A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      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).
    

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.
    

Intervention name(s): ELM Group; ELM Classes; ELM Individual
Intervention type(s): Behavioral; Other; Other
Intervention description(s): 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.; ELM classes will be administered through Rush Generations program and focus on 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.
Other intervention name(s): ELM Lifestyle Intervention; Health Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prediabetic State; Hypertension; Enlarged Waist Elevated Triglycerides; HDL Cholesterol, Low Serum