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Table 5 Summary of strategies intended to ensure fidelity of the STEPWISE programme

From: STructured lifestyle education for people WIth SchizophrEnia (STEPWISE): mixed methods process evaluation of a group-based lifestyle education programme to support weight loss in people with schizophrenia

Fidelity Components
DesignTrainingDeliveryReceiptEnactment
• Theory based intervention with treatment dose (i.e. number, frequency and duration of sessions) specified in the protocol.
• Protocol deviations recorded.
• Risks to implementation were mitigated by: 1) piloting the programme in one Trust prior to the RCT; 2) setting a minimum for the number (n = 4) of facilitators per Trust; and, 3) the tracking of trained staff availability and attrition.
• Written materials and facilitator training were standardised across providers; and, intended delivery style was modelled by expert trainers.
• Facilitators used role play to test skills and, reflected on their own performance and skill acquisition and made changes (as required).
• Optimum skillset for the role (including one of two having clinical skills) defined for providers.
• Level of education and experience of physical and/or mental health and group work captured.
• Peer support available during delivery.
• Service user feedback after sessions, semi-structured interview (after foundation course) and facilitator observations informed on the credibility of facilitators, non-specific treatment effects and differences across providers.
• Training materials, including resource lists, supported standardisation across providers.
• Adherence was monitored via recording attendance, facilitator self-reflection and direct observation of content and delivery; local coordination and monitoring by providers; and, facilitator and service user interviews.
• Contamination (of trial arms) was minimised by standardised study design training and on the ground instructions, regular supervision and on-site and remote monitoring.
• Service users invited to participate in sessions (e.g. discuss answers to questions with others); and, facilitators used scripted summaries to aid understanding and check comprehension.
• To ensure ability to use cognitive skills (e.g. goal setting and monitoring progress) and perform behaviour skills (e.g. identify and manage triggers), sessions encouraged identification of (and ways to overcome) obstacles; and, per-session (and overall) feedback was invited. Self-monitoring was encouraged and 1:1 support was provided by facilitators.
• Interviews invited feedback on the purpose of the intervention and experiences (skills, behaviours, goals); and explored learning and use (or not) of skills by service users and facilitators (self-report).
• Adherence (frequency and duration) of sessions delivered was monitored.
• Booster and telephone support maintained for 12 months.
Fidelity goals not monitored (or applicable)
• Equivalent dose is not applicable as there was no active control.• No strategies were employed to minimise “drift” in facilitator skills as no benchmark had been established.   
  1. Components and fidelity goals derived by the Behaviour Change Consortium recommendations for enhancing treatment fidelity (BCCr) [49]