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
  Purpose

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 Intervention
Metabolic Syndrome
Cardiovascular Disease
Atherosclerosis
Obesity
Behavioral: My Everyday Health

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Baptist Health South Florida:

Primary Outcome Measures:
  • Reduction in BMI [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 182
Study Start Date: August 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912209

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

No publications provided

Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT01912209     History of Changes
Other Study ID Numbers: 13-028
Study First Received: July 3, 2013
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baptist Health South Florida:
employees
metabolic syndrome
obesity
sub-clinical cardiovascular disease
weight loss
diet

Additional relevant MeSH terms:
Obesity
Cardiovascular Diseases
Metabolic Syndrome X
Atherosclerosis
Arteriosclerosis
Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014