An interventional study of ELM Group and ELM Classes in Metabolic Syndrome, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment
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).
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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 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.
Also known as: ELM Lifestyle Intervention
ELM classes will be administered through Rush Generations program and focus on health education.
Also known as: Health Education
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.
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.
Time frame: 6-month change
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.
Time frame: 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.
Time frame: At baseline and 6 months
International Physical Activity Questionnaire (IPAQ)
Measures engagement in physical activity
Time frame: At baseline and 6 months
Perceived Stress Scale
a 10-item questionnaire that measures stress
Time frame: At baseline, 3, and 6 months
Weight
Weight will be measured using stationary scale per standardized protocol.
Time frame: At baseline, 3, and 6 months
A1c
A plasma sample will be collected to measure HbA1c.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, 3, and 6 months
Medication questionnaire
The list of medications with dose and frequency of administration will be collected using a standardized questionnaire.
Time frame: At baseline, 3, and 6 months
Brief COPE
measures coping of stressors
Time frame: At baseline, and 6 months
Daily Hassles Questionnaire
measures primary and secondary appraisal of stressors.
Time frame: At baseline, 3, and 6 months
Three Factor Eating Questionnaire (TFEQ)
Measures disordered eating patterns.
Time frame: At baseline, and 6 months
Patient Health Questionnaire (PHQ-9)
Measures depressive symptoms
Time frame: 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
Time frame: At baseline, 3, and 6 months
Work Productivity and Activity Impairment Questionnaire
measures lost productivity in the form of absenteeism and presenteeism.
Time frame: At baseline, 3, and 6 months
Use of wellness, health, and preventive services
Wil be used for cost analysis.
Time frame: At baseline, 3, and 6 months
Perceived environment (food and exercise)
measures the built and food environment
Time frame: At baseline
Global health scale
Self-assessment of overall health.
Time frame: At baseline, 3, and 6 months
General Questionnaire
Measures basic sociodemographic characteristics.
Time frame: 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
Time frame: At baseline, and updated at 3 and 6 months
Treatment modality preferences and willingness
Captures participant preferences for lifestyle, medication, and surgical treatment modalities.
Time frame: At baseline and 6 months
Beliefs about medications
Captures participant's beliefs about the usefulness and safety of medications.
Time frame: At baseline
Time horizon
Assesses executive function
Time frame: At baseline and 6 months
Patient Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire
measures cognitive/executive function.
Time frame: At baseline and 6 months
Perceived lifestyle change for physical activity and diet
Captures participant's self-assessment of effort-related to lifestyle changes.
Time frame: At 3 and 6 months
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Plan to share: No
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Rush University Medical Center