle change program for patients with MetS included a 1-year of development of an intervention by an interdisciplinary team of experts in medicine and the behavioral sciences. The investigators then tested the efficacy of the intervention in a treatment-only, proof-of-concept study. The investigators achieved our goal of 50% MetS remission after 2 years, in a sample of 26 patients. This study is the second step of a research program testing an innovative bio-behavioral intervention aimed at remitting MetS through lifestyle intervention, by focusing on eating patterns, daily activity, and stress management. The overarching objective of this research program is to determine the efficacy of the ELM lifestyle intervention to achieve remission of MetS. This purpose of the current study is to prepare for a large, randomized, clinical trial by conducting a smaller clinical trial that examines the acceptability of the ELM intervention (ELM Group) as compared to two other intervention arms (ELM Classes, ELM Individual).

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: ELM Group; Other: ELM Classes; Other: ELM Individual

Detailed Description

The 3ELM ("Eat, Love, Move") study recruits 48 patients with MetS, and provides a 6-month intervention that aims to remit MetS by promoting the long-term adoption of healthier behaviors (diet, physical activity, stress reduction). Participants in 3ELM are randomly assigned to one of the study arms ("ELM Groups", "ELM Classes", "ELM Individual"); all of which receive some type of intervention in either group, class, or individual formats. The primary aim of this project is to pilot test the acceptability of each of the study arms and the outcome measures.

The study also includes outcome assessments at 3 time points: at the start of the study, and at 3, and 6 months post baseline. All study participants will receive medical care (including metabolic syndrome care) from their regular medical doctors. Study staff will track participants' use of health care and wellness services during the study after obtaining participant permission to collect this data.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women age 18-72 years (children and the elderly need age-specific lifestyle tailoring).
• Able to walk 2 blocks (the patients should be able to engage in moderate intensity exercise).
• Have preference for making lifestyle changes to treat MetS.
• Able to participate in a lifestyle intervention for 6 months.
• Meet at least 3 Metabolic syndrome criteria: abdominal obesity (waist girth >102♂/88♀ cm), high blood pressure (≥130/85 mm Hg or treatment), triglyceridemia (≥150 mg/dL or fibrate therapy), low HDL-cholesterol (<40♂/50♀ mg/dL or niacin therapy) or fasting glucose ≥100 mg/dL (or pre-diabetes).

Exclusion Criteria:

• Substance abuse within the past 12 months: alcohol use, current daily smokers (self-report); and illicit drug use.
• Weight loss, exceeding 10% of initial weight, in the past 6 months or current use of medications for weight loss, bowel resection surgery, bariatric surgery, eating disorder.
• Other medical or behavioral limitations judged to interfere with study participation or the ability to follow study procedures (eg, scheduled surgery, travel plans or scheduling difficulties that do not permit full participation), limited English language, cognitive impairment, pregnancy, or psychiatric comorbidities (such as severe major depression, or psychotic disorders).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ELM Group; A 6-month group lifestyle intervention, consisting of 12 weekly and 6 bi-weekly 2-hour sessions. The sessions consist of 30-min physical activity, 30-min meal demonstration, and 60-min group behavioral intervention, with a focus on experiential learning in naturalistic setting. Sessions are facilitated by dietitian/personal trainer and behavioral specialist.	Behavioral: ELM Group; ELM participants are trained to portion their meals according to the "Perfect Plate" method, a modified version of the USDA's ChooseMyPlate.gov. The stress management focuses on mindful living, cognitive restructuring; the enhancement of positive emotions. The physical activity component focuses on reduction of sedentary activity (by increasing daily step counts) and moderate-to-vigorous physical activity.; Other Names: ELM Lifestyle Intervention
Other: ELM Classes; A 6-month health education, consisting of 12 weekly and 6 bi-weekly 30-45 min sessions. The sessions consist of didactic classes, with a focus on health education curriculum. Sessions are facilitated by a health educator and medical providers.	Other: ELM Classes; ELM classes will be administered through Rush Generations program and focus on health education.; Other Names: Health Education
Active Comparator: ELM Individual; A 6-month intervention, that consists of educational manuals on physical activity, diet and stress reduction and recommended 3 medical visits every 3 months for medical counseling and feedback using 5A (Ask, Advise, Assess, Assist, and Arrange) framework . These Metabolic syndrome care materials and provider documentation will be embedded in electronic medical record system, and will be accessible to medical providers by usual means. This enhanced usual care by participant's usual health care provider focuses on metabolic syndrome and lifestyle modifications to reduce the risk of chronic disease.	Other: ELM Individual; ELM Individual arm participants will receive education materials on metabolic syndrome and diet, exercise, stress reduction recommendations. The participants will be recommended to follow these guidelines and discuss/seek support from their health care provider (visits at baseline, 3 and 6 months will be recommended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
metabolic syndrome remission, defined as <3 of the 5 standard diagnostic criteria.	metabolic syndrome remission will be assessed by measurement of waist girth, blood pressure, fasting serum lipid and glucose levels, and the number of medications to treat blood pressure.	6-month change

