- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05485675
Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program (SMWII)
January 13, 2026 updated by: Matthew P Buman, PhD, Arizona State University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Estimated)
4800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Matthew Buman, PhD
- Phone Number: 602-496-8617
- Email: mbuman@asu.edu
Study Contact Backup
- Name: Arlene Fernandez
- Phone Number: 6025433756
- Email: arlene11@asu.edu
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- Arizona State University College of Health Solutions
-
Contact:
- Matthew Buman, PhD
- Phone Number: 602-496-8617
- Email: mbuman@asu.edu
-
Principal Investigator:
- Matthew Buman, PhD
-
Contact:
- Arlene Fernandez
- Phone Number: 6025433756
- Email: arlene11@asu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Stand & Move at Work
Given an evidence-based workplace program to reduce sedentary behavior and increase standing and moving using a web-based platform.
The web platform has a toolkit with strategies and guides for the worksite Champions to address changes at the environmental, social, and cultural levels.
|
Web-based platform only.
Other Names:
|
|
Experimental: Stand & Move at Work+
This arm will receive access to the same web-based platform and toolkit as the other arm.
Additionally, worksites in this arm will be assigned and expert facilitator who will meet regularly with the worksite Champions to assist with implementation.
|
Web-based platform and support from an expert facilitator
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in posture
Time Frame: Baseline, 3 month, 12 months, and 24 months
|
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
|
|
Competence/Adherence
Time Frame: 3 months
|
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
|
|
Competence/Adherence
Time Frame: 12 months
|
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
|
|
Competence/Adherence
Time Frame: 24 months
|
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
|
|
Intervention Fidelity
Time Frame: 3 months
|
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
|
|
Intervention Fidelity
Time Frame: 12 months
|
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
|
|
Intervention Fidelity
Time Frame: 24 months
|
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
|
|
Researcher derived measures of fidelity
Time Frame: 3 months
|
A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.
|
3 months
|
|
Researcher derived measures of fidelity
Time Frame: 12 months
|
A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.
|
12 months
|
|
Researcher derived measures of fidelity
Time Frame: 24 months
|
A single composite measure of directly-observed intervention delivery assessed via web analytics, participation rates, and other calculated measures of fidelity.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of program-related costs
Time Frame: Baseline, 3 month, 12 months, and 24 months.
|
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.
|
|
Change in health-related quality of life
Time Frame: Baseline, 3 month, 12 months, and 24 months.
|
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.
|
|
Change in musculoskeletal pain
Time Frame: Baseline, 3 months, 12 months, and 24 months.
|
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.
|
|
Change in Work Productivity and Activity Impairment Questionnaire - General Health
Time Frame: Baseline, 3 months, 12 months, and 24 months.
|
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.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sedentary behavior
Time Frame: Baseline, 3 month, 12 months, and 24 months.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Buman, PhD, Arizona State University College of Health Solutions
- Principal Investigator: Mark Pereira, PhD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2022
Primary Completion (Estimated)
February 28, 2026
Study Completion (Estimated)
February 28, 2027
Study Registration Dates
First Submitted
December 1, 2021
First Submitted That Met QC Criteria
July 29, 2022
First Posted (Actual)
August 3, 2022
Study Record Updates
Last Update Posted (Estimated)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01CA250527 (U.S. NIH Grant/Contract)
- 1R01CA250527-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes.
Such access will be provided using web-based applications, as appropriate.
Publication of data shall occur during the project, if appropriate, and at the end of the project, consistent with normal scientific practices.
Research data to document, support and validate research findings will be made available after the main findings from the final research data set have been accepted for publication.
Such research data will be de-identified to prevent the disclosure of personal identifiers.
IPD Sharing Time Frame
Protocol and analysis plan will be available for sharing in 2022.
Analytical code and data sets will be available for sharing following publication of the primary and secondary outcome papers.
IPD Sharing Access Criteria
Public access via request to the study Principal Investigators
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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