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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Baptist Health South Florida
ClinicalTrials.gov Identifier:
NCT01912209
First received: July 3, 2013
Last updated: August 25, 2014
Last verified: August 2014

July 3, 2013
August 25, 2014
August 2013
February 2015   (final data collection date for primary outcome measure)
Reduction in BMI [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01912209 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Web-based Approach to Treating Cardiovascular Disease Risk in Employees With Metabolic Syndrome
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Cardiovascular Disease
  • Atherosclerosis
  • Obesity
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.
  • 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.
    Intervention: Behavioral: My Everyday Health
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
182
March 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01912209
13-028
No
Baptist Health South Florida
Baptist Health South Florida
Not Provided
Principal Investigator: Khurram Nasir, MD, MPH Baptist Health Medical Group
Baptist Health South Florida
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP