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Trial registered on ANZCTR


Registration number
ACTRN12616001177448
Ethics application status
Approved
Date submitted
24/08/2016
Date registered
26/08/2016
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting walking, less sitting and better mental health in older adults
Scientific title
The feasibility and efficacy of an motivationally embellished intervention to increase walking, reduce sitting and improve mental health in older adults in retirement villages: The Residents in Action Trial (RiAT)
Secondary ID [1] 289997 0
None
Universal Trial Number (UTN)
Trial acronym
RiAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary 300005 0
physical inactivity 300006 0
poor mental health 300007 0
Condition category
Condition code
Public Health 299902 299902 0 0
Health promotion/education
Mental Health 299935 299935 0 0
Depression
Physical Medicine / Rehabilitation 299936 299936 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a quasi-experimental trial, consisting of four conditions: experimental with ambassadors (motivationally trained resident ambassador and motivationally trained walkers), experimental walkers only (no resident ambassadors but motivationally trained walkers), control with ambassadors (ambassadors and walkers who have not received motivational training but only general information about walking and practicalities), and control walkers only (walkers only who have only received general information about walking and practicalities). Resident ambassadors are residents in the retirement villages who are healthy and already physically active themselves and who are willing and demonstrate commitment to take on this role.
Residents from 13 retirement villages in WA (most located in the Metropolitan area of Perth) took part in the trial, specifically 3 in the experimental with ambassadors condition, 3 villages in the experimental walkers only, 3 in the control with ambassadors, and 4 in the control walkers only arm. All resident ambassadors were trained by members of the research team via a 1.5 hour face-to-face workshop on safe walking and information regarding practicalities of organising small group-led walks. This workshop consisted of training in how to lead group walks in a safe manner, what to do in case of emergencies and specify the tasks needed to coordinate and lead the group walks. The workshop consisted of practical exercises and participants received manuals with printed hand-outs to support learning.
Approximately 1.5 hours were added to the workshop for the resident ambassadors in the experimental villages to train the ambassadors in applying motivational techniques to empower their physically inactive peers to increase walking, reduce sitting and improve mental health through a combination of group-led walks, group educational sessions, and booklets incorporating key behaviour change techniques. In these workshops, the ambassadors were briefly introduced to the basic principles of the motivational framework underpinning the intervention (i.e., SDT), and were engaged in practical exercises that aimed to show how to support other residents' autonomous motivation for walking and for reducing sitting behaviours. Specifically, the different motivations underpinning engagement in these behaviours were described and illustrated. The resident ambassadors were then introduced to ways in which autonomous motivation could be supported, for example via promoting participants' feelings of competence, personal volition and choice, and feelings of connectedness with other members of the walking group. Such activities have been shown in the SDT literature to support key psychological needs and hence boost autonomous motivation. The resident ambassadors were encouraged to discuss concrete examples of how they could put these principles into practice. They were also provided with relevant examples. Resident ambassadors were trained to be supportive, encourage participants' involvement and opinions in making choices (e.g., walking routes, ways to break up sitting time), use open-ended questions, be empathetic, avoid judgemental or controlling language, provide rationales for activities, and encourage personal responsibility and initiative. Such behaviours have been associated with an "autonomy-supportive" interpersonal communication style and sustained changes in individuals' motivation and well-being. This first workshop was supplemented by a 1.5 hour booster session at the end of week 2 of the intervention to catch up on progress, trouble shoot challenges in implementing the motivation strategies and plan the tasks for the remaining part of the intervention.
All resident ambassadors were asked to lead 3 weekly group walks for 10 weeks, each lasting 20-30 minutes. Resident participants were encouraged to engage in 2 further self-organised walks per week of similar duration for 10 weeks. After 10 weeks, the resident participants were encouraged to independently organise 5 weekly 20-30 minute walks for a further 6 weeks. Resident participants received one group-taught 1-hour session delivered face to face by the research team, at the beginning of the intervention, on the benefits of walking and reducing sitting time for health, and were provided with outdoor walk route maps, and information on step counts for specific walks to destinations inside and outside the villages. The participants also received a tips sheet on ways to break up sitting time which were based on the strategies. Further, all participants were provided with log-books for the documentation of step counts on a daily basis. They were also encouraged to use a tick sheet to indicate how many times per day they took a break from sitting (when sitting more than 30 minutes). Approximately 1 hour was added to the workshop for the resident participants in the experimental conditions on motivation and self-regulation strategies, and received printed materials and activity sheets to support their learning.
Intervention code [1] 295700 0
Lifestyle
Intervention code [2] 295701 0
Behaviour
Intervention code [3] 295702 0
Prevention
Comparator / control treatment
Resident ambassadors attended a 1.5 hour safe walk leader workshop but were not motivationally trained (in contrast to the resident ambassadors in the experimental condition). The resident ambassadors led 3 weekly group walks for 10 weeks, each lasting 20-30 minutes. Resident participants were encouraged to engage in 2 further self-organised walks per week of similar duration for 10 weeks. After 10 weeks, the resident participants were encouraged to independently organise 5 weekly 20-30 minute walks for another 6 weeks. Resident participants received one group-taught 1-hour session delivered by the research team, at the beginning of the intervention, on the benefits of walking and reducing sitting time for health, and were provided with outdoor walk route maps, and information on step counts for specific walks to destinations inside and outside the villages. The participants were asked to think about ways they could break up long periods of sitting. Further, all participants were provided with log-books for the documentation of step counts on a daily basis. They were also asked to use a tick sheet to indicate how many times per day they took a break from sitting (when sitting more than 30 minutes). The resident participants in this condition did not receive any training in specific motivational and self-regulation strategies.
Control group
Active

Outcomes
Primary outcome [1] 299386 0
Step counts assessed via ActivPal micro devices.
Timepoint [1] 299386 0
baseline, 16 weeks (end of the intervention), 6 month follow-up
Secondary outcome [1] 327001 0
Self-reported physical activity will be assessed via the Physical Activity Scale for the Elderly (PASE; Washburn et al., 1993; Journal of Clinical Epidemiology, 46, 153-162)
Timepoint [1] 327001 0
baseline, 16 weeks (end of the intervention), 6-month follow-up
Secondary outcome [2] 327004 0
Perceptions of health will be measured via one item from the SF-12 (Gandek et al., 1998, Journal of Clinical Epidemiology, 51, 1171-1178)
Timepoint [2] 327004 0
baseline, 16 weeks (end of the intervention), 6-month follow-up
Secondary outcome [3] 327005 0
General functioning and quality of life will be assessed suing the Dartmouth COOP Functional Assessment Charts (Nelson et al., 1987; Journal of Chronic Disease, 40, 55S-63S).
Timepoint [3] 327005 0
baseline, 16 weeks (end of the intervention), 6-month follow-up
Secondary outcome [4] 327006 0
Depression measured by the relevant sub-scale of the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983; Acta Psychiatrica Scandinavia, 67, 361-370).
Timepoint [4] 327006 0
baseline, 16 weeks (end of the intervention), 6-month follow-up
Secondary outcome [5] 327007 0
Subjective vitality as assessed via the Subjective Vitality Scale (Rubio & Hood, 2000; Social Indicators Research, 52, 313-324).
Timepoint [5] 327007 0
baseline, 16 weeks (end of the intervention), 6-month follow-up
Secondary outcome [6] 327008 0
Loneliness will be measured using the loneliness scale developed by Hawkley et al. (2005; Psychological Science, 16, 798-804).
Timepoint [6] 327008 0
baseline, 16 weeks (end of the intervention), 6-month follow-up
Secondary outcome [7] 327131 0
Anxiety as assessed by the relevant sub-scale of the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983; Acta Psychiatrica Scandinavia, 67, 361-370).
Timepoint [7] 327131 0
baseline, 16 weeks (end of intervention), 6-month follow-up

Eligibility
Key inclusion criteria
Eligible participants will be permanent village residents, aged 60 years or over, who are able to communicate well in English, provide consent, participate in baseline assessments, have no terminal illness or health problems that prevent them from walking (we will include those who use walking sticks and walking frames), do not have a known dementia diagnosis, can walk continuously on a flat surface at a light/moderate pace for fifteen minutes, have not had two or more falls in the past 3 months, and do not currently meet the physical activity recommendations for health (150 minutes moderate intensity physical activity per week in bouts of 10 minutes or more). Participants will also be asked to complete the Physical Activity Readiness Questionnaire to ensure that there are no contraindications for walking.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Sufficiently physically active (currently meets recommendation of 150 minutes of at least moderate physical activity per week), health problems preventing walking, contraindications for walking as specified by the Physical Activity Readiness Questionnaire, dementia diagnosis

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Cluster
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main purpose of the analyses is to develop power estimates for a subsequent definitive trial. Specifically, descriptive statistics of variables, adherence to, and drop-out rates from the intervention will be calculated. Further, internal reliability coefficients for questionnaire data will be estimated. The main analyses will be conducted using multilevel modelling (also called mixed-effects modelling). Missing values will be handled based on the intention-to-treat principle. Multilevel models are superior to standard regression analyses and repeated measures ANOVAs as they can adjusts standard errors to take into account village clustering effects. Given the small sample size, between arm comparisons (significance testing) will not be undertaken. We will examine mean scores and rates of change for walking and sitting behaviours, and all mental health outcomes; we will also examine individual variation from mean trends. Perceived environmental and village characteristics (lease for life, resident funded, and subsidised tenancy) will be described but they will not be analysed as moderators of the intervention effects due to the small sample size. Confidence intervals of outcome variability and effect sizes will be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2016
Actual
9/09/2016
Date of last participant enrolment
Anticipated
31/01/2017
Actual
10/11/2017
Date of last data collection
Anticipated
28/02/2018
Actual
3/08/2018
Sample size
Target
210
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294368 0
Government body
Name [1] 294368 0
Western Australian Health Promotion Foundation (Healthway)
Country [1] 294368 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street
Bentley
Perth
WA 6102
Country
Australia
Secondary sponsor category [1] 293211 0
None
Name [1] 293211 0
Address [1] 293211 0
Country [1] 293211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295785 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 295785 0
Ethics committee country [1] 295785 0
Australia
Date submitted for ethics approval [1] 295785 0
30/05/2016
Approval date [1] 295785 0
10/08/2016
Ethics approval number [1] 295785 0
HRE2016-0187

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

Contacts
Principal investigator
Name 68482 0
Prof Cecilie Thogersen-Ntoumani
Address 68482 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
Western Australia 6845
Australia
Country 68482 0
Australia
Phone 68482 0
+61 (0) 8 92 66 5171
Fax 68482 0
Email 68482 0
C.Thogersen@curtin.edu.au
Contact person for public queries
Name 68483 0
Cecilie Thogersen-Ntoumani
Address 68483 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
Western Australia 6845
Australia
Country 68483 0
Australia
Phone 68483 0
+61 (0) 8 92 66 5171
Fax 68483 0
Email 68483 0
C.Thogersen@curtin.edu.au
Contact person for scientific queries
Name 68484 0
Cecilie Thogersen-Ntoumani
Address 68484 0
School of Psychology
Curtin University
GPO Box U1987
Perth
WA6845
Australia
Country 68484 0
Australia
Phone 68484 0
+61 (0) 8 92 66 5171
Fax 68484 0
Email 68484 0
C.Thogersen@curtin.edu.au

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
EmbaseProtocol for the residents in action pilot cluster randomised controlled trial (RiAT): Evaluating a behaviour change intervention to promote walking, reduce sitting and improve mental health in physically inactive older adults in retirement villages.2017https://dx.doi.org/10.1136/bmjopen-2016-015543
N.B. These documents automatically identified may not have been verified by the study sponsor.