Table 2 Feasibility outcomes and associated criteria

Process:

 Recruitment

Response to recruitment strategies

Proportion remaining interested in the study after provided study information and completing eligibility screening.

 Refusal

Total number of eligible participants declining to participate

Proportion who met eligibility criteria but did not consent to participate.

 Enrolment

Total number of participants enrolled

Enrol 50 participants in 8 months.

 Retention

Total number of participants completing the protocol

Completed protocol in 35 participants (70%). Drop-out rates reported in similar studies are ~ 30%, and sample sizes between 24 and 50 have been previously recommended for feasibility studies [22, 23].

Resources:

 Compliance with data collection protocol

Weighed food record with concurrent pain and mood measures. Sleep log. GENEActiv wear time

Complete entries for 75% of participants who complete the protocol. A complete entry will include date and time of day of each eating occasion, food, and beverage intake (food and amount), with concurrent pain VAS and mood VAS rating, completed sleep log, and at least 4 days of ~ 20 h of GENEActiv wear time.

Scientific:

 Safety

Questionnaire

Absence of adverse effects.

 Participant’s view on intervention

Exit survey

Proportion of participants reporting that self-reported data collection processes were burdensome.

Proportion of participants satisfied with study setting and procedures (responding neutral and above).

 Research identified as appropriate for the target group

Food-related behaviours questionnaire

Participant responses identify pain influences diet (proportion reporting agreement with statements).