Comparing the acceptability of total diet replacement and food-based low energy diets for type 2 diabetes remission amongst South Asians: a public and patient involvement activity

Background With type 2 diabetes prevalence rising, low energy diets (total diet replacement and food-based low energy diets) are increasingly used to induce weight loss and achieve diabetes remission. The effectiveness of these diets has been primarily tested in the UK white population but not in the south Asian population at high risk of diabetes. Obtaining the opinion of members of the community on what would constitute a culturally acceptable diet is essential for successful interventions aiming to achieve diabetes remission in south Asians. Methods We organised two patient and public involvement activities in the North West of England to understand views of people from the south Asian population on whether low energy diets (850 Kcal) in the form of total diet replacement or food-based meals, are acceptable dietary interventions to achieve type 2 diabetes remission. Results Thirteen people, with either type 2 diabetes or having someone with diabetes in the family attended a virtual or a face-to-face meeting. Low energy total diet replacement in the form of soups and shakes was considered unacceptable, while there was a preference for a culturally tailored low energy food-based diet. Ready-made portion controlled catered meals were suggested as a likely approach to improve adherence. Conclusions This work provided valuable insights to shape a future study looking at the feasibility of a catered meal low-energy dietary intervention to induce T2D remission in primary care within the south Asian population.


Background
With type 2 diabetes prevalence rising, low energy diets (total diet replacement and food-based low energy diets) are increasingly used to induce weight loss and achieve diabetes remission.The effectiveness of these diets has been primarily tested in the UK white population but not in the south Asian population at high risk of diabetes.Obtaining the opinion of members of the community on what would constitute a culturally acceptable diet is essential for

Amendments from Version 3
In response to reviewers' comments, the report has been revised to include applicable elements of the GRIPP2 checklist (highlighted in the document).The checklist has been also added to the extended data 20 .In the report, the following statement has been added "We aimed to report the activities based on the international consensus for reporting PPIE activities in health and social science research (GRIPP2 guidelines) (Extended data 20 ), which aim is to improve the quality and consistency of reporting patient and public involvement in research 24 ".
Additionally, the report has been amended to include further details about the involvement of the community representative in the research team and in future grant applications as a "community delivery partner".The report now reads, "The community representative has been recruited to be part of the research team and was costed in the grant application as a "community delivery partner.They will assist in facilitating group panel meetings throughout the study and planning dissemination activities, either directly or through the recruitment of a public contributor belonging to the same community." Any further responses from the reviewers can be found at the end of the article

Introduction
Type 2 diabetes (T2D) rates are increasing worldwide causing significant health and economic impacts 1,2 .It is estimated that 4 million people (6% of the population) in the UK have T2D 1 .Diabetes UK has been committed to address the increased diabetes prevalence in the UK population, and has invested heavily in ground-breaking research looking to treat T2D and reduce the pressure on the NHS 3 .Diabetes UK-funded primarycare based trials were the first to report that T2D can be put in remission through weight loss brought about through low energy diets (~850 Kcal) in the form of total diet replacement (TDR) 4,5 , and efforts are now made to provide low energy (850 kcal) food-based alternatives in primary care 6 .
These approaches have been shown to be effective primarily in the white population in UK studies, and similar rates of weight loss have been shown to achieve T2D diabetes remission in a Middle Eastern population 7 and in small populations of south Asians living in India 8,9 .However, their value has largely not been considered in the south Asian population, the second largest ethnic group in the UK, who have significantly higher prevalence of T2D diabetes compared to the white population 10,11 .South Asians have been historically less successful in weight loss programmes compared to white individuals, with greater reluctance to lose weight and a lesser body dissatisfaction 12,13 .The lack of consideration and knowledge of ethnic-specific foods amongst educators has been suggested as a barrier for success 14 in this population for whom food constitutes an important social tradition, drawing on major socio-cultural differences and variances in dietary habits when compared to other ethnicities 15 .Therefore, obtaining the opinion of members of this community on what would constitute a culturally acceptable diet plan could help design an effective low energy dietary intervention in type 2 diabetes.
The south Asian population has been majorly underrepresented in large national diabetes studies, which has limited culturally appropriate evidence-based recommendations 16 .The barriers and facilitators to participation in health and T2D diabetes research within the south Asian population (such as perceived participation to improve health, cultural and language barriers, and lack of interest) have been described elsewhere 17 .It is therefore important to look at the suitability and barriers for success for low-energy interventions as a means of inducing T2D remission in this population.
Patient and public involvement refers to actively including service users and communities in designing and carrying out research, leading to a better success in clinical interventions 18 .We therefore organised two patient and public involvement activities in the NorthWest of England on the 1 st and 2 nd of September 2021, with the aim of informing on several elements of T2D diabetes dietary interventions, including choice of diet (TDR or food-based), acceptability of measurements tools used in the study (quality of life questionnaire, step counters, diet diary collection) and barriers and facilitators to participation and adherence.

Participants
Patients and family members were recruited face-to-face and by telephone through a GP practice and with the assistance of a community education representative with strong community links helping to spread the word within different sub-ethnic populations (Pakistani, Bangladeshi and Indian groups) in community local groups.Invitations included the researchers' contact details and were sent out by email and "Whatsapp" application either by the researcher directly or through the community representative.Overall, 18 people were approached, and 13 people accepted the invitation.Inclusion criteria included men and women over 18 years of age from a south Asian background who are either patients with type 2 diabetes or have someone with type 2 diabetes in the household.English and non-English speakers were invited to attend, and the community representative was available to help with the translation.

Meeting information
Meetings were held at the planning stage of the study protocol.Five people living with diabetes attended a virtual meeting (4 women and 1 man), and 8 women who either have diabetes or who live with people with type 2 diabetes in their household, attended a face-to-face meeting at the Ghausia community centre (Burnley, Lancashire, UK).The face-to-face meeting was to support gender representation in a community where gender segregation is an important barrier 19 .Additionally, the face-to-face meeting was aimed to overcome internet illiteracy which would normally hinder participation.Both meetings were facilitated by the researcher (GF, PhD, female) with the help of a community representative (SM) who have prior experience of leading meetings in the community and who joined both panels and helped overcome language barriers.The researcher had no prior links with the community and was presented to the panel as a University lecturer interested in diabetes research.Each meeting lasted for one hour.Participants were emailed information on the planned topics of discussion prior to the meetings and were provided with additional paper copies during the face-to-face meeting (Extended data 20 ).The information pack comprised an example of a diet consisting of soups and shakes to be consumed for 12 weeks, a 3-day low energy food-based diet plan [they were provided with information to explain that the diet has Mediterranean components (olive oil, fruits and vegetables) which have beneficial effects on remission of T2D and cardiovascular health] 21,22 as well as information on the use of step counters.We provided gift vouchers (£20) as an acknowledgment for volunteers' participation.
Questions asked during the meetings are listed in Table 1.Audio recordings were made of the meetings, and the researcher also took field notes.

Data analysis
Interviews were first transcribed verbatim by the researcher (GF), and a detailed summary of all responses was then produced.This summary was reviewed by the community representative.Relevant information was retained and included in the report.

Ethical considerations
As this is a patient and public involvement and engagement work, ethical approval was not required, as per NIHR guidelines.
Participants provided written informed consent to participate in the work and for their statements to be published anonymously.

Results
Characteristics of attendants are presented in Table 2.
Views on the use of total diet replacement Overall, 11 out of 13 people stated that TDR for 12 weeks was an unacceptable intervention.Older people (n=3) felt that they would be particularly unwilling to follow this type of diet, and their perception is that solid foods must be included to have a fulfilling diet.They provided examples of their preferences, as stated below: "Soups and shakes could be a short-term fix (2 weeks or so) but not a diet that could be adopted for 3 months" - Low energy food-based diets are more acceptable Panels were provided with an example of a 3-day meal plan low energy food-based diet.They were provided with information to explain that the diet has Mediterranean components (olive oil, fruits and vegetables), which have been shown to have beneficial effects on the prevention and management of type 2 diabetes and cardiovascular disease.
Eleven participants reported that the food-based diet would be more acceptable than TDR, but there was a unanimous opinion (n=13) that it would have to be culturally tailored to the south Asian population.There was a strong message that the use of spices is essential for acceptance of the intervention, as well as the inclusion of staple foods (chapati, rice etc..).For those born outside the UK (n=8), it was reported that it would be crucial that they adhere to a strict traditional diet as this is linked to their home culture, while south Asians born in the UK were more willing to accept non-traditional foods.Below are some statements reported by the panels: "Set-up meal plans (e.g., 14 menus) are preferred" -All participants "Add more vegetables that could be cooked with less oil" -Participant 3 -Female (40-65 years) Set-up catered meal plans are suggested as a convenient option While discussing food-based diet preferences, two members of the panel went on to discuss the idea of providing ready-made portion controlled catered meals.The idea received enthusiasm from the whole group, and it was suggested that this would be an excellent way to improve adherence among people, educate them on portions/ingredients, and give them an idea about cooking methods for when they planned to prepare similar meals for themselves.

"Meal plans will help me understand what ingredients and portions to use so I can then later on prepare food by myself" -Participant 1-Female (40-65 years)
Support: family and community The facilitator asked whether the presence of family and community support would be essential for the success of the intervention.Panels stressed the importance of peer support in the weight loss and diabetes remission journey.This includes peer support group meetings within the community (n=1).Patients (n=2) also welcomed the idea of having family members attending appointments and helping overcome language barriers.However, it was mentioned that "some meanings could be lost in the translation" (n=4), thus a translator with more expertise could be of greater help in conveying accurate information to patients.Another participant mentioned the potential importance of peer support group meetings in achieving adherence.

