Atherosclerosis, Cardiovascular Disease, Metabolic Syndrome, Obesity
Conditions
Keywords
employees, metabolic syndrome, obesity, sub-clinical cardiovascular disease, weight loss, diet
Brief 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. 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.
Interventions
BEHAVIORALMy 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.
Sponsors
Baptist Health South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in BMI | 4 months, 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lipids | 4 months, 12 months | Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size |
| Change in Blood Pressure | 4 months, 12 months | — |
| Change in waist circumference | 4 months, 12 months | — |
| Lifestyle Change | 4 months, 12 months | Changes in reported physical activity, diet, and behavioral scores based on self report by survey |
| Change in Sub-Clinical Disease | 12 months | Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium |
| Change in Glucose Regulation | 4 months, 12 months | Change in fasting blood glucose(FBG) and HbA1C |
Countries
United States
Outcome results
None listed