Chronic DiseaseNCT04308382
Evaluation of a Corporate Wellness Program
An observational study of Chronic Disease, run by Ohio University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Health Risk Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 20 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult employees of the Memorial Health System.
Who may be able to join
- -adult employee of Memorial Health System, or spouse of an employee who is participating in the employee wellness program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Health Risk Assessment
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Risk AssessmentBehavioural
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Care Expenditures
Cost for health care as a corporation
Measured: 20 years
Secondary outcomes (16)
Body Mass Index of employees
Calculated based on manually measured height (feet and inches) and weight (pounds)
Measured: 20 years
Hemoglobin A1c of employees
measured in %
Measured: 20 years
Blood pressure
measured in mm Hg with a sphygmomanometer while at rest
Measured: 20 years
Total cholesterol
laboratory blood analysis, reported in mg/dl
Measured: 20 years
Low density lipoprotein (LDL) cholesterol
laboratory blood analysis, reported in mg/dl
Measured: 20 years
High density lipoprotein (HDL) cholesterol
laboratory blood analysis, reported in mg/dl
Measured: 20 years
Triglycerides
laboratory blood analysis, reported in mg/dl
Measured: 20 years
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
Measured: 20 years
Hope
Hearth Hope Index
Measured: 20 years
Mood
Patient Health Questionnaire-4 (PHQ-4), higher score is more abnormal
Measured: 20 years
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
Measured: 20 years
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
Measured: 20 years
Diet composition
Questions concerning food types based on a 7 day dietary recall
Measured: 20 years
Food availability
Household Hunger scale
Measured: 20 years
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 _________
Measured: 20 years
Absenteeism
days absent per year
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start24 Aug 2020
- Primary completion1 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Health System
- Responsible party
- Principal investigator, David Drozek, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308382
- Sponsor's protocol ID
- 20-X-6
- Status last verified
- Nov 2024
- First submitted
- 11 Mar 2020
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified, aggregated data will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Corporate Wellness Program
- ClinicalTrials.gov ID
- NCT04308382
- Acronym / sponsor ID
- 20-X-6
- Conditions
- Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Memorial Health System
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult employees of the Memorial Health System.
Key inclusion criteria (1 listed)
- -adult employee of Memorial Health System, or spouse of an employee who is participating in the employee wellness program
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Risk AssessmentHeath 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 | Behavioural | – |
Primary outcome
Health Care Expenditures
Time frame: 20 years
Cost for health care as a corporation
16 secondary outcomes
Body Mass Index of employees
Time frame: 20 years
Hemoglobin A1c of employees
Time frame: 20 years
Blood pressure
Time frame: 20 years
Total cholesterol
Time frame: 20 years
Low density lipoprotein (LDL) cholesterol
Time frame: 20 years
High density lipoprotein (HDL) cholesterol
Time frame: 20 years
Triglycerides
Time frame: 20 years
Level of physical activity
Time frame: 20 years
Hope
Time frame: 20 years
Mood
Time frame: 20 years
Tobacco use
Time frame: 20 years
Alcohol use
Time frame: 20 years
Diet composition
Time frame: 20 years
Food availability
Time frame: 20 years
Readiness to Change
Time frame: 20 years
Absenteeism
Time frame: 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No. De-identified, aggregated data will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Care Expenditures (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.