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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity, Metabolic Syndrome, Cardiovascular Disease, Atherosclerosis

Intervention / Treatment
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* Behavioral: My Everyday Health


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: My Everyday Health Group<br>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. | Behavioral: My Everyday Health<br>* 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.<br>|
| No Intervention: WebMD Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in BMI |  | 4 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference |  | 4 months, 12 months | 
| Change in Lipids | Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size | 4 months, 12 months | 
| Change in Blood Pressure |  | 4 months, 12 months | 
| Change in Glucose Regulation | Change in fasting blood glucose(FBG) and HbA1C | 4 months, 12 months | 
| Lifestyle Change | Changes in reported physical activity, diet, and behavioral scores based on self report by survey | 4 months, 12 months | 
| Change in Sub-Clinical Disease | Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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employees, metabolic syndrome, obesity, sub-clinical cardiovascular disease, weight loss, diet