Clinical trial NCT05485675: Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program
Official title: Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Keywords: worksite health
sit-stand workstations
multilevel intervention
implementation science
fidelity
facilitation
effectiveness
sedentary behavior
posture
Light physical activity
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Minnesota
name: The University of Queensland
name: University of Nebraska
name: University of Utah
name: University of Virginia
First posted: 2022-08-03
Enrollment: 4800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SMW and SMW+ will be running simultaneously.
Primary purpose: PREVENTION

Brief summary: This is a 2-arm group-randomized hybrid effectiveness-implementation (HEI type 2) study to test an evidence-based intervention (EBI) known as Stand \& Move at Work(SMW) to reduce sedentary time in the workplace, and to test the role of expert facilitation (SMW+) for improving intervention fidelity.

Detailed description: Primary Aim: To assess worksite-level reduction in sedentary time and intervention fidelity over 12 months Secondary Aim: To assess cost effectiveness of the intervention at 12 and 24 months

Eligibility criteria: Worksite-Level Inclusion Criteria:

* More than 80% of employees work full time (30+ hours per week).
* At least 45 employees in the worksite with sit-stand workstations working at least three days per week
* Occupations require primarily desk-based work (e.g., computer- and telephone-based)
* Willing to allow the researchers to distribute online research surveys to all employees in order to allow the program to be evaluated.
* Allow 30 randomly selected individuals to wear an activity monitor in several 7-day intervals across two years.
* Willing to be randomized to either intervention.
* Willing to identify one or more worksite champions to implement the Stand \& Move at Work™ program.

Worksite-level exclusion criteria:

* Involved in previous interventions to reduce sitting and increase standing and moving at work in the last 24 months.
* Involved in the Stand and Move I intervention.
* Another worksite within the same organization is participating in the program and contamination across those worksites cannot be avoided.

Employee-level inclusion criteria:

* 18 years or older
* Willing to provide informed consent

Primary outcomes:
measure: Changes in posture
timeFrame: Baseline, 3 month, 12 months, and 24 months
measure: Competence/Adherence
timeFrame: 3 months
measure: Competence/Adherence
timeFrame: 12 months
measure: Competence/Adherence
timeFrame: 24 months
measure: Intervention Fidelity
timeFrame: 3 months
measure: Intervention Fidelity
timeFrame: 12 months
measure: Intervention Fidelity
timeFrame: 24 months
measure: Researcher derived measures of fidelity
timeFrame: 3 months
measure: Researcher derived measures of fidelity
timeFrame: 12 months
measure: Researcher derived measures of fidelity
timeFrame: 24 months
Secondary outcomes:
measure: Comparison of program-related costs
timeFrame: Baseline, 3 month, 12 months, and 24 months.
measure: Change in health-related quality of life
timeFrame: Baseline, 3 month, 12 months, and 24 months.
measure: Change in musculoskeletal pain
timeFrame: Baseline, 3 months, 12 months, and 24 months.
measure: Change in Work Productivity and Activity Impairment Questionnaire - General Health
timeFrame: Baseline, 3 months, 12 months, and 24 months.
Other outcomes:
measure: Change in sedentary behavior
timeFrame: Baseline, 3 month, 12 months, and 24 months.
Locations:
city: Phoenix
country: United States
facility: Arizona State University College of Health Solutions
state: Arizona
Study officials:
affiliation: Arizona State University College of Health Solutions
name: Matthew Buman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Mark Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
References: