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

Intervention

Intervention code Treatment: Other

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.
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Comparison

Control group Active

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 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.
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Outcomes

Outcome: Acceptability of the interventions assessed using semi-structured focus group interviews.
Timepoint: After the 8-week post-intervention follow-up period (i.e. at 16-weeks)

Outcome: 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: Completion of the interventions

Outcome: 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: At completion of the trial