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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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Metabolic Syndrome Cardiovascular Disease Atherosclerosis Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

My Everyday Health

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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My Everyday Health

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.

Intervention Type BEHAVIORAL

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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No