Clinical trial NCT01912209: A Web-based Approach to Treating Cardiovascular Disease Risk in Employees With Metabolic Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Cardiovascular Disease
Atherosclerosis
Obesity
Keywords: employees
metabolic syndrome
obesity
sub-clinical cardiovascular disease
weight loss
diet
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in BMI
timeFrame: 4 months, 12 months
Secondary outcomes:
measure: Change in waist circumference
timeFrame: 4 months, 12 months
measure: Change in Lipids
timeFrame: 4 months, 12 months
measure: Change in Blood Pressure
timeFrame: 4 months, 12 months
measure: Change in Glucose Regulation
timeFrame: 4 months, 12 months
measure: Lifestyle Change
timeFrame: 4 months, 12 months
measure: Change in Sub-Clinical Disease
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Miami Heart Center Outpatient Services
state: Florida
Study officials:
affiliation: Baptist Health Medical Group
name: Khurram Nasir, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.