A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 10/21/2017 |
| Start Date: | September 20, 2013 |
| End Date: | December 31, 2018 |
A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome
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).
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).
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.
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.
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 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:
- 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).
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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