A fresh start with high hopes: a qualitative evaluation of experiences of the Total Diet Replacement phase of the NHS Low Calorie Diet Programme pilot

CATHERINE HOMER,¹ KARINA KINSELLA,² KEVIN JAMES DREW,² JORDAN MARWOOD,² TAMARA BROWN,² SIMON ROWLANDS,² DUNCAN RADLEY,³ CHARLOTTE FREEMAN,² ABIMBOLA OJO,⁴ JENNIFER TEKE,⁴ KEN CLARE,² CHIRAG BAKHAI,⁵ LOUISA ELLS²

¹ Sport and Physical Activity Research Centre, Sheffield Hallam University, Olympic Legacy Park, Sheffield
² Obesity Institute, School of Health, Leeds Beckett University, City Campus, Leeds
³ Obesity Institute, School of Sport, Leeds Beckett University, Headingley Campus, Leeds
⁴ Re:Mission Patient and Public Involvement Group, Obesity Institute, School of Health, Leeds Beckett University, Leeds
⁵ Larkside Practice, Churchfield Medical Centre, Luton, Bedfordshire

Abstract

Background: The National Health Service (NHS) Low Calorie Diet (LCD) programme in England aims to support people with type 2 diabetes (T2DM) to lose weight, improve glycaemic parameters and potentially achieve diabetes remission. The programme pilot launched in 2020 using three different delivery models: one-to-one, group and digital via an App. Service users begin the programme with 12 weeks of Total Diet Replacement (TDR). This study aims to understand the experience of this TDR phase from the service user perspective.

Methods: This was a co-produced qualitative longitudinal and cross-sectional study, underpinned by a realist informed approach using semi-structured interviews and photovoice techniques. Service users (n=45) from the NHS LCD programme were recruited across the three delivery models and 21 pilot sites in England. Data were analysed using a thematic approach.

Results: Participant demographics were representative of the overall LCD pilot population sample and included experiences from a mix of delivery models and providers. Three themes were presented chronologically. 1) life pre-LCD: the LCD programme was viewed as an opportunity to reset eating behaviours and improve quality of life; 2) experience of TDR: flexibility in allowing supplementary non-starchy vegetables and adapting the flavour and texture of TDR products supported adherence; 3) looking ahead to food reintroduction: at the end of the TDR phase, weight and glycaemia had reduced, while subjective energy levels and mobility improved. Some participants were concerned about progressing to the food reintroduction phase and the possibility of weight regain. Conclusions: The paper reports insight from the TDR phase of the LCD programme. The co-production of this work has resulted in several recommendations for policy and practice which have informed the national roll out of the programme.

Br J Diabetes 2024;24(1):60-66
https://doi.org/10.15277/bjd.2024.435

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

Introduction

An overview of the 52-week Low Calorie Diet programme (now known as NHS Type 2 Diabetes Path to Remission Programme) has previously been reported.¹ Although clinical trials have demonstrated the clinical efficacy of Total Diet Replacement (TDR) approaches in driving weight loss, glycaemic improvements and diabetes remission in people with type 2 diabetes (T2DM) living with overweight or obesity,^2,3 there is a lack of qualitative data examining the service user journey. This is important given the wider population reach and delivery constraints within real-world implementation. It is therefore critical to explore service user experience, in order to understand what worked and what did not, for whom, why, and how the programme could be improved in the future.

This paper reports on the qualitative insights from a socio- demographically diverse range of service users after they completed the first phase of the programme. It explores their reasons for taking part in the programme, their experience of the first 12 weeks and their looking ahead to the reintroduction of food. This first phase of the programme comprises 12 weeks of following a diet composed solely of nutritionally-complete TDR products, alongside regular (a minimum of eight) behaviour change support sessions. The TDR products range in variety and can include soups, shakes and bars that provide a total energy intake of 800-900 kilocalories per day. When service users are unable to comply with full TDR, they may introduce a single meal of non-starchy vegetables, or substitute a single TDR meal for a nutritionally appropriate meal of no more than 300 calories. Fibre supplements are also provided to all service users during this phase, with advice to consume 7g per day.⁴

Methods

This article details the methodological approach taken using the COREQ guidelines, see the consolidated criteria in supplementary file 1 below.

