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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
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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)
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Secondary ID [1]
289997
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None
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Universal Trial Number (UTN)
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Trial acronym
RiAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
sedentary
300005
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physical inactivity
300006
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poor mental health
300007
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Condition category
Condition code
Public Health
299902
299902
0
0
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Health promotion/education
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Mental Health
299935
299935
0
0
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Depression
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Physical Medicine / Rehabilitation
299936
299936
0
0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
295700
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Lifestyle
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Intervention code [2]
295701
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Behaviour
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Intervention code [3]
295702
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
299386
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Step counts assessed via ActivPal micro devices.
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Assessment method [1]
299386
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Timepoint [1]
299386
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baseline, 16 weeks (end of the intervention), 6 month follow-up
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Secondary outcome [1]
327001
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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)
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Assessment method [1]
327001
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Timepoint [1]
327001
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baseline, 16 weeks (end of the intervention), 6-month follow-up
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Secondary outcome [2]
327004
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Perceptions of health will be measured via one item from the SF-12 (Gandek et al., 1998, Journal of Clinical Epidemiology, 51, 1171-1178)
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Assessment method [2]
327004
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Timepoint [2]
327004
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baseline, 16 weeks (end of the intervention), 6-month follow-up
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Secondary outcome [3]
327005
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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).
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Assessment method [3]
327005
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Timepoint [3]
327005
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baseline, 16 weeks (end of the intervention), 6-month follow-up
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Secondary outcome [4]
327006
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Depression measured by the relevant sub-scale of the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983; Acta Psychiatrica Scandinavia, 67, 361-370).
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Assessment method [4]
327006
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Timepoint [4]
327006
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baseline, 16 weeks (end of the intervention), 6-month follow-up
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Secondary outcome [5]
327007
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Subjective vitality as assessed via the Subjective Vitality Scale (Rubio & Hood, 2000; Social Indicators Research, 52, 313-324).
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Assessment method [5]
327007
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Timepoint [5]
327007
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baseline, 16 weeks (end of the intervention), 6-month follow-up
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Secondary outcome [6]
327008
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Loneliness will be measured using the loneliness scale developed by Hawkley et al. (2005; Psychological Science, 16, 798-804).
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Assessment method [6]
327008
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Timepoint [6]
327008
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baseline, 16 weeks (end of the intervention), 6-month follow-up
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Secondary outcome [7]
327131
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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).
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Assessment method [7]
327131
0
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Timepoint [7]
327131
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baseline, 16 weeks (end of intervention), 6-month follow-up
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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.
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
Cluster
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
9/09/2016
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Actual
9/09/2016
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Date of last participant enrolment
Anticipated
31/01/2017
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Actual
10/11/2017
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Date of last data collection
Anticipated
28/02/2018
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Actual
3/08/2018
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Sample size
Target
210
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Accrual to date
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Final
112
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
294368
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Government body
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Name [1]
294368
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Western Australian Health Promotion Foundation (Healthway)
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Address [1]
294368
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PO Box 1284
West Perth
WA 6872
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Country [1]
294368
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
Kent Street
Bentley
Perth
WA 6102
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Country
Australia
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Secondary sponsor category [1]
293211
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None
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Name [1]
293211
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Address [1]
293211
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Country [1]
293211
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295785
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Curtin University Human Research Ethics Committee
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Ethics committee address [1]
295785
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Curtin University Office of Research and Development GPO Box U1987 Perth Western Australia 6845
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Ethics committee country [1]
295785
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Australia
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Date submitted for ethics approval [1]
295785
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30/05/2016
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Approval date [1]
295785
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10/08/2016
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Ethics approval number [1]
295785
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HRE2016-0187
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Summary
Brief summary
Ageing Australians represent a growing proportion of the total population and retirement villages are becoming an increasingly popular residential option for older adults. Although initiatives designed to increase activity among residents are widely available in these settings, their uptake is limited and their sustainability unknown. There is an urgent need to identify effective, sustainable strategies that can serve to increase physical activity, reduce sitting, and improve mental health. We will examine whether a 16-week programme using well-established motivational techniques, will result in sustainable increases in walking, reduced sitting time and improved mental health in older adults (minimum 60 years old) residing in retirement villages in Western Australia. The program will use motivational strategies for which the research team is particularly expert and has successfully used in previously funded research. To make the intervention relevant to the target population, we have also conducted extensive interviews with residents and managers in retirement villages in preparation for this proposal. The results of these interviews have been used to adapt the program to the needs of the target group. It is expected that participants who are allocated to the treatment with trained walk ambassadors and who have received motivation training will show greater (sustained) increases in walking, reductions in sitting and larger improvements in mental health than the other conditions Residents allocated to the experimental with ambassadors group to one group will take part in a combination of 16 weeks of group-led and individual walks facilitated by motivationally trained resident ambassadors. Residents will also be taught motivation skills they can use to help them change and sustain a physically active lifestyle in the longer-term without the help of the resident ambassadors. The experimental walkers only group will also be taught motivation skills but will not have resident ambassadors. Participants in the control with ambassadors group will also be encouraged to engage in group and individual walks, but their resident ambassadors will not be trained in motivational techniques. The final group will not have ambassadors assigned to them. Changes in walking and sitting behaviour, and as a consequence, changes in mental health, will be examined. The effects of the surrounding physical environment (e.g., perceived safety, safety from traffic and proximity to amenities) will also be explored. This is a motivation-enhancing programme which has the potential to eventually be rolled out across various types of accommodation for older adults.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
68482
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Prof Cecilie Thogersen-Ntoumani
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Address
68482
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School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
Western Australia 6845
Australia
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Country
68482
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Australia
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Phone
68482
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+61 (0) 8 92 66 5171
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Fax
68482
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Email
68482
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[email protected]
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Contact person for public queries
Name
68483
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Cecilie Thogersen-Ntoumani
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Address
68483
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School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
Western Australia 6845
Australia
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Country
68483
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Australia
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Phone
68483
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+61 (0) 8 92 66 5171
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Fax
68483
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Email
68483
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[email protected]
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Contact person for scientific queries
Name
68484
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Cecilie Thogersen-Ntoumani
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Address
68484
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School of Psychology
Curtin University
GPO Box U1987
Perth
WA6845
Australia
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Country
68484
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Australia
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Phone
68484
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+61 (0) 8 92 66 5171
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Fax
68484
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Email
68484
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Protocol 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.
2017
https://dx.doi.org/10.1136/bmjopen-2016-015543
N.B. These documents automatically identified may not have been verified by the study sponsor.
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