Feasibility Trial

Summary for participants in the Feasibility Study:

We ran a small study comparing a new weight-management programme (called PROGROUP) to current weight management programmes in the NHS (National Health Service). This feasibility study took place in Cardiff, Coventry and Taunton.

The aim was to find out:  

Nearly 100 people took part. If you were a participant, thank you so much for your contribution.

Was the PROGROUP programme acceptable to people?  Yes. Overall, participants liked the PROGROUP programme. Most people were satisfied with the sessions that they attended.    

What people thought about being in the feasibility study:

Were the (appointments and) questionnaires used in the study acceptable to people? Yes. Overall, participants completed the online questionnaires. Those who took part in an interview after the study had finished told us they didn’t mind doing the questionnaires. We did find that certain parts of the questionnaire were left blank, and this was a very helpful indicator to us that improvements to the questionnaire were needed.

It is possible and practical to run a larger study? Yes. A large study of PROGROUP compared to current NHS weight management programmes is now underway. Healthcare professionals at the participating weight management services also gave us feedback. We have taken all the findings from the feasibility study in to account when setting up a larger study. In the large study we aim to see whether PROGROUP, compared to current programmes, results in weight loss. We will also work out the cost of running PROGROUP compared to the usual NHS programmes.

These are the main findings. We will add more details about the study results later this year. This will coincide with the publication of the results in a scientific journal.

The specific objectives of the feasibility trial were to:

  • Estimate rates of screening, enrolment, recruitment, randomisation, and retention.
  • Understand barriers to recruitment and reasons for declining participation.
  • Ascertain adherence to the intervention and usual care, including attendance rates and engagement with PROGROUP.
  • Assess the extent to which PROGROUP group facilitators deliver the intervention as it is intended.
  • Ascertain completeness of participant reported and clinical data collection.
  • Determine the acceptability of the planned approach for longer-term follow-up of participants, including consent rates for additional follow-up data after the end of the trial.
  • Refine the PROGROUP intervention, and the logic model which underpins it.

Ethical approval for the feasibility trial was granted (21/PR/0670) and we 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 ran test groups to establish if PROGROUP would work on a larger scale, following which we randomly allocated recruited patients to the new service if they were willing to be involved in the study. This stage included 120 patients at three clinics, receiving weight management services, with or without the new group programme. If successful we would 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 provided 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 could 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 generated 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 completed fidelity ‘checklists’ to assess the extent to which the intervention was delivered as intended. This data helped inform the plans for the main trial in WP3, including any refinements needed to the intervention.