Longitudinal interviews and photo elicitation were undertaken with 30 participants at the end of the TDR phase (12 weeks) (see participant characteristics summary table 1 in supplementary file 2. An additional 15 participants were interviewed cross-sectionally at six months, to plug any gaps in terms of representativeness of the longitudinal population (see participant characteristics summary table 2 in supplementary file 2. Any insights captured during the cross-sectional interviews that related to the TDR stage are also incorporated. All participants were recruited via the Re:Mission study survey or through an invitation from their service provider, and provided informed consent to participate.

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

Methods have previously been reported in full but, in brief, semi-structured interviews were conducted online using Microsoft Teams:1 12-week longitudinal interviews were conducted by KD and CH, who were supported by three Patient and Public Involvement (PPI) group members (KC, JT, AO),⁵ where PPI support was requested by the interviewee (n=11). Twenty-one of the 12-week interviewees shared photos, films, or audio recordings with the researcher via a secure file transfer link and explained the meaning behind the photos, films or audio recordings during the interview. KK and CF undertook the six- month cross-sectional interviews.

All interviews were transcribed verbatim and subjected to thematic analysis.⁶ Researchers (CH, KD, TB, KK, JM, SR) independently familiarised themselves with five transcripts from the 12-week interviews. An initial list of codes was identified by each researcher using the interview schedule as a deductive framework and this was discussed as a group. This led to the development of an initial framework from which each researcher then inductively coded five transcripts and added any additional codes. This stage also included a focus on the narrative that accompanied any images and recordings. All researchers met again to discuss additional codes, and CH and KK revised the coding framework accordingly. Cross-sectional interviews were coded by KK and any data relevant to the TDR stage were coded and included within the 12-week framework. Data were stored and organised using NVivo Software (QS International Play Ltd. Version 12.6).

Results

Participant demographics were representative of the overall LCD pilot population sample, according to interim data presented to the advisory group in summer of 2023. Participant characteristics are shown in Table 1.

Themes from the interviews are presented chronologically through the patient journey.

Life pre–Low Calorie Diet programme (Table 2)
Interviewees were asked to reflect on what their life was like prior to starting the LCD programme. For most participants, living with obesity and T2DM severely affected their daily lives. Physical health impacts included lethargy, loss of mobility, oedema, headaches, frequent urination and other broader health conditions. One participant shared a picture of the chair they had slept in for three years as a result of their weight and health conditions (see supplementary file 3). Psychosocial impacts of living with obesity led to avoidance of social situations, increased self-reported anxiety and depression. Participants reported using diet, exercise and medication to control their T2DM and manage their weight. Participants attributed their T2DM to a range of dietary habits and behaviours, from struggling to eat regular healthier meals, over- consumption of food and ‘bad habits’ exacerbated by the COVID-19 lockdowns. Weight cycling (losing and regaining weight) was a prominent theme in nearly all interviews. Poor mental health, lifelong emotional eating and perceived addiction to food were often cited as a response to manage anxiety or stressful situations. Exercise routines were reported to be impeded by barriers such as health problems, access, cost and work, with a lack of exercise cited as leading to further weight gain. Medications for T2DM and other co-morbidities were reported as compounding efforts to lose weight.

Most participants were prescribed medication to manage their T2DM and they reported unpleasant side effects. The aspiration of not requiring diabetes-related medication was viewed as a key driver for starting the LCD programme. Motivations for starting the programme also included the potential for improvements to current health and fear of future poor health, often linked to having seen premature morbidity in family members.

The LCD programme was viewed as an opportunity to reset emotional responses and relationships with food by taking a complete break from normal food preparation and consumption. Readiness to change was perceived by participants to be essential in the run-up to starting the LCD programme. Participants shared feelings of excitement for the future, anticipation of better health, quality of life, and desperation to change their current situation. The TDR element of the programme gave rise to expectations of rapid initial weight loss accompanied by requirements to stop glucose- lowering medications.

Experience of the Total Diet Replacement (Table 3)
Participants from all delivery models were provided with four TDR products each day for 12 weeks. The perceived quality and options of products varied across the providers: some offered a wide range of flavours and options (n=97 products), while others had a more limited selection (n=6 products). The acceptability of TDR products was influenced by several factors such as taste, variety, palatability of taste and texture, and cultural familiarity. Hunger and cravings were common experiences and the addition of non-nutritive items like teas and chewing gum was common practice. Participants were provided with fibre supplements, and some reported relying on them to manage constipation. Participants often adapted the taste of TDR products by incorporating spices and sugar-free syrups (see supplementary file 3 for images). Participants also found ways of adapting the form of TDR products by turning shakes into ice lollies or baking the mixture to make macaroons. Allowing supplementary foods such as non-starchy vegetables or calorie-controlled meals as a substitute for a single TDR meal provided important flexibility which helped individuals stick with the programme. One provider allowed participants to use ‘joker cards’ (one day of ‘normal’ food in the 12 weeks). Adherence was also influenced by the sense of control and convenience that the TDR products offered.

