Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program

Sedentary Behavior Clinical Trial

— SMWII  

Official title:

Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485675
• Other study ID #: 1R01CA250527
• Secondary ID: 1R01CA250527-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: May 2024
• Source: Arizona State University
• Contact: Matthew Buman, PhD
• Phone: 602-496-8617
• Email: mbuman[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4800
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• Stand & Move at Work
Web-based platform only.
• Stand & Move at Work+
Web-based platform and support from an expert facilitator

Locations

Country	Name	City	State
United States	Arizona State University College of Health Solutions	Phoenix	Arizona

Sponsors (7)

Lead Sponsor	Collaborator
Arizona State University	National Cancer Institute (NCI), The University of Queensland, University of Minnesota, University of Nebraska, University of Utah, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in sedentary behavior	Sedentary behavior questionnaire (SBQ) is a brief questionnaire to assess time spent sitting in different work and non-work contexts SCORING RANGE	Baseline, 3 month, 12 months, and 24 months.
Primary	Changes in posture	Accelerometer-based (activPAL) sensor fixed to the thigh that measures sitting, standing, and lying down over 7 days.	Baseline, 3 month, 12 months, and 24 months
Primary	Competence/Adherence	A questionnaire-based assessment of intervention fidelity completed by study champions (competence and adherence) through an online portal. Based on Likert-scales and interval scales. SCORING RANGE	3 months
Primary	Competence/Adherence	A questionnaire-based assessment of intervention fidelity completed by study champions (competence and adherence) through an online portal. Based on Likert-scales and interval scales. SCORING RANGE	12 months
Primary	Competence/Adherence	A questionnaire-based assessment of intervention fidelity completed by study champions (competence and adherence) through an online portal. Based on Likert-scales and interval scales. SCORING RANGE	24 months
Primary	Intervention Fidelity	A questionnaire-based assessment of intervention fidelity completed by study participants regarding the advocates (competence and adherence) through an online portal. SCORING RANGE	3 months
Primary	Intervention Fidelity	A questionnaire-based assessment of intervention fidelity completed by study participants regarding the advocates (competence and adherence) through an online portal. SCORING RANGE	12 months
Primary	Intervention Fidelity	A questionnaire-based assessment of intervention fidelity completed by study participants regarding the advocates (competence and adherence) through an online portal. SCORING RANGE	24 months
Primary	Researcher derived measures of fidelity	A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.	3 months
Primary	Researcher derived measures of fidelity	A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.	12 months
Primary	Researcher derived measures of fidelity	A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.	24 months
Secondary	Comparison of program-related costs	Program-related costs above and beyond cost of sit-stand workstation which may include advocate time spent implementing the intervention and intervention supplies.	Baseline, 3 month, 12 months, and 24 months.
Secondary	Change in health-related quality of life	36-Item Short Form Survey (SF36) assesses quality of life that will be used to estimate incremental cost effectiveness. Scored from 0 to 100, with 0 being maximum disability and 100 being no disability.	Baseline, 3 month, 12 months, and 24 months.
Secondary	Change in musculoskeletal pain	The Nordic Musculoskeletal Questionnaire (NMQ) assesses pain by bodily region on a Likert-type scale SCORING RANGE.	Baseline, 3 months, 12 months, and 24 months.
Secondary	Change in Work Productivity and Activity Impairment Questionnaire - General Health	Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) assesses impairment in paid work and activities in the preceding 7 days on an interval and Likert-type scale with a higher score indicating greater impariment.	Baseline, 3 months, 12 months, and 24 months.