PONE-D-21-24557Experiences and perceptions of people with a severe mental illness and health care professionals with a one-year group-based lifestyle program (SMILE)PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: I Don't Know

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: No

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: 1. Is the manuscript technically sound, and do the data support the conclusions?

This manuscript describes a qualitative research study designed to evaluate the experiences and perceptions of individuals who participated in a long-term (one year) ambulatory care (outpatient), group-based lifestyle program. All participants had a severe mental illness (SMI) (and, according to line 108, were overweight). The perceptions of health care providers (HCP) who led the group sessions were also evaluated. As acknowledged by the authors, the inclusion of the HCPs is a strength of the research as their experiences serve to complement the findings from the clients.

This research used semi-structured interviews to evaluate the perceptions of participants. Separate interview guides (described in the supplementary materials) were used for the two groups of participants. Four themes (and eight sub-themes) were identified and described. Together, these themes captured the perceived value and benefits of the program, the impact of the program on participants’ wellbeing, and factors that contributed to the effectiveness of the program. The perceptions of the HCPs complemented and extended the findings obtained from the clients. As described in the Discussion, the findings set the stage for evidence-based recommendations regarding the development and implementation of lifestyle-focused programs.

The focus of the research is important. It is well-established that wellbeing is adversely impacted by SMI. As the authors acknowledged, people with a SMI have poorer physical health and are at greater risk for premature mortality. They are generally less physically active and have a poorer diet. Other research has demonstrated that individuals with a SMI are often more isolated, experience greater loneliness, and have a lower quality of life and perceived wellbeing. While treatment of the SMI specifically is important, interventions that target lifestyle issues more generally can make a substantive difference to the wellbeing of these individuals. The described intervention is distinct from other programs that have been described in the research literature. First, it is a year-long program (weekly sessions for the first six months, followed by monthly sessions). It is offered as an outpatient group program. However, attention is paid to the needs and styles of individual clients. As described by the authors, the group nature of the intervention seemed to be a strong contributor to the effectiveness of the program.

The research is also timely. We continue to be in the midst of the COVID-19 pandemic, which has stretched health care systems to their limits. In addition, the mental health of people (with and without premorbid mental health concerns) has been adversely and substantively effected. Thus, intervention programs that focus upon lifestyle issues and that promote social connections may be especially important in the current context. In this regard, it was interesting that the researchers noted that response to recruitment attempts was more positive than expected. In particular, even individuals who did not meet the inclusion criteria wanted to participate. This was in contrast to the expectations of various stakeholders who anticipated that the group-nature of the program would limit participant’ interest. Furthermore, as indicated above, the group-nature of the intervention was found to be one of the critical strengths of the intervention.

Overall, I thought the research was well done and meaningful. I found the Introduction and Methods to be the weaker sections in that key aspects of the research were not always described clearly. The recommended revisions are relatively minor (that is, they should be easily achieved); however, they will substantively improve the quality of the manuscript.

Concerns:

1. Focus of the intervention: It would be helpful to acknowledge the primary focus of the lifestyle intervention (i.e., weight loss, physical activity) in the Abstract (Objective; lines 23-25) and Introduction. This was not clear until S1 Appendix was examined. Although there were hints of the focus (e.g., line 37, “Irrespective of weight loss …; description of the inclusion criteria (i.e., line 108), for the most part, the description of the program within the body of the manuscript was quite vague. This is problematic in that the descriptor “lifestyle intervention” is vague. Such programs can be narrow or broad. In the case of more narrow foci, programs can vary tremendously. It is recommended that the final paragraph of the introduction (lines 78-86) be revised to include a brief description of the program’s main focus.

2. The described research is part of a process evaluation of the intervention that was conducted in parallel with a pragmatic cluster-randomized control trial of the SMILE lifestyle intervention. While the main study was cited, it is not clear if the process evaluation of the intervention has been published. Moreover, it was not clear why the authors decided to present the qualitative data in a separate manuscript. While this decision may well be appropriate, it would be helpful if additional information was included about the primary process evaluation in the Study Design section of the Methods (lines 88 – 95). For example, was this evaluation quantitative in nature? If it has been published, a reference for that article should be provided (see lines 81 and 91-92). In revising this section, please ensure that the various components of the study as a whole are clearly described. Also, it may be pertinent, in the Discussion, for the authors to address the inter-relationships between the results of the two parts of the process evaluation. Are the two sets of results complementary? Are there any discrepancies?

3. SMILE Intervention (lines 96-108): Please provide more information about the structure of the program. How long was each session? What was the size of the groups (i.e., clients and HCPs; this information was finally provided in the Discussion section (lines 380-381))? Describe the SMI inclusion criterion. Were individuals with co-morbid mental health disorders eligible to participate? While a list of topics covered in the program is available in S1 Appendix, it would be helpful to describe briefly the kinds of topics addressed in the body of the manuscript.

4. Use of RE-AIM framework: It was stated that the interview guides were based on the RE-AIM framework (Glasgow et al., 2019). While this framework is very pertinent, it was not clear how it was used, even after reviewing the two interview guides (S2 Appendix). First, it may be helpful to describe more fully the nature of this framework and how it was used. That is, describe the fit between the framework and the interview guides. Presumably, RE-AIM was also considered when deciding who the participants would be in the current study. Some of the dimensions (e.g., implementation and maintenance; perhaps, adoption) are also pertinent to the implications of the research. Accordingly, it may be helpful to consider this framework in the Discussion section.

5. Participants (Results): Please include a brief description of the kinds of SMI experienced by the participants. Please note that the tables are incorrectly referred to on lines 154-155. That is, Table IA concerns the HCPs while Table 1B is client-focused.

