An interventional study of WHHIP PLUS and Education only control in Worksite Health Promotion, Lifestyle Risk Reduction and Cardiovascular Diseases, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention
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.
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.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's enrollment of 159 is below the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Education
Behavioral: Education only control
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
Behavioral: WHHIP PLUS
Worksite health promotion and occupational health and safety (total worker health)
Education at the start of the project
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
Time frame: baseline, 6-months, 12-months
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
Time frame: 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.
Time frame: baseline, 6-months, 12-months
Modified Nursing Assistant Self-efficacy for Restorative Care (NASERC)
Tool to assess staff encouraging their patients to engage in heart healthy behaviors, range 0-36, higher means more self-efficacy for staff
Time frame: baseline, 6-months, 12-months
Modified Nursing Assistant Outcome Expectations for Restorative Care (NAOERC)
Tool to assess staff encouraging their patients to engage in heart healthy behaviors, range 0-44, higher means more outcome expectations for staff
Time frame: baseline, 6-months, 12-months
Sleep
Accelerometer for staff
Time frame: baseline, 6-months, 12-months
Bioelectrical Impedance Analysis (BIA)
Percent of body fat and muscle mass for staff
Time frame: baseline, 6-months, 12-months
Modified Pittsburgh Sleep Quality Index
Individual items on sleep hours and quality for staff
Time frame: baseline, 6-months, 12-months
Barthel index
Assesses functional independence for residents
Time frame: baseline, 6-months, 12-months
Function focused care
This tool is on observational check list that assesses long-term care staff and resident interactions for encouragement in function focused care (i.e., how staff engage or encourage residents to engage in physical activity). Staff are observed for about 30 minutes and scored (performed, not performed, not observed) on encouragement of function focused care for 19 typical care items such as bed mobility, ambulation in hallway.
Time frame: baseline, 6-months, 12-months
3 word recall from mini-cog
Stating 3 words to residents and asking them to recall them words.
Time frame: baseline, 6-months, 12-months
Plan to share: Yes — De-identified raw data
Time frame: Once the study and preliminary analysis is complete (anticipated date 2025). Once published it will remain available
Access criteria: open
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Oct 2024, 28 months.
Of 167 non-industry interventional studies with no phase under Risk Reduction Behavior, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's 28 months is above that.
Counting every sponsor, half of 169 studies reached it within 25 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore →