Table 2.
Criterion | Achieved | Proceed | Proceed with amendments | |
Eligibility | ||||
Number of eligible participants | 2–3 per site, per month, totalling 6–9 per month | 63 participants screened in 7 months accounting for lockdowns and community restrictions in Melbourne (13 months elapsed) | Yes* | Strategies to identify more eligible participants. |
Recruitment | ||||
Number of participants recruited | 2 participants per month, per site, totalling 6 participants per month | 32 participants recruited over 7 months (13 months elapsed) | No | Strategies to increase recruitment rate. |
Adherence | ||||
Adherence to motivational interviewing sessions | Minimum 4/5 sessions (80%) | 100% of motivational interviewing sessions were attended within 1 week of scheduled session time | Yes | – |
ActivPAL | ||||
ActivPAL wear time | >16 hours for 7 days | Malfunctioning ActivPAL uploads resulted in 3 missing ActivPAL files. | Yes | – |
Drop-outs | ||||
Drop-out rate | <20% | 2 drop-outs (6%), both from the control group | Yes | – |
*Proceed with protocol deviation to expand the number of recruitment sites.