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NCT02233088 · ClinicalTrials.gov registry record · NA
A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)
A NA study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT02233088 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 48 participants.
The verdict
NCT02233088, a NA study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study 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).
Interventions
- BEHAVIORAL ELM Group
- OTHER ELM Classes
- OTHER ELM Individual
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-09-20 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02233088
The ClinicalTrials.gov registry entry for NCT02233088 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which ELM Group is the first listed.
NCT02233088 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02233088 about?
NCT02233088 is a clinical study titled "A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)". 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 cardiov...
What is the current status of trial NCT02233088?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2013-09-20. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT02233088?
The interventions under investigation include: ELM Group (BEHAVIORAL), ELM Classes (OTHER), ELM Individual (OTHER).
Who is sponsoring clinical trial NCT02233088?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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