Status:
COMPLETED
A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-72 years
Phase:
NA
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-choles...
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, physica...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02233088
Start Date
September 20 2013
End Date
December 31 2021
Last Update
January 12 2023
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612