Other components of the intervention
Other outcome measures such as the use of step counters was deemed acceptable (n=13), but only after the community representative explained their use to both panels.However, reporting diet through a phone app was reported to be unsuitable by 11 people.Therefore, using a paper record was preferred by the majority.

Taking part in diabetes research studies
Participants expressed their enthusiasm in taking part in the study should it be funded.Five patients were very keen to follow an intervention that could achieve remission.Importantly, one participant stated that diabetes was not perceived as a major risk that requires action due to it being very common among their community.Participants (n=13) unanimously stated that they had not taken part in research studies before because they have never been approached.This statement is in line with the findings of a previous report showing that people from this population did not participate in research studies because they have never been asked 17 Widening recruitment strategies is an important point to consider in future research.

Strengths and limitations
This report has several strengths.To our knowledge, this is the first activity that gauges the opinion of individuals from the south Asian population regarding the acceptability of TDR or food-based low-energy diets and empower them to participate in Although including a Mediterranean component in the foodbased diet (together with its potential beneficial effects) might have made the food-based diet appear more positive, this particular element was not the subject of discussion in both activities.All panel discussions focused on the culturally appropriate elements in the food-based diet such as spices and traditional foods) that made it more appealing.
future culturally tailored interventions to induce T2D remission.
In addition to a virtual meeting, we used face-to-face meetings to overcome internet illiteracy.The presence of a community representative helped overcome language barriers and gain insights from both English and non-English speakers.We aimed to report the activities based on the international consensus for reporting PPIE activities in health and social science research (GRIPP2 guidelines) (Extended data 20 ), which aim is to improve the quality and consistency of reporting patient and public involvement in research 24 .
There are some limitations.Whilst attempts were made to ensure that the group of people was representative of the background population, the small number of participants and our recruitment methods could have impacted the conclusions drawn from these meetings.The predominance of women, people from Pakistani/Bangladeshi background and those from low socio-economic groups in this activity might have limited the generalisability of these insights in males, other south Asian population subgroups and people from higher socio-economic backgrounds.However, these activities were helpful in gathering insights from underrepresented and more traditional south Asian groups.Information could have benefited by being reviewed by more than one researcher to reduce potential researcher bias.There may also have been social desirability bias amongst the PPIE group.Additionally, our description of the potential health benefits of a Mediterranean diet may have positively impacted how participants viewed the food-based diet.Lastly, the lack of knowledge and use of TDR might have affected their acceptability.White individuals have previously expressed negative perceptions of TDR too, yet their opinions changed after use 25 .Future research will be able to identify whether this will be the case in the south Asian population.

Clinical and research implications
The community representative has been recruited to be part of the research team and was costed in the grant application as a "community delivery partner".They will assist in facilitating group panel meetings throughout the study and planning dissemination activities, either directly or through the recruitment of a public contributor belonging to the same community.
Information from this activity including participants from a more traditional south Asian sub-group, suggest that TDR may have limited acceptability in this patient population.This work was pivotal in making changes to the project proposal, including study arms (we have reconsidered the addition of a TDR arm), outcome measures and dissemination tools.The potential utility of a food-based low-energy intervention was suggested, including looking at the feasibility of administering catered meals in primary care.Catered meal plans will be prepared together with members of the community and patient support members.An education element to increase knowledge of T2D risk and healthy eating was considered.This research for people with diabetes from the south Asian population will be promoted through the Greater Manchester Strategic Clinical Network and the Research for the Future campaign.This activity could potentially have economic benefits in terms of developing future interventions tailored to this population.As for future PPIE planning activities, more efforts into considering language barriers and cultural differences will improve the usefulness of this information and improve future research.

Conclusions
The south Asian population is an important target group for interventions designed to induce T2D remission.This activity does not negate the use of TDR in this population but provided useful insights to shape a future study looking at the feasibility of food-based interventions for T2D remission in primary care in a high-risk population.This work aims to encourage more patients to become involved in T2D research, which may lead in the long-term to improved quality of life, health, and economic benefits.

Extended data
Zenodo: Comparing the acceptability of total diet replacement and food-based low energy diets for type 2 diabetes remission amongst south Asians: a public and patient involvement activity, https://doi.org/10.5281/zenodo.572075420 .
This project contains the information sheet that participants were provided with before and during the meetings.

Julie Abayomi
School of Medicine and Nutrition, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK Thank you for asking me to review this interesting and well written paper.The research is timely and important as achieving T2DM remission in the south Asian population is much needed.It is interesting to read that participants rejected the idea of meal replacements (soups and shakes) but were open to the idea of low calorie diets that included real, but culturally appropriate food.These findings will certainly help to influence culturally appropriate interventions for T2DM remission in the South Asian population in future.
I have only a couple of suggestions to make and they both relate to the PPI aspects of the paper: There are now international guidelines published, regarding the reporting of PPI, see GRIPP2 (Staniszewska et al., 2017 1 ).It would be helpful for this paper to refer to these guidelines and show how the methods and findings relate to GRIPP2 guidelines.

