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Recruiting NCT05485675

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

No phase Interventional Sedentary Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stand & Move at Work, Stand & Move at Work+.
Who it may be relevant to
Registry conditions: Sedentary Behavior. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

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

Primary outcome measures

  • Changes in posture [Time frame: Baseline, 3 month, 12 months, and 24 months]
  • Competence/Adherence [Time frame: 3 months]
  • Competence/Adherence [Time frame: 12 months]
  • Competence/Adherence [Time frame: 24 months]
  • Intervention Fidelity [Time frame: 3 months]
  • Intervention Fidelity [Time frame: 12 months]
  • Intervention Fidelity [Time frame: 24 months]
  • Researcher derived measures of fidelity [Time frame: 3 months]
  • Researcher derived measures of fidelity [Time frame: 12 months]
  • Researcher derived measures of fidelity [Time frame: 24 months]
Secondary outcome measures (4)
  • Comparison of program-related costs [Time frame: 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.]
  • Change in musculoskeletal pain [Time frame: 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Arizona State University College of Health Solutions — Phoenix

Identifiers

NCT: NCT05485675 · 1R01CA250527 · 1R01CA250527-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