A qualitative study of the experiences of individuals who did not complete the NHS Low Calorie Diet Programme Pilot

KEVIN J DREW,1 CATHERINE HOMER,2 DUNCAN RADLEY,3 CHIRAG BAKHAI,4 LOUISA ELLS1

1 Obesity Institute, School of Health, Leeds Beckett University, City Campus, Leeds
2 Sport and Physical Activity Research Centre, Sheffield Hallam University, Olympic Legacy Park, Sheffield
3 Obesity Institute, School of Sport, Leeds Beckett University, Headingley Campus, Leeds
4 Larkside Practice, Churchfield Medical Centre, Luton, Bedfordshire

Address for correspondence: Dr Kevin Drew
Obesity Institute, School of Health, Leeds Beckett University, City Campus, Leeds, LS6 3QW, UK
E-mail: k.drew@leedsbeckett.ac.uk https://orcid.org/0000-0003-0149-2521

Abstract

Background: Attrition remains a significant public health challenge as individuals who do not complete programmes are likely to have poorer programme outcomes. On calorie- restricted diets, including the NHS Low Calorie Diet (LCD) Programme pilot, approximately 50% of people are discharged prematurely, and thus do not complete the programme. Reducing attrition therefore has the potential to improve programme efficacy, impact and cost-effectiveness.

Methods: Ten semi-structured interviews were conducted with purposively sampled individuals who did not complete the NHS LCD programme. Interviews explored service user experiences of the programme and experiences of being discharged. Interview data were analysed thematically.

Results: Four core themes were identified: 1) the pre- programme struggles of service users and their route to LCD; 2) a positive and impactful programme; 3) life gets in the way; and 4) a perceived lack of support from the provider. These findings show that individuals had pre-programme struggles and a series of life events that constrained their good intentions, and whilst they were positive about the programme, they were critical of the support they received from providers to deal with their life circumstances.

Conclusions: Policy makers and providers can act proportionately to ensure that programmes, such as the NHS LCD Programme pilot, recognise the circumstances and context of people’s lives, and take a more person-centred approach.

Br J Diabetes 2024;24:ONLINE AHEAD OF PUBLICATION
https://doi.org/10.15277/bjd.2024.434

Key words: type 2 diabetes, obesity, Low Calorie Diet, Re:Mission study

Introduction

This paper presents data from a larger study exploring the qualitative experience of service users of the NHS England Low Calorie Diet (LCD) programme (now known as NHS Type 2 Diabetes Path to Remission Programme). A full summary of the programme and methods used in the study is reported elsewhere.1

Programme attrition, a process whereby individuals are discharged or withdraw from a programme prior to completion, remains a significant public health challenge as these individuals are likely to have poorer programme outcomes. For example, in weight management interventions, high levels of attrition or low completion rates are associated with fewer health-related benefits, a smaller weight loss and the regain of weight sooner.2-6 On calorie-restricted diets attrition rates can be as high as 50%,7 while evidence suggests that the more complex and intense the intervention is, the greater is the rate of attrition.8,9 Reducing attrition, therefore, has the potential to improve intervention efficacy, impact and cost-effectiveness.10,11 Thus, there is a need to understand the experiences of individuals who do not complete programmes.12

Discharge from the NHS Low Calorie Diet Programme pilot
Of the first 7,554 people referred to the LCD programme, 55% who started the Total Diet Replacement (TDR) phase were still active at 12 months.13 Thus, 45% of programme starters were discharged before completing the 52-week programme. Six commercial providers, who employed either registered dietitians or nutritionists to deliver the programme, or health coaches with a relevant undergraduate or postgraduate degree (for example, in nutrition, public health, sports exercise, or psychology), were mandated by a service specification to follow discharge procedures. For example, service users could be discharged from the programme if they missed one session and did not contact the provider within a specific time period (which varies by stage of the programme [TDR weeks 1-4 weekly session (x4), TDR weeks 5-12 biweekly sessions (x4), food reintroduction weeks 13-18 biweekly sessions (x3), and maintenance sessions weeks 19-52 monthly sessions (x8)]), or if they were unable to comply with the programme requirements, such as attending a specific number of sessions. Service users could also be discharged if they experienced an adverse or concurrent event of sufficient severity that no longer made it appropriate for them to continue. This paper, therefore, aims to explore the experiences of individuals who did not complete the NHS LCD programme.

Methods

Ten individuals discharged from the NHS LCD programme were recruited for interview, either by provider invitation (x5), through the research team (x3) [Three individuals completed either 12-week or 12- and 18-week interviews as part of the longitudinal cohort before being discharged] or by website advertisement (x2). A representation of people discharged was sought in the sample: sampling was purposeful to achieve maximum variation by recruiting participants with differing demographics and programme characteristics (see Table 1 and Table 2).

1189 Drew Table 1

1189 Drew Table 2

Ethical approval was received from the Health Research Authority (REF 21/WM/0126) and Leeds Beckett University (REF 107887 and 79441).

Semi-structured interviews (using MS Teams and lasting between 60 and 110 minutes) were carried out by KD between June 2022 and June 2023. An interview guide was designed to elicit discussion of the participants’ experiences of the programme, and programme discharge. Interviews were audio recorded, transcribed verbatim, and then read multiple times by KD who conducted a thematic analysis as described by Braun et al,14 which allowed for the identification of themes in the data. Following initial coding, CH read through a sample of transcripts as a second coder to search for alternative meanings in the data not previously tagged. The initial identification, reviewing, defining and naming of themes to consolidate themes into clusters allowed higher-level patterns in the data to be identified. NVivo software (QS International Pty Ltd. Version 12) was used to assist the storing and organising of textual data. Reporting follows COREQ guidelines (see supplementary file 1 – online at www.bjd-abcd.com).15

Findings

The following section presents the four core themes constructed from the data. Table 2 presents the principal reasons for leaving the programme prematurely; exemplar quotes are presented in Table 3 to Table 6, with further supporting quotations in supplementary file 2 below.

Table 3. Theme one - The pre-programme struggles of service users and their route to LCD: exemplar quotes


“It’s been in the last three years, I’m under [area] mental health team, in the last three years I've had appointments once a year because my psychiatrist has  over 900 patients and by the time you get around, a year will lapse” (P1).

“I struggle with like low mood and suicidal thoughts and don't really wanna be alive and I'd rather have, I'd rather if I had a choice of euthanasia, I'd take it” (P3). “I explained about my anxiety and my depression. I explained everything to them about it” (P9).

“it wasn't really an exercise thing, it was more eating the wrong foods if I’m honest […] And I think that is a large part of the problem is that I wasn't eating healthy and probably eating too much.” (P10)

“I went to her [GP] because I said, what do I do about this? I'm struggling with the comfort eating again” (P4). 
“I have a weird diet because it, ‘cause I'm gluten and lactose free and there's like probably only about 20 foods that I tolerate” (P5).

“I wanted to reverse my diabetes. I was 100% set on doing that and I've done it. But I wanted to once and for all tackle my weight issues and lose it, not just for myself, for my family, for my daughters, I've got grandchildren as well and I wanted to make sure I was gonna be around for a lot, a lot longer period” (P10).

“I actually read it on an article on Facebook a bit before. I mentioned it to my doctor about it and that’s how it all started.” (P9)

Table 4. Theme two - A positive and impactful programme: exemplar quotes


“Even though they kicked me off, and that limited time of four weeks that I was on there for it's had a big impact on me” (P2).

“my blood pressure became normal. My heart became normal, like resting heart rate was at 60, where my resting heart rate’s 120. Blood pressure gone from 180 / 130 to a normal blood pressure. My diabetes, I'd had the blood test done and my diabetes was under 40. My HbC was under 40. So I was classed as put in remission.” (P6).

“I would, I would still want to go on a, a programme. It hasn't changed because that was just I was on a journey and I had a blip, my brother's death]” (P7).

“I got low, and I phoned the place up where you phone, the main number. It wasn't that woman that we see on the camera, it wasn’t her. And I asked to speak to somebody, and she said why? And I told her why, I felt suicidal. This, they said oh yeah, we'll put you through […] it was the dietitian I spoke to at the end. I said I didn't want to be kicked off. You won't be kicked off, we'll try and get you some help. Blah, blah, blah. Next minute a letter saying you're off” (P2).

“I've devised my own programme now to get to that goal because now I'm more savvy and I've got, I know what to do. OK, so I've got that knowledge and I know what to do and how to do it” (P1).

“I kept to it. I made it quite clear I was gonna keep to it, and I did […] I finished that powder. And then I spoke to the company. […] [the provider said] You're not allowed to buy that stuff. It's dangerous. So, I rang the [product manufacturer] up, they said yes, we can sell you it £50. So since finishing that diet I, I bought a another one and kept it on for my breakfast only. Eat normally in the day but […] milkshake for breakfast that's it” (P2).

Table 5. Theme three - Life gets in the way: exemplar quotes


I've always been an over overweight person and yo-yo diet, you know, a bit a bit of a yo-yo dieter if you like. And life gets in the way and then you go off that plan and I'm one of these that you know, when I go off it I tend to proper go off It” (P8).

“I've had setbacks over seven months, eight months. I've lost my paternal grandmother and one of my uncles. I've been struggling with my Open University degree due to a torn ligament in my right wrist. So there's been a lot of attention on my Uni work more than anything.” (P4).

“If there’s anything else that happens because by this time I were worrying about things, I were getting myself into a state mentally. You know what’s, what else is going to happen? Is this going to go wrong? Is that going to go wrong? I wasn’t sleeping, And I was just really grumpy with my husband and everything because I was just stressing out too much” (P9).

“I also got a lot of kidney stones funnily enough during that period as well, even though I was drinking a lot of liquid. And it's traditional in my family, we all suffer from kidney stones, so I do get them on and off, but I happened to go, got a lot more during the programme” (P10).

“I've got one at the High School, one at the Junior School, one at the Infant School. They've all got, they all do like a million after school clubs and I've, I've got, and there's just always so much going on and rushing around. Also, my mother-in-law had a stroke and we're trying to get her home at the moment. So, I've got a lot of dealing with social services and stuff like that, trying to sort everything out and for them. So, it's just, just life’s just busy at the moment” (P5).

“I did explain to her. I said look, I'm not being funny, but I told you I was robbed, we were burgled, had no devices, had to wait to get them replaced, I had no way of contacting you. I explained all this, explained the situation” (P1).

“when I had the news that my brother had passed away, we were in COVID. I had to travel to another country to go and bury him. I wasn't going to leave him in the mortuary […] The light is not constant. So, for me it was that blip” (P7).

“the programme worked for me in that sense. But then when it got to the point of OK, my mental health’s now coming into play, what do I do? And I was just told, well, there's nothing, we don't know what you do kind of thing.” (P6).

“when I phoned the head office once because I was feeling low. And I've just come out with I felt suicidal and. I just heard nothing from the GP. They said they phoned the GP, but I heard nothing. I just left it. It subsided like it always does. And then I got that letter saying you're off it. We're not having this. You're off” (P2).

“I did feel quite suicidal. I did feel like complete and utter hopelessness, and I just thought, what's the point? Excuse my language. What's the ******* point?” (P1).

Table 6. Theme four - A perceived lack of support from the provider: exemplar quotes


“One basically raised the same issues of lack of support, no understanding and nobody was there to answer the phones or no one’s replying to emails, lack of people who care.” (P1).

“But obviously when you rang up, you don't get the person you really want to talk to. You get the helpdesk or the call centre. So you don't speak to the one you really want to speak to. So you're just telling somebody that probably doesn't know what you're really on about, and that you may need to talk to somebody else, and then you have to wait for the call” (P4).

“I started to sink into a little bit of a depression, but that wasn't why I left. It was more to do with the facts I didn't know what I was eating. I didn't know. And I felt like I was putting on weight. And it kind of like was, am I eating the wrong things or when I'm asking questions I was getting no answers. They said you can e-mail this thing. When I emailed, I never got an answer. If you rang, I'd ring 3, 4 times. Somebody will get back to you, but no one ever got back to you. And it was just like that's what I meant by lack of support” (P6).

“But when I was then highlighting issues it just seemed to get glossed over by the person who was supposed to be supporting me. And I think it was about a third of the way through they shocked the person supporting me. But every time I sort of raised anything with them, they seemed to just do platitudes more than anything else and say oh well, I'm sure it will come better type of thing” (P10)

“There's no mental health help either so like I suffer with mental health, I suffer with PTSD and emotionally unstable personality disorder. So one of my things is if I go into a manic, I want to eat and there was no help for that part. There was no like, OK, so you've got to remember the majority of people who are diabetic probably have a slight hint of depression. So one of the things we do is eat. So there was no like, OK, so if I get depressed, what do I do?” (P6).

“But it was quite weird because if I'm honest, they were really unprofessional and disjointed the way they were dealing with things. They, they started the app earlier, two weeks prior to my actually commencing the diet so the app was actually out of sync with my diet throughout the entire programme” (P10).

“It’s unempathetic, apathetic. You know it just seems unsympathetic. It just seems so dispassionate. It’s like well we don’t care that you’ve got to deal with that. This is your problem now. There you go. It's almost like someone giving you P45, cheers, thanks, bye” (P1).

“It was kind of like, here's your food for 12 weeks and then once you start reintroducing it kind of a bit left to your own devices really” (P5).

Theme One - The pre-programme struggles of service users and their route to LCD
Seven interviewees discussed struggling with their mental health pre-programme. Anxiety and depression were reported widely; four were receiving mental health support, three were taking antidepressants, and three discussed having suicidal thoughts. Three interviewees had at least one other mental health diagnosis, such as emotionally unstable personality disorder. Interviewees also noted that their provider was made aware of their mental health struggles before and during the programme.

In the context of having made previous weight loss attempts, interviewees discussed eating the wrong foods whilst also struggling to maintain previous lifestyle changes. Four interviewees also discussed deeper psychological struggles with food, such as eating when they are under stress. Food struggles were also related to physical ill-heath; one interviewee was living with inflammatory bowel disease and had a very limited diet. In total, three interviewees discussed struggling with physical ill-health, including osteoarthritis, inflammatory bowel disease, lymphoedema, lipoedema and rheumatoid arthritis.

In this context, interviewees started the programme because they wanted to improve their health and were conscious of the impact of their weight. Furthermore, the majority approached their GP and asked to be referred to the programme and were subsequently happy to have been given the opportunity to attend.

Theme Two - A positive and impactful programme 
Interviewees noted that the programme had a positive impact on them. Six interviewees talked of improved physical health, including improved blood pressure and blood sugars, while one interviewee had put their diabetes into remission. Weight loss, improved levels of physical activity and dietary changes were also reported in a context where interviewees felt supported at home by family. Two interviewees also noted improvements in their mental health.

Interviewees thought the idea of the programme was great and were initially happy with their experience, whilst stating they either wanted to continue with the programme or said they would try it again in the future. Subsequently, the experience of being discharged was framed negatively. Five interviewees perceived that the provider had discharged them against their will, without presenting them with an opportunity to continue.

Despite leaving the programme prematurely, seven interviewees had either continued to use the products without supervision after being discharged or had kept the provider- supplied product to use in the future. For example, one interviewee continued on a full TDR diet for eight weeks after being discharged. Thus, the programme and products were not framed as the defining reasons for withdrawal once people started TDR. However, the perception of poor product choice was the reason why one interviewee choose to withdraw pre- programme.

Theme Three - Life gets in the way
Interviewees reported that life gets in the way of the programme, as setbacks or life events constrain their attempts to attend all sessions or comply with the programme’s requirements. The majority of life events were episodes of poor mental health, while two interviewees discussed having suicidal thoughts. One interviewee declared this to the provider and was discharged as a result. Health-related life events, such as kidney stones, a hernia and a stroke in the family were also physical in nature for some interviewees.

Life events were also non-health-related. Being burgled and dealing with the abandonment of a child in the family were mentioned. Three interviewees discussed the death of family members, which for one resulted in burying a family member abroad during COVID-19. Two interviewees discussed moving to a new house or changing jobs during the programme.

Life events, pre-programme struggles and adverse reactions to the TDR products led to a range of daily challenges, such as being in pain due to pre-existing health conditions and having bad stomach cramps because of the products. One interviewee had university work which took precedence over the programme, while others missed sessions due to hospital appointments. This all had an impact on interviewees, who became stressed by the circumstances of their lives and felt like they were unable to focus fully on the programme.

Theme Four - A perceived lack of support from the provider
Six interviewees, with experience of four providers, perceived that there was a lack of provider support. They reported difficulty speaking with anybody outside of scheduled sessions, or getting timely responses to e-mails. However, a lack of support was not just framed as communication issues, as interviewees felt that their struggles and life events were not addressed, which was further exacerbated by difficulty speaking with their coach outside of sessions. Five interviewees also said they perceived there to be no mental health support. Some interviewees regarded the behaviour of providers as sometimes lacking professionalism and empathy, and verbalised the view that nobody really cares, a point exemplified by their experiences of discharge. Some interviewees learnt about being discharged via a letter, which was seen as dispassionate, while it was perceived that no attempt was really made to understand and accommodate their situation.

Interviewees who completed TDR also noted a lack of support during food reintroduction. Support became infrequent, and interviewees perceived there to be a lack of structure that gave them a clear sense of what they should be eating during this phase, such as a meal plan that provided a bank of meal ideas. As a result, in the perceived absence of meaningful support from their provider, they informed the provider of their intention to stop attending sessions and were subsequently discharged.

Discussion

In this paper we have explored the experiences of individuals on the NHS LCD programme who were discharged from the programme prematurely. Our findings show interviewees had often approached their GP about the LCD Programme and were happy to have been referred. Individuals also spoke positively about the programme, in part because of a positive impact on their health and wellbeing, as has been evidenced elsewhere.6,16 Subsequently, interviewees were often dissatisfied at being discharged, and some continued using TDR products to work towards their goals. These findings suggest that some interviewees had bridged the intention-behaviour gap, and thus had the internal motivation to change.17

Our findings also show that interviewees were referred to the programme with a variety of lived experiences that were framed as struggles, upon which the occurrence of life events were layered. Mental health was discussed widely, while literature has reported links between mental health, T2DM and obesity,18-20 and the increased likelihood of missing sessions when baseline mental health is poorer.21 Furthermore, health, physical limitations, family issues, significant events and stress are prominent barriers to lifestyle change and reasons for programme withdrawal, as has been previously reported.5,22,23 These multiple circumstances can be seen as social stressors,24,25 and were effectively out of the control of individuals, thus constraining their best intentions by drawing their attention and resource away from the programme.

In this context, when seeking support, some interviewees reported not being able to get in touch with their coach, or the provider more generally not meeting their needs. When they did have contact, the social stressors with which interviewees were contending were often not addressed. There is evidence suggesting that out-of-hours provision is linked to reduced attrition,26 and that intensive support plays an important role in programme adherence.27,28 Previous research has also shown that transition from TDR to food reintroduction is challenging and needs increased support.6 Thus, interviewees needed support that was reflective of their life circumstances, not a one size fits all approach. While the frustrations of interviewees were directed towards the provider, many cases of dissatisfaction were the result of the provider applying the discharge procedures mandated in the service specification.

Strengths and limitations
This is the first study to explore the experiences of a small sample of service users discharged from a national LCD programme. We recognise our recruitment may have resulted in a selection process whereby individuals keen to do the programme but who subsequently felt dissatisfied or unfairly treated were more likely to put themselves forward for interview. Furthermore, most of the sample were British in origin, whilst being primarily drawn from the group delivery model. Whilst this is representative of the LCD programme pilot, which was weighted towards group delivery, an insight into more people attending the one-to-one and digital models would be useful in future studies.

The programme providers were commercial organisations so commercially sensitive data such as staffing levels which might have affected programme retention were not available to the authors.

1189 Drew Key Messages

Recommendations for policy and practice
Based on our findings, the following recommendations may help inform commissioners, practitioners and policy makers attempting to improve attrition rates on the NHS LCD (and similar) programmes:

  1. To better understand the context of people’s lives, providers should account for opportunities to listen to the social stressors people are dealing with. The 1-to-1 delivery model may better facilitate this process.
  2. Coaches should be given time to follow up with service users outside the scheduled sessions. To ensure that out- of-hours support is equitable, coaches should be encouraged to spend more time with those individuals dealing with more social stressors.
  3. Consideration should be given to how support for mental health can be better embedded throughout the programme.
  4. Providers should deal with people empathetically and ensure compassionate discharge processes.
  5. GP practices are required to assess suitability for referral, acknowledging any concurrent physical or psychological issues likely to impact engagement. Improved communication with practices about the programme is recommended to support this process.
  6. Service users should be able to take a pause from the programme to allow them to deal with social stressors in their lives without being discharged from the programme. Indeed, this has been incorporated by NHS England in an updated service specification that allows service users dealing with life circumstances to take a planned pause of up to four weeks.

Conclusions

Programme attrition remains a public health challenge, and our findings show that people’s life circumstances, regardless of their best intentions, significantly influence their ability to comply. While practitioners may not be able to alleviate all life circumstances, programmes can have degrees of proportionality at both a policy and delivery level. Policy makers can acknowledge the need for certain people to pause the programme, and thus avoid discharging individuals who otherwise want to continue; Providers can also recognise the need to provide more support to people who have more life challenges. Such proportionality is likely to mean a greater emphasis on person-centredness, subsequently ensuring everyone has a fairer opportunity to attain their full health potential without being disadvantaged in any way.29

© 2024. This work is openly licensed via CC BY 4.0

© 2024. This work is openly licensed via CC BY 4.0.

This license enables reusers to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use. CC BY includes the following elements: BY – credit must be given to the creator.

Copyright ownership The author(s) retain copyright.

Conflict of interest The authors declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: CB is a primary care adviser to the national diabetes programme for NHS England.

Funding This work was supported by the National Institute for Health Research, Health Services and Delivery Research [NIHR 132075]. The NHS LCD programme is funded by NHS England. For the purpose of open access, the author has applied a Creative Commons Attribution (CC BY) licence to any author accepted manuscript version arising. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care.

Acknowledgements The authors would like to acknowledge Clare Helm from NHS England, who has worked on the coproduction of this study, identification of study aims and who provided feedback on an earlier draft of this manuscript.

The authors would also like to acknowledge the Patient and Public Involvement team that have worked on the coproduction of the Re:Mission study, including Ken Clare, Abimbola Ojo, Jennifer Teke, Mike Willis, Gulsoom Akhtar, Beth Clegg and Clair Goddard. Members of the steering and oversight groups are also acknowledged by the authors for their input and involvement in the Re:Mission study, including the clinical lead Dr Mark Ashton.

The Re:Mission study includes a multidisciplinary team of academics from across the North of England. The authors would like to acknowledge the team, including Dr Jamie Matu, Prof Jim McKenna, Dr Maria Maynard, Pat Watson, Dr Susan Jones, Dr Simon Rowlands, Karina Kinsella, Dr Tanefa Apekay, Dr Stuart Flint, Prof Janet Cade, Dr Adam Martin, Dr Maria Bryant, Dr Jordan Marwood, Dr Tamara Brown, Dr Wendy Burton, Mick Martson, Pooja Dhir and Tamla Evans. 

Ethical approval Ethical approval was received from the Health Research Authority (REF 21/WM/0126) and Leeds Beckett University (REF 107887 and 79441). Participants provided informed consent to participate in the Re:Mission study, including consent for publication. All participant data were anonymised and where photos have been used in publications or presentations, permission was sought from each participant.

References

  1. Homer C, Kinsella K, Marwood J, et al. The Re:Mission study: Evaluating the NHS Low Calorie Diet pilot - an overview of service user data collection. Br J Diabetes 2024;24:ONLINE AHEAD OF PUBLICATION. https://doi.org/10.15277/bjd.2024.433
  2. Moroshko I, Brennan L, O'Brien P. Predictors of dropout in weight loss interventions: a systematic review of the literature. Obesity Reviews 2011;12(11):912-34. https://doi.org/10.1111/j.1467-789X.2011.00915.x
  3. Mattfeldt-Beman MK, Corrigan SA, Stevens VJ, et al. Participants’ evaluation of a weight-loss program. J American Dietetic Association  1999;99(1):66-71.  https://doi.org/10.1016/S0002-8223(99)00018-8
  4. Miller BM, Brennan L. Measuring and reporting attrition from obesity treatment programs: a call to action! Obesity Research Clinical Practice 2015;9(3):187-202. https://doi.org/10.1016/j.orcp.2014.08.007
  5. Burgess E, Hassmén P, Pumpa K. Determinants of adherence to lifestyle intervention in adults with obesity: a systematic review. Clinical Obesity 2017;7:123-35. https://doi.org/10.1111/cob.12183
  6. Rehackova L, Rodrigues AM, Thom G, et al. Participant experiences in the diabetes REmission clinical trial (DiRECT). Diabetic Medicine 2022;39(1):e14689. https://doi.org/10.1111/dme.14689
  7. Brown A, Frost G, Taheri S. Is there a place for low-energy formula diets in weight management. Br J Obes 2015;1(3):84-119.
  8. Mata J, Todd PM, Lippke S. When weight management lasts. Lower perceived rule complexity increases adherence. Appetite 2010; 54(1):37-43. https://doi.org/10.1016/j.appet.2009.09.004
  9. Dansinger ML, Gleason JA, Griffith JL, et al. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA 2005; 293(1):43-53. https://doi.org/10.1001/jama.293.1.43
  10. Handjieva‐Darlenska T, Handjiev S, Larsen TM, et al. Predictors of weight loss maintenance and attrition during a 6‐month dietary intervention period: results from the DiOGenes study. Clinical Obesity 2011;1(2‐3):62-8. https://doi.org/10.1111/j.1758-8111.2011.00010.x
  11. Nobles J, Griffiths C, Pringle A, et al. Design programmes to maximise participant engagement: a predictive study of programme and participant characteristics associated with engagement in paediatric weight management. Internat Journal Behavioral Nutrition Physical Activity 2016;13(1):76. https://doi.org/10.1186/s12966-016-0399-1
  12. Rodrigues AM, Haste A, Penn L, et al. Stakeholders’ perceptions and experiences of the National Health Service diabetes prevention programme in England: qualitative study with service users, intervention providers and deliverers, commissioners and referrers. BMC Health Serv Res 2020;20:1-13. https://doi.org/10.1186/S12913- 020-05160-2
  13. Bakhai C, Barron E, Gorton T, et al. Early findings from the NHS Type 2 Diabetes Path to Remission Programme (formerly NHS Low Calorie Diet Programme). Diabetes UK Professional Conference; 26 to 28 April; Exhibition Centre Liverpool, 2023.
  14. Braun V, Clarke V, Weate P. Using thematic analysis in sport and exercise research. In: Smith B, Sparkes AC, editors. Routledge Handbook of Qualitative Research in Sport and Exercise. London: Routledge; 2016. pp 191-205.
  15. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International Journal Quality Health Care 2007;19(6): 349-57. https://doi.org/10.1093/intqhc/mzm042
  16. Brown A, Dornhorst A, McGowan B, et al. Low-energy total diet replacement intervention in patients with type 2 diabetes mellitus and obesity treated with insulin: a randomized trial. BMJ Open Diabetes Research Care 2020;8(1):e001012. https://doi.org/10.1136/bmjdrc-2019-001012
  17. Strack F, Deutsch R. Reflective and impulsive determinants of social behavior. Personality Social Psychology Review 2004;8(3):220-47. https://doi.org/10.1207/s15327957pspr0803_1
  18. Maina JG, Balkhiyarova Z, Nouwen A, et al. Bidirectional Mendelian randomization and multiphenotype GWAS show causality and shared pathophysiology between depression and type 2 diabetes. Diabetes Care 2023;46(9):1707-14. https://doi.org/10.2337/dc22-2373
  19. Sartorius N. Depression and diabetes. Dialogues Clinical Neuroscience 2022;20:47-52. https://doi.org/10.31887/DCNS.2018.20.1/nsartorius
  20. Abiri B, Hosseinpanah F, Banihashem S, et al. Mental health and quality of life in different obesity phenotypes: a systematic review. Health Quality of Life Outcomes 2022;20(1):1-14. https://doi.org/10.1186/s12955-022-01974-2
  21. Jones RA, Mueller J, Sharp SJ, et al. The impact of participant mental health on attendance and engagement in a trial of behavioural weight management programmes: secondary analysis of the WRAP randomised controlled trial. International Journal Behavioral Nutrition Physical Activity 2021;18(1):1-13. https://doi.org/10.1186/s12966-021-01216-6
  22. Toth-Capelli KM, Brawer R, Plumb J, et al. Stage of change and other predictors of participant retention in a behavioral weight management program in primary care. Health Promotion Practice 2013;14(3):441-50. https://doi.org/10.1177/1524839912460871
  23. Hession M, Rolland C, Kulkarni U, et al. Systematic review of randomized controlled trials of low‐carbohydrate vs. low‐fat/ low‐calorie diets in the management of obesity and its comorbidities. Obesity Reviews 2009;10(1):36-50. https://doi.org/10.1111/j.1467-789X.2008.00518.x
  24. Avison WR, Thomas Graduate SS. Stress. In: Cockerham WC, editor. The New Blackwell Companion to Medical Sociology. Oxford: Wiley- Blackwell; 2009.
  25. Cockerham WC. The social causes of health and disease, 3rd Edition. Polity; 2020.
  26. Howarth E, Bower PJ, Kontopantelis E, et al. ‘Going the distance’: an independent cohort study of engagement and dropout among the first 100 000 referrals into a large-scale diabetes prevention program. BMJ Open Diabetes Research Care 2020;8(2):e001835. https://doi.org/10.1136/bmjdrc-2020-001835
  27. Kleine HD, McCormack LA, Drooger A, et al. Barriers to and facilitators of weight management in adults using a meal replacement program that includes health coaching. Journal Primary Care Community Health 2019;10:2150132719851643. https://doi.org/10.1177/2150132719851643
  28. Ross LJ, Byrnes A, Hay RL, et al. Exploring the highs and lows of very low carbohydrate high fat diets on weight loss and diabetes‐and cardiovascular disease‐related risk markers: a systematic review. Nutrition Dietetics 2021;78(1):41-56. https://doi.org/10.1111/1747-0080.12649
  29. Whitehead M. The concepts and principles of equity and health. Health Promotion International 1991;6(3):217-28. https://doi.org/10.1093/heapro/6.3.217

Supplementary file 1: Consolidated criteria for reporting qualitative studies (COREQ): 32-item checklist

1189 Drew Supplementary file 1 (image 1)

1189 Drew Supplementary file 1 (image 2)

1189 Drew Supplementary file 1 (image 3)

1189 Drew Supplementary file 1 (image 4)

1189 Drew Supplementary file 1 (image 5)

Developed from:
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care. 2007. Volume 19, Number 6: pp. 349 – 357

Personal Characteristics:

Dr Kevin J Drew PhD (Male). Post-doctoral Research Fellow with 7 years’ experience of conducting qualitative evaluations of health-based interventions.

Dr Catherine Homer PhD (Female). Senior Research Fellow with experience working in academia and extensive experience working in public health.

Dr Duncan Radley PhD (Male). Reader with 25 years’ experience conducting obesity research, and previously research manager in weight management service providers.

Dr Chirag Bakhai (Male), General Practitioner, Clinical Lead on the Re:Mission Study Oversight group and Primary Care Advisor to the NHS Diabetes Programme

Dr Louisa Ells (Female). Professor of Obesity with a specialist interest in multi-disciplinary, cross- sector applied obesity research, with extensive experience of leading programme evaluations.

Supplementary file 2: Supporting quotations

The pre-programme struggles of service users and their route to LCD (Theme 1)

“She's looked after me mental health wise for many years. I mean I have been under a psychiatrist for a long time […]. I have mental health issues anyway so I, but my GP keeps me going” (P4).

“I was trying to get help for my mental health, for anxiety or depression, that kind of thing. And so, it was more like a peripheral thing, the binge eating wasn't the number one problem […]. But when I was sort of struggling to get help on the NHS and […] for the OCD and stuff, I wasn't really finding treatments that were helping me” (P3).

“I suffer [with] depression and I've got mental health issues. So, I eat because I'm bored. I eat because I wanna eat, […] but it tends to be sweet, chocolates, crisps” (P6).

“Part of me feels like I’ve lost who I am, who I was. Because I can’t do things that I used to love doing” (P9).

“I've always been an over overweight person and yo-yo diet, you know, a bit a bit of a yo-yo dieter if you like. And life gets in the way and then you go off that plan and I'm one of these that you know, when I go off it, I tend to proper go off It” (P8).

“So, somebody outside told me about the programme. They mentioned it to me and then when I went to the GP, I told the GP, can I be considered for this” (P7).

“it was well explained. I was well over the moon. What I wasn't well over the moon about is the GP acting awkward. And not referring me quicker and obviously after all that time I was getting angry, because of my mental health and everything” (P2).

“Weight is my reason for my diabetes. It's 100% the reason for 90% of my mental, not my mental health, my medical problems. And we recognised that weight was a big issue. So that's why the programme as soon as it came out, she was like, this would be really good because if you could lose the weight, we could maybe resolve the blood pressure, we could resolve the diabetes” (P6).

“my weight was 83 kilogrammes and I brought it down to 75 kilogrammes from November 2018 to April. 2019. But then when my birthday came, I had a big cake, and then I just went back to eating the way I’d eaten before, like whatever I wanted” (P3).

A positive and impactful programme (theme 2)

“I'm literally walking, enjoying the birds, enjoying the scenery. There's a place in [city] called [woods] […], it's a 20K walk. And you go up a hill, a slope that is literally like that. […] By the third, fourth time I was running up it. Like getting to the top and then like yay big jumping stars. Like I hadn't just took this massive hill. And it was just doing things like that. And then mental health it, I got down from weekly visits to monthly visits [with mental health team]” (P6).

“I’d lost the weight, and I could start running again which was great” (P5).

“I kept to it. I made it quite clear I was gonna keep to it, and I did. I think I've finished. […] I rang the company [product manufacturer] up, they said yes, we can sell you it, £50. So since finishing that diet I bought a another one and kept it on for my breakfast only. Eat normally in the day but just for breakfast, milkshake for breakfast that's it” (P2).

“But it does say on the letter that you shouldn't be using them without supervision. You should only consume TDR products under medical supervision. If you have any unused, dispose of them. But I'm ignoring that” (P5)

“if you take the programme, the ethos of the programme, the idea of the programme is great. Because you can get people into, I mean, my you see HCAB1, whatever it's called, HBA, my diabetes level right, has actually gone down since I started it” (P1).

“It's the same as it was before I started the course, the programme. Obviously, I've had setbacks over seven months, eight months. I've lost my paternal grandmother and one of my uncles. I've been struggling with my Open University degree due to a torn ligament in my right wrist. So, there's been a lot of attention on my Uni work more than anything. So, it's just the same as it was. I've now asked my GP about bariatric treatment and the fat jab because I put on the weight that I did lose back on. Because obviously with the setbacks I comfort ate again. Even though I did the reset weeks” (P4).

“I was quite happily on the shakes. I was quite happily starting to reintroduce food” (P6).

“Had this guy he phoned me who, who I was calling each week and he was quite good and just went over everything with me. So, all the initial contact was all good you know, and ever, everything was delivered on time or before, like really quite quickly and things like that. They, there was no issue whatsoever” (P8).

Life gets in the way (theme 3)

“the programme worked for me in that sense. But then when it got to the point of OK, my mental health’s now coming into play, what do I do? And I was just told, well, there's nothing, we don't know what you do kind of thing.” (P6).

“when I phoned the head office once because I was feeling low. And I've just come out with I felt suicidal and. I just heard nothing from the GP. They said they phoned the GP, but I heard nothing. I just left it. It subsided like it always does. And then I got that letter saying you're off it. We're not having this. You're off” (P2).

“I did feel quite suicidal. I did feel like complete and utter hopelessness, and I just thought, what's the point? Excuse my language. What's the ******* point?” (P1).

“you don't plan for when your brother, you know, this is my younger brother. So, blips, a blip in life happened and I don't think they had anything to, you know. This program is a year. So, blips in life do happen, so anyway. […] When I had the news that my brother had passed away, we were in COVID. I had to travel to another country to go and bury him. I wasn't going to leave him in the mortuary. I was going to [country of origin]. The light is not constant. So, for me it was that blip” (P7).

“A lot for me is walking from my bedroom to the kitchen. Which isn’t, which is about ten foot if that. I used to go walking. And if I do a little bit more than that I can, I need to rest for days because my legs are just so sore, they hurt so much. It’s happened with swimming, which I used to love doing swimming. But the last time I did swimming were a few years back. I needed to rest for three days afterwards ‘because I were just so sore. I hurt. I was so tired” (P9).

“I was going to a country where the electricity is not constant. And you know what, even if it was, I don't think I was in that frame of mind. Cause they did ask me; can you continue to do the measurements? And I'm thinking I'm going to bury my brother; I just can't deal with this” (P7).

“I was just kind of getting stressed and ill and I just, I needed to eat my weird food that I eat that I know doesn't make me ill and I, and I found it really difficult to kind of go to the fridge and be like, right I need something that's good for diabetes, something that's good for bowel disease and something that's gonna, gonna be good for this diet as well. And I just haven't got the capacity for that at the moment. I've got so much else going on in my life that I just need to eat what I know isn't gonna make me ill” (P5).

“Real world events will happen when you least expect it when you think everything's rosy. These things will happen. People will die. People leave, people lose their jobs. People have to go to hospital. People become ill. These are what reality is that happens around the world. That these changing circumstances is the only constant in a life. People struggle with like oh they're so against change, but change is the only constant in our lives because things happened that change the course of our lives and these real world events occur every single moment to every single person to every single day of every person's existence. They come to you in different moments of your life, but they happen” (P1).

“my nephew come live with us in February last year and he had been living with us a few months before with his mum, but she then abandoned him in February. So that was at the time that I started that diet as well. So, everything sort of happened over around the same sort of time. My dad sort of happened [serious illness] probably about 8 weeks into the diet, 6 to 8 weeks into the diet and dealing with a very emotional five year, four year old that had been abandoned and two children of my own of the age of two and four. It was just life events, there was a lot of it” (P8).

“I'm stuck indoors and not going out and also I had a knee injury or knee issue for a year and the doctors won't give me anything, they just give me anti-inflammatories that didn't work, and so I was in a lot of pain constantly. Finally, then I got seen, I got an x-ray and got diagnosed with osteoarthritis in my knee.” (P1).

“I started to get really, really bad stomach cramps and things that was affecting my ability to work. I'd be out and doing surveys and I’d start getting stomach pains that I wouldn't be able to work through. I'd have to stop” (P10).

“It was the last couple. Or the last few. But I had my Uni work. I'm sorry […], I had no choice.” (P4)

“But like I say, it's all about the same time that I'd issues like with my dad and stuff like that. And also, we had other issues as well and it was just all. I couldn't focus on too many things” (P8).

“I felt they should have stopped me, and they should have put me on another group. Because it wasn’t, I pulled out because I don't like this or. It was just they need to have that process because it, I really, I don't think well of them. Because I just felt this wasn't a case of me saying I can't continue. It was a case of I'm not in that headspace because of this event that happened in my life” (P7)

A lack of support and strained relations with the provider (theme 4)

“They said you can e-mail this thing. When I emailed, I never got an answer. If you rang, I'd ring 3, 4 times. Somebody will get back to you, but no one ever got back to you. And it was just like that's what I meant by lack of support. There was a lack of anything” (P6).

“when I was then highlighting issues it just seemed to get glossed over by the person who was

supposed to be supporting me. And I think it was about a third of the way through [the issues] shocked the person supporting me. But every time I sort of raised anything with them, they seemed to just do platitudes more than anything else” (P10).

“I did ring up one time and said look, I'm getting really depressed. It's not even about the eating. I had other issues going on in my life. What do I do? And it was like I was kind of shrugged off” (P6).

“I called […] one of the directors of [provider] […] to basically tell her how I felt about what happened etc. And she kept denying it said, well, you know, everyone else seems to be happy. I said well that's not true because I know for a fact that two were discharged and one basically raised the same issues of lack of support, no understanding and nobody was there to answer the phones or no one’s replying to emails, lack of people who care” (P1).

“And when I didn't get a call back, I'm not going to keep calling them because if they can't even pass the message on or somebody can't even phone, to me what's the point? If they can’t look after the people on the programme” (P4).

“they did ask me; can you continue to do the measurements? And I'm thinking, I'm going to bury my brother, I just can't deal with this” (P7).

“Basically, you had a call centre and background staff with a dietitian or something. There was no GP, no nurse, no physio, no what else did I get, can't remember now but there was more staff mentioned” (P4).

“I didn't have the psychological support that I needed or mental health support that I needed because I couldn't see anybody” (P1).

“I've got no help with my mental health. They’ve closed it all down. I don't have anything. I'm just left to my own devices” (P2).

“it’d be easier if they could say this is, let me give you a proper meal plan, even if it wasn’t, they provided you the ingredients. If they gave you like an actual meal plan and that they could then actually sit there and, and if they had like a general two week meal plan and then they could go through it with me and say well what can we tweak with this so we can make it so that you can eat it as well” (P5).

“I think a lot of it is the mental health, because if I have structure then mentally I can. So mentally I can do my day like today I knew 2 o'clock I’m going to speak to you. I know this morning at 10:30 I had to do something” (P6).

“I think I would have benefited if they, if like the meeting before the food reintroduction they’d kind of said right what are you gonna have for your first meal? Or what meal are you gonna eat your first meal and let's, let's decide what you're gonna make. Like, make it a bit more helpful in that sense, rather than just talking through about, I don’t know, all the, have you looked at all the modules that that they do?” (P5).

“I was thinking about it and I thought, why did I really leave? And it was like it was actually because there was no structure and for somebody who I like structure, I like guidance, I like if we're going to do some this, what we're going to do this, how we're going to do it” (P6)

“I said I didn't want to be kicked off. ‘You won't be kicked off; we'll try and get you some help’. Blah, blah, blah. Next minute a letter saying you're off” (P2).

“It’s unempathetic, apathetic. You know it just seems unsympathetic. It just seems so dispassionate. It’s like well we don’t care that you’ve got to deal with that. This is your problem now. There you go. It's almost like someone giving you P45, cheers, thanks, bye” (P1).

“I mean I was able to adapt with my mental health providers that there was a gap between one appointment and the other and if I needed to make a phone call I could. So, I was coping. So, I was managing that. But all that happened with [provider] is a direct correlation to the state that I was in and the suicidal tendency that I had and everything that I suffer as a result. So, I mean I'm not going to exaggerate, but yes they caused me harm” (P1).

“So, like I felt like I was going, and I was wasting his time and my time because I was ‘because I'd have like a day where I'd do it and then about three days when I didn't, if you know what I mean, when I’d just eat what I wanted to eat, and what, what made me feel OK. So, I kind felt like I was, I wasn't doing it so what was the point, if that makes sense? So, it stressed me out then I'd try again and then I'd go, it's like a vicious cycle really, that I'd keep trying to eat, eat this food. And then, then I'd be ill, and I'd go back to eating. And it kind of went round and round like that” (P5).

“I just, with how they’ve tret me I just feel cheated out of all of this because I think I could have done really well on that programme. I really really do. I did have really good hopes and expectations and I just feel totally, totally, and utterly cheated. They took that away from me” (P9).

“I felt they should have stopped me, and they should have put me on another group. Because it wasn’t, I pulled out because I don't like this or. It was just they need to have that process because it, I really I don't think well of them” (P7).

“I feel like I hit a bump and then they just ignored that bump to think oh she’ll just be alright. We'll speak to her at the next meeting, not knowing that some people with my kind of mental health will just be like I'm not coming to your next meeting” (P6).

“I called back before I think it was in the summer and I had issues, I wasn't particularly well. And I called left a message. Now I can’t remember the person’s name, but this is the person that never picked, that I never spoke too before. So, it was someone else, but still a part, and I left a message, a detailed message, OK, I won't be able to do the meeting because I'm feeling unwell, please call me back. I didn’t get a call back. I called back two weeks and I said, well, you didn’t get my message. No, no, we didn't get any message. So, nobody cares. Nobody cares or even writes a message down on the piece of paper or nobody cared to even let somebody know, or nobody just cared. That's all. Complete apathy, complete, you know, like oh why should I bother?” (P1).

“the food I was eating when I started eating again, it was only Aldi anyway, so it was only cheap. So, it's not like the foods expensive. And it's like it was just literally a lack of structure. I like structure. I like to know in my day this is my day, that's how it's going to go” (P6).

“But when I did decide to withdraw, there was, they kind of they’ve sent me a letter saying I've withdrawn. But there was never a why did you withdraw, like from the company itself. Obviously, I spoke to the, the coach. I went and saw him and said look, I'm withdrawing. But they never kind of followed up saying like, why did you withdraw? What could? Is there anything we could do to for you to stay, sort of thing or anything like that? They were just like, OK then bye” (P5).