Metabolic Syndrome3ELMNCT02233088
A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome (3ELM Study)
A study testing ELM Group, ELM Classes and ELM Individual in people with Metabolic Syndrome, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- ELM Group, ELM Classes and ELM Individual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2013to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: 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).
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- ELM Group, ELM Classes, ELM Individual
- Keywords
- Prediabetic State, Hypertension, Enlarged Waist Elevated Triglycerides, HDL Cholesterol, Low Serum
- Medical subject headings
- Metabolic Syndrome, Prediabetic State, Hypertension, Hypertriglyceridemic Waist, Hypoalphalipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELM GroupBehavioural
Also called ELM Lifestyle Intervention
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.
ELM ClassesOther
Also called Health Education
ELM classes will be administered through Rush Generations program and focus on health education.
ELM IndividualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ELM Group | Experimental | 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. Receives: Behavioral: ELM Group |
| ELM Classes | Other | 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. Receives: Other: ELM Classes |
| ELM Individual | Active comparator | 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. Receives: Other: ELM Individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-month change
Secondary outcomes (9)
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.
Measured: Baseline, and 6 months
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.
Measured: At baseline and 6 months
International Physical Activity Questionnaire (IPAQ)
Measures engagement in physical activity
Measured: At baseline and 6 months
Perceived Stress Scale
a 10-item questionnaire that measures stress
Measured: At baseline, 3, and 6 months
Weight
Weight will be measured using stationary scale per standardized protocol.
Measured: At baseline, 3, and 6 months
A1c
A plasma sample will be collected to measure HbA1c.
Measured: At baseline and 6 months
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.
Measured: At baseline, 3, and 6 months
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.
Measured: At baseline, 3, and 6 months
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.
Measured: At baseline, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study start20 Sep 2013
- Primary completion31 Aug 2015
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Rasa Kazlauskaite, MD, Principal investigator, Rush University Medical CenterLisa Walt, PhD, Study director, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233088
- Sponsor's protocol ID
- 11111701-CA01
- Other IDs
- R56HL118343-01A1
- Acronym
- 3ELM
- Status last verified
- Jan 2023
- First submitted
- 29 Aug 2014
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Lifestyle Intervention on the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02233088
- Acronym / sponsor ID
- 3ELM / 11111701-CA01
- Conditions
- Metabolic Syndrome
- Keywords
- Prediabetic State, Hypertension, Enlarged Waist Elevated Triglycerides, HDL Cholesterol, Low Serum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Sep 2013 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ELM Group | Experimental | Behavioral: ELM GroupA 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. |
| ELM Classes | Other | Other: ELM ClassesA 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. |
| ELM Individual | Active comparator | Other: ELM IndividualA 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. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELM GroupAlso: ELM Lifestyle InterventionELM 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. | Behavioural | ELM Group |
| ELM ClassesAlso: Health EducationELM classes will be administered through Rush Generations program and focus on health education. | Other | ELM Classes |
| ELM IndividualELM 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. | Other | ELM Individual |
Primary outcome
metabolic syndrome remission, defined as <3 of the 5 standard diagnostic criteria.
Time frame: 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.
9 secondary outcomes
Nutrition intake
Time frame: Baseline, and 6 months
Accelerometry
Time frame: At baseline and 6 months
International Physical Activity Questionnaire (IPAQ)
Time frame: At baseline and 6 months
Perceived Stress Scale
Time frame: At baseline, 3, and 6 months
Weight
Time frame: At baseline, 3, and 6 months
A1c
Time frame: At baseline and 6 months
Credibility and expectancies questionnaire (CEQ)
Time frame: At baseline, 3, and 6 months
Vitality Index
Time frame: At baseline, 3, and 6 months
Continuous metabolic syndrome score
Time frame: At baseline, 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- What Is Metabolic Syndrome?Link provided by the sponsor.
- What Causes Metabolic Syndrome?Link provided by the sponsor.
- Who Is at Risk for Metabolic Syndrome?Link provided by the sponsor.
- What Are the Signs and Symptoms of Metabolic Syndrome?Link provided by the sponsor.
- How Is Metabolic Syndrome Diagnosed?Link provided by the sponsor.
- How Is Metabolic Syndrome Treated?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasa Kazlauskaite, MD principal investigator
Rush University Medical Center
Lisa Walt, PhD study director
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELM Group, ELM Classes and ELM Individual in people with Metabolic Syndrome, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic syndrome remission, defined as <3 of the 5 standard diagnostic criteria. (time frame: 6-month change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.