Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001017314
Ethics application status
Approved
Date submitted
9/07/2017
Date registered
14/07/2017
Date last updated
19/10/2023
Date data sharing statement initially provided
12/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Trialling the feasibility and acceptability of physical activity self-monitoring and supervised exercise interventions for adults with mental illness
Scientific title
Trialling the feasibility and acceptability of physical activity self-monitoring and supervised exercise interventions for adults with mental illness
Secondary ID [1] 292381 0
nil
Universal Trial Number (UTN)
U1111-1198-9640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Illness 303943 0
Condition category
Condition code
Mental Health 303298 303298 0 0
Depression
Mental Health 303299 303299 0 0
Schizophrenia
Mental Health 303300 303300 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two-arm, parallel, randomised controlled trial with active control. This is a pilot study of physical activity (PA) behaviour change interventions with adults with mental illness. The study conditions will be: (1) Motivational intervention (MOT), and (2) Opportunity intervention (OPP). The MOT intervention will be considered the 'treatment', and the OPP intervention will be considered the 'comparator'. Details that are identical for both interventions are outlined below, followed by the MOT intervention's unique characteristics:

-Location: Both interventions will involve attending a Police-Citizens Youth Club gym facility in metro north or metro south regions of Brisbane, Australia (Lang Park, Fortitude Valley, Logan).
-Mode: Both interventions will be delivered face-to-face by a researcher (qualification: a tertiary qualification in a health related field) and an exercise physiologist (tertiary qualification in exercise physiology, current first aid), in groups of up to 10 participants.
-Duration: Both interventions are delivered once/week for eight (8) weeks (total of eight contact sessions). Group sessions are 1-hr in duration (total eight hours of intervention-related contact time). Participants will be followed-up 8-weeks post-intervention (i.e. they will be reassessed on study outcomes over eight weeks after the face-to-face intervention ceases).
-Adherence: As a pilot study, intervention adherence will be assessed as attendance to the sessions (recorded by the research assistant).

The study interventions will differ in content, and in the targeted mechanisms of behaviour change.
1) MOT: Motivation to increase PA will be provided through i) external feedback about PA participation from an electronic PA monitoring device (Garmin Vivofit 3; https://buy.garmin.com/en-AU/AU/p/539963) which provides real-time feedback about daily PA on the face of the device (e.g. step count, ‘Intensity Minutes’); and ii) structured, facilitated group discussions about individual PA goals, strategies for overcoming barriers, and available community opportunities (e.g. walking groups etc). Participants will be informed (verbally and in print) about the National PA guidelines of 150-300 minutes/week of moderate-to-vigorous physical activity (MVPA), and encouraged to work towards meeting the guidelines. The Garmin Vivofits will be password protected so that detailed data about weekly PA intensity, sleep quality, step count, etc. can only be downloaded at group sessions (therefore normalising participant interaction with the device; e.g. not all participants may have smartphones/computers that would allow access to more detailed feedback outside the facilitated sessions). Participants will be asked to record physical activity in a diary that will be supplied to each participant. Participants will keep Garmin Vivofits for 8-weeks after the intervention for follow-up assessment to provide continued external feedback absent of the facilitation and group support.
-The MOT intervention has a personalised component: Participants will be asked to record personal physical activity goals in week 1, and to think about strategies for reaching goals. Participants will be informed about existing community-based physical activity programs, and asked to identify any that they would like to attend, and to develop an action plan to attend (e.g. planning transport). Participants will be asked each week about their goal progression, barriers that they face to becoming physically active, and ways to work around barriers. This will be done at the face-to-face group intervention sessions, following the supplied study diaries.
Intervention code [1] 298559 0
Treatment: Other
Comparator / control treatment
This is a two-arm, parallel, randomised controlled trial with active control. This is a pilot study of physical activity (PA) behaviour change interventions with adults with mental illness. The study conditions will be: (1) Motivational intervention (MOT), and (2) Opportunity intervention (OPP). The MOT intervention will be considered the 'treatment', and the OPP intervention will be considered the 'comparator'. Details that are identical for both interventions are outlined below, followed by the OPP intervention's unique characteristics:

-Location: Both interventions will involve attending a Police-Citizens Youth Club gym facility in metro north or metro south regions of Brisbane, Australia (Lang Park, Fortitude Valley, Logan).
-Mode: Both interventions will be delivered face-to-face by a research assistant (qualification: Master of Philosophy in healthcare and health outcomes for people with intellectual disability) and an exercise physiologist (tertiary qualification in exercise physiology, current first aid), in groups of up to 10 participants.
-Duration: Both interventions are delivered once/week for eight (8) weeks (total of eight contact sessions). Group sessions are 1-hr in duration (total eight hours of intervention-related contact time). Participants will be followed-up 8-weeks post-intervention (i.e. they will be reassessed on study outcomes over eight weeks after the face-to-face intervention ceases).
-Adherence: As a pilot study, intervention adherence will be assessed as attendance to the sessions (recorded by the research assistant).

The study interventions will differ in content, and in the targeted mechanisms of behaviour change.
2) OPP: Opportunity to increase PA will be provided through i) local gym membership, and ii) supervised exercise instruction sessions designed to increase gym confidence and exercise knowledge. Participants will be informed about the National PA guidelines of 150-300 minutes/week of MVPA (verbally and in print), but will not be encouraged to meet guidelines, as in MOT. The exercise type will be heart-rate based aerobic exercise, combined with simple resistance exercises that follow an educational program that focuses on proper equipment use (outlined in supplied participant diaries). Participants will be provided heart rate monitors to use while attending the gym sessions. Participant gym memberships will be valid for 8-weeks after the supervised period to enable continued attendance absent of the supervision and group support. The exercise physiologist will provide educational instruction only, i.e. they will not engage in motivational or goal setting discussion.
-The OPP intervention has a personalised component: Participants do not have to follow the exact exercise program set out in the participant diaries if they do not want to. The intervention is about improving exercise knowledge and gym confidence - not about prescribing an exercise protocol. Participants may be limited by previous injuries (e.g. can't do squats because of knee pain), and the exercise physiologist will take this into account when showing participants exercises. Participants can also request to do specific exercises if they have a preference, and the exercise physiologist will help them and give advice on how to exercise correctly. This will be done in the face-to-face group sessions.
Control group
Active

Outcomes
Primary outcome [1] 302688 0
Feasibility of the trial methods will be assessed using recruitment numbers, rate of recruitment, trial costs (e.g. equipment, staff time), completion of research measures, safety (adverse events related or unrelated to the intervention) and reasons for withdrawal from the study.
Timepoint [1] 302688 0
At completion of the trial
Primary outcome [2] 302689 0
Feasibility of the interventions assessed using uptake of, and adherence to, the intervention (e.g. attendance), completion rate, and reasons for withdrawal from the programs.
Timepoint [2] 302689 0
Completion of the interventions
Primary outcome [3] 302690 0
Acceptability of the interventions assessed using semi-structured focus group interviews.
Timepoint [3] 302690 0
After the 8-week post-intervention follow-up period (i.e. at 16-weeks)
Secondary outcome [1] 336753 0
Physical activity will be objectively measured using GENEActiv ‘Original’ wrist-worn accelerometers (https://www.geneactiv.org/products/compare-products/). These monitors measure bodily acceleration, which can be converted into an estimate of physical activity and sleep quality.
Timepoint [1] 336753 0
Physical activity will be measured at baseline and throughout the 8-week intervention.
Secondary outcome [2] 336754 0
General psychological distress assessed using the Kessler-6 scale
Timepoint [2] 336754 0
The Kessler-6 scale will be completed at baseline, weekly during the intervention, post-intervention (8-weeks), and follow-up (16-weeks).
Secondary outcome [3] 336755 0
Physical capacity measured using 6-minute walk test
Timepoint [3] 336755 0
The 6-minute walk test will be completed at baseline and post-intervention (8-weeks).
Secondary outcome [4] 336756 0
Waist circumference measured using a tape measure
Timepoint [4] 336756 0
Waist circumference will be measured at baseline and post-intervention (8-weeks).
Secondary outcome [5] 336757 0
Sleep quality measured using self-administered questionnaire (PSQI)
Timepoint [5] 336757 0
Sleep quality will be measured at baseline and post-intervention (8-weeks).
Secondary outcome [6] 336874 0
body mass index calculated as weight (kg) / height (cm) squared. Weight measured using electronic scales, height measured using stadiometer
Timepoint [6] 336874 0
BMI will be measured at baseline and post-intervention (8-weeks).
Secondary outcome [7] 336875 0
Resting blood pressure measured using digital sphygmomanometer
Timepoint [7] 336875 0
Resting blood pressure will be measured at baseline and post-intervention (8-weeks).
Secondary outcome [8] 344301 0
The Behavioural Regulation In Exercise Questionnaire (BREQ-3). The BREQ enquires about participants' exercise motivations.
Timepoint [8] 344301 0
The BREQ will completed at baseline, post-intervention (8-weeks), and follow-up (16-weeks).
Secondary outcome [9] 344302 0
The SIMple Physical Activity Questionnaire (SIMPAQ). The SIMPAQ is a self-administered physical activity questionnaire which assesses sleep, sedentary time, and physical activity across the domains of leisure time, domestic, work and transport.
Timepoint [9] 344302 0
The SIMPAQ will be completed at Baseline, Post-intervention (8-weeks), then post-follow-up (16-weeks).
Secondary outcome [10] 352440 0
Questionnaire about physical activity intentions, attitudes and habit formation

This questionnaire has been developed by the investigators for this study; however, it is based on existing questionnaires. Physical activity and motivation is measured using items from the self-report automaticity index and investigator-developed items about intentions and attitudes.
Timepoint [10] 352440 0
Each week of the intervention (weekly, for 8 weeks)

Eligibility
Key inclusion criteria
i) Current adult consumer of Metro North Mental Health Services, and Metro South Addiction and Mental Health Services (other than acute care teams)
ii) Aged 18-65 years
iii) Willingness to provide written informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Diagnosed with an eating disorder (assessed by referring clinician)
ii) Identification of medical risk factors on the Adult Pre-exercise Screening Tool, and NOT cleared to participate by a medical professional
iii) Physically active, defined as more than 300 minutes/week of self-reported moderate-to-vigorous PA (assessed using the Active Australia questionnaire)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed: allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
-Primary outcomes of this pilot study are feasibility and acceptability: Intervention acceptability will be assessed qualitatively (focus groups); procedural statistics (e.g. recruitment, staff and equipment costs, attendance, withdrawal rates) will be used to assess feasibility of the trial and interventions. These analyses will be predominantly descriptive. Comparisons of feasibility of each intervention group will be performed between conditions (e.g. t-test of attendance rates). Feasibility of the PA assessments will be assessed using data management statistics, such as the number of valid days of wearing the accelerometer, and potentially over-reported PA values (identified using the data management protocol of the questionnaire). Acceptability will be assessed by asking participants to rate the perceived ease/difficulty of completing the measures on a 7-point Likert scale; results will be ranked to determine the most acceptable research measures.

