<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233088</url>
  </required_header>
  <id_info>
    <org_study_id>11111701-CA01</org_study_id>
    <secondary_id>R56HL118343-01A1</secondary_id>
    <nct_id>NCT02233088</nct_id>
  </id_info>
  <brief_title>A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)</brief_title>
  <acronym>3ELM</acronym>
  <official_title>A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately 24% of the US adult population meet criteria for metabolic syndrome (MetS),&#xD;
      diagnosed by a combination of abdominal obesity, elevated blood pressure, high triglyceride&#xD;
      and low HDL-cholesterol level, and pre-diabetes. MetS quintuples the risk of diabetes, and&#xD;
      doubles the risk of cardiovascular disease (CVD), particularly heart failure. Lifestyle&#xD;
      modification is the initial step of treatment, but few studies have demonstrated early and&#xD;
      sustained efficacy in remission of MetS. Our preliminary studies of a lifestyle change&#xD;
      program for patients with MetS included a 1-year of development of an intervention by an&#xD;
      interdisciplinary team of experts in medicine and the behavioral sciences. The investigators&#xD;
      then tested the efficacy of the intervention in a treatment-only, proof-of-concept study. The&#xD;
      investigators achieved our goal of 50% MetS remission after 2 years, in a sample of 26&#xD;
      patients. This study is the second step of a research program testing an innovative&#xD;
      bio-behavioral intervention aimed at remitting MetS through lifestyle intervention, by&#xD;
      focusing on eating patterns, daily activity, and stress management. The overarching objective&#xD;
      of this research program is to determine the efficacy of the ELM lifestyle intervention to&#xD;
      achieve remission of MetS. This purpose of the current study is to prepare for a large,&#xD;
      randomized, clinical trial by conducting a smaller clinical trial that examines the&#xD;
      acceptability of the ELM intervention (ELM Group) as compared to two other intervention arms&#xD;
      (ELM Classes, ELM Individual).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 3ELM (&quot;Eat, Love, Move&quot;) study recruits 48 patients with MetS, and provides a 6-month&#xD;
      intervention that aims to remit MetS by promoting the long-term adoption of healthier&#xD;
      behaviors (diet, physical activity, stress reduction). Participants in 3ELM are randomly&#xD;
      assigned to one of the study arms (&quot;ELM Groups&quot;, &quot;ELM Classes&quot;, &quot;ELM Individual&quot;); all of&#xD;
      which receive some type of intervention in either group, class, or individual formats. The&#xD;
      primary aim of this project is to pilot test the acceptability of each of the study arms and&#xD;
      the outcome measures.&#xD;
&#xD;
      The study also includes outcome assessments at 3 time points: at the start of the study, and&#xD;
      at 3, and 6 months post baseline. All study participants will receive medical care (including&#xD;
      metabolic syndrome care) from their regular medical doctors. Study staff will track&#xD;
      participants' use of health care and wellness services during the study after obtaining&#xD;
      participant permission to collect this data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2013</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>metabolic syndrome remission, defined as &lt;3 of the 5 standard diagnostic criteria.</measure>
    <time_frame>6-month change</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutrition intake</measure>
    <time_frame>Baseline, and 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accelerometry</measure>
    <time_frame>At baseline and 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire (IPAQ)</measure>
    <time_frame>At baseline and 6 months</time_frame>
    <description>Measures engagement in physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>a 10-item questionnaire that measures stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>Weight will be measured using stationary scale per standardized protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A1c</measure>
    <time_frame>At baseline and 6 months</time_frame>
    <description>A plasma sample will be collected to measure HbA1c.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Credibility and expectancies questionnaire (CEQ)</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitality Index</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous metabolic syndrome score</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Medication questionnaire</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>The list of medications with dose and frequency of administration will be collected using a standardized questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>Brief COPE</measure>
    <time_frame>At baseline, and 6 months</time_frame>
    <description>measures coping of stressors</description>
  </other_outcome>
  <other_outcome>
    <measure>Daily Hassles Questionnaire</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>measures primary and secondary appraisal of stressors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Three Factor Eating Questionnaire (TFEQ)</measure>
    <time_frame>At baseline, and 6 months</time_frame>
    <description>Measures disordered eating patterns.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>Measures depressive symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Self-Regulation Questionnaire (TSRQ for eating and physical activity)</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>Measures self-regulation abilities for eating and physical activity</description>
  </other_outcome>
  <other_outcome>
    <measure>Work Productivity and Activity Impairment Questionnaire</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>measures lost productivity in the form of absenteeism and presenteeism.</description>
  </other_outcome>
  <other_outcome>
    <measure>Use of wellness, health, and preventive services</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>Wil be used for cost analysis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived environment (food and exercise)</measure>
    <time_frame>At baseline</time_frame>
    <description>measures the built and food environment</description>
  </other_outcome>
  <other_outcome>
    <measure>Global health scale</measure>
    <time_frame>At baseline, 3, and 6 months</time_frame>
    <description>Self-assessment of overall health.</description>
  </other_outcome>
  <other_outcome>
    <measure>General Questionnaire</measure>
    <time_frame>At baseline, updated at 3, and 6 months</time_frame>
    <description>Measures basic sociodemographic characteristics.</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight history and experiences with wellness/weight management programs</measure>
    <time_frame>At baseline, and updated at 3 and 6 months</time_frame>
    <description>Captures weight fluctuations and participation in commercial or health care based wellness or weight loss programs</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment modality preferences and willingness</measure>
    <time_frame>At baseline and 6 months</time_frame>
    <description>Captures participant preferences for lifestyle, medication, and surgical treatment modalities.</description>
  </other_outcome>
  <other_outcome>
    <measure>Beliefs about medications</measure>
    <time_frame>At baseline</time_frame>
    <description>Captures participant's beliefs about the usefulness and safety of medications.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time horizon</measure>
    <time_frame>At baseline and 6 months</time_frame>
    <description>Assesses executive function</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire</measure>
    <time_frame>At baseline and 6 months</time_frame>
    <description>measures cognitive/executive function.</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived lifestyle change for physical activity and diet</measure>
    <time_frame>At 3 and 6 months</time_frame>
    <description>Captures participant's self-assessment of effort-related to lifestyle changes.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>ELM Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ELM Classes</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ELM Individual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ELM Group</intervention_name>
    <description>ELM participants are trained to portion their meals according to the &quot;Perfect Plate&quot; 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.</description>
    <arm_group_label>ELM Group</arm_group_label>
    <other_name>ELM Lifestyle Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ELM Classes</intervention_name>
    <description>ELM classes will be administered through Rush Generations program and focus on health education.</description>
    <arm_group_label>ELM Classes</arm_group_label>
    <other_name>Health Education</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ELM Individual</intervention_name>
    <description>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.</description>
    <arm_group_label>ELM Individual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women age 18-72 years (children and the elderly need age-specific lifestyle&#xD;
             tailoring).&#xD;
&#xD;
          -  Able to walk 2 blocks (the patients should be able to engage in moderate intensity&#xD;
             exercise).&#xD;
&#xD;
          -  Have preference for making lifestyle changes to treat MetS.&#xD;
&#xD;
          -  Able to participate in a lifestyle intervention for 6 months.&#xD;
&#xD;
          -  Meet at least 3 Metabolic syndrome criteria: abdominal obesity (waist girth &gt;102♂/88♀&#xD;
             cm), high blood pressure (≥130/85 mm Hg or treatment), triglyceridemia (≥150 mg/dL or&#xD;
             fibrate therapy), low HDL-cholesterol (&lt;40♂/50♀ mg/dL or niacin therapy) or fasting&#xD;
             glucose ≥100 mg/dL (or pre-diabetes).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substance abuse within the past 12 months: alcohol use, current daily smokers&#xD;
             (self-report); and illicit drug use.&#xD;
&#xD;
          -  Weight loss, exceeding 10% of initial weight, in the past 6 months or current use of&#xD;
             medications for weight loss, bowel resection surgery, bariatric surgery, eating&#xD;
             disorder.&#xD;
&#xD;
          -  Other medical or behavioral limitations judged to interfere with study participation&#xD;
             or the ability to follow study procedures (eg, scheduled surgery, travel plans or&#xD;
             scheduling difficulties that do not permit full participation), limited English&#xD;
             language, cognitive impairment, pregnancy, or psychiatric comorbidities (such as&#xD;
             severe major depression, or psychotic disorders).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rasa Kazlauskaite, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Walt, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.nhlbi.nih.gov/health/health-topics/topics/ms</url>
    <description>What Is Metabolic Syndrome?</description>
  </link>
  <link>
    <url>https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome</url>
    <description>What Causes Metabolic Syndrome?</description>
  </link>
  <link>
    <url>https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome</url>
    <description>Who Is at Risk for Metabolic Syndrome?</description>
  </link>
  <link>
    <url>https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome</url>
    <description>What Are the Signs and Symptoms of Metabolic Syndrome?</description>
  </link>
  <link>
    <url>https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome</url>
    <description>How Is Metabolic Syndrome Diagnosed?</description>
  </link>
  <link>
    <url>https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome</url>
    <description>How Is Metabolic Syndrome Treated?</description>
  </link>
  <link>
    <url>https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome</url>
    <description>Living With Metabolic Syndrome</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prediabetic State</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Enlarged Waist Elevated Triglycerides</keyword>
  <keyword>HDL Cholesterol, Low Serum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>PMC6589338</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.ncbi.nlm.nih.gov/pubmed/30234352</doc_url>
      <doc_comment>A manuscript summarizing the development of the intervention.</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>11111701-IRB01</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://rrp.rush.edu/researchportal/sd/ResourceAdministration/Project/PrintSmartForms?Project=com.webridge.entity.Entity%5BOID%5B4B88F935265BF94D8A92A0BD5A70A202%5D%5D&amp;rootEntity=com.webridge.entity.Entity%5BOID%5B4B88F935265BF94D8A92A0BD5A70A202%5D%5D&amp;PrintBySection=False&amp;PrintHeaderView=True&amp;PrintHeaderInfo=True&amp;PrintPageBreak=True&amp;PrintLogo=True&amp;showHiddenData=False&amp;showCDTFormsAtEnd=True</doc_url>
      <doc_comment>The informed consent is available through RuMC IRB portal.</doc_comment>
    </study_doc>
  </study_docs>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 12, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT02233088/Prot_ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 28, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT02233088/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233088
org study id: 11111701-CA01
secondary id: R56HL118343-01A1
nct id: NCT02233088
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: metabolic syndrome remission, defined as <3 of the 5 standard diagnostic criteria.
time frame: 6-month change
description: 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.
measure: Nutrition intake
time frame: Baseline, and 6 months
description: 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.
measure: Accelerometry
time frame: At baseline and 6 months
description: 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.
measure: International Physical Activity Questionnaire (IPAQ)
time frame: At baseline and 6 months
description: Measures engagement in physical activity
measure: Perceived Stress Scale
time frame: At baseline, 3, and 6 months
description: a 10-item questionnaire that measures stress
measure: Weight
time frame: At baseline, 3, and 6 months
description: Weight will be measured using stationary scale per standardized protocol.
measure: A1c
time frame: At baseline and 6 months
description: A plasma sample will be collected to measure HbA1c.
measure: Credibility and expectancies questionnaire (CEQ)
time frame: At baseline, 3, and 6 months
description: 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.
measure: Vitality Index
time frame: At baseline, 3, and 6 months
description: 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.
