Data

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

QIMR Berghofer Medical Research Institute

Dataset description

This randomised controlled trial compared the effectiveness of two interventions to promote physical activity in adults with mental illness. The two interventions were; supervised exercise and gym membership, and motivational discussions and self-monitoring of PA using fitness trackers. The intervention duration was 16 weeks, including 8 weeks of weekly supervised group sessions, and 8 weeks of access to the gym or fitness tracker unsupervised. Participants are community-dwelling adults recruited from outpatient clinics of public mental health services. The primary outcome is physical activity adoption assessed using GENEActiv accelerometers worn continuously over 8 weeks. Secondary outcomes measured at baseline, postintervention (8 weeks) and follow-up (16 weeks), include exercise motivation, psychological distress and self-reported physical activity assessed using self-administered questionnaires and indicators of physical health measured by a researcher blinded to allocation (blood pressure, weight, waist circumference, 6 min walk test). Participant experiences will be assessed using qualitative focus groups with analysis informed by a theoretical model of behaviour (COM-B).
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Source Study

Purpose

Educational / counselling / training

Phase

Not Applicable

Funding

Charities/Societies/Foundations,Royal Brisbane Women's Hospital Foundation

Scientific enquiries

Dr Justin Chapman

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 ....
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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.

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)

Can healthy volunteers participate?

No

 

Population

Sample Size    64

Min. age    18 Years

Max. age    65 Years

Sex    Both males and females

Condition category    Mental Illness

Condition code    Mental Health

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 ....
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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 ....
Read more

Outcomes

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

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: 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)

Will individual participant data (IPD) for this trial be available?

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?

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

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au