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| ID | Type | Description | Link |
|---|---|---|---|
| R56HL118343-01A1 | U.S. NIH Grant/Contract | View source |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELM Group | Experimental | 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. |
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| ELM Classes | Other | 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. |
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| ELM Individual | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELM Group | Behavioral | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasa Kazlauskaite, MD | Rush University Medical Center | Principal Investigator |
| Lisa Walt, PhD | Rush University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| Label | URL |
|---|---|
| What Is Metabolic Syndrome? | View source |
| What Causes Metabolic Syndrome? | View source |
| Who Is at Risk for Metabolic Syndrome? |
| ID | Type | URL | Comment |
|---|---|---|---|
| PMC6589338 | Clinical Study Report | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Aug 12, 2014 | Jan 10, 2023 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2013 | Jan 10, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D011236 | Prediabetic State |
| D006973 | Hypertension |
| D064250 | Hypertriglyceridemic Waist |
| D052456 | Hypoalphalipoproteinemias |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ELM Classes | Other | ELM classes will be administered through Rush Generations program and focus on health education. |
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| ELM Individual | Other | 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. |
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| 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 |
| 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 |
| What Are the Signs and Symptoms of Metabolic Syndrome? | View source |
| How Is Metabolic Syndrome Diagnosed? | View source |
| How Is Metabolic Syndrome Treated? | View source |
| Living With Metabolic Syndrome | View source |
A manuscript summarizing the development of the intervention. |
| 11111701-IRB01 | Informed Consent Form | View IPD | The informed consent is available through RuMC IRB portal. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D015228 | Hypertriglyceridemia |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |