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

6 de septiembre de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

216

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Nottingham, Reino Unido, NG7 2HA
        • University of Nottingham

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Employee of participating organisation

Exclusion Criteria:

Not an employee of participating organisation

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Sin intervención: Wait-list control group
No intervention for 12 weeks. Then received the MoveIt Intervention for 12 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
International Physical Activity Questionnaire (IPAQ) Taiwanese short form
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Health and Work Performance Questionnaire (HPQ).
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2013

Finalización primaria (Actual)

7 de octubre de 2013

Finalización del estudio (Actual)

31 de enero de 2014

Fechas de registro del estudio

Enviado por primera vez

23 de julio de 2019

Primero enviado que cumplió con los criterios de control de calidad

29 de julio de 2019

Publicado por primera vez (Actual)

31 de julio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

6 de septiembre de 2021

Última verificación

1 de septiembre de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Lai/27/6/13

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Will adhere to data sharing regulations of target journal

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

Data accessible on request - available for 7 years.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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