PPI.

The importance of PPI in the development of novel interventions has been highlighted by the NIHR [27,28]. Accordingly, collaborators with lived experience of obesity, recruited through CEW clinic contacts, the SHINE weight management programme, and social media advertisements, provided input throughout the research process: (i) pre-ethics committee approval (two sessions); (ii) during the data-gathering and analysis stages (two sessions); (iii) design of next study (one session); (iv) discussion of findings and to get feedback on our PPI approach. All PPI sessions were facilitated by our Public Contributor research team member (GT), who has advised and participated throughout the research process, and co-authored this paper. Importantly, there was no overlap between the PPI advisory group members and the young people in the co-development sessions (referred to as participants or co-developers for greater clarity).

The PPI Advisory Group meetings were evaluated using the CUBE methodology [28,29] to understand perceptions of attendees’ experience in four areas: how they could contribute (one-way to many ways), voice (strong to weak), agenda-setting (public members to organisation) and potential to change the intervention (organisation resistant to intervention changes up to willingness to change). After the meetings, attendees answered each question using a slider under each question from a score of 0 at one end of each dimension up to 1 at the other end. Contributors could also add a comment regarding each dimension. All data were recorded anonymously in a spreadsheet associated with the CUBE link. The mapping of responses on the CUBE could be viewed by all contributors (after logging into the online system).

The AIM2Change intervention.

The template intervention was based on the DNA-V model of ACT [24] aiming to increase intrinsic motivation in young people for making and maintaining lifestyle changes by connecting them with their personal values [19]. It comprised seven 45-minute sessions (Fig 1) and was delivered on an individual basis (by JC) using the Microsoft Teams online platform: minimising clinic visits, saving time and travel costs. Where required, arrangements were made to provide computer tablets and data packages, and participants were offered a suitable, private, space in which to hold the sessions. Concepts from the model were introduced in each session, along with relevant metaphors and experiential exercises to help the young person understand how to apply the concepts and activities in their lives. The young people were encouraged to practice the skills and techniques in between the sessions in their particular contexts.

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Fig 1. Stages and theoretical framework of AIM2Change intervention development.

https://doi.org/10.1371/journal.pone.0308770.g001

Co-development with qualitative interviews.

The initial therapy framework was iteratively co-developed with the participants, through 15-minute semi-structured interviews. The interviews were conducted by a qualitative researcher (AS) immediately following each therapy session to elicit feedback. The interviews were appraised on an individual basis rather than on aggregated data from multiple participants/sessions, to enable real-time changes to be made. Pertinent feedback, shared during the therapy sessions and the interviews, was compiled into a ‘Table of Changes’ (S1 Table), along with the insights from the PPI Advisory Groups and consensus meetings (see below). Once a point was raised, evidence in support of this suggestion, and opposing thoughts, were collated in the table. The research team (EH, AS, JC) met regularly to discuss the content of the Table of Changes and make iterative changes to the intervention accordingly. The MoScoW (Must do, Should do, Could do, Would like to do) coding scheme [26] was used to classify suggestions. Appropriate changes were also made to the interview topic guide to gather further opinions on the suggestions raised.

Consensus meetings.

Once all participants had completed the intervention, two consensus meetings were held to discuss the proposed changes and make additional refinements, with the aim of coming to a consensus about the final intervention manual. The first meeting involved participants in the co-development process (young people and their parents if involved), and the second meeting involved members of the clinical MDT, collaborators involved in the research and the management group. Agreed amendments were recorded in the ‘Table of Changes’ (S1 Table).

Coding of qualitative interviews and consensus meeting.

Inductive coding was used to explore participants’ overall experience of receiving and engagement with the therapy. All interviews were transcribed by AS and II and were managed in NVivo software. Independent ‘open’ coding was undertaken, by AS and II, on a subsample of the interview transcripts (7 of 63), representing four participants: one interview from each of the seven therapy sessions. The initial coding and any discrepancies in coding between the coders were discussed until consensus was reached. A final coding frame was developed jointly, and then applied to the entire dataset by AS. The codes were discussed further by AS, II and EH to inform the development of four themes. The consensus meeting with young people and/or parents was open coded using existing codes developed in the analysis of the ‘Think-aloud’ interviews. (NB: the second consensus meeting was not subjected to coding and analysis, as the focus of that meeting was on the practical delivery of the intervention within the NHS. Insights were captured through inclusion in the Table of Changes, S1 Table).

Framework analysis.

A framework approach enabled summarising the data pertaining to the four themes in matrices that display the responses from (i) each participant and (ii) each therapy/intervention session attended [30]. These coded data from the consensus meeting were also integrated by AS and II into the framework matrices, wherever they were considered in relation to the existing themes (e.g., provided additional insight or perspective to responses derived from the Think-aloud interviews).

Participants’ characteristics.

Fourteen co-developers were recruited (Fig 3, Table 2), although one did not start due to access difficulties. Of the 13 remaining individuals (six female; mean age, 14.9 years; mean IMD score 4.9), neurodiversity was experienced by two participants with Autism Spectrum Disorder (ASD) or ASD and Attention deficit hyperactivity disorder (ADHD) and seven were receiving a GLP-1 agonist as adjuvant treatment. Eight participants recruited had previous experience of psychological therapy. When asked the question “How would you describe your ethnicity?”, participants used the following terms to describe themselves: Afro-Caribbean (n = 1), Black African (n = 1), Black British (n = 1), Eastern European White (n = 1), Pakistani (n = 2), Roma Gypsy (n = 1), White Romanian (n = 1), White (n = 2), and White British (n = 4).

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Table 2. Sample characteristics.

https://doi.org/10.1371/journal.pone.0308770.t002

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Fig 3. Participant flow diagram.

This diagram is prepared in the style of a CONSORT flow diagram (https://www.consort-spirit.org/).

https://doi.org/10.1371/journal.pone.0308770.g003

Qualitative theme: Theoretical understanding.

Through this theme, it emerged that there was no “one size fits all” approach to understanding DNA-V; different activities worked for different people.

Interviewer: What was offered for your stress, what strategies were on offer?

Ppt: Oh, we did try breathing, counted breathing. It was very helpful. (Ppt 8, Session 5, Male)

In previous ones [sessions], we talked about the Advisor. But it wasn’t about one big thing really. But today we talked about lots of different things. Yeah, we did where you shut your eyes and the leaves on the stream [therapeutic exercise] and everything. Yeah, that was quite good. (Ppt 4, Session 5, Female)

Whilst the videos and generic explanations of the DNA-V concepts were well received, young people valued the support of the therapist guiding them to understand and apply the DNA-V concepts to their own lives, values and experiences:

After that [video], we started talking about those three parts of the brain and that went on for the rest of the time, talking about examples of it. OK. It was really well explained. At first, I was thinking, well, how do these relate to how people think? Because I didn’t think how well it could be simplified into three different aspects. But eventually realised it does fit perfectly, whether you’re, like, a little voice in your head, or what. You’re just noticing things. It was familiar to me, I never had quite a name for it, but it was recognisable. (Ppt 7, Session 1, Male)

We went back on to what we did last week, which was starting off with the DNA. And then we added the “V” in the middle, so it was like a geometric shape type thing. And it was quite helpful because we looked at one and then we were like, OK, Ohh, how can you apply it? (Ppt 1, Session 2, Female)

The space for self-reflection also supported young people to link the programme with their own experiences:

There’s, like, a good amount of self-reflection, I suppose, and sort of placing emotions on certain memories. It makes you feel stuff like that. (Ppt 2, Session, Female)

Outcome: The manual will contain ‘core content’ that carries the fundamental DNA-V content followed by several different, flexible, exercises that explore the concepts in slightly different ways. Together the therapist and patient will experiment to see which activities help them to understand and embed the content in the context of their life and experience. Therefore, all patients will be guided using the same therapeutic principles led by DNA-V but will not experience an identical programme.

Qualitative theme: Delivery and receipt of therapy.

