A Web-based Approach to Treating Cardiovascular Disease Risk in Employees With Metabolic Syndrome (BEHHS)
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.
Behavioral: My Everyday Health
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Reduction in BMI [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]
- Change in waist circumference [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]
- Change in Lipids [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size
- Change in Blood Pressure [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]
- Change in Glucose Regulation [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]Change in fasting blood glucose(FBG) and HbA1C
- Lifestyle Change [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]Changes in reported physical activity, diet, and behavioral scores based on self report by survey
- Change in Sub-Clinical Disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium
|Study Start Date:||August 2013|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
Behavioral: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912209
|United States, Florida|
|South Miami Heart Center Outpatient Services|
|Miami, Florida, United States, 33143|
|Principal Investigator:||Khurram Nasir, MD, MPH||Baptist Health Medical Group|