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

2021年9月6日 更新者: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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

216

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nottingham、英国、NG7 2HA
        • University of Nottingham

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Employee of participating organisation

Exclusion Criteria:

Not an employee of participating organisation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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
无干预:Wait-list control group
No intervention for 12 weeks. Then received the MoveIt Intervention for 12 weeks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
International Physical Activity Questionnaire (IPAQ) Taiwanese short form
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Health and Work Performance Questionnaire (HPQ).
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年3月1日

初级完成 (实际的)

2013年10月7日

研究完成 (实际的)

2014年1月31日

研究注册日期

首次提交

2019年7月23日

首先提交符合 QC 标准的

2019年7月29日

首次发布 (实际的)

2019年7月31日

研究记录更新

最后更新发布 (实际的)

2021年9月14日

上次提交的符合 QC 标准的更新

2021年9月6日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • Lai/27/6/13

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Will adhere to data sharing regulations of target journal

IPD 共享时间框架

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

IPD 共享访问标准

Data accessible on request - available for 7 years.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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