-Secondary outcomes: Physical activity adoption will be assessed by converting GENEActiv accelerometer data into time spent in sleep, sedentary behaviour, light activity and moderate-to-vigorous activity (MVPA), using validated thresholds and algorithms. Minutes spent in MVPA (continuous variable), and the proportion of participants meeting PA guidelines (150 minutes/week of MVPA), will be compared between conditions for each week of monitor wear. Simple regression will be performed with PA adoption as DV, and psychological distress and stage of change as IVs. To assess the intervention impact on physical and mental health, the percentage change in K6 score, sleep quality, functional capacity (6MWT distance), weight, and waist circumference will be compared between conditions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/08/2017
Actual
16/11/2017
Date of last participant enrolment
Anticipated
1/03/2020
Actual
1/11/2019
Date of last data collection
Anticipated
1/07/2020
Actual
31/12/2019
Sample size
Target
60
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8497 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 12057 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 12058 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 16583 0
4029 - Herston
Recruitment postcode(s) [2] 24214 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 24215 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 296934 0
Charities/Societies/Foundations
Name [1] 296934 0
Royal Brisbane Women's Hospital Foundation
Country [1] 296934 0
Australia
Funding source category [2] 298955 0
Government body
Name [2] 298955 0
Study, Education and Research Trust Account (SERTA)
Country [2] 298955 0
Australia
Primary sponsor type
Other
Name
QIMR Berghofer Medical Research Institute
Address
300 Herston rd. Herston, Queensland, 4006
Country
Australia
Secondary sponsor category [1] 295985 0
None
Name [1] 295985 0
Address [1] 295985 0
Country [1] 295985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298140 0
Royal Brisbane Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 298140 0
Ethics committee country [1] 298140 0
Australia
Date submitted for ethics approval [1] 298140 0
28/05/2017
Approval date [1] 298140 0
25/07/2017
Ethics approval number [1] 298140 0
HREC/17/QRBW/302

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1917 1917 0 0
/AnzctrAttachments/373268-3a. HREC approval 17-302 signed.pdf (Ethics approval)
Attachments [2] 3129 3129 0 0
/AnzctrAttachments/373268-Chapman_2018_protocol paper RCT.pdf (Publication)

Contacts
Principal investigator
Name 76130 0
Dr Justin Chapman
Address 76130 0
QIMR Berghofer
300 Herston rd. Herston, Queensland, 4006
Country 76130 0
Australia
Phone 76130 0
+61432299240
Fax 76130 0
Email 76130 0
[email protected]
Contact person for public queries
Name 76131 0
Justin Chapman
Address 76131 0
QIMR Berghofer
300 Herston rd. Herston, Queensland, 4006
Country 76131 0
Australia
Phone 76131 0
+61432299240
Fax 76131 0
Email 76131 0
[email protected]
Contact person for scientific queries
Name 76132 0
Justin Chapman
Address 76132 0
QIMR Berghofer
300 Herston rd. Herston, Queensland, 4006
Country 76132 0
Australia
Phone 76132 0
+61432299240
Fax 76132 0
Email 76132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant data supporting the publication result and participant data relating to primary outcomes
When will data be available (start and end dates)?
Data may be available straight after publication with no end date.
Available to whom?
Data are potentially available to:
- Researchers from not-for-profit organisations

Based in:
- Any location

Further information:
All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see our data sharing policy attached.
Available for what types of analyses?
Individual de-identified participant data may be available for meta-analysis or systematic review, assessed on a case-by-case basis
How or where can data be obtained?
As of 1st July 2023, access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial.
For further information, see our data sharing policy attached.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4525Study protocolChapman JJ, Suetani S, Siskind D, et al Protocol for a randomised controlled trial of interventions to promote adoption and maintenance of physical activity in adults with mental illness BMJ Open 2018;8:e023460. doi: 10.1136/bmjopen-2018-023460https://bmjopen.bmj.com/content/8/9/e023460  373268-(Uploaded-04-09-2019-10-41-06)-Study-related document.pdf
4526Ethical approval    RBWH HREC Study approval 25/07/2019 373268-(Uploaded-11-09-2019-09-43-26)-Study-related document.pdf
4527Informed consent form    Information Sheet and Informed Consent Version 5 (... [More Details] 373268-(Uploaded-04-09-2019-10-49-53)-Study-related document.docx
20693Data dictionary    373268-(Uploaded-31-08-2023-15-08-16)-Study-related document.xlsx
20694Other    Data management policy for QIMR Berghofer provided 373268-(Uploaded-31-08-2023-15-07-56)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA comparison study of three physical activity measurement tools examining acceptability in people with psychosis.2020https://dx.doi.org/10.1177/1039856219881957
N.B. These documents automatically identified may not have been verified by the study sponsor.