1.
To ensure that the main follow up study has adequate PPI throughout (from research design to dissemination of findings), did you use this initial work to recruit PPI representatives, to be part of the research team and costed in the grant application for the main study?Could the community representative be considered as a PPI rep for this present study?If so this would follow GRIPP2 guidelines and they should be named as a coresearcher and Co-author on the paper. 2.

Grace Farhat
Many thanks for reviewing our manuscript.We are very grateful for providing helpful comments.Here, we respond to these point-by-point.
There are now international guidelines published, regarding the reporting of PPI, see GRIPP2 (Staniszewska et al., 2017 1 ).It would be helpful for this paper to refer to these guidelines and show how the methods and findings relate to GRIPP2 guidelines.
○ Response 1: Thank you for referring to the guidelines.In response to this helpful comment, the report has been revised to include applicable elements of the GRIPP2 checklist (highlighted in the document).The checklist has also been added to the extended data 20 .
The following statement has now been added to the report:

Department of Internal Medicine, Leiden University Medical Center (LUMC), Leiden, The Netherlands
This paper describes the results of a "patient and public involvement activity", gathering patient (and family members) viewpoints on meal replacement / food-based strategies for weight loss in the treatment of type 2 diabetes (T2D).As most clinical studies evaluating the impact of calorie restriction in T2D were done in Caucasian people, while South Asians are particularly prone to develop the disease and constitute a considerable part of the British (and global) population, the study specifically recruited people of South Asian background.18 people were approached, 13 (of whom only one was male) agreed to participate.5 of them attended a virtual meeting and the rest came together for a face-to-face gathering.Viewpoints on total diet replacement vs food-based low-calorie diets, acceptability of questionnaires and wearables, as well as (culturally specific) barriers to follow low-energy diets were identified.The authors claim that their results indicate that meal replacement strategies are unacceptable to the South Asian population.Instead, culturally tailored food-based interventions are preferred.The use of online tools to report diet was presented as unsuitable, while quality of life questionnaires (which ones?) were apparently OK.
The study design and interpretation of the data have several flaws in my opinion.
It seems not appropriate to use the opinion of 13 people, of whom 12 are female, as representative for the South Asian population.Moreover, only 9 of 13 people were actual patients.4 were family members whose opinion was apparently used to represent the view of relatives/caretakers.The authors fail to scientifically substantiate the generalizability of their conclusions.

1.
Unfortunately, the paper does not report the reasons for unacceptability of the meal replacement strategy.It doesn't even specify the composition of the replacements (it only says "soups and shakes").In my experience, the taste of meal replacement products is critically important for their acceptability.In addition, social hurdles (not being able to have dinner with friends) are an issue with meal replacement, but this supposedly hinders compliance with food-based strategies as well.Anyway, it seems short-sighted to reject the option of all variants of meal replacement and advocate the use of any food-based strategy on the basis of a single survey evaluating a very limited number (2?, not specified) of options.

2.
It is unclear from the list of questions provided in table 1 for how long the patients were supposed to follow dietary prescriptions.And this conceivably matters a lot.For example, using total diet replacement for 1 week every months may be perfectly acceptable for 3.
people.Was this an option?Or was dietary intervention primarily meant to induce significant (> 10%) weight loss (as in DiRECT) and therefore very likely to be long-term?
The acceptability of questionnaires, e-health tools and online reporting instruments heavily depends on their design and ease of use.The paper does not report which tools were judged by the participants.Eventually, such instruments need to be tested in clinical practice to draw decisive conclusions regarding their usability.

Are sufficient details of methods and analysis provided to allow replication by others? Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Not applicable
Are all the source data underlying the results available to ensure full reproducibility?No

Are the conclusions drawn adequately supported by the results? No
Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Lifestyle treatment of diabetes and cancer
I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
patient (and family members) viewpoints on meal replacement / food-based strategies for weight loss in the treatment of type 2 diabetes (T2D).As most clinical studies evaluating the impact of calorie restriction in T2D were done in Caucasian people, while South Asians are particularly prone to develop the disease and constitute a considerable part of the British (and global) population, the study specifically recruited people of South Asian background.18 people were approached, 13 (of whom only one was male) agreed to participate.5 of them attended a virtual meeting and the rest came together for a face-to-face gathering.
Viewpoints on total diet replacement vs food-based low-calorie diets, acceptability of questionnaires and wearables, as well as (culturally specific) barriers to follow low-energy diets were identified.The authors claim that their results indicate that meal replacement strategies are unacceptable to the South Asian population.Instead, culturally tailored foodbased interventions are preferred.The use of online tools to report diet was presented as unsuitable, while quality of life questionnaires (which ones?) were apparently OK.
The study design and interpretation of the data have several flaws in my opinion.
It seems not appropriate to use the opinion of 13 people, of whom 12 are female, as representative for the South Asian population.Moreover, only 9 of 13 people were actual patients.4 were family members whose opinion was apparently used to represent the view of relatives/caretakers.The authors fail to scientifically substantiate the generalizability of their conclusions. 1.