Participants reported rapid improvements in their weight and blood glucose levels during the TDR phase. Some reported significant levels of weight loss of up to 20% of starting body weight. Other reported outcome measures included feelings of increased energy, mobility, functional fitness and improved self- esteem. Participants shared pictures of things they could now do because of the weight loss such as painting their toenails (see supplementary file 3. Conversely participants also reported some negative impacts such as constipation, tiredness and feeling cold.

The support of family and friends was discussed positively as a source of support and motivation during TDR. However, social isolation and avoidance of social situations where food was concerned was also common. In the home environment some participants talked about their family eating in other rooms so not to tempt them with food, and others had to continue to cook meals for their family. Where available across the different delivery models, some participants found peer support from other LCD service users helpful, whether gained through WhatsApp groups (group delivery model) or online community forums (group and digital model). On some occasions, particularly in group sessions, some people reported that the peer support groups were not cohesive. The need for some form of peer support was highlighted within the 1:1 delivery model.

Looking ahead to food reintroduction (Table 4)
The second stage of the LCD programme (weeks 12-18) was food reintroduction (FR), when service users were supported in their transition from TDR products back to normal meals. Participants interviewed at 12 weeks shared their hopes and concerns as they embarked on this next stage of the programme. Expectations around meeting weight loss targets and improving blood glucose levels were high, due to the rapid improvements experienced in the first 12 weeks of TDR. However, the prospect of reintroducing meals also drove apprehension that weight loss would slow, and there could be weight regain, thereby undoing the positive changes they had experienced. Participants discussed how the control they felt whilst using the TDR products would be removed, as they had to make choices about food again. Participants were concerned about the challenges of planning meals for themselves and others around them who might want to eat differently. Participants talked about the strategies they were planning to use to manage their diets during FR, such as spreadsheets to record calories and meals and food shop planning. Discussions also focused on the potential continued use of TDR products, with some participants indicating they might continue using TDR products (outside the programme specification) for convenience and to sustain weight loss.

Discussion

In this paper we have explored the experiences of participants who completed 12 weeks of TDR. Their experiences of living with excess weight and T2DM influenced their motivation to take part in the programme. The reset that participants sought from the TDR, and their associated expectations of changes to health and quality of life, were similar to the expectations of people seeking other weight loss interventions and bariatric surgery.⁷ Participants were very focused on weight and glycaemic outcomes during the TDR phase, and many experienced immediate positive effects related to starting the TDR products. The general positivity at this early stage is perhaps not surprising given the rapid weight loss and improvement in glycaemia that are reached.⁸ Participants’ focus appeared not to be on weight loss per se, but on weight loss to control T2DM, which can help improve long-term weight maintenance.⁹ Participants also discussed other psychosocial issues that were important, as well as personal motivation related to the desire to improve associated health outcomes related to weight loss. This finding was also reported in the qualitative evaluation of the DiRECT study,¹⁰ and may support long-term management: this is improved when motivations are aligned with personal values and preferences,¹¹ and when patient-reported outcome measures are used.¹²

Personal motivation and sense of control were constantly challenged in everyday life, with adaptations to home life and social situations commonplace whilst undertaking TDR. These findings reflect the importance of recognising the wider environment and systems that influence behaviour.¹³ Placing behaviour inside the system rather than just on the individual allows us to identify how the individual and system interact,¹⁴ and to move away from an individual focus to more holistic person-centred care.¹⁵ The identified importance of peer support also aligns with evidence from other peer support interventions that are associated with significant short-term weight loss.^16,17

Participants reported that using TDR gave them a sense of control over their energy consumption that they struggled to manage within their standard diet. Participants reported feeling anxious about food reintroduction, with some participants planning to continue using TDR products outside the programme specification. A person-centred approach which seeks to understand the intentions and motivations of individuals who plan to continue to use TDR products could reduce anxiety and provide strategies to discourage longer- term TDR usage. Previous analyses have shown binge eating and emotional eating to be prevalent in this population.¹⁸ Although it is recognised that extreme restriction and control over food are risk factors and symptoms of disordered eating,¹⁹ the long-term impact of TDR programmes in this context is not yet well established and is a key area for future research.

