Table 1 Progression criteria from feasibility to full randomised controlled trial [15]
Progression criterion | Method of assessment |
|---|---|
1. Are appropriate and effective routes of recruitment available to achieve a powered sample size in a full trial? | − Coming close to the sample size, as judged by the Trial Steering Committee, with reasonable expectations of being able to address any recruitment issues |
2. Are participants willing to be randomised to the intervention? | − Recruitment experiences of the study team and fieldworkers − Insight from qualitative interviews with participants |
3. Are appropriate retention rates achieved at 12-month follow-up? | − Measured using the following scale in both the intervention and control group at 12-months: If ≥ 70% followed-up proceed; if 50–69% followed-up discuss with Trial Steering Committee; if ≤ 49% followed-up do not proceed |
4. Is the intervention feasible to deliver and acceptable to participants and their helpers? | − USE questionnaire − Participant/helper interviews |
5. Do the majority (> 50%) of participants within the intervention group visit the app at least twice OR do 25% of participants randomised use it three or more times? | − App usage statistics |
6. Are identified barriers and challenges to implementation of the intervention planned for and surmountable? | − Process evaluation which will present a SWOT analysis and action plan |
7. Do the data collection procedures effectively collect the data required for a full trial? Successful completion of at least one data collection outcome measure (BMI, physical activity or healthy eating) at both baseline and at 12 months in those retained measured using the following scale: | − If > 90% of at least one data collection measure completed proceed; − If 70–89% of at least one data collection measure completed discuss strategies for improvement in future trial with Trial Steering Committee; − If < 70% of all three data collection measures completed do not proceed without further modification and pilot |
8. Are the intervention costs of a full trial covered? | − Identification of a source to pay access and treatment costs |