WHHIP-PLUS: The Worksite Heart Health Improvement Project-PLUS

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04166643
Collaborator
(none)
164
2
20

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: WHHIP PLUS
  • Behavioral: Education only control
N/A

Detailed Description

This is a cluster randomized control trial (n=164) delivered in four long-term care worksites. Aim 1 is to evaluate the preliminary efficacy of the Worksite Heart Health Improvement Project-PLUS (WHHIP-PLUS) on workers' composite Life's Simple 7 scores. Hypothesis: workers exposed to the WHHIP-PLUS will report improved adherence to heart healthy behaviors and a reduction in cardiovascular disease risk factors measured by a composite Life's Simple 7 score at 6 months and 12 months compared to those exposed to education-only control. Aim 2 is to evaluate the preliminary efficacy of the WHHIP-PLUS on workers' stress levels. Hypothesis: workers exposed to the WHHIP-PLUS will report decreased stress as measured by stress scales at the same 2 time-points compared to those exposed to education-only control. Aim 3 is to evaluate the feasibility of integrating the WHHIP-PLUS with long-term care workers over time. Feasibility will be based on evidence of delivery, receipt, and enactment of the intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Worksite Heart Health Improvement Project-PLUS
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: WHHIP-PLUS

Component I: Stakeholder Group Involvement: Component II: Environment Assessment: Component III: Organizational Changes To Reduce Job Stress: Component IV- Worker Health Behavior Change:

Behavioral: WHHIP PLUS
Worksite health promotion and occupational health and safety (total worker health)

Active Comparator: Education only

Education

Behavioral: Education only control
Education at the start of the project

Outcome Measures

Primary Outcome Measures

  1. Cardiovascular disease risk [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)

Secondary Outcome Measures

  1. Short version of the Depression Anxiety Stress Scale-Stress- (DASS-S) [baseline, 6-months, 12-months]

    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

  2. Modified Whitehall Job Characteristics Questionnaire [baseline, 6-months, 12-months]

    Tool, measures, control (range 0-45 or can be split into 2 further subscales), demands (range 0-12), and support (range 0-27)

Other Outcome Measures

  1. Modified Nursing Assistant Self-efficacy for Restorative Care (NASERC) [baseline, 6-months, 12-months]

    Tool to assess staff encouraging their patients to engage in heart healthy behaviors, range 0-36, higher means more self-efficacy

  2. Modified Nursing Assistant Outcome Expectations for Restorative Care (NAOERC) [baseline, 6-months, 12-months]

    Tool to assess staff encouraging their patients to engage in heart healthy behaviors, range 0-44, higher means more outcome expectations

  3. Sleep [baseline, 6-months, 12-months]

    Accelerometer

  4. Bioelectrical Impedance Analysis (BIA) [baseline, 6-months, 12-months]

    Percent of body fat and muscle mass

  5. Modified Pittsburgh Sleep Quality Index [baseline, 6-months, 12-months]

    Individual items on sleep hours and quality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Over the age of 18

  • Able to understand and speak English

Exclusion Criteria:
  • Not employed by the facility

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kelly Doran, associate professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT04166643
Other Study ID Numbers:
  • 19TPA34830011
First Posted:
Nov 18, 2019
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022