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Clinical Trials/NCT05485675
NCT05485675RecruitingNot Applicable

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

Arizona State University1 site in 1 country4,800 target enrollmentStarted: October 7, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
4,800
Locations
1
Primary Endpoint
Intervention Fidelity

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion 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

Arms & Interventions

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.

Intervention: Stand & Move at Work (Behavioral)

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.

Intervention: Stand & Move at Work+ (Behavioral)

Outcomes

Primary Outcomes

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

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.

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.

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

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

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

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

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

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.

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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Matthew P Buman, PhD

Professor

Arizona State University

Study Sites (1)

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