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition intake	Healthy Eating Index (HEI-2010) will be computed using data from 24-h dietary recalls, conducted on nonconsecutive days, including one weekend day, using the Nutrition Data System for Research (NDSR).128 The HEI-2010 is a quantifiable method of assessing the adherence to Dietary Guidelines for Americans.	Baseline, and 6 months
Accelerometry	Accelerometry (Actigraph) is the gold standard objective method for daily activity data collection. Standard methods for equipment programming and data reduction, supplemented by activity and sleep log will be used to calculate minutes/week of moderate/vigorous activity, sedentary activity, sleep, and accelerometer step counts.	At baseline and 6 months
International Physical Activity Questionnaire (IPAQ)	Measures engagement in physical activity	At baseline and 6 months
Perceived Stress Scale	a 10-item questionnaire that measures stress	At baseline, 3, and 6 months
Weight	Weight will be measured using stationary scale per standardized protocol.	At baseline, 3, and 6 months
A1c	A plasma sample will be collected to measure HbA1c.	At baseline and 6 months
Credibility and expectancies questionnaire (CEQ)	A 4-item questionnaire measures participants acceptability ratings - specifically whether they think the treatments are credible and if they think they will help them with their health goals.	At baseline, 3, and 6 months
Vitality Index	will be tracked using a 4 item subscale of Medical Outcomes Study (MOS) 36-Item Short Form Health survey that measures perceived energy and fatigue within the last 30 days.	At baseline, 3, and 6 months
Continuous metabolic syndrome score	calculated as a sum of z-scores of the individual 5 MetS components using reported methodology from other clinical trials. This MetS research tool has methodological advantage accounting for severity of MetS.	At baseline, 3, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication questionnaire	The list of medications with dose and frequency of administration will be collected using a standardized questionnaire.	At baseline, 3, and 6 months
Brief COPE	measures coping of stressors	At baseline, and 6 months
Daily Hassles Questionnaire	measures primary and secondary appraisal of stressors.	At baseline, 3, and 6 months
Three Factor Eating Questionnaire (TFEQ)	Measures disordered eating patterns.	At baseline, and 6 months
Patient Health Questionnaire (PHQ-9)	Measures depressive symptoms	At baseline, 3, and 6 months
Treatment Self-Regulation Questionnaire (TSRQ for eating and physical activity)	Measures self-regulation abilities for eating and physical activity	At baseline, 3, and 6 months
Work Productivity and Activity Impairment Questionnaire	measures lost productivity in the form of absenteeism and presenteeism.	At baseline, 3, and 6 months
Use of wellness, health, and preventive services	Wil be used for cost analysis.	At baseline, 3, and 6 months
Perceived environment (food and exercise)	measures the built and food environment	At baseline
Global health scale	Self-assessment of overall health.	At baseline, 3, and 6 months
General Questionnaire	Measures basic sociodemographic characteristics.	At baseline, updated at 3, and 6 months
Weight history and experiences with wellness/weight management programs	Captures weight fluctuations and participation in commercial or health care based wellness or weight loss programs	At baseline, and updated at 3 and 6 months
Treatment modality preferences and willingness	Captures participant preferences for lifestyle, medication, and surgical treatment modalities.	At baseline and 6 months
Beliefs about medications	Captures participant's beliefs about the usefulness and safety of medications.	At baseline
Time horizon	Assesses executive function	At baseline and 6 months
Patient Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire	measures cognitive/executive function.	At baseline and 6 months
Perceived lifestyle change for physical activity and diet	Captures participant's self-assessment of effort-related to lifestyle changes.	At 3 and 6 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Rasa Kazlauskaite, MD, Rush University Medical Center; Study Director: Lisa Walt, PhD, Rush University Medical Center

Publications and helpful links

Helpful Links

• What Is Metabolic Syndrome?
• What Causes Metabolic Syndrome?
• Who Is at Risk for Metabolic Syndrome?
• What Are the Signs and Symptoms of Metabolic Syndrome?
• How Is Metabolic Syndrome Diagnosed?
• How Is Metabolic Syndrome Treated?
• Living With Metabolic Syndrome

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2013
• Primary Completion (Actual): August 31, 2015
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Prediabetic State; Enlarged Waist Elevated Triglycerides; HDL Cholesterol, Low Serum
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 11111701-CA01; R56HL118343-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Clinical Study Report
   Information identifier: PMC6589338
   Information comments: A manuscript summarizing the development of the intervention.
2. Informed Consent Form
   Information identifier: 11111701-IRB01
   Information comments: The informed consent is available through RuMC IRB portal.