It was also noted in the Methods that during the second half of the intervention, individual phone support was available as an adjunct to the monthly group sessions (line 99-100). It is recommended that information about the frequency of these contacts be described in this section or in Table IB. Was this type of support addressed by clients in the interviews? This is especially important given that HCPS recommended offering increased individual face-to-face support for some clients (see lines 318-321; see also lines 431-432). Again, was this recommendation fairly general or are there sub-groups of clients that would benefit from this support?

6. Results (Themes 1 and 2): The description of these themes seem to focus upon the experiences and perceptions of the majority of clients. The experiences of the minority, however, can be very pertinent – especially in considering the effectiveness of a program and steps to enhance the program. Accordingly, it may be helpful to describe some of the dissenting views. For example, it was stated that some participants wanted to gain more knowledge about lifestyle related issues (lines 174-175). What were the primary interests of the other clients? Did the interests seem to vary as a function of participant characteristics (e.g., gender, age, etc.)? The answers have help to refine and extend some of the recommendations made in the Discussion.

7. Discussion (appropriateness of a group-based intervention): On line 369, the authors state that “a group setting will not be ideal for all people with SMI …” Any thoughts as to who will benefit most from a group-based intervention?

8. Discussion (cognitive impairments): On line 382, it was acknowledged that many of the clients had cognitive impairments and that these impairments may be a barrier for successful change. What kinds of cognitive impairments? The nature of these impairments may lead to specific recommendations/procedures for addressing this potential barrier.

Comments related to the other specific Review Questions:

*2. Has the statistical analysis been performed appropriately and rigorously?

The described study uses qualitative methods and, as such, the issue of statistical analysis per se is not relevant. Having said that, it is important to consider the thematic analysis methods used. Overall, the methods used to analyze the transcripts and identify emerging themes were appropriate. In addition, member checking was conducted (lines 133-134) to help demonstrate credibility of the data and identified themes. Importantly, they had a strong response rate.

It was indicated that two members of the study team reviewed and coded each transcript (line 138). However, no information was provided about the consistency (or congruence) of the two sets of codes and how differences were resolved. It is recommended that a brief description of this process be included.

The statement on Line 141 regarding the validity of the themes was unclear. It is unusual to talk about the validity of qualitative data or themes, more generally.

*3. Have the authors made all data underlying the findings in their manuscript fully available?

No, some restrictions were identified. Specifically, the authors indicated that in response to “reasonable request[s],” the data will be made available from the corresponding author and with permission of the Vrije Universiteit Amerstdam.

Limited access to qualitative data is not unusual.

*4. Is the manuscript presented in an intelligible fashion and written in standard English?

Overall, the manuscript was clearly written in standard English. There were sections that were awkward such that it was hard to understand some of the points being made (e.g., lines 70-71, 137, 164, 171-172, 408-409). Careful proof-reading and editing will be sufficient to address this comment.

Reviewer #2: While I have expertise in severe mental illness and knowledge of qualitative methods, I do not use such methods in my work. Rather, I appreciate the approach in terms of its yield of underlying processes that are invisible in RCTs and quantitative approaches. This study did not disappoint as I found it very useful and informative. Note that I cannot judge the statistics other than recognizing that those described are used in qualitative studies. The lack of fully publically available data does not surprise me given confidentiality matters for clinical samples. The authors make it available under appropriate conditions, in my view.

In terms of suggestions to the authors, here is my list:

1) Abstract should be clear about the objectives so persons unfamiliar with SMILE will know what the study is about.

2) Extensive use of acronyms that are unexplained is problematic for clarity, e.g., what is FACT?

3) Explain more of the technical jargon, e.g., what is "process evaluation" exactly? Look for jargon and clarify meaning so the work is consumable by persons not steeped in qualitative methods.

4) The authors state that selection bias possibly occurred. Of course it occured, be clear that it did.

5) When describing themes, terms like most participants and some participants are frequent. I would suggest giving percentage to make things more concrete.

6) Address as a potential limitation that some participants attended a very small percentage of the 30 available sessions. What might be the impact or such.

7) Likewise, as a limitation concern, what are the potential implications that only 48% of the client interviewees "responded to the member check, and agreed with the summary". Why were they unresponsive at such a higher rate and does it degrade the contribution?

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Reviewer #1: Yes: Carolyn Szostak

Reviewer #2: No

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Experiences and perceptions of people with a severe mental illness and health care professionals of a one-year group-based lifestyle programme (SMILE)

PONE-D-21-24557R1

Dear Dr. Walburg,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Vincenzo De Luca

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: (No Response)

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

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4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: All major concerns have been addressed. I enjoyed reading the revised manuscript. It was very informative. However, there are a few minor revisions concerning writing that should be addressed.

1. On a number of occasions a word is preceded by a single quotation mark (i.e., '). There should be a closing quotation mark. See lines: 224, 392, 416, and 437.

2. Lines 81-82: the second clause of the sentence that starts, "The intervention was ..." is awkward and hard to follow. Please re-phrase.

3. Lines 119 and 121: HCPs and clients should be the possessive (i.e., HCPs' and clients'), respectively. Similarly, on line 362, "clients" should be the possessive and read, clients'.

4. Line 284: The sentence, "This change that was ..." is incomplete. Alternatively, omit "that" from the sentence.

5. The first sentence of the Strengths section is confusing (line 432). Given what follows, it seems that the first sentence should be descriptive of the current study.

6. Line 434: There should be a comma after "together".

With regards to the requirement to make all data full available (see Point 4), the authors provide an appropriate explanation for restricting access. Moreover, they have indicated that they will make it available under appropriate conditions.

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Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Carolyn Szostak, Ph.D.

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