Overall, the evidence generated from the interviews shows the importance of taking a person-centred approach if we truly want to help people living with obesity and T2DM to maintain a healthy lifestyle.

Strengths and limitations
This is the first qualitative study to explore the lived experiences of service users who have attended the NHS LCD programme. Despite repeated efforts to engage service users from all service providers, this was challenging as the level of engagement in the evaluation process varied hugely between providers. A limitation of the data reported in this paper was the low number of participants from diverse minoritised ethnic groups. Barriers to compliance with the programme disproportionately impact people from minoritised ethnic groups. We have some understanding of how ethnicity and socioeconomic status intersect. This was presented in the paper by Dhir,²⁰ which interviewed 12 services users identifying as South Asian ethnicity and through the perceptions of the commercial providers.²¹ Representation was however strengthened by the addition of reflections from the cross- sectional data. This paper presents outcomes at 12 weeks into a 52-week programme and, as such, the positive outcomes experienced at this point may not be reflective of outcomes reported at the end of the LCD programme. The use of photovoice methodology gave power to the participants in the research process as they used prepared visual methods and audio recordings to illustrate their points.

Recommendations for policy and practice

1. Opportunities to encourage peer support in different forms (web-based, online) should be routinely promoted by providers.
2. TDR sessions need to be person-centred, recognising that a one-size-fits-all approach is not readily amenable to meeting the individual needs of service users.
3. Including Patient Reported Outcome Measures (such as increased energy, feeling happier) as well as clinical outcome measures in service monitoring and data collection may aid motivation and expectation of outcomes from the service user perspective.
4. Coaching sessions during the TDR phase should prioritise supporting readiness for food reintroduction, including support for behaviour change, targeted support regarding emotional or disordered eating, managing expectations and addressing fears regarding weight gain and loss of control.

Conclusions

Reducing the biopsychosocial impacts of living with T2DM and excess weight are a motivator for people starting the LCD programme. The experiences of people at the end of the TDR phase are largely positive, with service users reporting significant weight loss, improved glycaemia and better quality of life. TDR provides control and structure for people who seek to change their eating behaviours. As participants begin to transition from TDR, some reported experiencing anxiety regarding reintroducing food and how this may impact on weight and blood glucose. This co-produced study sought to explore the experience of service users at the end of the first 12 weeks of the LCD programme. Several of the recommendations for policy and practice have already informed the national roll out of the programme and have been incorporated into its new specification.

© 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 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 Tanefa Apekey, Dr Stuart Flint, Prof Janet Cade, Dr Adam Martin, Dr Tayamika Kamwanja, Dr Maria Bryant, 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

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

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; 19: 349 – 57.

Personal characteristics of interviewers:

Dr Catherine Homer PhD (Female). Associate Professor of Obesity and Public Health with experience working in academia and extensive experience working in public health.

Karina Kinsella MRes (Female). Research Officer for the Re:Mission Study with extensive experience of evaluating interventions.

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

Dr Jordan Marwood PhD (Female). Research Fellow with extensive experience conducting obesity research with particular focus on disordered and emotional eating.

Dr Tamara Brown PhD (Female). Reader in Obesity, with 5 years’ experience of focus groups and research in weight management.

Dr Simon Rowlands PhD (Male). 25 years’ experience in public health practice, research and education with specialist interest in obesity and men's health.

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

Charlotte Freeman (Female). Research Officer for the Re:Mission Study with experience of evaluating interventions in academia and experience of working in public health.

Dr Abimbola Ojo PhD (Female). Member of the Patient and Public Engagement team for Re:Mission and Local Authority Public Health Specialist.

Dr Jennifer Teke (PhD) (Female) Member of the Patient and Public Engagement team for Re:Mission and Hospital Trust Research Manager.

Ken Clare (Male) Patient and Public Engagement Lead (Obesity Institute at Leeds Beckett University) and Director of Operations (Obesity UK) and chair of Board of Directors European Coalition for People Living with Obesity.

Dr Chirag Bakhai (Male). General Practitioner, Clinical Lead on the Re:Mission Study Oversight group and Primary Care Adviser 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: Participant characteristics

Supplementary file 3: Photovoice and quotes