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CompletedNCT04166643Updated Dec 16, 2025

Worksite Wellness Within Long-term Care Facilities

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

Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Worksite Health Promotion
  • Lifestyle Risk Reduction
  • Cardiovascular Diseases
  • Occupational Stress
  • Healthcare Workers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Active comparator
    Education only

    Education

    Behavioral: Education only control

  • Experimental
    WHHIP-PLUS and Function Focused Care

    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

Interventions

  • BehavioralWHHIP PLUS

    Worksite health promotion and occupational health and safety (total worker health)

  • BehavioralEducation only control

    Education at the start of the project

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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

  2. 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

  3. Sleep

    Accelerometer for staff

    Time frame: baseline, 6-months, 12-months

  4. Bioelectrical Impedance Analysis (BIA)

    Percent of body fat and muscle mass for staff

    Time frame: baseline, 6-months, 12-months

  5. Modified Pittsburgh Sleep Quality Index

    Individual items on sleep hours and quality for staff

    Time frame: baseline, 6-months, 12-months

  6. Barthel index

    Assesses functional independence for residents

    Time frame: baseline, 6-months, 12-months

  7. 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

  8. 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

06

Study locations

1 site
  • University of Maryland School of Nursing
    Baltimore, Maryland 21201, United States
07

References and documents

Individual participant data

Plan to share: Yes — De-identified raw data

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04166643
Lead sponsor
University of Maryland, Baltimore
Collaborators
American Heart Association, Building Healthy Behaviors Across the Life Span Research Center
Responsible party
Kelly Doran (associate professor, University of Maryland, Baltimore) — Principal investigator
First posted
Nov 18, 2019
Start date
Jun 28, 2022
Primary completion
Oct 31, 2024
Completion
Nov 8, 2024
Last update
Dec 16, 2025

Study contacts

Kelly Doran, PhD, RN
principal investigator · UMB

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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