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NCT Number: NCT02233088

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

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).

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Key information

Conditions

Metabolic Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Dyslipidemias Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertension Hypertriglyceridemia Hypertriglyceridemic Waist Hypoalphalipoproteinemias Hypolipoproteinemias Insulin Resistance Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms Vascular Diseases

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: ELM Lifestyle Intervention

ELM Classes

Other

ELM classes will be administered through Rush Generations program and focus on health education.

Other names: Health Education

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.

Primary outcomes

  1. metabolic syndrome remission, defined as <3 of the 5 standard diagnostic criteria.

    Time frame: 6-month change

    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.

Secondary outcomes

  1. Nutrition intake

    Time frame: Baseline, and 6 months

    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.

  2. Accelerometry

    Time frame: At baseline and 6 months

    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.

  3. International Physical Activity Questionnaire (IPAQ)

    Time frame: At baseline and 6 months

    Measures engagement in physical activity

  4. Perceived Stress Scale

    Time frame: At baseline, 3, and 6 months

    a 10-item questionnaire that measures stress

  5. Weight

    Time frame: At baseline, 3, and 6 months

    Weight will be measured using stationary scale per standardized protocol.

  6. A1c

    Time frame: At baseline and 6 months

    A plasma sample will be collected to measure HbA1c.

  7. Credibility and expectancies questionnaire (CEQ)

    Time frame: At baseline, 3, and 6 months

    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.

  8. Vitality Index

    Time frame: At baseline, 3, and 6 months

    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.

  9. Continuous metabolic syndrome score

    Time frame: At baseline, 3, and 6 months

    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.

Other outcomes

  1. Medication questionnaire

    Time frame: At baseline, 3, and 6 months

    The list of medications with dose and frequency of administration will be collected using a standardized questionnaire.

  2. Brief COPE

    Time frame: At baseline, and 6 months

    measures coping of stressors

  3. Daily Hassles Questionnaire

    Time frame: At baseline, 3, and 6 months

    measures primary and secondary appraisal of stressors.

  4. Three Factor Eating Questionnaire (TFEQ)

    Time frame: At baseline, and 6 months

    Measures disordered eating patterns.

  5. Patient Health Questionnaire (PHQ-9)

    Time frame: At baseline, 3, and 6 months

    Measures depressive symptoms

  6. Treatment Self-Regulation Questionnaire (TSRQ for eating and physical activity)

    Time frame: At baseline, 3, and 6 months

    Measures self-regulation abilities for eating and physical activity

  7. Work Productivity and Activity Impairment Questionnaire

    Time frame: At baseline, 3, and 6 months

    measures lost productivity in the form of absenteeism and presenteeism.

  8. Use of wellness, health, and preventive services

    Time frame: At baseline, 3, and 6 months

    Wil be used for cost analysis.

  9. Perceived environment (food and exercise)

    Time frame: At baseline

    measures the built and food environment

  10. Global health scale

    Time frame: At baseline, 3, and 6 months

    Self-assessment of overall health.

  11. General Questionnaire

    Time frame: At baseline, updated at 3, and 6 months

    Measures basic sociodemographic characteristics.

  12. Weight history and experiences with wellness/weight management programs

    Time frame: At baseline, and updated at 3 and 6 months

    Captures weight fluctuations and participation in commercial or health care based wellness or weight loss programs

  13. Treatment modality preferences and willingness

    Time frame: At baseline and 6 months

    Captures participant preferences for lifestyle, medication, and surgical treatment modalities.

  14. Beliefs about medications

    Time frame: At baseline

    Captures participant's beliefs about the usefulness and safety of medications.

  15. Time horizon

    Time frame: At baseline and 6 months

    Assesses executive function

  16. Patient Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire

    Time frame: At baseline and 6 months

    measures cognitive/executive function.

  17. Perceived lifestyle change for physical activity and diet

    Time frame: At 3 and 6 months

    Captures participant's self-assessment of effort-related to lifestyle changes.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome

Acronym: 3ELM

Important dates

Study start
2013
Primary completion
2015
Study completion
2021
First posted
Sep 8, 2014
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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