Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000807257
Ethics application status
Approved
Date submitted
8/05/2018
Date registered
11/05/2018
Date last updated
11/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting walking, improving psychological wellbeing and enhancing work outcomes in physically inactive employees
Scientific title
Piloting a peer-led workplace walking intervention to increase walking, and improve health, well-being and work outcomes in physically inactive employees
Secondary ID [1] 294814 0
None
Universal Trial Number (UTN)
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 307744 0
sedentary behaviour 307745 0
Psychological wellbeing 307746 0
Condition category
Condition code
Public Health 306801 306801 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a 16-week cluster randomised pilot trial with 8 work-sites randomly assigned to two conditions; a ‘minimal treatment’ condition (n=4 worksites; n=40 employees) and an ‘enhanced treatment’ condition (n=4 worksites; n=40 walkers (employees); n=8 peer leaders (employees)).
Peer leaders in the ‘enhanced treatment’ condition will initially be sent online material developed for the purpose of this project (relating to peer leader tasks and information about health benefits of walking for health, and information about safe walking) via email, which will be complemented by a brief manual, which is also developed specifically for this project. Subsequently, they will be requested to partake in 2 interactive workshops, led by the research team, at their workplace during work time (as arranged with the employing organisation). The workshops will focus on how to use strategies that will support the motivation and walking behaviour change of the participants in their group. The first of these workshops will take place approx. 1 week prior to the start of the intervention and will last approximately 2 hours, with the second one (lasting 1 hour) taking place 2 weeks into the intervention to reinforce training materials, and where the identification of problems/challenge, and proposed solutions in running the groups will be identified. The latter two workshops will be complemented by another training manual which will be available in both hard copy and online formats. The peer leaders will be asked to work towards specific motivational ‘goals’ each week in which they apply the training they have received. For example, in week 1 their goals will be to get to know the walkers, help them feel at ease and help them feel like a valued member of the group. In week 2, the goal will be to help them make walking more enjoyable, and in week 3 to help walkers feel successful. This will be supplemented by weekly reflections which can be notes in their manuals or via links online (whichever they prefer) and sent to the research team.
Walkers in the ‘enhanced treatment’ condition will be trained approximate 1 week prior to the start of the intervention in a 1-hour workshop provided by the research team which will take place at their workplace during lunchtime. The session will be interactive in nature and will cover health benefits of walking, increasing understanding of how motivation is important to increase walking and learning motivational strategies that walkers can use to help then become and stay active. This session will be complemented by a hardcopy manual which will also be available in an online format. Participants will also receive a FitBit Zip which they can use to track daily step counts (the devices will serve as a motivational, not as an assessment, tool). Additionally, participants will be requested to download on their mobile phone a mobile app, specifically developed for this project (the ‘START app’) which consists of evidence-based behaviour change techniques (including goal setting, action and coping planning, self-monitoring, feed-back on goal progress) which they will be requested to use throughout the 16-week intervention. Peer leaders will also have access to this app, and will be requested to set team goals related to step counts accumulated for the whole group from weeks 1-16. Peer leaders can also note who attends the group walks in the app. Participants who do not own a mobile phone will be provided with iPads by the research team for the duration of the study.
Walkers will be requested to take part in a combination of peer-led (i.e., organised and led by the peer leader) and self-organised 20-30 minute walks over the duration of the intervention, and will get a personalised step count goal based on their baseline values. To facilitate the achievement of their goals, during the first 6 weeks, they will be asked to participate in 2 peer-led walks and 1 self-organised walks of 20-30 minutes duration (20 minutes in the first 2 weeks and 30 minutes in the next 4 weeks; participants may break these up into walks of 10 minutes duration). In weeks 7-10, group-led walks will decrease to 1 and they will be asked to also engage in 3 self-organised walks, each of 30 minutes duration. In weeks 11-16, peer-led group walks will cease to exist and self-organised walks will increase to 5 per week for 30 minutes duration (or equivalent). They will be assigned to a peer leader who will be trained in evidence-based motivational strategies designed to support the motivation of the participants in their groups. This will be complemented by access to a mobile application designed for the purpose of the study. App usage will be monitored by the research team and this will be explained to the participants. All participants (except peer leaders) will also be asked to complete online questionnaires at baseline and immediately post-intervention. A survey assessing motivation for walking will also be distributed mid-intervention (.ie., 8 weeks post commencement of the intervention). Additionally, participants’ height, weight, and waist circumference will be assessed at baseline and post-intervention. A purposive sample of approximately ten walkers and the peer leaders (depending on when data saturation is reached) will be interviewed face-to-face on an individual basis at the end of the trial exploring in more detail their perceptions of various elements of the intervention.