Author response 1
We are very grateful to the reviewer for this comment.Although we tried to ensure that the study cohort was representative of the background population, we accept that the conclusions may be limited by the predominance of women, who historically tend to engage with research more than men.We have highlighted this as a limitation in the "limitations section" of the manuscript.However, we believe that the rich insights gained from our study cohort (coming a more traditional, less represented background) were still useful to help us develop a protocol to test the feasibility of this food-based option before planning a full-scale trial.Moreover, we felt that the inclusion of family members/carers who may be involved in the food preparation have added strength to our PPIE activities.
Unfortunately, the paper does not report the reasons for unacceptability of the meal replacement strategy.It doesn't even specify the composition of the replacements (it only says "soups and shakes").In my experience, the taste of meal replacement products is critically important for their acceptability.In addition, social hurdles (not being able to have dinner with friends) are an issue with meal replacement, but this supposedly hinders compliance with food-based strategies as well.Anyway, it seems short-sighted to reject the option of all variants of meal replacement and advocate the use of any food-based strategy on the basis of a single survey evaluating a very limited number (2?, not specified) of options. 1.

Author response 2
Thank you for this comment.In the manuscript, there are added statements from participants indicating their reasons for unacceptability in the section entitled "Views of the use of total diet replacement".For example, participants explained that they perceived soups as foods that are consumed when people are ill.Another participant mentioned that soups don't 'fill you up' and that other solid foods (such as chapati bread) need to be added.
In the extended data (please see https://zenodo.org/record/5720754#.YkqowOjMKiw), the composition of the soups (including ingredients and flavours) were added to the pack given to participants to read before attending the activities.
We would like to make it clear that the results of these activities did not lead for us to completely reject the use of total diet replacement in future trials but, based on the responses obtained, we were encouraged to look at the acceptability of a food-based diet in our planned feasibility study.

We have now added this statement to the conclusion section 'This activity does not negate the use of TDR in this population but provided useful insights to shape a future study looking at the feasibility of food-based intervention for T2D remission in primary care in a high-risk population'.
It is unclear from the list of questions provided in table 1 for how long the patients were supposed to follow dietary prescriptions.And this conceivably matters a lot.For example, using total diet replacement for 1 week every months may be perfectly acceptable for people.Was this an option?Or was dietary intervention primarily meant to induce significant (> 10%) weight loss (as in DiRECT) and therefore very likely to be long-term?

Author response 3
In the extended data (please see https://zenodo.org/record/5720754#.YkqowOjMKiw), we have indicated to participants in their pack that the low-calorie intervention will last for 12 weeks.This has been also pointed out during the activities.Since we are building on success of the DiRECT trial, we were looking to assess the feasibility of our intervention over 12 weeks (the duration of the DiRECT intervention).Further clarification has now been added to the "Meeting information" section: "The information pack consisted of an example of a diet consisting of soups and shakes to be consumed for 12 weeks".The acceptability of questionnaires, e-health tools and online reporting instruments heavily depends on their design and ease of use.The paper does not report which tools were judged by the participants.Eventually, such instruments need to be tested in clinical practice to draw decisive conclusions regarding their usability. 1.

Author response 4
Thank you for the request for further information.The quality-of-life questionnaire that we used was the EuroQoL5 EQ-5D-3L which we included in the participant's pack ( please see https://zenodo.org/record/5720754#.YkqowOjMKiw).However, after consideration, we felt that this questionnaire does not add much information and we decided not to use it in our proposed feasibility study.We have also chosen not to report its outcomes in this PPIE paper.The statement reporting acceptability of PPIE has now been removed from the "Other components of the intervention" section.
As for online reporting instruments, the population comes from a more traditional background (and will be our target cohort in the feasibility study) for whom the use of computers/internet was not acceptable to many, hence we felt it would be more appropriate to use paper-based forms.We have mentioned in the manuscript that 11

