- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912209
A Web-based Approach to Treating Cardiovascular Disease Risk in Employees With Metabolic Syndrome (BEHHS)
February 19, 2015 updated by: Baptist Health South Florida
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
182
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33143
- South Miami Heart Center Outpatient Services
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: My Everyday Health Group
Subjects 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.
|
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.
|
No Intervention: WebMD Group
This 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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in BMI
Time Frame: 4 months, 12 months
|
4 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in waist circumference
Time Frame: 4 months, 12 months
|
4 months, 12 months
|
|
Change in Lipids
Time Frame: 4 months, 12 months
|
Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size
|
4 months, 12 months
|
Change in Blood Pressure
Time Frame: 4 months, 12 months
|
4 months, 12 months
|
|
Change in Glucose Regulation
Time Frame: 4 months, 12 months
|
Change in fasting blood glucose(FBG) and HbA1C
|
4 months, 12 months
|
Lifestyle Change
Time Frame: 4 months, 12 months
|
Changes in reported physical activity, diet, and behavioral scores based on self report by survey
|
4 months, 12 months
|
Change in Sub-Clinical Disease
Time Frame: 12 months
|
Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Khurram Nasir, MD, MPH, Baptist Health Medical Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
July 3, 2013
First Submitted That Met QC Criteria
July 30, 2013
First Posted (Estimate)
July 31, 2013
Study Record Updates
Last Update Posted (Estimate)
February 20, 2015
Last Update Submitted That Met QC Criteria
February 19, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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