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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome

Brief 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 Summary:

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.


Sponsor: Rush University Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • International Physical Activity Questionnaire (IPAQ) [ Time Frame: At baseline and 6 months ]
    Measures engagement in physical activity
  • Perceived Stress Scale [ Time Frame: At baseline, 3, and 6 months ]
    a 10-item questionnaire that measures stress
  • Weight [ Time Frame: At baseline, 3, and 6 months ]
    Weight will be measured using stationary scale per standardized protocol.
  • A1c [ Time Frame: At baseline and 6 months ]
    A plasma sample will be collected to measure HbA1c.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Rush University Medical Center

Dates:
Date Received: August 29, 2014
Date Started: July 2014
Date Completion: August 2015
Last Updated: November 18, 2014
Last Verified: November 2014