Adrian Brown
Centre for Obesity Research, University College London, London, UK Thank you for asking me to review this manuscript entitled "Comparing the acceptability of total diet replacement and food-based low-calorie diets for type 2 diabetes remission amongst Southeast Asians: a public and patient involvement activity".This looked at gaining opinions of people from Southeast Asian community regarding what constitutes a culturally acceptable diet.This is a very important topic of work with the scarcity of information in the area and with the increased interest of using total diet replacements within clinical practice for remission, the question around whether these types of diets are culturally sensitive and relevant is important.These PPI activities provide novel information suggesting that low energy food-based diets might be preferred within Southeast Asian ethnic groups.This is an interesting report with some important views related to the use of low energy TDR and food-based diets in people from Southeast Asian ethnicity.Including that ready-made catered meals would be welcomed, peer support was key and the need for experienced translators.It was excellent to see the inclusion of a community representative to help with PPI meetings to help with engagement and also translation.
The major comment within this manuscript is the risk of unconscious researcher bias.Looked at the extended data and the participant information sent prior to the events, the framing of the diets appears different.The information about the TDR diet could be seen as neutral with the following "People who take part in the diabetes research study will be asked to consume a diet only consisting of soups and shakes for 12 weeks.Food will be reintroduced after then.Here is an example of soups and shakes diets for one day (850 Kcal)".However, the food-based diet had the additional of this sentence "The diet has been tailored to include components of the Mediterranean diet; this diet had many health benefits in the past for preventing diabetes and its complications", which appears to the framing the diet more positively.This might have therefore impact on how the participants view the diets and therefore the interpret your data and conclusions.This would benefit from being explored.
There are a few points that would benefit from being addressed: Please can the authors consider changing the terminology from "low calorie" to "low energy".Although this terminology is used, a calorie is a unit of energy, therefore it should be "low energy diets".

Abstract:
Please can you change the white population to capital "W".

Introduction:
When discussing diabetes and risk can you please ensure that you use Type 2 diabetes (T2D) and not diabetes as this could confuse individuals believing other forms can be put into remission e.g., people living with type 2 diabetes not living with diabetes.

○
Please can you look at the language that is used as some could be viewed as stigmatising e.g."tackling" "diabetes crisis" "the burden".These are combative terms and appears to suggest that people with type 2 diabetes are a burden.Instead, can you look for alternative terms such as "address" instead of "tackling"; "increased diabetes prevalence" instead of "crisis" ○ Can you please use the word "remission" instead of "reversed" as T2D cannot be reversed in terms of the underlying biological changes e.g., pancreatic beta cell death, but can be put in remission, transiently, assuming the patient losses weight and keeps it off.

○
When discussing the barrier and facilitators to participation in research could the authors, please give an example or two to avoid the reader having to leave the paper completely to look at the reference.

Methods:
Can the authors please explain how the people were selected i.e., how the community education presentative identified people.Also were there only 18 people invited to the PPI group or were there more, in order to get a sense of how many people did not respond to the invitation.

Meeting information:
The Mediterranean diet has also been shown to be able to engender remission from the PREDIMED study -please see my review 1 for details.Also, can you reference your comment related to the beneficial effects.

Data analysis:
Please can the authors include more detail on the analysis.Were the interviews transcribed verbatim?Was there then checking of the data and reviewed by another researcher to avoid bias?

Table 2:
Would it be possible to have mean/median for age?Also was this gender or sex, were participants asked about the gender they identified with or was this from medical records?It is possible to identify which ethnic groups the participants were from e.g.Pakistani, Indian as culture is different and help to see generalisability of the data.Also was there data on socio-economic class, this again could impact the interpretation of the data and views.

○
Did the participants explain why it was crucial that they adhere to a "strict traditional diet"?This seems a crucial point related to perceptions and an area to address around why people from Southeast Asian ethnic group might prefer using food-based diets and not a TDR.Could these points be addressed to increase acceptance of a TDR.

Taking part in research:
Interesting that your data showed that people hadn't taken part of research as they hadn't been asked, please can you check the reference (9) you quote here as it appears not to be related to lack of interest in taking part in research.Instead related to prevalence of type 2 diabetes diagnoses in the UK primary care setting

Limitations:
Only having one researcher review the data could be considered a limitation.If this was not the case, please including this in the methodology.

○
It is important that the authors consider the impact of researcher bias and also social desirability bias.

Clinical and research implications:
The conclusion to avoid using TDR completely in this group based on the opinions of 13 people and with the possible chance of unconscious researcher bias could be considered premature.

○
With data showing that TDR is effective at engendering remission in individuals from a Middle Eastern population (as you referenced; ) appears important here.Perceptions of TDR prior to their use are often negative, but opinion frequently changes once they use them.In addition, the team responsible for the DiRECT study in Glasgow are conducting a study in a South Asian population using a TDR which results are expected soon.This will provide data to see if those that used a TDR stuck to it and if it was acceptable.

○
It would seem that within this cohort that TDR is not preferred but viewing it as not being an option for remission is questionable considering previous data.It seems that in relation to how PPI might impact on the research, it appears that acceptability should be accessed with through a feasibility trial with a direct comparison between food-based diet and TDR as a start point.While also exploring some of the opinions of the PPI group further to related to why they considered the TDR unacceptable in formal qualitative research.

Conclusions:
In the first sentence should focus on the aim of the study which is remission, it is not clear the reason there is discussion about prevention as this was not the aim of the PPI activities.
Please can you review.

