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

• ClinicalTrials.gov Identifier: NCT01912209
• Recruitment Status: Completed
• First Posted: July 31, 2013
• Last Update Posted: February 20, 2015
• Sponsor: Baptist Health South Florida
• Information provided by (Responsible Party): Baptist Health South Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome; Cardiovascular Disease; Atherosclerosis; Obesity	Behavioral: My Everyday Health	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 182 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: August 2013
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Reduction in BMI [ Time Frame: 4 months, 12 months ]

Secondary Outcome Measures :

1. Change in waist circumference [ Time Frame: 4 months, 12 months ]
2. Change in Lipids [ Time Frame: 4 months, 12 months ]
   Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size
3. Change in Blood Pressure [ Time Frame: 4 months, 12 months ]
4. Change in Glucose Regulation [ Time Frame: 4 months, 12 months ]
   Change in fasting blood glucose(FBG) and HbA1C
5. Lifestyle Change [ Time Frame: 4 months, 12 months ]
   Changes in reported physical activity, diet, and behavioral scores based on self report by survey
6. Change in Sub-Clinical Disease [ Time Frame: 12 months ]
   Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

South Miami Heart Center Outpatient Services

Miami, Florida, United States, 33143

Sponsors and Collaborators

Baptist Health South Florida

Investigators

• Principal Investigator: Khurram Nasir, MD, MPH; Baptist Health Medical Group

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Aziz M, Gannarapu S, Humayun C, Siddiqui U, Nasir K, Aneni EC. Association of particles of lipoprotein subclasses with arterial stiffness in a high-risk working population: the Baptist Employee Healthy Heart Study (BEHHS). Egypt Heart J. 2020 Mar 19;72(1):12. doi: 10.1186/s43044-020-00046-4.

Post JM, Ali SS, Roberson LL, Aneni EC, Shaharyar S, Younus A, Jamal O, Ahmad R, Aziz MA, Malik R, Spatz ES, Feldman T, Fialkow J, Veledar E, Cury RC, Agatston AS, Nasir K. Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population. Trials. 2016 Jul 1;17(1):308. doi: 10.1186/s13063-016-1424-z.

• Responsible Party: Baptist Health South Florida
• ClinicalTrials.gov Identifier: NCT01912209
• Other Study ID Numbers: 13-028
• First Posted: July 31, 2013
• Last Update Posted: February 20, 2015
• Last Verified: February 2015

Keywords provided by Baptist Health South Florida:

employees; metabolic syndrome; obesity; sub-clinical cardiovascular disease; weight loss; diet

Additional relevant MeSH terms:

Cardiovascular Diseases; Atherosclerosis; Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases