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

Primary Purpose

Metabolic Syndrome, Cardiovascular Disease, Atherosclerosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

My Everyday Health

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring employees, metabolic syndrome, obesity, sub-clinical cardiovascular disease, weight loss, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

South Miami Heart Center Outpatient Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

My Everyday Health Group

WebMD Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduction in BMI

Secondary Outcome Measures

Change in waist circumference

Change in Lipids

Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size

Change in Blood Pressure

Change in Glucose Regulation

Change in fasting blood glucose(FBG) and HbA1C

Lifestyle Change

Changes in reported physical activity, diet, and behavioral scores based on self report by survey

Change in Sub-Clinical Disease

Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium

Full Information

NCT ID

NCT01912209

First Posted

July 3, 2013

Last Updated

February 19, 2015

Sponsor

Baptist Health South Florida

1. Study Identification

Unique Protocol Identification Number

NCT01912209

Brief Title

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

Acronym

BEHHS

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

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baptist Health South Florida

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Cardiovascular Disease, Atherosclerosis, Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

My Everyday Health Group

Arm Type

Experimental

Arm Description

Arm Title

WebMD Group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

My Everyday Health

Intervention Description

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 Outcome Measure Information:

Title

Reduction in BMI

Time Frame

4 months, 12 months

Secondary Outcome Measure Information:

Title

Change in waist circumference

Time Frame

4 months, 12 months

Title

Change in Lipids

Description

Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size

Time Frame

4 months, 12 months

Title

Change in Blood Pressure

Time Frame

4 months, 12 months

Title

Change in Glucose Regulation

Description

Change in fasting blood glucose(FBG) and HbA1C

Time Frame

4 months, 12 months

Title

Lifestyle Change

Description

Changes in reported physical activity, diet, and behavioral scores based on self report by survey

Time Frame

4 months, 12 months

Title

Change in Sub-Clinical Disease

Description

Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khurram Nasir, MD, MPH

Organizational Affiliation

Baptist Health Medical Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

South Miami Heart Center Outpatient Services

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32193785

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.

Results Reference

derived

PubMed Identifier

27369488

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.

Results Reference

derived

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

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