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Completed

NCT Number: NCT01912209

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

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.

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Key information

Conditions

Metabolic Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Body Weight Body Weight Changes Cardiovascular Disease Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Miami Heart Center Outpatient Services

Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Waist circumference >=40 inches in and male and >= 35 inches in a female
  • Fasting triglyceride level > 150 mg/dl*
  • HDL-C < 40 mg/dl in men or < 50 mg/dl in women*
  • BP > 130/85 mm Hg*
  • Fasting blood glucose > 110 mg/dl
  • Or currently on medication to treat the abnormal condition

Exclusion criteria

  • Prior history of major cardiovascular events (angina, myocardial infarction, prior coronary revascularization
  • Any woman of childbearing potential who is pregnant, breastfeeding/currently lactating, seeking to become pregnant or suspects that she may be pregnant**
  • Active treatment for cancer
  • Known history of a bilateral mastectomy
  • Known history of diabetes (already being treated as high-risk group, would not qualify as having Metabolic Syndrome for purposes of our study)
  • Known history of Chronic Obstructive Pulmonary Disease
  • Currently in atrial fibrillation
  • Known history of hypo-tension
  • Known history of heart failure
  • Known history of aortic valve stenosis
  • Known history of heart block
  • Chest CT scan in the last year
  • Cognitive inability as judged by the interviewer

Treatment and study plan

My Everyday Health

Behavioral

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.

Primary outcomes

  1. Reduction in BMI

    Time frame: 4 months, 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Registry information

Official study 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

Acronym: BEHHS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2013
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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