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Metabolic SyndromeBEHHSNCT01912209

A Web-based Approach to Treating Cardiovascular Disease Risk in Employees With Metabolic Syndrome

A study testing My Everyday Health in people with Metabolic Syndrome and Cardiovascular Disease, run by Baptist Health South Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of BEHHS is first to assess the baseline sub-clinical disease in a population of Baptist Health Employees who have Metabolic Syndrome, a known contributor to cardiovascular disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
My Everyday Health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 siteUnited States
Study dates
Aug 2013to Feb 2015
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Employee of Baptist Health
  • Access to Internet
  • Has a smart phone (Android or Apple supported) with data plan
  • Has an email address
  • Diagnosis of three or more of the following:
  • Waist circumference >=40 inches in and male and >= 35 inches in a female
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  • Fasting triglyceride level > 150 mg/dl*
  • HDL-C < 40 mg/dl in men or < 50 mg/dl in women*
  • BP > 130/85 mm Hg*
  • Fasting blood glucose > 110 mg/dl
  • Or currently on medication to treat the abnormal condition

Who cannot join

  • Prior history of major cardiovascular events (angina, myocardial infarction, prior coronary revascularization
  • Any woman of childbearing potential who is pregnant, breastfeeding/currently lactating, seeking to become pregnant or suspects that she may be pregnant**
  • Active treatment for cancer
  • Known history of a bilateral mastectomy
  • Known history of diabetes (already being treated as high-risk group, would not qualify as having Metabolic Syndrome for purposes of our study)
  • Known history of Chronic Obstructive Pulmonary Disease
Show all 13Show fewer
  • Currently in atrial fibrillation
  • Known history of hypo-tension
  • Known history of heart failure
  • Known history of aortic valve stenosis
  • Known history of heart block
  • Chest CT scan in the last year
  • Cognitive inability as judged by the interviewer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • South Miami Heart Center Outpatient Services

    Miami, Florida, 33143

Other trials in United States

About this study

Official title: Baptist Employee Healthy Heart Study (BEHHS) - A Novel Web-based Approach to Reduce Cardiovascular Disease Risk in a Diverse Employee Population With Metabolic Syndrome Via Diet and Lifestyle Change

The purpose of BEHHS is first to assess the baseline sub-clinical disease in a population of Baptist Health Employees who have Metabolic Syndrome, a known contributor to cardiovascular disease. Second, the investigators wish to encourage a healthy lifestyle through personalized nutrition and fitness advice, delivered as part of a web based program, which will in turn lead to increases in heart healthy behaviors such as increased consumption of heart healthy foods, increased exercise initiation, and more positive attitudes about health. To assess this, the investigators plan to randomize 200 employees with Metabolic Syndrome to either the new web-based diet and lifestyle program, or to care-as-usual, which is the currently offered MyWellnessAdvantage and WebMD websites. The investigators hypothesize that the web-based group will show greater improvements in physical health (such as weight loss, cholesterol reduction, etc.) as well as increased consumption of heart healthy foods, exercise initiation, and quality of sleep as measured by surveys administered at the 4,8, and 12 month follow-up appointments.

Being tested
My Everyday Health
Keywords
employees, metabolic syndrome, obesity, sub-clinical cardiovascular disease, weight loss, diet
Medical subject headings
Metabolic Syndrome, Cardiovascular Diseases, Atherosclerosis, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My Everyday HealthBehavioural

    MyEveryday Health is a web-based nutritional and lifestyle management program. The program includes personalized diet and weight guidance, meal planners, shopping list generator, recipe finder, weight tracker and dining out and fast food guides. Based on specific algorithms, tips and suggestions on how to make changes in their diet and lifestyle will be give each time the subject logs in. The MyEverydayHealth website will also be available as an app for their smart phone to the participants. If they choose to use the app, daily reminders to log in and use their tools will be sent, along with motivating tool/tips/tricks to stay with the program.

Study groups in NCT01912209
Study groupRoleWhat they receive
My Everyday Health GroupExperimentalSubjects in this group will be randomized to a web based diet and weight modification program (MyEveryday Health) and provided personal access codes. They will also continue to have access to the WebMD website provided as part of their employment with Baptist Health South Florida.
Receives: Behavioral: My Everyday Health
WebMD GroupNo interventionThis group will continue to have access to a website that is available for use of all employees (WebMD) at Baptist Health South Florida. This is the care-as-usual arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in BMI

    Measured: 4 months, 12 months

Secondary outcomes (6)

  1. Change in waist circumference

    Measured: 4 months, 12 months

  2. Change in Lipids

    Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size

    Measured: 4 months, 12 months

  3. Change in Blood Pressure

    Measured: 4 months, 12 months

  4. Change in Glucose Regulation

    Change in fasting blood glucose(FBG) and HbA1C

    Measured: 4 months, 12 months

  5. Lifestyle Change

    Changes in reported physical activity, diet, and behavioral scores based on self report by survey

    Measured: 4 months, 12 months

  6. Change in Sub-Clinical Disease

    Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01912209
Sponsor's protocol ID
13-028
Acronym
BEHHS
Status last verified
Feb 2015
First submitted
3 Jul 2013
Last updated
20 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Aziz M, Gannarapu S, Humayun C, Siddiqui U, Nasir K, Aneni EC. Association of particles of lipoprotein subclasses with arterial stiffness in a high-risk working population: the Baptist Employee Healthy Heart Study (BEHHS). Egypt Heart J. 2020 Mar 19;72(1):12. doi: 10.1186/s43044-020-00046-4.

    PubMed 32193785

  • Post JM, Ali SS, Roberson LL, Aneni EC, Shaharyar S, Younus A, Jamal O, Ahmad R, Aziz MA, Malik R, Spatz ES, Feldman T, Fialkow J, Veledar E, Cury RC, Agatston AS, Nasir K. Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population. Trials. 2016 Jul 1;17(1):308. doi: 10.1186/s13063-016-1424-z.

    PubMed 27369488

Questions about this trial

What is this clinical trial studying?

A study testing My Everyday Health in people with Metabolic Syndrome and Cardiovascular Disease, run by Baptist Health South Florida 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 11 inclusion and 13 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 20 Feb 2015. 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?

Reduction in BMI (time frame: 4 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01912209, which also lists 2 linked publications.

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 20 Feb 2015.

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