Analysis

The feasibility outcomes of recruitment rate, retention rate, adverse events, compliance and acceptability will be reported using a descriptive approach with 95% confidence intervals for any estimates. The qualitative data regarding acceptability will be subjected to, thematic analysis following Braun and Clarke’s (2006) guidelines. To prevent potential coding bias, the researcher conducting the semi-structured interview will not participate in the coding. The final coding structure will be validated with the remaining members of the research team.

Clinical outcomes will be reported as means, standard deviations and ranges for all outcome measures at T1–T4, with between-group differences analysed using a repeated measures analysis of variance (MANOVA). Due to the underpowered nature of the pilot trial, these results will focus on point estimates and associated 95% confidence intervals as opposed to significance testing, to explore potential efficacy of the program. Missing data will be dealt with by adopting appropriate imputation procedures which will include mean or last observation carried forward.