○
As before please avoid using reverse, please use remission instead.There are a few points that would benefit from being addressed: Please can the authors consider changing the terminology from "low calorie" to "low energy".Although this terminology is used, a calorie is a unit of energy, therefore it should be "low energy diets".
please give an example or two to avoid the reader having to leave the paper completely to look at the reference.

Author response:
Examples of barriers and facilitators to participation have been added to the introduction which reads, "The barriers and facilitators to participation in health and T2D diabetes research within the south Asian population (such as perceived participation to improve health, cultural and language barriers, and lack of interest) have been described elsewhere 16 .

It is therefore important to look at the suitability and barriers for success for low energy interventions as a means of inducing T2D remission in this population."
Methods: Can the authors please explain how the people were selected i.e., how the community education presentative identified people.Also were there only 18 people invited to the PPI group or were there more, in order to get a sense of how many people did not respond to the invitation.

Author response:
The community representative recruited participants by getting in touch with a local GP practice and through word-of mouth in community local groups.This has resulted in 18 people being approached and 13 responding.We were only aiming to recruit around 12 people.

We have made this information clearer in the manuscript which now reads, "Patients and family members were recruited face-to-face and by telephone through a GP practice and with the assistance of a community education representative with strong community links helping to spread the word within different sub-ethnic populations (Pakistani, Bangladeshi and Indian groups) in community local groups. Invitations included the researchers' contact details and were sent out by email and "Whatsapp" application either by the researcher directly or through the community representative. Overall, 18 people were approached, and 13 people accepted the invitation. Inclusion criteria included men and women over 18 years of age from a south Asian background who are either patients with type 2 diabetes or have someone with type 2 diabetes in the household. English and non-English speakers were invited to attend, and the community representative was available to help with the translation."
Meeting information: The Mediterranean diet has also been shown to be able to engender remission from the PREDIMED study -please see my review 1 for details.Also, can you reference your comment related to the beneficial effects.Limitations: Only having one researcher review the data could be considered a limitation.If this was not the case, please including this in the methodology.

Author response: Thank you. We have referenced a study linking Mediterranean diet to T2D remission & beneficial effects on cardiovascular health in the introduction section "The information pack consisted of an example of a diet consisting of soups and shakes, a 3-day low energy food-based diet plan [they were provided with information to explain that the diet has Mediterranean components (olive oil, fruits and vegetables) which have beneficial effects on remission of T2D and cardiovascular health".
It is important that the authors consider the impact of researcher bias and also social desirability bias.

Author response: These limitations have been included to the limitations section of the discussion which now reads, "Our data could have benefited by being reviewed by more than one researcher to reduce potential researcher bias. There may also have been social desirability bias amongst the PPIE group".
Clinical and research implications: The conclusion to avoid using TDR completely in this group based on the opinions of 13 people and with the possible chance of unconscious researcher bias could be considered premature.
With data showing that TDR is effective at engendering remission in individuals from a Middle Eastern population (as you referenced; Taheri et al., 2020 2 ), that People from Southeast Asia can achieve remission using a liquid low energy diet (Bhatt et al., 2017 3 ) and qualitative data, although mainly in White individuals, identifying that TDR were easier to follow than initially thought (Harper et al., 2018 4 ) appears important here.Perceptions of TDR prior to their use are often negative, but opinion frequently changes once they use them.In addition, the team responsible for the DiRECT study in Glasgow are conducting a study in a South Asian population using a TDR which results are expected soon.This will provide data to see if those that used a TDR stuck to it and if it was acceptable.
It would seem that within this cohort that TDR is not preferred but viewing it as not being an option for remission is questionable considering previous data.It seems that in relation to how PPI might impact on the research, it appears that acceptability should be accessed with through a feasibility trial with a direct comparison between food-based diet and TDR as a start point.While also exploring some of the opinions of the PPI group further to related to why they considered the TDR unacceptable in formal qualitative research.
unexpected views of our participants we have designed our next study to assesses the feasibility and acceptability of a culturally appropriate food-based low energy intervention delivered through catered meals.We have not used people's input simply as data to address a specific research question.This makes this a PPIE activity rather than qualitative research.
Power: the views of our participants completely changed our thoughts about the nature of an appropriate future intervention in this patient population.As mentioned above, the research participants guided us in designing a more appropriate clinical intervention which will be tested in a clinical trial therefore this is clearly a PPIE activity rather than qualitative research in which only the researchers have the power to influence the conduct of the research.

5.
Use of the findings: we recognise that the opinions of our participants relate to them and that their views may have limited generalisability.For example, in the clinical implications section of the manuscript we write, "Data from this cohort, including participants from a more traditional south Asian sub-group, suggest that TDR may have limited acceptability in this patient population."We also write in the limitations section, "Whilst attempts were made to ensure that the study cohort was representative of the background population, the small number of participants and our recruitment methods could have impacted the conclusions drawn from these meetings."We recognise that we need to study a larger sample that may be more representative of the SAP and therefore our feasibility study will recruit a larger cohort from a wider geographical region.Since we openly recognise the limited generalisability of our findings, this makes this a PPIE activity rather than qualitative research.