Intervention code [1] 301126 0
Behaviour
Intervention code [2] 301127 0
Prevention
Intervention code [3] 301128 0
Lifestyle
Comparator / control treatment
Participants in the worksites randomised to the 'minimal treatment’ condition will not have any peer leaders. They will be asked to wear a FitBit Zip device to measure step counts. They will get a generic daily step count goal to achieve a minimum of 7,500 steps per day for 16 weeks. Participants in this group will also receive general information about the health benefits of walking for health, and information about safe walking via a 1-hour introductory lunchtime session complemented by a printed leaflet which has been developed specifically for this project.
Control group
Active

Outcomes
Primary outcome [1] 305807 0
daily step counts will be retrieved via ActivPal micro devices.
Timepoint [1] 305807 0
baseline, post intervention (16 weeks)
Secondary outcome [1] 346628 0
minutes spent sitting per day assessed using ActivPal micro devices.
Timepoint [1] 346628 0
baseline, post intervention (16 weeks)
Secondary outcome [2] 346629 0
Body Mass Index (weight(kgs)/height2) and waist circumference. Weight (kgs) will be assessed via a TANITA weighing scale, height will be measured via a SECA stadiometer, and the waist circumference measure will be taken using a tape measure.
Timepoint [2] 346629 0
baseline, post intervention (16 weeks)
Secondary outcome [3] 346630 0
Job-related affect will be assessed by a questionnaire developed by Warr et al., (2014; Journal of Work and Organisational Psychology, 23, 342-363).
Timepoint [3] 346630 0
baseline, post intervention (16 weeks)
Secondary outcome [4] 346631 0
workplace stressors and appraisals will be assessed using an adapted version of Campbell and Nobel’s (2009) scale (Military Psychology, 21 (Suppl 2), S47-S67).
Timepoint [4] 346631 0
baseline, post intervention (16 weeks)
Secondary outcome [5] 346632 0
Self-reported presenteeism will be measured using Kessler et al’s (2003) brief WHO Health and Performance Questionnaire (Journal of Occupational and Environmental Medicine, 45, 156-174).
Timepoint [5] 346632 0
baseline, post intervention (16 weeks)
Secondary outcome [6] 346633 0
Absenteeism records (if permission is granted from both employer and individual employee).
Timepoint [6] 346633 0
baseline, post intervention (16 weeks)
Secondary outcome [7] 346634 0
Quality of life will be measured using the EQ-5D scale (Krabbe & Weijnen, 2003; The measurement and valuation of health status using EQ-5D. Netherlands: Springer).
Timepoint [7] 346634 0
baseline, post intervention (16 weeks)
Secondary outcome [8] 346635 0
Well-being will be assessed using the WHO Well-Being Index (Bech et al., 2003; International Journal of Methods in Psychiatry Research, 12, 85-91).
Timepoint [8] 346635 0
baseline, post intervention (16 weeks)
Secondary outcome [9] 346636 0
Psychological capital (resilience, hope, optimism and efficacy in relation to work) will be measured using the Psychological Capital Questionnaire (PCQ-12; Luthans et al., 2007; Personnel Psychology, 60, 541-572).
Timepoint [9] 346636 0
baseline, post intervention (16 weeks)
Secondary outcome [10] 346637 0
Motivation for walking will be assessed via the Behavioural Regulation in Walking Questionnaire (Niven & Markland, 2016; Psychology of Sport and Exercise, 23, 90-100).
Timepoint [10] 346637 0
baseline, mid-intervention (8 weeks post intervention commencement), post intervention (16 weeks)
Secondary outcome [11] 346640 0
Psychosocial safety climate will be assessed using Dollard and Bakker’s (2010) scale (Journal of Occupational and Organisational Psychology, 83, 579-599).
Timepoint [11] 346640 0
baseline, post intervention (16 weeks)
Secondary outcome [12] 346641 0
Mobile application evaluation (experimental condition only) will be completed using the Mobile Application Rating Scale (Stoyanov et al., 2015; JMIR MHealth UHealth, 3, e27).
