- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04308382
Evaluation of a Corporate Wellness Program
The purpose of this project is to determine the effectiveness of the corporate wellness program at Memorial Health System (MHS) in regards to:
- Improvement of health of employees
- Savings on health care expenses
The corporate wellness program itself is not the object of the study, but rather the results of the program are the focus. The program will be a dynamic process, changing over time to address the needs of the hospital system employees.
This study will look at the effects of the program as a whole to impact employee health and the cost of healthcare. This study will also evaluate individual components of the program (physical activity, stress management, etc) to determine specific benefits of those components to those who participate.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the effectiveness of a corporate wellness program to improve the health of its employees and to save healthcare costs.
Many studies have been done evaluating the effectiveness of corporate wellness programs. Over the past 30 years, multiple iterations of corporate wellness programs have been utilized, causing a continual shift in philosophy and implementation. The current program is following closely the model instituted by Cleveland Clinic, utilizing recommendations and tools provided by the CDC and WELCOA via their web sites and publications.
Description of Program to be Evaluated MHS is initiating a corporate wellness program to be offered to all adult employees. The program will include a health risk assessment (HRA), which is the minimum required for enrollment in the program, as well as many additional optional benefits, such as access to exercise equipment, personal coaches, stress management classes, etc. There will also be corporate wide changes to the environment to include food options in the cafeteria and vending machines.
The HRA will be offered annually, and before and after completion of specific activities offered by the wellness program.
The HRA includes a survey, which requires about 30 minutes to complete, lab evaluation and biomarkers.
Research to Evaluate the Program As people are enrolling in the wellness program on line, participants will be invited to participate in this study. People can participate in the wellness program without participating in this study.
The invitation to participate will provide a brief description of the study and a link which will take them to the consent. Once consented, there will be a link to return to the on line program enrollment. They will have the option to email members of the research team with any questions or to request a paper version of the consent and survey.
They may decline study participation, without any penalty, and will be allowed to participate in the wellness program as would anyone who is participating in the study.
There will be an option to use a paper consent. If a paper consent is utilized, these will be collected by the research team. Paper consents will then be stored in a secure location at MHS.
To participate, subjects will also be asked to sign a study specific HIPAA authorization form allowing access to personal health information to be utilized for the study.
Data collected for this study will be maintained with multilevel encryption; devices and cloud storage will be encrypted. Data will need to be identified to allow collation of data from various sources.
For the evaluation of absenteeism and health claims data, aggregated de-identified data for groups of subjects will be requested from HR. These groups will be determined by level of participation in various wellness activities.
The data will be analyzed by the research team to determine overall effectiveness in improving health and reducing health care expenses, as well as looking for correlations with specific variables (age, gender, participation in particular components of the program, etc.)
It is anticipated that aggregated de-identified results will be presented publicly in the form of abstracts, posters and publication.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: David S Drozek, DO
- Phone Number: 678 447 2509
- Email: drozek@ohio.edu
Study Locations
-
-
Ohio
-
Athens, Ohio, United States, 45701
- Recruiting
- Ohio University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-adult employee of Memorial Health System, or spouse of an employee who is participating in the employee wellness program
Exclusion Criteria: NA
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Care Expenditures
Time Frame: 20 years
|
Cost for health care as a corporation
|
20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index of employees
Time Frame: 20 years
|
Calculated based on manually measured height (feet and inches) and weight (pounds)
|
20 years
|
Hemoglobin A1c of employees
Time Frame: 20 years
|
measured in %
|
20 years
|
Blood pressure
Time Frame: 20 years
|
measured in mm Hg with a sphygmomanometer while at rest
|
20 years
|
Total cholesterol
Time Frame: 20 years
|
laboratory blood analysis, reported in mg/dl
|
20 years
|
Low density lipoprotein (LDL) cholesterol
Time Frame: 20 years
|
laboratory blood analysis, reported in mg/dl
|
20 years
|
High density lipoprotein (HDL) cholesterol
Time Frame: 20 years
|
laboratory blood analysis, reported in mg/dl
|
20 years
|
Triglycerides
Time Frame: 20 years
|
laboratory blood analysis, reported in mg/dl
|
20 years
|
Level of physical activity
Time Frame: 20 years
|
Are you able to walk a mile without significant pain or discomfort? ❒ Yes ❒ No In the past 7 days, how many days did you exercise? ______ days On days when you exercised, for how long did you exercise (in minutes)? ❒______ minutes per day ❒ Does not apply How intense was your typical exercise?
|
20 years
|
Hope
Time Frame: 20 years
|
Hearth Hope Index
|
20 years
|
Mood
Time Frame: 20 years
|
Patient Health Questionnaire-4 (PHQ-4), higher score is more abnormal
|
20 years
|
Tobacco use
Time Frame: 20 years
|
In the last 30 days, have you used tobacco? ❒ Yes ❒ No Smoked? ❒ Yes ❒ No Used a smokeless tobacco product? ❒ Yes ❒ No If Yes to any of the above, would you be interested in quitting tobacco use within the next month? ❒ Yes ❒ No |
20 years
|
Alcohol use
Time Frame: 20 years
|
In the past 7 days, on how many days did you drink alcohol? ______ days On days when you drank alcohol, how often did you have:
Do you ever drive after drinking, or ride with a driver who has been drinking? ❒ Yes ❒ No |
20 years
|
Diet composition
Time Frame: 20 years
|
Questions concerning food types based on a 7 day dietary recall
|
20 years
|
Food availability
Time Frame: 20 years
|
Household Hunger scale
|
20 years
|
Readiness to Change
Time Frame: 20 years
|
On a scale of 1-10, how ready are you to participate in a lifestyle change (diet change, exercise, stress management, control of tobacco, alcohol, etc.) to help improve your health? 1 being not ready at all, 10 being extremely ready _________ On a scale of 1-10, how confident are you that by participating in a lifestyle change program that you will be successful? 1 being not confident at all, 10 being extremely confident _________ |
20 years
|
Absenteeism
Time Frame: 20 years
|
days absent per year
|
20 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-X-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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