6.
Therefore, based on the criteria above, we conclude that our study clearly represents a PPIE activity rather than a qualitative research study.
Although feedback was sought on a proposed questionnaire and the use of step counters, it appeared rather superficial and there was no evidence as to how this feedback modified the researchers' plans.

Author response:
The The participants appeared to have no prior experience of research while those in patient and public involvement usually have some experience of research, either as part of a charity or lay group.

""
Clinical and research implications" and conclusion sections in the manuscript have indicated how this feedback has helped in our research plans with the following statements: Data from this cohort, including participants from a more traditional south Asian sub-group, suggest that TDR may have limited acceptability in this patient population.This work will help us design a randomised controlled study using low energy diets in South Asian people with T2D with the aim of inducing remission.These activities suggest the potential utility of a food-based low energy intervention, including looking at the feasibility of administering catered meals in primary care when compared to usual care.Meal plans will be prepared together with members of the community and patient support members.An education element to increase knowledge of T2D risk and healthy eating will be considered.Through the Greater Manchester Strategic Clinical Network and the Research for the Future intervention, we will promote engagement with this research for people with diabetes from the south Asian population.""The south Asian population is an important target group for interventions designed to induce T2D remission.This activity provided useful insights to shape a future study looking at the feasibility of food-based intervention for T2D remission in primary care in a high-risk population.It will encourage more patients to become involved in T2D research, which may lead in the long-term to improved quality of life, health, and economic benefits".

differences in the prevalence of type 2 diabetes diagnoses in the UK: cross-sectional analysis of the health improvement network primary care database
Zenodo: COREQ checklist for 'Comparing the acceptability of total diet replacement and food-based low energy diets for type 2 diabetes remission amongst south Asians: a public and patient involvement activity', https://doi.org/10.5281/zenodo.572075420 .Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

in weight loss based on ethnicity, age and comorbidity status in a publicly funded adult weight management centre: 1-year results. Clin
PubMed Abstract | Publisher Full Text 19.Grace C, Begum R, Subhani S, et al.: Prevention of type 2 diabetes in British Bangladeshis: qualitative study of community, religious, and professional perspectives.BMJ.2008; 337: a1931.PubMed Abstract | Publisher Full Text | Free Full Text 20.Grace F, Sajda M, Martin R, et al.: Comparing

of using very low energy diets for weight loss by people with overweight or obesity: a review of qualitative research. Obes
Rev. 2018; 19(10): 1412-1423.

PubMed Abstract | Publisher Full Text I
am happy with the amendments that have been made to the paper.No competing interests were disclosed.Weight management and nutrition in pregnancy.Diabetes in pregnancy.PPI.

have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Version 3
https://doi.org/10.3310/nihropenres.14396.r28769© 2022 Abayomi J.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Not applicable Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes
1. Staniszewska S, Brett J, Simera I, Seers K, et al.: GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research.BMJ.2017;358: j3453 PubMed Abstract | Publisher Full Text Is Competing Interests: No competing interests were disclosed.Reviewer Expertise: Weight management and nutrition in pregnancy.Diabetes in pregnancy.PPI.I confirm that I

the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes
We aimed to report the activities based on the international consensus for reporting PPIE activities in health and social science research (GRIPP2 guidelines) (Extended data 20 ), which aimIsCompeting Interests: No competing interests were disclosed.Reviewer Expertise: Lifestyle treatment of diabetes and cancerI confirm that I

have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
https://doi.org/10.3310/nihropenres.14381.r28540©2022 Pijl H.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Taheri et al., 2020 2 ), that People from Southeast Asia can achieve remission using a liquid low energy diet (Bhatt et al., 2017 3 ) and qualitative data, although mainly in White individuals, identifying that TDR were easier to follow than initially thought (Harper et al., 2018 4

the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Not applicable Are all the source data underlying the results available to ensure full reproducibility? No Are the conclusions drawn adequately supported by the results? Partly Competing Interests:
No competing interests were disclosed.Obesity, Type 2 diabetes, Weight Stigma and use of very low and low energy diets in Type 2 diabetes remission and other obesity related diseases.

1
Diabetes UK (2009).Diabetes UK and South Asian Health Foundation recommendations on diabetes research priorities for British South Asians.Available at https://www.diabetes.org.uk/resources-s3/2017-11/south_asian_report.pdfTakingpart in research: Interesting that your data showed that people hadn't taken part of research as they hadn't been asked, please can you check the reference (9) you quote here as it appears not to be related to lack of interest in taking part in research.Instead related to prevalence of type 2 diabetes diagnoses in the UK primary care setting