Table 1 Lifestyle Matters RCT fidelity assessment strategy (adapted from Bellg et al.[46])

Trial Design

Comparable treatment

All participants have received the same programme tailored to the needs of the group/setting.

• 16 weekly meetings will be offered to all participants with delivery of a minimum of 8.

• Four, one-to-one meetings will be offered to all participants. Uptake and attendance recorded by the facilitator.

Risk to implementation

Plan for potential issues that could affect the delivery of the Lifestyle Matters programme.

• A range of recruitment strategies will be implemented including GP mail-outs for each geographical area, referrals from health and social care, referrals from third sector and posters/leaflets.

• A pre-arranged set of days and times for weekly meetings will be offered from which participants can choose.

• Undertake three recruitment cycles in three geographically separate areas, one per cycle, to prevent saturation.

Monitoring provider training

Standardised training and facilitator skill acquisition

All facilitators receive the same training programme tailored to the group/setting.

• Observation of the training session by two researchers using a content checklist (evidence of skill transference as demonstrated through, for example, role playing activities and reflective exercises).

All facilitators understand and engage with the intervention programme training in a similar way.

• Training delivered by the same trainer.

• Manual and CD-Rom provided to all trainees.

• Completion of training exercises by facilitators.

Monitoring intervention delivery

Standardised delivery

All facilitators use the same techniques and content from the programme.

• Observation using a content checklist by two researchers.

• 75% of opportunities for completing goal setting are recorded (both for individual and group).

• Range of materials from the Lifestyle Matters programme received by all participants.

• Facilitators maintain reflective diaries.

• Weekly facilitator record from group meetings.

• Participant and facilitator semi-structured interviews.

• All participants receive certificate of attendance/achievement.

• Facilitators meet the NHS Band 4 equivalent job description.

Minimise drift in skills/delivery

Adherence to training content and delivery over the three cycles of the intervention.

• Observation using a content checklist by two researchers

• OT supervisor protocol.

• Each facilitator will attend between 8 and 16 sessions in total of which half should be delivered face-to face.

Monitoring receipt of intervention

Participant attendance and engagement

Record the numbers of participants attending the programme each week

• Registers completed by facilitators for weekly meetings and one-to-one sessions where arranged.

All participants take part in the group meetings and activities

• 75% of opportunities for completing goal setting are recorded (both for individual and group).

Impact of intervention on participant in terms of well-being

• Participant and facilitator semi-structured interviews.

• Patient Reported Outcome Measures (PROMS).