Clinical trial NCT02233088: A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)
Official title: A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Prediabetic State
Hypertension
Enlarged Waist Elevated Triglycerides
HDL Cholesterol, Low Serum
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-09-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: metabolic syndrome remission, defined as <3 of the 5 standard diagnostic criteria.
timeFrame: 6-month change
Secondary outcomes:
measure: Nutrition intake
timeFrame: Baseline, and 6 months
measure: Accelerometry
timeFrame: At baseline and 6 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: At baseline and 6 months
measure: Perceived Stress Scale
timeFrame: At baseline, 3, and 6 months
measure: Weight
timeFrame: At baseline, 3, and 6 months
measure: A1c
timeFrame: At baseline and 6 months
measure: Credibility and expectancies questionnaire (CEQ)
timeFrame: At baseline, 3, and 6 months
measure: Vitality Index
timeFrame: At baseline, 3, and 6 months
measure: Continuous metabolic syndrome score
timeFrame: At baseline, 3, and 6 months
Other outcomes:
measure: Medication questionnaire
timeFrame: At baseline, 3, and 6 months
measure: Brief COPE
timeFrame: At baseline, and 6 months
measure: Daily Hassles Questionnaire
timeFrame: At baseline, 3, and 6 months
measure: Three Factor Eating Questionnaire (TFEQ)
timeFrame: At baseline, and 6 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: At baseline, 3, and 6 months
measure: Treatment Self-Regulation Questionnaire (TSRQ for eating and physical activity)
timeFrame: At baseline, 3, and 6 months
measure: Work Productivity and Activity Impairment Questionnaire
timeFrame: At baseline, 3, and 6 months
measure: Use of wellness, health, and preventive services
timeFrame: At baseline, 3, and 6 months
measure: Perceived environment (food and exercise)
timeFrame: At baseline
measure: Global health scale
timeFrame: At baseline, 3, and 6 months
measure: General Questionnaire
timeFrame: At baseline, updated at 3, and 6 months
measure: Weight history and experiences with wellness/weight management programs
timeFrame: At baseline, and updated at 3 and 6 months
measure: Treatment modality preferences and willingness
timeFrame: At baseline and 6 months
measure: Beliefs about medications
timeFrame: At baseline
measure: Time horizon
timeFrame: At baseline and 6 months
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire
timeFrame: At baseline and 6 months
measure: Perceived lifestyle change for physical activity and diet
timeFrame: At 3 and 6 months
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Rasa Kazlauskaite, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Lisa Walt, PhD
role: STUDY_DIRECTOR
References: