Discussion
obesity, type-2 diabetes
OBESITY, SECONDARY, SAID, RECRUITMENT
This trial tested the feasibility of delivering an RCT of ACT It appeared that although data collection was hampered by lack of retention, other trial processes (i.e. recruitment, consent, data collection in those retained in the trial) would be feasible for a future trial but that the intervention, as delivered, may not be. We therefore decided to explore acceptability of the trial processes and intervention in detail using an established framework–The TFA [Our interview data also suggested that the acceptability construct of ‘ethicality’ was important. This refers to the fit of trial and intervention with an individual’s values. The intervention fitted with what the participants said they wanted (i.e. information and psychological support), and satisfaction with this was expressed as evidenced by the positive comments coded under the ‘Affective Attitude’ acceptability construct. However, joining the trial was commonly motivated by a desire to ‘help others’ or ‘give back’. This, and another expressed desire, namely to meet other patients and share their experiences, was thwarted by the high levels of attrition in both groups This may explain why poor attendance at the first session led to reduced motivation to return, with subsequent drop out having a negative impact on future attendance.Further, our finding that participants consented to join the study out of a motivation to help others, may suggest that they were not ‘ready’ for therapy themselves, an idea supported by our PPI advisors. The impact on weight loss of ‘readiness’ or motivation for bariatric surgery has been tested retrospectively [With regard to perceived effectiveness and intervention coherence, few participants received a sufficient course of ACT for it to be meaningful. It is, therefore, unsurprising that no trends indicating a difference between the groups were identified. However, participants who attended the ACT groups reported some benefits and behaviour changes linked to ACT processes, especially regarding contacting the present moment, becoming more aware of behaviours and improved self efficacy. ACT group participants varied in their understanding of ACT processes, this appeared linked to attendance, but participants’ description of the intervention was generally simplistic, with few able to give concrete examples of the processes covered in sessions and homework.Nevertheless, this work has demonstrated that it is possible to deliver group ACT as part of routine care post bariatric care with minimal additional cost to services. Future trials could impact on large numbers of individuals and, if successful, reduce NHS costs significantly. For instance, in 2017/18 (latest available data NHS digital) there were 6,627 hospital admissions with a primary diagnosis of obesity and a main or secondary procedure of bariatric surgery; an increase of 2% on 2016/17 (6,492). However, approximately 20% of bariatric surgery patients regain lost weight with cost implications of £10,000 per re-operation as well as return of co-morbidities such as type-2 diabetes. If ACT is found, in future trials, to be effective at preventing weight regain, significant saving could be made. This study also highlights that the decision regarding the best primary and secondary outcome measures for a full RCT of ACT would require the careful consideration of many aspects of the proposed trial, including consensus in the most relevant patient-centred outcome to demonstrate efficacy. The data collected during this feasibility study for a range of outcomes would be sufficient to inform the necessary sample size calculations for a future trial through estimates of standard deviation of the chosen outcome, but the final decision on the choice of primary endpoint should be taken by the research team following extensive consultation with patient representatives.A strength of this feasibility trial is that, to reduce selection bias, we invited all eligible patients to participate. We noted early on that there was low attendance, so we ran additional iterations of the groups which confirmed that retention to the group rather than recruitment to the trial was an issue. We then explored acceptability of the trial and group processes with both high and low attenders using an established framework. This allowed us to pinpoint areas to address in a future trial to increase acceptability and retention. Nevertheless, due to the lack of attendance, few people received a meaningful level of the ACT intervention, so we are unable to recommend a definitive primary outcome for a future trial or suggest the processes by which ACT may work.In conclusion, this study has demonstrated that an RCT of group ACT is feasible to deliver in bariatric patients post-surgery, but that the intervention is not feasible or acceptable as delivered. Low attendance at groups, due mainly to travel and scheduling difficulties, reduced acceptability as participants were unable to gain the peer support or to provide the help to others that had motivated them to join the trial. This suggests that acceptability, and hence retention, could be improved in a future full trial of effectiveness by using online intervention delivery whilst taking care to maximise participant satisfaction by providing opportunity for interaction with peers. The data from this trial also suggest the need for future research to explore the factors which influence when and which bariatric patients are most likely to benefit from psychological therapy and why in order to inform recruitment of suitable candidates to trials.