A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ELM Group 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 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 Names:
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| Other: ELM Classes 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 classes will be administered through Rush Generations program and focus on health education.
Other Names:
|
| Active Comparator: ELM Individual 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
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.
|
Outcome Measures
Primary Outcome Measures
- metabolic syndrome remission, defined as <3 of the 5 standard diagnostic criteria. [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.
Secondary Outcome Measures
- Nutrition intake [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 [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) [At baseline and 6 months]
Measures engagement in physical activity
- Perceived Stress Scale [At baseline, 3, and 6 months]
a 10-item questionnaire that measures stress
- Weight [At baseline, 3, and 6 months]
Weight will be measured using stationary scale per standardized protocol.
- A1c [At baseline and 6 months]
A plasma sample will be collected to measure HbA1c.
- Credibility and expectancies questionnaire (CEQ) [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 [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 [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.
Other Outcome Measures
- Medication questionnaire [At baseline, 3, and 6 months]
The list of medications with dose and frequency of administration will be collected using a standardized questionnaire.
- Brief COPE [At baseline, and 6 months]
measures coping of stressors
- Daily Hassles Questionnaire [At baseline, 3, and 6 months]
measures primary and secondary appraisal of stressors.
- Three Factor Eating Questionnaire (TFEQ) [At baseline, and 6 months]
Measures disordered eating patterns.
- Patient Health Questionnaire (PHQ-9) [At baseline, 3, and 6 months]
Measures depressive symptoms
- Treatment Self-Regulation Questionnaire (TSRQ for eating and physical activity) [At baseline, 3, and 6 months]
Measures self-regulation abilities for eating and physical activity
- Work Productivity and Activity Impairment Questionnaire [At baseline, 3, and 6 months]
measures lost productivity in the form of absenteeism and presenteeism.
- Use of wellness, health, and preventive services [At baseline, 3, and 6 months]
Wil be used for cost analysis.
- Perceived environment (food and exercise) [At baseline]
measures the built and food environment
- Global health scale [At baseline, 3, and 6 months]
Self-assessment of overall health.
- General Questionnaire [At baseline, updated at 3, and 6 months]
Measures basic sociodemographic characteristics.
- Weight history and experiences with wellness/weight management programs [At baseline, and updated at 3 and 6 months]
Captures weight fluctuations and participation in commercial or health care based wellness or weight loss programs
- Treatment modality preferences and willingness [At baseline and 6 months]
Captures participant preferences for lifestyle, medication, and surgical treatment modalities.
- Beliefs about medications [At baseline]
Captures participant's beliefs about the usefulness and safety of medications.
- Time horizon [At baseline and 6 months]
Assesses executive function
- Patient Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire [At baseline and 6 months]
measures cognitive/executive function.
- Perceived lifestyle change for physical activity and diet [At 3 and 6 months]
Captures participant's self-assessment of effort-related to lifestyle changes.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women age 18-72 years (children and the elderly need age-specific lifestyle tailoring).
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Able to walk 2 blocks (the patients should be able to engage in moderate intensity exercise).
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Have preference for making lifestyle changes to treat MetS.
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Able to participate in a lifestyle intervention for 6 months.
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Meet at least 3 Metabolic syndrome diagnostic 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:
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Substance abuse within the past 12 months: alcohol use, current daily smokers (self-report); and illicit drug use.
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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.
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- Rush University Medical Center
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Rasa Kazlauskaite, MD, Rush University Medical Center
- Study Director: Lisa Walt, PhD, Rush University Medical Center
- Study Chair: Lynda H Powell, PhD, Rush University Medical Center, Department of Preventive Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 11111701-CA01
- R56HL118343-01A1