Data collection and primary analysis
RECRUITMENT
We extracted relevant data from publicly available records and trial specific case report forms.We distributed feedback forms to:participants who attended group sessions asking them about the venues, facilitators and sessions, andparticipating GP practices about their experiences of being in the trial – this was discontinued when the COVID 19 pandemic started to avoid burdening practices.We entered quantitative data onto the study database and analysed using descriptive statistics. We took a random 3% sample of expression of interest forms from people who chose not to enter the trial and categorised reasons given. We assessed dose received based on the a priori definition of adherence for the trial: partial = day one plus one-to-one session, full = two sessions plus one-to-one.We assessed fidelity of eight components of the intervention (see Table We interviewed participants from both arms of the trial at four and 12-months post randomisation. Recruitment to the process evaluation is detailed in the process evaluation protocol. All participants provided informed consent to participant in the trial and a purposive sample of these who, at the time of consent, agreed that they could be contacted to consider involvement in the process evaluation interview study were informed and consented to this [On completion of the trial, we held focus groups with the nurses and allied health professionals (AHP) who delivered the intervention. These consisted of two parts: 1) nurses and AHP facilitators reflected on the training they received and their experiences of delivering the intervention; 2) nurse facilitators reflected on the nurse specific training they received and delivering the nurse one-to-one sessions. We analysed thematically.We reported our full analysis in detail, online, prior to trial results becoming available [