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

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

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

Conditions
-----------------
Sedentary Behavior

Intervention / Treatment
-----------------
* Behavioral: Stand & Move at Work
* Behavioral: Stand & Move at Work+


Participation Criteria
=================
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 on site 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 60 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SMW and SMW+ will be running simultaneously.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stand & Move at Work<br>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<br>* Web-based platform only.<br>* Other names: SMW;|
| Experimental: Stand & Move at Work+<br>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+<br>* Web-based platform and support from an expert facilitator<br>* Other names: SMW+;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
worksite health, posture, fidelity, sit-stand workstations, multilevel intervention, implementation science, facilitation, effectiveness, sedentary behavior, Light physical activity