Evaluation of a Corporate Wellness Program

Chronic Disease Clinical Trial

Official title:

Evaluation of a Corporate Wellness Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04308382
• Other study ID #: 20-X-6
• Status: Recruiting
• Start date: August 24, 2020
• Est. completion date: December 31, 2041

Study information

• Verified date: April 2023
• Source: Ohio University
• Contact: David S Drozek, DO
• Phone: 678 447 2509
• Email: drozek[@]ohio.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2041
• Est. primary completion date: December 31, 2040
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria: NA

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• Health Risk Assessment
Heath Risk Assessment consists of: Survey to include questions about physical activity, stress, hope, household hunger and demographics. Lipid panel and HbA1c Height and Weight, blood pressure and resting pulse

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	Memorial Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Care Expenditures	Cost for health care as a corporation	20 years
Secondary	Body Mass Index of employees	Calculated based on manually measured height (feet and inches) and weight (pounds)	20 years
Secondary	Hemoglobin A1c of employees	measured in %	20 years
Secondary	Blood pressure	measured in mm Hg with a sphygmomanometer while at rest	20 years
Secondary	Total cholesterol	laboratory blood analysis, reported in mg/dl	20 years
Secondary	Low density lipoprotein (LDL) cholesterol	laboratory blood analysis, reported in mg/dl	20 years
Secondary	High density lipoprotein (HDL) cholesterol	laboratory blood analysis, reported in mg/dl	20 years
Secondary	Triglycerides	laboratory blood analysis, reported in mg/dl	20 years
Secondary	Level of physical activity	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?; Light (like stretching or slow walking); Moderate (like brisk walking); Heavy (like jogging or swimming); Very heavy (like fast running or stair climbing); I am currently not exercising	20 years
Secondary	Hope	Hearth Hope Index	20 years
Secondary	Mood	Patient Health Questionnaire-4 (PHQ-4), higher score is more abnormal	20 years
Secondary	Tobacco use	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
Secondary	Alcohol use	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: If you are a man: 5 or more alcoholic drinks on one occasion?; If you are a woman: 4 or more alcoholic drinks on one occasion?; Never; Once during the week; 2-3 times during the week; More than 3 times during the week; Doesn't apply to me; Do you ever drive after drinking, or ride with a driver who has been drinking?; ? Yes ? No	20 years
Secondary	Diet composition	Questions concerning food types based on a 7 day dietary recall	20 years
Secondary	Food availability	Household Hunger scale	20 years
Secondary	Readiness to Change	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
Secondary	Absenteeism	days absent per year	20 years