Feasibility Trial

The specific objectives of the feasibility trial are to:

Ethical approval for the feasibility trial has been granted (21/PR/0670) and we have submitted a ‘protocol’ of the feasibility trial for publication in an academic journal.

Following a review of the literature and consultation, and taking into consideration likely patient burden, we developed the pack of outcome measures for use in the feasibility trial. This includes eight key health outcome measures linked to the study objectives and include eating and physical activity behaviour, wellbeing, and quality of life amongst others. Weight change is our main outcome (the ‘primary’ outcome).

Initially we will run test groups to establish if PROGROUP will work on a larger scale, following which we will randomly allocate recruited patients to the new service if they are willing to be involved in the study. This stage will include 120 patients at three clinics, receiving weight management services, with or without the new group programme. If successful we will move to a large trial in the final stage.

Recruitment of participants into the trial

Identification of and approach to potential participants was undertaken by the local Tier 3 service staff. If staff deemed a patient to be eligible for the trial (i.e., if the patient met the PROGROUP study criteria), then they were given an information sheet containing more details about the study. Patients were given at least 24 hours to consider the study information before being contacted by members of the PROGROUP research team by telephone. If they were still interested in taking part, their eligibility was re-confirmed and their consent to participate was formally taken. Tier 3 staff were then notified and asked to provide clinical measures for consented patients of: height, weight, blood lipid profile (Total Cholesterol, HDL Cholesterol, Triglycerides), systolic blood pressure, glycaemia measurement (HbA1c). Patients were then randomly allocated to either the intervention (PROGROUP) group or the control group (usual care), using a web-based randomisation system provided by the PenCTU.

Facilitator training

For the feasibility trial, a 4-day training programme was developed. The programme was organised around good practice for classroom-based learning, and covered: underpinning theories, models and principles (e.g., Social Identity Model of Behaviour Change; Behaviour Change Wheel), communication skills for delivering behaviour change techniques, and group facilitation skills. During training, facilitators had the opportunity to practice their skills in a supportive environment. Facilitators were originally planned to be trained at one site. This approach had to be modified to online to account for COVID-based changes to social distance, safety, and developments in the learning environment.

Support for facilitators

The PROGROUP team provides ongoing support to facilitators during the feasibility study in the following ways:

  1. Telephone and email access to a dedicated member of the research team that can signpost queries to an appropriate member of the wider PROGROUP team where necessary,
  2. Individual post-session telephone debriefs for facilitators following the delivery of every group session to identify and address any issues raised,
  3. Group MS Teams conferences with facilitators from different sites to allow for cross-site learning and the sharing of ideas.

Data collection

The feasibility trial will generate data from several different sources, including patient feedback forms, questionnaires, and interviews with patients and other stakeholders (site staff; trainers). The research team and facilitators will complete fidelity ‘checklists’ to assess the extent to which the intervention is delivered as intended. These data will help inform the plans for the main trial in WP3, including any refinements that may be needed to the intervention.