Clinical trial NCT04308382: Evaluation of a Corporate Wellness Program
Official title: Evaluation of a Corporate Wellness Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: Memorial Health System
First posted: 2020-03-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult employees of the Memorial Health System.

Brief summary: The purpose of this project is to determine the effectiveness of the corporate wellness program at Memorial Health System (MHS) in regards to:

1. Improvement of health of employees
2. 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.

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.

Eligibility criteria: Inclusion Criteria:

-adult employee of Memorial Health System, or spouse of an employee who is participating in the employee wellness program

Exclusion Criteria: NA

Primary outcomes:
measure: Health Care Expenditures
timeFrame: 20 years
Secondary outcomes:
measure: Body Mass Index of employees
timeFrame: 20 years
measure: Hemoglobin A1c of employees
timeFrame: 20 years
measure: Blood pressure
timeFrame: 20 years
measure: Total cholesterol
timeFrame: 20 years
measure: Low density lipoprotein (LDL) cholesterol
timeFrame: 20 years
measure: High density lipoprotein (HDL) cholesterol
timeFrame: 20 years
measure: Triglycerides
timeFrame: 20 years
measure: Level of physical activity
timeFrame: 20 years
measure: Hope
timeFrame: 20 years
measure: Mood
timeFrame: 20 years
measure: Tobacco use
timeFrame: 20 years
measure: Alcohol use
timeFrame: 20 years
measure: Diet composition
timeFrame: 20 years
measure: Food availability
timeFrame: 20 years
measure: Readiness to Change
timeFrame: 20 years
measure: Absenteeism
timeFrame: 20 years
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
References: