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Trialling the feasibility and acceptability of physical activity self-monitoring and supervised exercise interventions for adults with mental illness

Trialling the feasibility and acceptability of physical activity self-monitoring and supervised exercise interventions for adults with mental illness

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001017314
Enrollment
64
Registered
2017-07-14
Start date
2017-11-16
Completion date
2019-11-01
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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)

Interventions

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 th

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.

Sponsors

QIMR Berghofer Medical Research Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026