Throughout early PPI work, the whole-person approach to therapy was commended, as opposed to an approach that solely looked at issues around weight. However, during the intervention co-development itself, some young people requested that discussions of weight, eating and self-image were introduced earlier in the therapy to have time to expand on the issues raised. However, other young people noted that the topic was difficult to discuss, and that balance was important:

It’s a hard thing for me to talk about. I just don’t feel comfortable with it, but it’s sort of like putting in a bit of it to every single aspect that we talk about, that sort of the right amount rather than being constantly talking about it (Ppt 7, Session 5, Male)

The therapeutic relationship was deemed important for therapeutic success, and building rapport was often successful:

I think the environment when I was talking to JC [therapist] was quite comfortable and welcoming. I think at the start of the session I was quite stressed out and now I’m feeling quite calm through the techniques that JC taught me and that we went through today. Well, I guess I never really talked to someone about how I felt. (Ppt 1, Session 1, Female)

First time ever having therapy, so I was a bit nervous about what to expect. I was quite shocked.... It was very well explained. I think it was structured and planned out quite well. (Ppt 7, Session 1, Male)

Not all began the sessions feeling able to engage:

I don’t like doing it [talking] with people like strangers. I just don’t feel comfortable. But even if I do know the person, it’s not like it’s guaranteed that I’ll tell them everything, like. Weird in a way to say everything you feel whenever you feel and whatnot. (Ppt 12, Session 1, Male)

However, resistance to engagement began to dissipate over the course of the sessions:

I mean, it’s still, it’s not, like, the most enjoyable thing ever. So still quite boring, but it’s not as bad as I thought. (Ppt 12, Session 3, Male).

The choice, in the design, of online therapy was made initially for pragmatic reasons, to reduce the time commitment and cost to the co-developers of traveling to the hospital weekly. Feedback suggested that this did not affect the rapport:

[I’ve] had therapy before with someone online, and it never really flowed... Whereas this flows, it absolutely flows. It feels like you’re in-person. (Ppt 4, Session 3, Female)

Ppt 7: I like doing it on Zoom as well, I felt quite safe and secure.

Mother: He was in his room. He was on his territory (Ppt 7, Consensus meeting, Male)

However, several young people could not find a private area at home to receive the therapy, and experienced frequent interruptions:

Interviewer: What about your situation at home, is it private enough for you?

Ppt: Yeah. Go[a]way [shouting to Brother]. (Ppt 9, Session 7, Male)

This sibling interaction did not seem to affect this young person’s experience of the therapy but is an important consideration for the therapist when session planning.

The co-developers felt that the approach they received, to have one-to-one sessions was optimal:

I don’t really like the idea of group therapy because everyone has different opinions on things and they have different things that they want to talk about, and, depending on how long the group therapy lasts for, I feel like not everyone gets to have a say. (Ppt 1, Session 7, Female).

The earlier learnings regarding tailoring the explanations to the individual’s circumstances, and adapting activities, also lend themselves to one-to-one therapy. The intervention design intentionally allowed participants to choose the level of involvement their parents had in the therapy, and young people reflected on this favourably:

I wouldn’t be as open as I probably am. I think if I was to have my parents [it] would probably be a big argument. (Ppt 1, Session 7, Female)

I like it better just me (Ppt 10, Session 7, Male)

I personally like my mum being with me, but because I’m quite open with those sort things. But I guess it depends on what sort of relationship you have with your parents. If you’re quite open with them or not, in a way. So, for some people it can be good, but for some people they may not like it. (Ppt 4, Consensus meeting, Female)

Finally in this theme, the young people concluded that they would like to have had more therapy sessions than the seven they received:

I got the impression that it took a few sessions to kind of get going and then when it was really getting good it was finished. (Ppt 2, Female)

So yeah, I think a bit longer might have, you know, that it might have been quite good in the next four sessions. (Ppt 2, Female)

I think that it did take a couple of sessions to get used to what we were, like, talking about and, you know, feeling comfortable to talk to [the therapist] because I feel like a few more sessions would have been good. (Ppt 4, Female).

Expanding on this suggestion, we discussed the spacing of sessions and asked: would offering a longer duration of therapy yield any additional benefits? However, the participants favoured the weekly spacing of the current design:

I think if you spread stuff out too much then you kind of lose the kind of train of thought. I guess there’s a more of a struggle to connect stuff from different sessions and if I thought something, like, on Monday and I had to wait all the way until, like, Saturday to tell [the therapist], that’s already a long time. But if it was, like, two weeks from then I just think it’s, like, too long and there’s not really a lot of opportunity to address immediate problems that you’re facing. (Ppt2, Female)

I think the timing was about right. (Ppt 7, Male)

During the clinical team consensus meeting, discussion concluded that a focus on increasing the amount, and the way that participants practice between sessions to integrate theory learnt during the therapy with life, could support a more intrinsic approach.

