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

Obesity Clinical Trial

— BEHHS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912209
• Other study ID #: 13-028
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: February 19, 2015
• Start date: August 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	South Miami Heart Center Outpatient Services	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in BMI		4 months, 12 months	No
Secondary	Change in waist circumference		4 months, 12 months	No
Secondary	Change in Lipids	Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size	4 months, 12 months	No
Secondary	Change in Blood Pressure		4 months, 12 months	No
Secondary	Change in Glucose Regulation	Change in fasting blood glucose(FBG) and HbA1C	4 months, 12 months	No
Secondary	Lifestyle Change	Changes in reported physical activity, diet, and behavioral scores based on self report by survey	4 months, 12 months	No
Secondary	Change in Sub-Clinical Disease	Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium	12 months	No