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

Metabolic Syndrome Clinical Trial

— 3ELM  

Official title:

A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233088
• Other study ID #: 11111701-CA01
• Secondary ID: R56HL118343-01A1
• Status: Completed
• Phase: N/A
• Start date: September 20, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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).

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• ELM Group
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:
• ELM Classes
ELM classes will be administered through Rush Generations program and focus on health education.
• ELM Individual
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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication questionnaire	The list of medications with dose and frequency of administration will be collected using a standardized questionnaire.	At baseline, 3, and 6 months
Other	Brief COPE	measures coping of stressors	At baseline, and 6 months
Other	Daily Hassles Questionnaire	measures primary and secondary appraisal of stressors.	At baseline, 3, and 6 months
Other	Three Factor Eating Questionnaire (TFEQ)	Measures disordered eating patterns.	At baseline, and 6 months
Other	Patient Health Questionnaire (PHQ-9)	Measures depressive symptoms	At baseline, 3, and 6 months
Other	Treatment Self-Regulation Questionnaire (TSRQ for eating and physical activity)	Measures self-regulation abilities for eating and physical activity	At baseline, 3, and 6 months
Other	Work Productivity and Activity Impairment Questionnaire	measures lost productivity in the form of absenteeism and presenteeism.	At baseline, 3, and 6 months
Other	Use of wellness, health, and preventive services	Wil be used for cost analysis.	At baseline, 3, and 6 months
Other	Perceived environment (food and exercise)	measures the built and food environment	At baseline
Other	Global health scale	Self-assessment of overall health.	At baseline, 3, and 6 months
Other	General Questionnaire	Measures basic sociodemographic characteristics.	At baseline, updated at 3, and 6 months
Other	Weight history and experiences with wellness/weight management programs	Captures weight fluctuations and participation in commercial or health care based wellness or weight loss programs	At baseline, and updated at 3 and 6 months
Other	Treatment modality preferences and willingness	Captures participant preferences for lifestyle, medication, and surgical treatment modalities.	At baseline and 6 months
Other	Beliefs about medications	Captures participant's beliefs about the usefulness and safety of medications.	At baseline
Other	Time horizon	Assesses executive function	At baseline and 6 months
Other	Patient Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire	measures cognitive/executive function.	At baseline and 6 months
Other	Perceived lifestyle change for physical activity and diet	Captures participant's self-assessment of effort-related to lifestyle changes.	At 3 and 6 months
Primary	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	Nutrition intake	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.	Baseline, and 6 months
Secondary	Accelerometry	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.	At baseline and 6 months
Secondary	International Physical Activity Questionnaire (IPAQ)	Measures engagement in physical activity	At baseline and 6 months
Secondary	Perceived Stress Scale	a 10-item questionnaire that measures stress	At baseline, 3, and 6 months
Secondary	Weight	Weight will be measured using stationary scale per standardized protocol.	At baseline, 3, and 6 months
Secondary	A1c	A plasma sample will be collected to measure HbA1c.	At baseline and 6 months
Secondary	Credibility and expectancies questionnaire (CEQ)	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.	At baseline, 3, and 6 months
Secondary	Vitality Index	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.	At baseline, 3, and 6 months
Secondary	Continuous metabolic syndrome score	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.	At baseline, 3, and 6 months

External Links

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