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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]

nil

Universal Trial Number (UTN)

U1111-1198-9640

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mental Illness

Condition category

Condition code

Mental Health

Depression

Mental Health

Schizophrenia

Mental Health

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]

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]

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]

At completion of the trial

Primary outcome [2]

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]

Completion of the interventions

Primary outcome [3]

Acceptability of the interventions assessed using semi-structured focus group interviews.

Timepoint [3]

After the 8-week post-intervention follow-up period (i.e. at 16-weeks)

Secondary outcome [1]

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]

Physical activity will be measured at baseline and throughout the 8-week intervention.

Secondary outcome [2]

General psychological distress assessed using the Kessler-6 scale

Timepoint [2]

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]

Physical capacity measured using 6-minute walk test

Timepoint [3]

The 6-minute walk test will be completed at baseline and post-intervention (8-weeks).

Secondary outcome [4]

Waist circumference measured using a tape measure

Timepoint [4]

Waist circumference will be measured at baseline and post-intervention (8-weeks).

Secondary outcome [5]

Sleep quality measured using self-administered questionnaire (PSQI)

Timepoint [5]

Sleep quality will be measured at baseline and post-intervention (8-weeks).

Secondary outcome [6]

body mass index calculated as weight (kg) / height (cm) squared. Weight measured using electronic scales, height measured using stadiometer

Timepoint [6]

BMI will be measured at baseline and post-intervention (8-weeks).

Secondary outcome [7]

Resting blood pressure measured using digital sphygmomanometer

Timepoint [7]

Resting blood pressure will be measured at baseline and post-intervention (8-weeks).

Secondary outcome [8]

The Behavioural Regulation In Exercise Questionnaire (BREQ-3). The BREQ enquires about participants' exercise motivations.

Timepoint [8]

The BREQ will completed at baseline, post-intervention (8-weeks), and follow-up (16-weeks).

Secondary outcome [9]

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]

The SIMPAQ will be completed at Baseline, Post-intervention (8-weeks), then post-follow-up (16-weeks).

Secondary outcome [10]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [2]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [3]

Logan Hospital - Meadowbrook

Recruitment postcode(s) [1]

4029 - Herston

Recruitment postcode(s) [2]

4102 - Woolloongabba

Recruitment postcode(s) [3]

4131 - Meadowbrook

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Brisbane Women's Hospital Foundation

Address [1]

Block 20 Royal Brisbane and Women’s Hospital, Butterfield St, Herston QLD 4006

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Study, Education and Research Trust Account (SERTA)

Address [2]

Metro South Addiction and Mental Health Service
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba, QLD
postcode: 4102

Country [2]

Australia

Primary sponsor type

Other

Name

QIMR Berghofer Medical Research Institute

Address

300 Herston rd. Herston, Queensland, 4006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield Street
Herston, Qld, 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/05/2017

Approval date [1]

25/07/2017

Ethics approval number [1]

HREC/17/QRBW/302

Summary

Brief summary

This pilot study will be a randomised controlled trial of two physical activity (PA) interventions for adults with mental illness: i) PA self-monitoring using technology (wrist-worn Garmin Vivofits, which provide real-time feedback on the face of the device), and ii) supervised exercise intervention at a community gym. As a pilot study, the primary outcomes will be 1) feasibility of the trial, and 2) feasibility and acceptability of the interventions. Secondary outcomes will be the impact on PA behaviour change (assessed using accelerometers and self-report questionnaires), PA motivations, physical health (weight, waist, blood pressure) and psychosocial wellbeing (self-reported sleep quality and psychological distress). 

The interlinked aims of this pilot study are to: 
i)	Assess the feasibility of the trial
ii)	Assess the feasibility and acceptability of the PA interventions
iii)	Compare the change in PA participation in response to interventions that either promote PA motivation, or provide PA opportunity. 

Additional aims are to assess: 
i)	The utility of the 6-min walk test, wrist-worn accelerometry, and questionnaires on physical activity, sedentary behaviour and sleep.
ii)	The impact of the intervention on mental and physical health. 

It is hypothesised that: 
i)	The trial will be feasible to conduct on a larger scale. 
ii)	The PA interventions will be feasible to implement in the mental health service
iii)	There will be a qualitative difference in the acceptability of the interventions, dependent upon how they influence capability, opportunity and motivation to promote behaviour change. 

Inclusion criteria: 
i)	Current adult consumer of Metro North Mental Health Services and Metro South Addictions and Mental Health Services (other than acute care teams) 
ii)	Aged 18-65 years
iii)	Willingness to provide written informed consent.
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)

Trial website

Trial related presentations / publications

A protocol paper has been published outlining the intervention protocol in greater detail.
https://bmjopen.bmj.com/content/8/9/e023460
Citation: Chapman 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-2018-023460

Public notes

Attachments [1]

/AnzctrAttachments/373268-3a. HREC approval 17-302 signed.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/373268-Chapman_2018_protocol paper RCT.pdf (Publication)

Contacts

Principal investigator

Name

Dr Justin Chapman

Address

QIMR Berghofer
300 Herston rd. Herston, Queensland, 4006

Country

Australia

Phone

+61432299240

Fax

justin.chapman@qimrberghofer.edu.au

Contact person for public queries

Name

Justin Chapman

Address

QIMR Berghofer
300 Herston rd. Herston, Queensland, 4006

Country

Australia

Phone

+61432299240

Fax

justin.chapman@qimrberghofer.edu.au

Contact person for scientific queries

Name

Justin Chapman

Address

QIMR Berghofer
300 Herston rd. Herston, Queensland, 4006

Country

Australia

Phone

+61432299240

Fax

justin.chapman@qimrberghofer.edu.au

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.	Type	Citation	Link	Other Details	Attachment
4525	Study protocol	Chapman 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-2018-023460	https://bmjopen.bmj.com/content/8/9/e023460		373268-(Uploaded-04-09-2019-10-41-06)-Study-related document.pdf
4526	Ethical approval			RBWH HREC Study approval 25/07/2019	373268-(Uploaded-11-09-2019-09-43-26)-Study-related document.pdf
4527	Informed consent form			Information Sheet and Informed Consent Version 5 (... [More Details]	373268-(Uploaded-04-09-2019-10-49-53)-Study-related document.docx
20693	Data dictionary				373268-(Uploaded-31-08-2023-15-08-16)-Study-related document.xlsx
20694	Other			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

Source	Title	Year of Publication	DOI
Embase	A comparison study of three physical activity measurement tools examining acceptability in people with psychosis.	2020	https://dx.doi.org/10.1177/1039856219881957

N.B. These documents automatically identified may not have been verified by the study sponsor.

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