Worksite Health PromotionNCT04166643
Worksite Wellness Within Long-term Care Facilities
A study testing WHHIP PLUS in people with Worksite Health Promotion and Lifestyle Risk Reduction, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Worksite Health Promotion, Lifestyle Risk Reduction, Cardiovascular Diseases
- What is being tested?
- WHHIP PLUS
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to 8 Nov 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Staff inclusion criteria:
18 years or older; Able to understand and speak English; Employed by the facility; Passed the evaluation to sign consent
Resident inclusion criteria:
55 years or older; Able to understand and speak English; Resident of the facility; Passed the evaluation to sign consent
No exclusion criteria for staff or residents
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Nursing
Baltimore, Maryland, 21201
About this study
Official title: The Worksite Heart Health Improvement Project (WHHIP) + Function Focused Care (FFC)
The goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. We also aim to test if increasing wellness behaviors in staff will translate to increased wellness behaviors in residents due to positive role modeling.
Read the detailed description
This is a cluster randomized control trial (initially intended to recruit 246 staff and 180 residents) implemented in six long-term care worksites. Three sites will be randomized to the WHHIP-PLUS \& FFC and three sites will be randomized to the education-only.
The intervention occurs over 12 months and measures will be collected at three timepoints. We will test treatment fidelity as well as if our intervention improves Life's Simple 7 scores and reduces stress levels among long-term care workers and increases physical activity among residents.
- Conditions
- Worksite Health Promotion, Lifestyle Risk Reduction, Cardiovascular Diseases, Occupational Stress, Healthcare Workers
- Being tested
- WHHIP PLUS, Education only control
- Medical subject headings
- Risk Reduction Behavior, Cardiovascular Diseases, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHHIP PLUSBehavioural
Worksite health promotion and occupational health and safety (total worker health)
Education only controlBehavioural
Education at the start of the project
| Study group | Role | What they receive |
|---|---|---|
| Education only | Active comparator | Education Receives: Behavioral: Education only control |
| WHHIP-PLUS and Function Focused Care | Experimental | Component I: Stakeholder Group Involvement:
Component II: Environment Assessment:
Component III: Organizational Changes To Reduce Job Stress:
Component IV- Worker Health Behavior Change including function focused care interventions Receives: Behavioral: WHHIP PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease risk
Composite life simple 7 scores and individual scores from life simple 7 components (blood pressure, weight, cholesterol, blood sugar, tobacco exposure, diet, physical activity) for staff
Measured: baseline, 6-months, 12-months
Secondary outcomes (2)
Short version of the Depression Anxiety Stress Scale-Stress- (DASS-S)
Personal mood assessment tool, it can be scored as a composite mood score or three individual subscales, higher indicates more stress, 0-21 for each subscale or 0-63 for the composite for staff
Measured: baseline, 6-months, 12-months
Job strain model tool
Tool to measure work environment for staff including job control (including decision authority [9 items, range 9-36] and skill discretion [6 items, range 6-24]), job demands (4 items, range 4-16), social support (6 items, range 6-24 ), and organizational justice (5 items, range 5-20). Lower scores are desired.
Measured: baseline, 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start28 Jun 2022
- Primary completion31 Oct 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Worksite Health PromotionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Building Healthy Behaviors Across the Life Span Research Center
- Responsible party
- Principal investigator, Kelly Doran, University of Maryland, Baltimore
- Investigators
- Kelly Doran, PhD, RN, Principal investigator, UMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166643
- Sponsor's protocol ID
- HP-00086939
- Other IDs
- 19TPA34830011
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2019
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified raw data
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Worksite Heart Health Improvement Project (WHHIP) + Function Focused Care (FFC)
- ClinicalTrials.gov ID
- NCT04166643
- Acronym / sponsor ID
- HP-00086939
- Conditions
- Worksite Health Promotion, Lifestyle Risk Reduction, Cardiovascular Diseases, Occupational Stress, Healthcare Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- American Heart Association, Building Healthy Behaviors Across the Life Span Research Center
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 18 Nov 2019 (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 goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. We also aim to test if increasing wellness behaviors in staff will translate to increased wellness behaviors in residents due to positive role modeling.
Detailed description
This is a cluster randomized control trial (initially intended to recruit 246 staff and 180 residents) implemented in six long-term care worksites. Three sites will be randomized to the WHHIP-PLUS \& FFC and three sites will be randomized to the education-only.
The intervention occurs over 12 months and measures will be collected at three timepoints. We will test treatment fidelity as well as if our intervention improves Life's Simple 7 scores and reduces stress levels among long-term care workers and increases physical activity among residents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education only | Active comparator | Behavioral: Education only controlEducation |
| WHHIP-PLUS and Function Focused Care | Experimental | Behavioral: WHHIP PLUSComponent I: Stakeholder Group Involvement: Component II: Environment Assessment: Component III: Organizational Changes To Reduce Job Stress: Component IV- Worker Health Behavior Change including function focused care interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| WHHIP PLUSWorksite health promotion and occupational health and safety (total worker health) | Behavioural | WHHIP-PLUS and Function Focused Care |
| Education only controlEducation at the start of the project | Behavioural | Education only |
Primary outcome
Cardiovascular disease risk
Time frame: baseline, 6-months, 12-months
Composite life simple 7 scores and individual scores from life simple 7 components (blood pressure, weight, cholesterol, blood sugar, tobacco exposure, diet, physical activity) for staff
2 secondary outcomes
Short version of the Depression Anxiety Stress Scale-Stress- (DASS-S)
Time frame: baseline, 6-months, 12-months
Job strain model tool
Time frame: baseline, 6-months, 12-months
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified raw data
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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.
Kelly Doran, PhD, RN principal investigator
UMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHHIP PLUS in people with Worksite Health Promotion and Lifestyle Risk Reduction, run by University of Maryland, Baltimore 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?
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 16 Dec 2025. 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?
Cardiovascular disease risk (time frame: baseline, 6-months, 12-months). 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 16 Dec 2025.