Timepoint [12] 346641 0
post intervention (16 weeks)
Secondary outcome [13] 346734 0
Self-reported absenteeism will be measured using Kessler et al’s (2003) brief WHO Health and Performance Questionnaire (Journal of Occupational and Environmental Medicine, 45, 156-174).
Timepoint [13] 346734 0
baseline, post-intervention (16 weeks)
Secondary outcome [14] 346735 0
Work performance will be measured using Kessler et al’s (2003) brief WHO Health and Performance Questionnaire (Journal of Occupational and Environmental Medicine, 45, 156-174).
Timepoint [14] 346735 0
baseline, post-intervention (16 weeks)

Eligibility
Key inclusion criteria
• spend a minimum of 50% of work time sitting;
• aged 18 and over;
• can communicate well in English;
• have no chronic illness or health problem which prevent you from walking;
• can walk continuously on a flat surface at a light-to-moderate pace for fifteen minutes;
• currently take part in less than 150 minutes of moderate intensity activity per week (equivalent to walking)
• willing to download and use a mobile app designed to promote walking which is specifically developed for this project
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
150 minutes or more of moderate-to-vigorous physical activity per week, health problems precluding walking, work less than 2 days per week.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Cluster
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
As the present study is a pilot trial, the main purpose of the analyses is to develop reliable power estimates for a subsequent definitive trial. Trial feasibility will be examined through the use of descriptive statistics (quantitative data) and via inductive thematic analysis (qualitative data). Further, estimation of mean change from baseline, standard deviation of change, and effect sizes will be calculated. Furthermore, internal reliability coefficients for questionnaire data will be estimated. To analyze the qualitative interview data, we will use inductive thematic analysis outlined in Braun et al. (2013; in B. Smith & A. Sparkes, Routledge Handbook of qualitative research in sport and exercise (pp. 191-205)). Rigour of the analysis will be ensured through the development of an audit trail, discussion with ‘critical friends’ and through participant reflection as per recent recommendations proposed by Smith and McGannon (2017; International Review of Sport and Exercise Psychology; https://doi.org/10.1080/1750984X.2017.1317357).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/04/2018
Date of last participant enrolment
Anticipated
28/05/2018
Actual
Date of last data collection
Anticipated
1/10/2018
Actual
Sample size
Target
80
Accrual to date
72
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 299412 0
Charities/Societies/Foundations
Name [1] 299412 0
Cancer Council WA
Country [1] 299412 0
Australia
Funding source category [2] 299429 0
Government body
Name [2] 299429 0
Department of Health WA
Country [2] 299429 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St
Bentley
Perth
WA 6102
Country
Australia
Secondary sponsor category [1] 298715 0
None
Name [1] 298715 0
Address [1] 298715 0
Country [1] 298715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300312 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 300312 0
Ethics committee country [1] 300312 0
Australia
Date submitted for ethics approval [1] 300312 0
Approval date [1] 300312 0
09/01/2018
Ethics approval number [1] 300312 0
HRE2017-0732

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83254 0
Prof Cecilie Thogersen-Ntoumani
Address 83254 0
School of Psychology
Curtin University
Kent St
Bentley
WA 6845
Country 83254 0
Australia
Phone 83254 0
+610892665171
Fax 83254 0
Email 83254 0
[email protected]
Contact person for public queries
Name 83255 0
Cecilie Thogersen-Ntoumani
Address 83255 0
School of Psychology
Curtin University
Kent St
Bentley
WA 6845
Country 83255 0
Australia
Phone 83255 0
+610892665171
Fax 83255 0
Email 83255 0
[email protected]
Contact person for scientific queries
Name 83256 0
Cecilie Thogersen-Ntoumani
Address 83256 0
School of Psychology
Curtin University
Kent St
Bentley
WA 6845
Country 83256 0
Australia
Phone 83256 0
+610892665171
Fax 83256 0
Email 83256 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility and preliminary effects of a peer-led motivationally-embellished workplace walking intervention: A pilot cluster randomized trial (the START trial).2020https://dx.doi.org/10.1016/j.cct.2020.105969
EmbaseDevelopment and feasibility of a mobile phone application designed to support physically inactive employees to increase walking.2021https://dx.doi.org/10.1186/s12911-021-01391-3
N.B. These documents automatically identified may not have been verified by the study sponsor.