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

Baptist Health South Florida

Status: Completed

Conditions: Obesity; Atherosclerosis; Metabolic Syndrome; Cardiovascular Disease

Treatments: Behavioral: My Everyday Health

Study type: Interventional

Funder types: Other

Identifiers

NCT01912209

13-028

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. Waist circumference >=40 inches in and male and >= 35 inches in a female

  2. Fasting triglyceride level > 150 mg/dl*

  3. HDL-C < 40 mg/dl in men or < 50 mg/dl in women*

  4. BP > 130/85 mm Hg*

  5. Fasting blood glucose > 110 mg/dl

     • Or currently on medication to treat the abnormal condition

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

My Everyday Health Group

Experimental group

Description:

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.

Treatment:

Behavioral: My Everyday Health

WebMD Group

No Intervention group

Description:

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.