NCT01912209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

1.5 years

First QC Date

July 3, 2013

Last Update Submit

February 19, 2015

Conditions

Metabolic SyndromeCardiovascular DiseaseAtherosclerosisObesity

Keywords

employeesmetabolic syndromeobesitysub-clinical cardiovascular diseaseweight lossdiet

Outcome Measures

Primary Outcomes (1)

  • Reduction in BMI

    4 months, 12 months

Secondary Outcomes (6)

  • Change in waist circumference

    4 months, 12 months

  • Change in Lipids

    4 months, 12 months

  • Change in Blood Pressure

    4 months, 12 months

  • Change in Glucose Regulation

    4 months, 12 months

  • Lifestyle Change

    4 months, 12 months

  • +1 more secondary outcomes

Study Arms (2)

My Everyday Health Group

EXPERIMENTAL

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

WebMD Group

NO INTERVENTION

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.

Interventions

My Everyday HealthBEHAVIORAL

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.

My Everyday Health Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Miami Heart Center Outpatient Services

Miami, Florida, 33143, United States

Location

Related Publications (2)

  • 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.

    PMID: 32193785DERIVED

  • 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.

    PMID: 27369488DERIVED

MeSH Terms

Conditions

Metabolic SyndromeCardiovascular DiseasesAtherosclerosisObesityWeight Loss

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Khurram Nasir, MD, MPH

    Baptist Health Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 31, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

US(1)