Sedentary Lifestyle Clinical Trial
Official title:
A Study to Assess the Impact of a Multicomponent Intervention to Reduce Prolonged Sitting in the Workplace
This dual-arm randomised study aims to test a multi-component intervention to reduce sedentary behaviour in a cohort of desk-based office workers.
There is increasing evidence to demonstrate that excessive and unhealthy patterns of
sedentary behaviour can increase the risk of a range of health problems,independent to
levels of physical activity. Increasingly, people are employed in low activity occupations
with office workers being identified as one of the most sedentary roles. Small scale studies
using prompts to remind office workers to stand have shown promising results, as well as
representing a low-cost solution for employers. This study builds upon a recent pilot study
investigating the impact of prompts delivered via Microsoft Outlook, on the sedentary
behaviour of office workers.
Developed in accordance with the Medical Research Council framework for designing
multi-component interventions this study utilises Social Cognitive Theory (SCT) as a
theoretical basis. SCT describes the complex interaction between individuals and their
environment. The influence of the office environment on sedentary behaviour is clearly
illustrated by differences in people's sitting patterns inside and outside of working hours
. Behavioural change techniques linked to the constructs of SCT have also been shown to have
a positive impact on sedentary behaviour, namely education, goal setting and feedback.
Participants in this study will therefore receive education on the benefits of breaking
their sitting, tips on how to achieve this, and feedback on their baseline sitting
behaviour. This study will test the impact of these techniques on sitting time and patterns,
and also track their influence on the different constructs of SCT and individuals' readiness
to change by measuring these at time points throughout the intervention. To address the fact
that sitting at work may not be a conscious decision, but performed out of habit, half of
participants will also receive prompts reminding them to stand. The same prompts will be
used as in the pilot study, but the addition of an extra activity monitoring period will
enable us to ascertain whether the impact of prompts diminishes during the intervention
period.
This study will aim to recruit 60 desk-based office employees via email invitation.
Volunteers will be screened using inclusion/exclusion criteria and asked to provide signed
consent. Sitting will be de-emphasised in the participant information sheet, and other
documentation used at recruitment, in order to minimise any impact on baseline activity
measurements. Cluster randomisation will be used to split participants into two equal groups
(Group 1 n=30, group 2 n=30) based on their physical location within the office(s) in order
to minimise contamination between groups. Randomisation software will be used to allocate
groups on www.randomisation.com. Baseline measurement for all participants will consist of
completion of questionnaires and activity monitoring as follows:
1. Questionnaires:
- Q1: Demographic data - to obtain basic information on participants
- Q2: Stage of change questionnaire - measuring readiness to change
- Q3: Social cognitive theory questionnaire - measuring key constructs of SCT
2. Activity monitoring:
- Participants will be asked to wear a water-proofed activPAL activity monitor* on
the front of their thigh for a period of 7 consecutive days (24 hours a day)
- A brief diary will be completed for the same 7 days
- The activPAL activity monitor has been validated for measuring and
categorising sitting/lying, standing and walking using an acceleration signal
from the thigh .
Following the collection of baseline data, all participants will attend a 1 hour education
session during which they will receive a presentation outlining: the health problems
associated with prolonged sedentary behaviour; how much sitting is recommended; feedback on
their own baseline sitting behaviour; and tips on how to reduce and break up sedentary
behaviour. They will be given a summary of their baseline activity data . Group 1 will then
return to work as normal. Group 2 will receive an excel file to upload to Microsoft Outlook
which will deliver prompts to break sitting at random times, once within an hour. The
prompts will run for a period of 10 weeks and their content will be the same brief,
positively framed messages that were evaluated favourably by participants in the pilot
project. Measurements for all participants will be repeated as follows: Questionnaires Q2
and Q3 will be repeated after the education session and at 12 week follow-up; 1 week of
activity monitoring will be repeated between weeks 2-4 of the intervention period, 8-10 of
the intervention period, and at 12 week follow up.
Following final measurements, participants will be invited to one of a series of
semi-structured focus groups to explore the feasibility, acceptability, meaningfulness and
effectiveness of the intervention. Focus groups will be recorded using a digital voice
recorder and transcribed.
Data will be treated as confidential, it will be anonymised, and stored securely in line
with GCU's data protection policies. Electronic copies of the activity data will be kept for
10 years, alongside electronic and paper copies of the questionnaires and diaries and audio
and transcribed accounts of the focus groups. Physical activity data and basic demographic
data will also be kept on a password protected database on a secure server. The data held on
the database will not be identifiable. The information collected may be used for further
analysis by staff and students in the School of Health and Life Sciences at Glasgow
Caledonian University at a later date. Access to data will be restricted and controlled by
Dr Ben Stansfield, PGRT in the School of Health and Life Sciences, GCU. Individuals will not
be identifiable from any reports published and the employer, JJML, will receive a report
containing only amalgamated data.
: Each participant will receive a brief summary of their baseline activity data at the
education session. In addition, at the end of the study they will be provided with an
activity report, summarising their individual activity data for all 4 measurement periods. A
report of amalgamated data, including the results of the focus groups, will be produced for
JJML and this will also be made available to study participants. Furthermore, the results
will be written up as a PhD thesis, published in appropriate academic journals and discussed
in conference presentations.
;
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