NCT05485675

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,800

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2022Feb 2027

First Submitted

Initial submission to the registry

December 1, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 7, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Expected
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

December 1, 2021

Last Update Submit

January 13, 2026

Conditions

Keywords

worksite healthsit-stand workstationsmultilevel interventionimplementation sciencefidelityfacilitationeffectivenesssedentary behaviorpostureLight physical activity

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Comparison of program-related costs

    Baseline, 3 month, 12 months, and 24 months.

  • Change in health-related quality of life

    Baseline, 3 month, 12 months, and 24 months.

  • Change in musculoskeletal pain

    Baseline, 3 months, 12 months, and 24 months.

  • Change in Work Productivity and Activity Impairment Questionnaire - General Health

    Baseline, 3 months, 12 months, and 24 months.

Other Outcomes (1)

  • Change in sedentary behavior

    Baseline, 3 month, 12 months, and 24 months.

Study Arms (2)

Stand & Move at Work

ACTIVE COMPARATOR

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.

Behavioral: Stand & Move at Work

Stand & Move at Work+

EXPERIMENTAL

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.

Behavioral: Stand & Move at Work+

Interventions

Web-based platform and support from an expert facilitator

Also known as: SMW+
Stand & Move at Work+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • years or older
  • Willing to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University College of Health Solutions

Phoenix, Arizona, 85004, United States

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Matthew Buman, PhD

    Arizona State University College of Health Solutions

    PRINCIPAL INVESTIGATOR
  • Mark Pereira, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Buman, PhD

CONTACT

Arlene Fernandez

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: SMW and SMW+ will be running simultaneously.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2021

First Posted

August 3, 2022

Study Start

October 7, 2022

Primary Completion

February 28, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
Access Criteria
Public access via request to the study Principal Investigators

Locations