Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation (Move-It)

September 6, 2021 updated by: Holly Blake, University of Nottingham

Move-It: A Cluster-randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation

The aim of the study is to evaluate the outcomes and processes of a video and web-based worksite exercise intervention for sedentary office workers in China.

The intervention is informed by behaviour change theory, and is a digital workplace intervention (called Move-It) involving a 10-minute Qigong exercise session (video demonstration via website) which is delivered twice a day at set break times during the working day for 12 consecutive weeks.

The setting is a large organisation with 2 sites (in Beijing and Guangzhou). The objectives are to examine the effect of a video-based intervention on employees' physical activity, time spent sitting and work performance. This is tested in a 2-group, randomised wait-list control trial. This means that employees at one site receive the intervention first (site 1 - intervention group), and when they have completed (12 weeks later), the other site then receives the same intervention (site 2 - wait-list control). At the end of the intervention, there is a process evaluation with the intervention group which includes focus groups with employees and managers to gather information about the way in which the intervention was implemented. The process evaluation is based on a framework called 'Reach Effectiveness Adoption Implementation Maintenance' (RE-AIM). Data were collected at baseline (before the intervention began) and after 12 weeks in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim The aim of the study is to deliver a digital video-based worksite exercise intervention in China and conduct outcome and process evaluation. The objectives are: [1] to examine the effect of a video-based intervention on physical activity (PA) and weekday sitting hours (individual level); [2] to examine the effect of a video-based intervention on individual work performance (individual level); [3] to conduct a process evaluation of the intervention implementation (individual and cluster level).

Design This is a 2-arm cluster-randomised wait-list control trial, with outcomes assessed in two groups: intervention and wait-list control (objectives 1 and 2).

Clusters (sites) will be randomly allocated to groups at 1:1 ratio using computer-generated random number sequence.

Setting 2 sites of a major organisation in China (one in Beijing, one in Guangzhou), with a total of 490 employees.

Data Collection Data will be collected through online questionnaires emailed to all employee participants (Time 1 = T1). Employees in both groups will complete a second online questionnaire (Time 2 = T2). For the intervention group T2 will be immediately post-intervention, for the wait-list control group this will be just prior to receiving the intervention.

Sample size At an individual level, the estimated sample size is a minimum 72 for intervention group and 72 for control group, alpha 0.05, beta 0.2 and power 0.8.

Intervention This digital intervention consists of a series of six video clips demonstrating Qigong exercises designed to be undertaken at set exercise break times during the working day. The intervention includes a specially designed logo and selected images to be used on promotional posters and a dedicated 'Move-It' webpage. The six promotional videos are designed to be posted in sequence, one every two weeks, on the Move-It website. A Move-It icon on each employee's desktop computer screen will be scheduled to pop up twice a day as a prompt to interrupt sitting. The intervention is designed to be completed within 12 weeks.

Measures Self-report measures of PA, work performance and weekday sitting hours are taken at T1 (baseline) and T2 (12 week follow-up).

Data analysis Intervention outcome data will be analysed using the Statistical Package for the Social Sciences (IBM SPSS) Version 24.

Outcomes will be compared between the pre- and post-intervention time points. Intracluster correlations and estimated effects sizes will be presented for each outcome. Data from both clusters will be included in all analyses, and analysis is by intention-to-treat.

Process evaluation Will take place at the end of the intervention (intervention site only). This will include up to 6 focus groups (up to n=35) with employees (both participants and non-participants), organisational committee members and senior management.

These will be aligned with the RE-AIM framework to explore intervention reach, effectiveness, adoption, implementation and maintenance.

Study Type

Interventional

Enrollment (Actual)

216

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 Locations

      • Nottingham, United Kingdom, NG7 2HA
        • University of Nottingham

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Employee of participating organisation

Exclusion Criteria:

Not an employee of participating organisation

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (MoveIt)
10-minute Qigong exercise session (video demonstration via website) delivered twice a day at set break times during the working day for 12 consecutive weeks
No Intervention: Wait-list control group
No intervention for 12 weeks. Then received the MoveIt Intervention for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire (IPAQ) Taiwanese short form
Time Frame: Covers a person's record of physical activity for a period of seven days
Measure of self-reported physical activity. Includes culturally sensitive Chinese translations for the terms "moderate", "vigorous" and "physical activity" as well as to identify representative types of physical activity for Taiwanese. Content validity 0.994.
Covers a person's record of physical activity for a period of seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health and Work Performance Questionnaire (HPQ).
Time Frame: Overall performance rating for the days worked over the past 4 weeks.

Self-reported work performance. Single item was used from this scale. Item was measured on a 10-point scale ranging from 0=worst performance to 10=top performance.

Item is: 'how would you rate your overall performance on the days you worked during the past 4 weeks?'.

Overall performance rating for the days worked over the past 4 weeks.
Weekday sitting hours
Time Frame: 1 day (average)
Self-reported average sitting hours per day: participants report number of hours (to the nearest whole hour) spent sitting on a typical workday.
1 day (average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

March 1, 2013

Primary Completion (Actual)

October 7, 2013

Study Completion (Actual)

January 31, 2014

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Lai/27/6/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will adhere to data sharing regulations of target journal

IPD Sharing Time Frame

Study registered online at clinical trials.gov (permanent). This includes statistical analysis plan. Data accessible on request - available for 7 years.

IPD Sharing Access Criteria

Data accessible on request - available for 7 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

Clinical Trials on Physical Activity

Clinical Trials on Move-It

3
Subscribe