YP do need to be prepared to ‘act’ (e.g., accepting difficult feelings in the service of their values). It’s not homework, its facilitating change for them (tweak linguistically or the activities themselves to embed in their life not just about coming back to therapy or clinic appointments). (Psychologist)

However, feedback from the ‘Think-Aloud’ interviews suggested that additional work may not be favourably received:

Interviewer: Would you like a workbook to have alongside these sessions?

Ppt: No, I actually don’t feel like I would use it. (Ppt 12, Male, Session 7)

Outcomes: (i) The intervention was adapted to introduce discussions about eating, weight and self-image earlier, but with the scope to focus more intensely on it, throughout, being optional. For example, many activities request that the young person offers an example to work through, and the individual could choose to focus on an eating behaviour, body image concern or a more general example for the exercises. (ii) The programme structure of exercises that support rapport building within the early sessions was retained, and further rapport building exercises were made available for later sessions, if required to support the ongoing maintenance of a strong patient-therapist relationship. (iii) Online delivery modality retained, with space at the hospital offered for young people unable to have a private space at home to ensure inclusivity (this offer was available but not taken up during the current research). (iv) One-to-one therapy to be recommended as the first-choice approach, both directly answering the co-developers’ requests, and enabling the flexible manual approach. (v) To retain the young people’s ability to choose parental/companion involvement. (vi) The length of the therapy programme and the spacing between sessions would remain the same. However, there will be an increase to the expectation setting at the beginning of the programme to clarify how time with the therapist and independent time in the week to be implementing/practising the skills, come together to develop the outcome.

Qualitative theme: Views on strategies and engagement.

The qualitative interviews facilitated feedback from the young people on a strategy-by-strategy basis. These data were used in real-time to evolve the therapy manual and were included in the Table of Changes (S1 Table).

An example of this feedback:

Our bad moments are like thunder or something, but it’s trying to remind ourselves that despite that thunder, that bad weather, that there’ll always be that good bit of sky there. It was one of the best ones... I didn’t really understand it at first, but after I thought about it a bit more it made more sense to me and I think, as I think about that more often, and I put that in practical situations, it’ll become more useful. (Ppt 7, Session 5, Male)

One young person felt that the sessions were offering a different approach from the main clinic, but that sometimes this felt confusing or that the approaches conflicted with one another.

I mean, the fact that you’re at the CoCo clinic and kind of being told to kind of count calories and look at the diet and, you know, really focus on the food and take the drugs and so on, with the very clear focus about, you know, losing weight and focusing on that. And then in the counselling [AIM2Change], it’s much more about feeling good about yourself, being positive and it’s those two things are almost in conflict with each other. (Ppt 2, Female)

It was suggested that a key outcome of the therapy could be seen to be that attending the therapy helps the young person to navigate the CEW clinics, and the difficult feelings and thoughts that arise during them.

How YP may feel when they are weighed (using ACT to understand the world, clinic or family factors are part of that). (Psychologist)

Outcomes: (i) Data collected on individual strategies were used to adapt the manual. This process enabled the young people to shape the programme of therapy. (ii) Each therapy session should include a check-in regarding the young person’s experiences within the main CEW service that week, to ensure that they are being directly supported to understand any seemingly conflicting approaches and any difficult feelings that may have arisen.

Qualitative theme: Real world benefits of co-development process.

The young people’s reflections suggest that they experienced benefits from taking part in this therapy. For instance, by incorporating strategies into their lives:

I think urge surfing or surfing the urge [strategy]. I happen to like ride along with it because there’s no point trying to stop a wave because it would just be wasting energy and have a more negative effect. (Ppt 7, Session 6, Male)

Becoming more aware of their internal experiences:

As the sessions have gone on, it’s been easier to think about these sort of things. These analogies have been more clear. And with, like, the time going on, it’s much more easier to think about feelings or easy examples to actually give. (Ppt 7, Session 3, Male)

And feeling that they were able to connect and share more with other people in their social world:

Well, I’m opening up to people more. I’m talking more about me and how much will work personally in my life. I thought, I really want to tell my friends I lost weight. Yeah. (Ppt 8, Session 7, Male)

Outcome: The co-developers report anecdotal positive effects from experiencing the therapy that should be explored quantitatively in future research trials.