measure: Continuous metabolic syndrome score
time frame: At baseline, 3, and 6 months
description: 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.
measure: Medication questionnaire
time frame: At baseline, 3, and 6 months
description: The list of medications with dose and frequency of administration will be collected using a standardized questionnaire.
measure: Brief COPE
time frame: At baseline, and 6 months
description: measures coping of stressors
measure: Daily Hassles Questionnaire
time frame: At baseline, 3, and 6 months
description: measures primary and secondary appraisal of stressors.
measure: Three Factor Eating Questionnaire (TFEQ)
time frame: At baseline, and 6 months
description: Measures disordered eating patterns.
measure: Patient Health Questionnaire (PHQ-9)
time frame: At baseline, 3, and 6 months
description: Measures depressive symptoms
measure: Treatment Self-Regulation Questionnaire (TSRQ for eating and physical activity)
time frame: At baseline, 3, and 6 months
description: Measures self-regulation abilities for eating and physical activity
measure: Work Productivity and Activity Impairment Questionnaire
time frame: At baseline, 3, and 6 months
description: measures lost productivity in the form of absenteeism and presenteeism.
measure: Use of wellness, health, and preventive services
time frame: At baseline, 3, and 6 months
description: Wil be used for cost analysis.
measure: Perceived environment (food and exercise)
time frame: At baseline
description: measures the built and food environment
measure: Global health scale
time frame: At baseline, 3, and 6 months
description: Self-assessment of overall health.
measure: General Questionnaire
time frame: At baseline, updated at 3, and 6 months
description: Measures basic sociodemographic characteristics.
measure: Weight history and experiences with wellness/weight management programs
time frame: At baseline, and updated at 3 and 6 months
description: Captures weight fluctuations and participation in commercial or health care based wellness or weight loss programs
measure: Treatment modality preferences and willingness
time frame: At baseline and 6 months
description: Captures participant preferences for lifestyle, medication, and surgical treatment modalities.
measure: Beliefs about medications
time frame: At baseline
description: Captures participant's beliefs about the usefulness and safety of medications.
measure: Time horizon
time frame: At baseline and 6 months
description: Assesses executive function
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire
time frame: At baseline and 6 months
description: measures cognitive/executive function.
measure: Perceived lifestyle change for physical activity and diet
time frame: At 3 and 6 months
description: Captures participant's self-assessment of effort-related to lifestyle changes.
arm group label: ELM Group
arm group type: Experimental
description: 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.
arm group label: ELM Classes
arm group type: Other
description: 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.
arm group label: ELM Individual
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: ELM Group
description: 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.
arm group label: ELM Group
other name: ELM Lifestyle Intervention
intervention type: Other
intervention name: ELM Classes
description: ELM classes will be administered through Rush Generations program and focus on health education.
arm group label: ELM Classes
other name: Health Education
intervention type: Other
intervention name: ELM Individual
description: 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.
arm group label: ELM Individual
criteria: 
gender: All
minimum age: 18 Years
maximum age: 72 Years
healthy volunteers: No
last name: Rasa Kazlauskaite, MD
role: Principal Investigator
affiliation: Rush University Medical Center
last name: Lisa Walt, PhD
role: Study Director
affiliation: Rush University Medical Center
facility: 
country: United States
url: https://www.nhlbi.nih.gov/health/health-topics/topics/ms
description: What Is Metabolic Syndrome?
url: https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome
description: What Causes Metabolic Syndrome?
url: https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome
description: Who Is at Risk for Metabolic Syndrome?
url: https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome
description: What Are the Signs and Symptoms of Metabolic Syndrome?
url: https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome
description: How Is Metabolic Syndrome Diagnosed?
url: https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome
description: How Is Metabolic Syndrome Treated?
url: https://www.nhlbi.nih.gov/health-topics/metabolic-syndrome
description: Living With Metabolic Syndrome
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No
study doc: 
study doc: 
provided document: 
provided document: 