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

NCT02233088 | Completed DMC

• 2 other identifiers: 11111701-CA01R56HL118343-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Metabolic Syndrome

Keywords

Prediabetic State; Hypertension; Enlarged Waist Elevated Triglycerides; HDL Cholesterol, Low Serum

Outcome Measures

Primary Outcomes (1)

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

  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.

  6-month change

Secondary Outcomes (9)

• Nutrition intake

  Baseline, and 6 months

• Accelerometry

  At baseline and 6 months

• International Physical Activity Questionnaire (IPAQ)

  At baseline and 6 months

• Perceived Stress Scale

  At baseline, 3, and 6 months

• Weight

  At baseline, 3, and 6 months

Other Outcomes (17)

• Medication questionnaire

  At baseline, 3, and 6 months

• Brief COPE

  At baseline, and 6 months

• Daily Hassles Questionnaire

  At baseline, 3, and 6 months

Study Arms (3)

ELM Group

EXPERIMENTAL

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.

Behavioral: ELM Group

ELM Classes

OTHER

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.

Other: ELM Classes

ELM Individual

ACTIVE COMPARATOR

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.

Other: ELM Individual

Interventions

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.

Also known as: ELM Lifestyle Intervention

ELM Group

ELM Classes OTHER

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

Also known as: Health Education

ELM Classes

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.

ELM Individual

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Links

• What Is Metabolic Syndrome?
• What Causes Metabolic Syndrome?
• Who Is at Risk for Metabolic Syndrome?
• What Are the Signs and Symptoms of Metabolic Syndrome?
• How Is Metabolic Syndrome Diagnosed?
• How Is Metabolic Syndrome Treated?
• Living With Metabolic Syndrome

MeSH Terms

Conditions

Metabolic Syndrome; Prediabetic State; Hypertension; Hypertriglyceridemic Waist; Hypoalphalipoproteinemias

Condition Hierarchy (Ancestors)

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

Study Officials

• Rasa Kazlauskaite, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Lisa Walt, PhD

  Rush University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 8, 2014
• Study Start: September 20, 2013
• Primary Completion: August 31, 2015
• Study Completion: December 31, 2021
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)