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R E S E A R C H A R T I C L E Open Access
STructured lifestyle education for people
WIth SchizophrEnia (STEPWISE): mixed
methods process evaluation of a group-
based lifestyle education programme to
support weight loss in people with
schizophrenia
Rebecca Gossage-Worrall
1*
, Daniel Hind
1
, Katharine D. Barnard-Kelly
2
, David Shiers
3
, Angela Etherington
4
,
Lizzie Swaby
1
, Richard I. G. Holt
5,6
and on behalf of The STEPWISE Research Group
Abstract
Background: STEPWISE is a theory-informed self-management education programme that was co-produced with
service users, healthcare professionals and interventionists to support weight loss for people with schizophrenia.
We report the process evaluation to inform understanding about the intervention and its effectiveness in a randomised
controlled trial (RCT) that evaluated its efficacy.
Methods: Following the UK Medical Research Council (MRC) Guidelines for developing and evaluating complex
interventions, we explored implementation quality. We considered causal mechanisms, unanticipated consequences
and contextual factors associated with variation in actual and intended outcomes, and integrated treatment fidelity,
using the programme theory and a pipeline logic model.
We followed a modified version of Linnan and Steckler’s framework and single case design. Qualitative data from
semi-structured telephone interviews with service-users (n= 24), healthcare professionals delivering the intervention
(n=20)andinterventionists (n= 7) were triangulated with quantitative process and RCT outcome data and with
observations by interventionists, to examine convergence within logic model components.
Results: Training and course materials were available although lacked co-ordination in some trusts. Healthcare
professionals gained knowledge and some contemplated changing their practice to reflect the (facilitative) ‘style’
of delivery. They were often responsible for administrative activities increasing the burden of delivery. Healthcare
professionals recognised the need to address antipsychotic-induced weight gain and reported potential value
from the intervention (subject to the RCT results). However, some doubted senior management commitment and
sustainability post-trial.
Service-users found the intervention highly acceptable, especially being in a group of people with similar
experiences. Service-users perceived weight loss and lifestyle benefits; however, session attendance varied with
23% (n= 47) attending all group-sessions and 17% (n= 36) attending none. Service-users who lost weight wanted
(Continued on next page)
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* Correspondence: r.gossage-worrall@sheffield.ac.uk
1
Clinical Trials Research Unit, School of Health and Related Research, The
University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK
Full list of author information is available at the end of the article
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https://doi.org/10.1186/s12888-019-2282-5
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(Continued from previous page)
closer monitoring and many healthcare professionals wanted to monitor outcomes (e.g. weight) but it was
outside the intervention design. No clinical or cost benefit was demonstrated from the intermediate outcomes
(RCT) and any changes in RCT outcomes were not due to the intervention.
Conclusions: This process evaluation provides a greater understanding of why STEPWISE was unsuccessful in
promoting weight loss during the clinical trial. Further research is required to evaluate whether different levels of
contact and objective monitoring can support people with schizophrenia to lose weight.
Trial registration: ISRCTN, ISRCTN19447796. Registered 20 March 2014.
Keywords: Complex intervention, Process evaluation, Schizophrenia, Psychosis, Weight management, Logic model,
Background
Obesity and excessive weight gain pose a serious health
concern for people with schizophrenia. The prevalence
of obesity and rates of cardiovascular disease and type 2
diabetes are 2–3 times higher than in the general popu-
lation and, weight gain is a key contributor to the excess
morbidity and mortality with accelerated rates of obesity
contributing to reduced life expectancy of between 10
and 20 years [1–3]. The impact of weight gain is not
confined to poor physical health, but also may further
add to the experience of distress and stigma [4]. Suscep-
tibility to weight gain for people with schizophrenia can
be explained by many factors. As well as the impact of
antipsychotic medication on weight gain [5], schizophre-
nia can affect neuro-endocrine functioning as well as
impairing cognition and motivation to modify daily rou-
tines. The disease and treatment interact with environ-
mental factors such as poor diet [6–8], social isolation,
physical inactivity and poverty [7–10]. Thus, the devel-
opment of effective weight loss treatments to support
people with schizophrenia must overcome challenges
posed by a varied set of antecedent factors.
Complex interventions are those with “several interact-
ing components”[11]. The theory-informed STEPWISE
programme was developed using the well-established ap-
proach to developing type 2 diabetes education - Diabetes
Education and Self-Management for Ongoing and Diag-
nosed (DESMOND) [12]. It involves interactions between
healthcare professionals, service users and equipment.
The multifaceted nature of STEPWISE can create prob-
lems when determining what affected outcomes and the
extent to which the intervention could be standardised.
Complex interventions tend to be more sensitive to
features of the local context, with long and complex causal
chains linking the intervention with the outcome. As such,
they can be difficult to evaluate and it has been argued
that RCTs may not be the best method of evaluation as
they seek to remove variation between interventions,
agents and contexts and how they interact [13].
We conducted an RCT to assess the effectiveness of
STEPWISE. The trial protocol and main results have
been published previously [14,15]. In brief, between 10
March 2015 and 31 March 2016, we recruited 414
people with schizophrenia, schizoaffective disorder or
first episode psychosis from ten mental health organisa-
tions in England. Participants were randomly allocated
to the STEPWISE intervention or treatment as usual.
The STEPWISE programme was a 12-month interven-
tion which comprised a foundation course of four
weekly 2.5-h sessions delivered by two trained health-
care professionals or associated staff; one-to-one
support contact of ~ 10 min every two weeks, usually by
telephone, and additional group-based sessions of 2.5 h
scheduled at four, seven and 10 months post-
randomisation. The intervention is described in full
elsewhere [15].
We conducted a process evaluation, in line with MRC
guidance alongside the RCT, to assess fidelity and quality
of implementation, and sought to clarify causal mecha-
nisms and identify contextual factors associated with
variation in outcomes [16].
Methods
Theoretical framework
Qualitative research was undertaken alongside the RCT
to explore implementation of the intervention. We
sought to understand how service users and facilitators
responded to the intervention [17–19] and potential
causal pathways to success or failure [17–20]. The
evaluation’s rationale was principally pragmatic [21]as
we sought a basis for ‘organising future observations and
experiences’[22], and investigating plausible real-world
consequences [23] of future decisions.
We used a modified version of Linnan and Steckler’s
framework [24] and a single case design with the unit of
analysis at the service user (n= 24) and the intervention
programme (n= 20 healthcare professionals; n= 7 inter-
ventionists) levels.
The World Health Organisation (WHO) Inter-
national Classification of Functioning (ICF) for schizo-
phrenia was used as a conceptual framework for
describing ‘context’[25,26]. Similar published studies
[27,28] informed a priori the topic guide for service
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user interviews. Normalisation Process Theory (NPT),
a model used to support implementation and evalu-
ation of innovations [29–32], formed the basis of the
topic guide for healthcare professional interviews. To
characterise stakeholder’s understanding of the inter-
vention we used the Theoretical Domains Framework
(TDF), an approach to determine causes of behaviours
[33]. TDF codes were mapped post hoc to the theories
underpinning the intervention, which were Leventhal’s
Self-Regulation Theory [34], Bandura’s Self-Efficacy
Theory [35], and Marlatt & Gordon’s Relapse Prevention
Model [36].
We considered the programme components critical to
successful replication of the intervention theory, along
with potential causes of failure from these components
interacting together [37–39], to develop a logic model
[40,41]. A summary of logical model components and
intended outcomes is shown in Fig. 1.
Recruitment, reach, intervention dose delivered/re-
ceived and fidelity were characterised, both
qualitatively and quantitatively, based on the National
Institute for Health Behaviour Change Consortium’s
(NIHBCC’s) approach to treatment fidelity [42]. We
described context qualitatively, and triangulated all
data sources, which included interventionist, service
user and facilitator interviews, RCT data and quanti-
tative fidelity data.
Participant selection
Written informed consent was obtained to approach all
service users as part of the RCT and re-consent (audio-re-
corded) took place for those sampled (intervention arm
only) prior to the interview. Healthcare professionals were
approached and consented via telephone (audio-re-
corded), and interventionists by email. Written and verbal
(audio-recorded) consent was documented using NHS
REC-approved written consent forms and were provided
to all participants. Service users were purposively sampled
by study site, gender and age. A summary of selected char-
acteristics of the service users sampled is shown in Table 1.
Facilitators (n= 40) were purposively sampled by site,
occupation, gender and experience of group facilitation. A
summary of education and professional categories of
facilitators is shown in Table 2. Seven interventionists (all
those involved in developing the intervention) were
interviewed.
Data collection
Qualitative data were collected via semi-structured tele-
phone interviews with service users (n= 24) and facilita-
tors (n= 20) by RG-W, using piloted topic guides [16].
Unstructured interviews with interventionists (n=7)
were conducted by DH to explore observations during
fidelity assessments, elements from the behaviour change
Fig. 1 Summary of logic model components for the implementation of the STEPWISE intervention.
Legend: HCP Health Care Professional, BP Blood Pressure, BMI Body Mass Index, NICE National Institute for Health and Care Excellence
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wheel [43], the NIHBCC framework [42] and the
Programme logic model.
All interviews were audio-recorded using an encrypted
device and transcribed verbatim. Table 3shows median
(range) duration of interviews. Data saturation was
achieved in all datasets.
Transcripts or analyses were not returned to inter-
viewees. Field notes captured during and after interviews
were reviewed by RG-W, DH, KBK, DS, AE and LS. No
prior relationship was established between researcher
(RG-W) and service users. RG-W was known to two
facilitators (dual role as research nurse) prior to interview.
Two interventionists knew DH, from project management
meetings, prior to interview.
Data analysis
Transcripts were coded systematically (RG-W and DH)
using QSR International (Warrington, UK) NVivo version
11. Table 4summarises the systematic and opportunistic
coding by interviewee group. A sample of transcripts were
reviewed by KBK, DS, AE and emerging themes discussed.
Fidelity assessment
Fidelity assessment of the intervention was assessed via
direct observationusingtheSTEPWISECoreFacilitator
Behavioural Observation Sheet (CFBOS) which tests for the
presence or absence of 35 behaviour domains relating to 9
items assessing behavioural change, planning and goal-
setting. The DESMOND Observation Tool (DOT) also
measured facilitator versus service user talk time using
timed audio cues during a sample of sessions. There is evi-
dence to indicate a link between more effective receipt of
self-management education and less facilitator talk [44].
Fidelity strategies are summarised in Table 5. Facilitator
attrition was also recorded. A programme like STEPWISE
would require national and local infrastructure for quality
control and mentoring but was not available during our
study; therefore, facilitators did not receive formal feedback
nor could evaluation of these components take place.
Triangulation
A triangulation protocol [45,46] was used to compare out-
come data from the RCT [47], qualitative and quantitative
process data and observations during fidelity observations.
The presence and level of convergence was examined
within the 18 components of the logic model. We did not
prioritise any one data source over the other in assessing
the intervention. Feedback on the results of triangulation
was integrated into the findings. We did not formally assess
the coding between researchers due to time limitations.
Results
Context
We used the WHO ICF [25,26] to explore ‘context’for
people with schizophrenia and considered the challenges
Table 1 Summary of selected characteristics of service users interviewed
Age (years) n Sex n Ethnicity n Dx n Outcome (weight) n Sessions attended n
18–25 5 Male 12 White British 19 F20 11 Weight loss (CI) 7 0 0
26–35 7 Female 12 African 2 FEP 8 Weight loss (NCI) 6 1–21
36–45 8 White Other 1 F25 5 Weight gain (CI) 3 3–44
46–55 4 Bangladeshi 1 Weight gain (NCI) 6 5–612
Indian 1 No data 2 7 7
FEP First Episode Psychosis, F20 Schizophrenia, F25 Schizoaffective disorder; CI Clinically important, NCI Not clinically important, Dx Diagnosis
Table 2 Summary of selected characteristics of healthcare
professionals interviewed
Sample Characteristics n
Education
Undergraduate degree 10
Postgraduate degree 3
Postgraduate diploma 2
Other 4
No data 1
Professional Category
Mental Health Nurse 8
Occupational Therapist 3
Support Worker 2
Research staff 2
Physiotherapist 1
Pharmacy Technician 1
Dietician 1
Healthy Living Advisor 1
Community Development 1
Table 3 Median (range) duration of interviews (minutes)
Interviewee
category
Number
interviewed
Median duration (range)
in minutes
Service users 24 18:57 (13:06, 30:33)
Facilitators 20 46:13 (29:29–79:32)
Interventionists 7 39:20 (43:39–64:00)
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which may be experienced, either as a direct result of
symptoms and medication, or environmental factors
(e.g. stigma) that may have impacted on service users’
interaction with the intervention in the broadest sense.
Whilst some people with schizophrenia are high func-
tioning but experience hallucinations and/or delusions,
others are more cognitively challenged requiring con-
sideration of how the information can be delivered and
in what ways.
There could be like mild learning disabilities running
alongside their mental illness as well and that, I have
definitely noticed that that’s hindered ...someone’s
ability to engage. (Facilitator S09/F03)
Contextual factors considered in the implementation
of the intervention are summarised in Fig. 2.
Of those service users interviewed, three lost and three
gained a significant amount of weight. Two of those who
gained weight had first episode psychosis and reported
more symptoms, whilst almost all service users talked
about self-monitoring (e.g. support tools). When ordered
by weight loss, only the top three service uers talked
about self-belief and persuasion.
When he phoned me... It was like, “how did you know
I was eating rubbish?"... But he was really good, like
really motivating. It was like, “I'm going to see him in
February; I don't want [him] to see I’ve put on what
I’d lost.”(Service user S01/Q01, -12.7kg).
“…if I wasn't in, they [the facilitator] would leave a
postcard saying, you know, you can do it. And it was
really nice, really kept me going.”(Service user S08/
Q05, -9.3kg)
Those who succeeded in losing weight valued monitoring
and feedback from others, although monitoring and feed-
back of behaviour or outcomes was not explicitly part of
the intervention and they wanted more monitoring.
“It needs to be longer …like 10 weeks …give us
updates on how we are coping, on what we are doing
…to monitor us more closely …it was becoming a
routine and then it just stopped …”(Service
user S04/Q02, -6.1kg)
“more regular support …see how you’re doing,
because …the next session’s quite far away”
(Service user S08/Q05, -9.3kg)
Triangulation
We triangulated quantitative and qualitative findings with
data types contributing to 14 and 16 (of 18) logic model
components. Agreement on three components was found,
partial agreement on two, and dissonance on seven com-
ponents. Six components were found to be silent which
was anticipated due to these areas only being amenable to
one method of assessment. In some areas of dissonance,
we found data were measuring difference elements of the
constructs e.g. committed resources as opposed to how the
result was valued. Analysis of qualitative data revealed
nuances in some areas e.g. inadequate resource allocation
for co-ordination. A summary of triangulated findings is
presented within components of the Logic Model in Fig. 3.
Resources
Training resources were found to be adequate according to
healthcare professionals. Course materials were universally
popular although availability of venues was sometimes lim-
ited. Healthcare professionals seemed motivated to become
STEPWISE facilitators; and whilst many facilitators conti-
nued to support STEPWISE, over the course of 2 years, a
third stopped largely because of job moves (Fig. 4).
Healthcare professionals and interventionists inter-
viewed felt buy-in from senior managers in some trusts
was insufficient.
“Anything above team leader level... there is no
expectation really... they all go yes it's lovely, but... the
Trusts and the NHS do not then provide us with the
resources to be able to do it.”(Facilitator S05/F02)
“Within this particular trust, one of the deputy directors
had been involved right from the start and he was very
keen for it to happen so it’s been sort of disseminated
downwards from there”(Facilitator S03/F05)
Table 4 Summary of coding by interviewee group and source
Interviewee
group
Theory/ Constructs
TDF domains NIHBCC framework NPT Logic Model BCT Acceptability
Service users Systematic Opportunistic Opportunistic Systematic Systematic
Facilitators Opportunistic Systematic Opportunistic Opportunistic
Interventionists Systematic Systematic Systematic
SSystematic, OOpportunistic, BCT Behaviour Change Taxonomy, TDF Theoretical Domains Framework [45], NPT Normalisation Process Theory [30–33], NIHBCC
National Institute for Health Behaviour Change Consortium
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Table 5 Summary of strategies intended to ensure fidelity of the STEPWISE programme
Fidelity Components
Design Training Delivery Receipt Enactment
•Theory based intervention with
treatment dose (i.e. number,
frequency and duration of sessions)
specified in the protocol.
•Protocol deviations recorded.
•Risks to implementation were
mitigated by: 1) piloting the
programme in one Trust prior to
the RCT; 2) setting a minimum for
the number (n= 4) of facilitators
per Trust; and, 3) the tracking of
trained staff availability and
attrition.
•Written materials and facilitator
training were standardised across
providers; and, intended delivery
style was modelled by expert
trainers.
•Facilitators used role play to test
skills and, reflected on their own
performance and skill acquisition
and made changes (as required).
•Optimum skillset for the role
(including one of two having
clinical skills) defined for providers.
•Level of education and experience
of physical and/or mental health
and group work captured.
•Peer support available during
delivery.
•Service user feedback after sessions,
semi-structured interview (after
foundation course) and facilitator
observations informed on the
credibility of facilitators, non-specific
treatment effects and differences
across providers.
•Training materials, including
resource lists, supported
standardisation across providers.
•Adherence was monitored via
recording attendance, facilitator
self-reflection and direct
observation of content and
delivery; local coordination and
monitoring by providers; and,
facilitator and service user
interviews.
•Contamination (of trial arms) was
minimised by standardised study
design training and on the ground
instructions, regular supervision and
on-site and remote monitoring.
•Service users invited to participate in
sessions (e.g. discuss answers to
questions with others); and, facilitators
used scripted summaries to aid
understanding and check
comprehension.
•To ensure ability to use cognitive skills
(e.g. goal setting and monitoring
progress) and perform behaviour skills
(e.g. identify and manage triggers),
sessions encouraged identification of
(and ways to overcome) obstacles;
and, per-session (and overall) feedback
was invited. Self-monitoring was encour-
aged and 1:1 support was provided by
facilitators.
•Interviews invited feedback on the
purpose of the intervention and
experiences (skills, behaviours,
goals); and explored learning and
use (or not) of skills by service
users and facilitators (self-report).
•Adherence (frequency and
duration) of sessions delivered was
monitored.
•Booster and telephone support
maintained for 12 months.
Fidelity goals not monitored (or applicable)
•Equivalent dose is not applicable as
there was no active control.
•No strategies were employed to
minimise “drift”in facilitator skills as
no benchmark had been
established.
Components and fidelity goals derived by the Behaviour Change Consortium recommendations for enhancing treatment fidelity (BCCr) [49]
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In some trusts, healthcare professionals delivering
the intervention felt coordination of resources were
not adequate. Service users were motivated to par-
ticipate (82.6% attended at least 2 of 7 group ses-
sions), liked the course materials and how the
sessions were run; however, some healthcare profes-
sionals doubted the sustainability of delivery outside
the RCT.
“I think the resources were excellent... I think that
would be a concern going forward... there
wouldn’tbefunds...forustohavetaxisfor
everyone and some of the other resources we’ve
been given... Where would that money …come
from?Ithinkthetaxithingwasreallyhelpful.A
lotofpeopleprobablywouldn’thavecome
without the taxis.”(Facilitator S06/F04)
Activities
Facilitator training was delivered as scheduled with
additional training provided to NHS trusts where
required. Healthcare professionals highlighted that
planning and delivery of sessions took significant re-
sources, greater than advertised, and often felt stress
as a result of under-resourced programme and case
management. Healthcare professionals and interven-
tionists highlighted the importance of co-ordination
activities to programme delivery. Clinical gatekeeping,
restricting access to eligible services users, was not
thought to be widespread.
“It took almost the entire day by the time we’d been
out to buy the stuff that we needed for the lunches
and set the room up and do the preparation...and then
following the group sort of just writing the notes and
Fig. 2 Summary of context for people with schizophrenia informed by the ICF conceptual framework.
Legend: ICF International Classification of Functioning. Reprinted from Towards a common language for functioning, disability and health
ICF, World Health Organization, Diagram (‘model of disability’), Page 9, WHO Reference Number: WHO/EIP/GPE/CAS/01.3, Copyright 2002.
APM = Antipsychotic medication
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things up, so it was a day out effectively a week.”
(Facilitator S08/F05)
“Had it not been for [the co-ordinator] …it
would have took me a full day. It's only because
she had everything organised, and ... she knew
what we needed for each week...”(Facilitator S01/
F02)
“there were sites where you had a very proactive
coordinator …in some other places …that wasn’t
quite the case …it was very much left to them
[facilitator]”(Interventionist, D03)
“Some of the feedback that I was getting during
telephone conversations was …people with mental
health problems might need something additional
Fig. 3 Summary of triangulated findings within logic model components.
Legend: Areas are highlighted to indicate where findings from the data triangulation supported (green), diverged (red) or varied (amber) when
analysed against the theory of change
Fig. 4 Time (weeks) to facilitator attrition from foundation training
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…they’ve got mental health problems...other
stuff...difficult social stuff...adapting it straight from
a study for people with diabetes whether or not
they have like co-morbidity... it might not be as
transferable.”(Facilitator S01/F04)
Immediate outcomes
Fidelity of intervention delivery
We examined immediate outcomes associated with de-
livery of the intervention using the Behaviour Change
Consortium recommendations for enhancing treatment
fidelity (BCCr) [48]. Fidelity assessment showed mean
(SD) facilitator talk time was 47.6% (12.2%) and facilita-
tor behaviours deemed positive was 54.1% (17.6) with a
range between centres of 31.8% (13.2%) to 64.6%
(17.67%). Lapses in fidelity were observed by assessors
e.g. giving answers, rather than eliciting, solutions from
service users to discussion topics.
All foundation and all but one booster sessions were de-
livered as scheduled. A total of 171 (82.6%) service users
attended at least 2 (of 7) group sessions. Approximately
23% (n= 47) of service users attended all sessions; how-
ever, 17.4% (n= 36) did not attend any sessions.
Whilst the trial included 414 people with schizophre-
nia, schizoaffective disorder or first episode psychosis
and less than 20% dropped out (‘reach’), this number
represents only a small proportion of those potentially
eligible at study sites.
Service user acceptability
Using Sekhon’s acceptability framework [31], we found
service users were extremely positive about the interven-
tion. Most respondents found the provision of taxis, lunch
and support tools for each session highly acceptable. They
understood the purpose of the intervention and found it
realistic, flexible, accessible and not burdensome. Service
users perceived benefits to include lifestyle change and/or
weight loss although this was not always the case.
“Oh yes definitely, I've lost quite a bit of weight
and I'm in much better shape …”(Service User
S06/Q06; -12.3 Kg at 3 months, lost to follow-up
at 12 months)
“…it helped me lose weight and it helped me write
down what I was eating, what I was drinking, and
helped me do more exercise.”(Service User S04/Q08;
29.7 Kg 0-12 months)
There was an overwhelming sense that service users
found the peer group interaction and social support to
be beneficial. Some service users had never met others
with schizophrenia and had attempted weight loss at
commercial programmes but did not want to talk about
the impact of their medication because of stigma at-
tached to severe mental illness.
“I find it fantastic …meeting other groups of people
on a similar medication with similar problems...”
(Service User S01/Q01)
Through triangulation of service user perspectives, RCT
outcomes and analyses of intervention components we
found that most service users talk about self-monitoring
(support tools); more successful service users seem to
value monitoring and feedback by others; however,
objective monitoring and feedback of behaviour and out-
comes by others was not part of the intervention design.
Healthcare professionals (facilitators)
A summary of qualitative findings understood through
the Normalisation Process Theory [32]isshownin
Fig. 5. Most healthcare professionals distinguished
STEPWISE from other interventions, reported under-
standing what was required of them, shared its aims
with other healthcare professionals,believed it was
therightthingtobedoingandconstructedpotential
value from the intervention.
“I think that it’s definitely something that we haven't
been doing. And I think it's something that we should
be doing.”(Facilitator S02/F06)
Healthcare professionals reported that service users’
understanding of the intentions of the programme was
not immediately or always understood. Some felt this
was due to cognitive difficulties or services users being
more familiar with a didactic, rather than, facilitative
approach.
“And their functioning is quite different, you know,
there's really quite a high level functioning lady
there who sort of understood the thing straight
away, and another guy …it's very difficult to find
out what his understanding actually is. Because he
tends to talk in slightly psychotic terms.”
(Facilitator S05/F02)
“We do repeat, you know …it's a lifestyle choice...
we're not saying that you've got to ban all bad
food... they think they're going to go there, get
weighed, and they'll go on a diet, we're going to
give them a diet sheet. And for some people that
would work, and for other people empowering
them works... sometimes the like peer pressure and
going to Weight Watchers and knowing that you
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know there's some expectation you've lost some
weight, because it's been marked down, that works
verywellforsomepeoplebutnotothers.”
(Facilitator S01/F02)
Healthcare professionals could perform the tasks re-
quired by the intervention and universally complemen-
tary about the training and printed materials they
received, although one noted:
“It was a lot to take in just those three days initially …
quite intense.”(Facilitator S08/03)
Staff highlighted organisational challenges in some
trusts including: key individuals not driving implementa-
tion, lack of commitment from senior leadership, under-
resourced delivery and doubt regarding sustainability of
the programme post-RCT.
“If it works …it's going to become part of like the
working practice for everybody. We won't be giving
out free gifts …It will just be …part of people's care
plan.”(Facilitator S01/F02)
The extent to which healthcare professionals could
access information about the intervention effects (e.g.
weight) was limited. STEPWISE has no mechanisms by
which healthcare professionals could access objective
information about the effects of STEPWISE.
“No one seems to be taking weight! I'm not gathering
data on individual clients …we don't even have an
ongoing way of monitoring weight now [in the trust]
…”(Facilitator S05/F02)
Similarly, healthcare professionals reported finding it
difficult to ensure services uses comprehended the
course content and had sufficient cognitive skills to
perform the necessary behaviour change. This was
echoed by some service users who wanted more moni-
toring by others. Interventionists reported that (subject-
ive) information about the extent to which service users
Fig. 5 Summary of the facilitator qualitative findings understood through the Normalisation Process Theory.
Legend: May CR. BMC Health Serv Res. 2011;11(1):245
Gossage-Worrall et al. BMC Psychiatry (2019) 19:358 Page 10 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
understood the material could have been elicited by fa-
cilitators during sessions.
“Sometimes it wasn’t explored to check understanding...
I would want to say with somebody like summarise
what key message you’ve taken away from that session...
Idon’t think we ... cover it in [facilitator] training... it’s
something that could be emphasised more to check
people’s understanding.”(Interventionist, D07)
Intermediate outcomes
Most service users found the intervention to be highly
acceptable and many of those interviewed reported mak-
ing important changes in levels of physical activity, im-
proved nutrition and reduction in weight; however, RCT
outcome data showed that this was only true for a small
number of service users. Any differences between inter-
vention and control groups could not be explained by
receipt of the intervention.
Discussion
This process evaluation explored how context affected
programme implementation and may help understand
why the STEPWISE intervention was unsuccessful in
supporting weight loss in people with schizophrenia,
schizoaffective disorder and first episode psychosis. The
process evaluation found that the programme design re-
quired closer (objective) monitoring of service users’
progress towards their lifestyle goals, greater integration
of the programme within the organisation, i.e. coordin-
ation of resources, supporting staff appropriately to run
the programme, and consideration of the context and
variation in symptoms for people living with schizophre-
nia to achieve the desired lifestyle change.
The evaluation identified poverty, under-resourced
services and stigma associated with severe mental illness
as important issues for providers of tailored weight man-
agement programmes, as have others [49]. Service users
valued the provision of (funded) transport and found
patient-focused educational approach acceptable; how-
ever, healthcare professionals felt the level of resource
employed would be unsustainable outside of the trial. If
born out, ensuring adequate resources would be essen-
tial for successful implementation. Recent research con-
ducted by McGinty and colleagues identified ways to
adapt and scale up a severe mental illness weight loss
intervention (ACHIEVE); including, building staff cap-
acity, engaging leaders and organisational change and
financial policy strategies [50] which may overcome
some of the perceived and actual resourcing and leader-
ship challenges we found in our study.
We investigated intervention fidelity via direct obser-
vation of STEPWISE courses, which is considered the
gold standard approach [48]. Observations were under-
taken by interventionists; however, qualitative and quan-
titative process and implementation data were collected
and analysed by evaluators (DH and RGW) with suffi-
cient independence to critically observe stakeholders, as
recommended in guidance [20].
Limitations
We coded participant transcripts to the Behaviour
Change Wheel [43] during analysis ‘after the event’, ra-
ther than integrating constructs within the interview
schedule. Therefore, the subsequent analysis did not
draw methodologically from these constructs rather it
reflected service users’patterns of attention. Programme
infrastructure that would, if rolled out, be required to
Fig. 6 Potential modifications to improve the STEPWISE intervention
Gossage-Worrall et al. BMC Psychiatry (2019) 19:358 Page 11 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
support training, provision of materials and ongoing
quality assurance, was not in place and therefore could
not be evaluated. In addition, in at least one trust facili-
tators were managed by the Research and Development
department which meant greater control over resource
management for intervention delivery.
Implications
As the theory underpinning the intervention is sound,
we have explored the intervention design and considered
how it has been packaged (session content/timings),
along with organisation issues (resources, lack of moni-
toring/tailoring for individuals) and the context of living
with a severe mental illness to assist in understanding
why the required behaviour change mechanisms have
not been triggered. The process evaluation points to po-
tential modifications which are highly likely to improve
the design and organisation of this or similar interven-
tions for this population (Fig. 6).
Conclusions
The triangulation of qualitative and quantitative findings
of the STEPWISE intervention reveal barriers and facili-
tators that influenced programme delivery. System level
infrastructure, local leadership and providing sufficient
time and resources for adequate coordination and deliv-
ery are essential. There is demand from people with
schizophrenia for this type of programme; and, the need
for interventions to support weight loss is unlikely to re-
duce because few tailored programmes exist, and obesity
rates generally are rising. Findings from our study sug-
gest certain strategies may improve and support delivery
in any future adaptions and in subsequent real-world
implementation. Although further research is required
to identify what type and format of interventions will
best support people with schizophrenia to lose weight,
and associated costs, our study found that close objective
monitoring of desired outcomes to assess progress to-
wards individual lifestyle goals (e.g. weight) and an
adequately resourced programme at local (i.e. personnel,
support tools, venues) and national (manual, training,
quality assurance) levels are essential. Furthermore, con-
sideration of the range of contextual factors, which vary
in their applicability to, and impact on, people living
with schizophrenia, will help ensure interventions are
tailored and flexible; and therefore, more likely to
achieve lifestyle changes which can reduce the health in-
equalities experienced by services users when compared
to the general population.
Abbreviations
BCCr: Behaviour Change Consortium recommendations; BCT: Behaviour
Change Taxonomy; CTRU: Clinical Trials Research Unit; CFBOS: Core Facilitator
Behavioural Observation Sheet; DOT: DESMOND Observation Tool;
DESMOND: Diabetes Education and Self-Management for Ongoing and
Diagnosed; ICF: International Classification of Functioning; MA: Master of Arts;
MRC: Medical Research Council; NIHBCC: National Institute for Health
Behaviour Change Consortium; NPT: Normalisation Process Theory;
PI: Principal Investigator; PhD: Philosophiae doctor; RCT: Randomised
Controlled Trial; SMI: Severe Mental Illness; SD: Standard Deviation;
STEPWISE: STructured lifestyle Education for People WIth SchizophrEnia;
TDF: Theoretical Domains Framework; WHO: World Health Organisation
Acknowledgements
We acknowledge and thank the contributions of: 414 RCT participants of which
24 service users also took part in a qualitative interview, the facilitators and
interventionists who contributed their time and data to the process evaluation
and, the STEPWISE Research Group for making this research possible.
The STEPWISE Research Group
University of Southampton: Richard I. G. Holt (chief investigator), Katharine
Barnard-Kelly. University of Sheffield: Rebecca Gossage-Worrall (research
associate, trial manager), Mike Bradburn (senior statistician), Daniel Hind
(CTRU assistant director), David Saxon (statistician), Lizzie Swaby (research
assistant). Greater Manchester Mental Health NHS Foundation Trust: Paul
French (principal investigator), John Pendlebury (community psychiatric
nurse –retired). Leeds and York Partnership Trust: Stephen Wright (principal
investigator). Sheffield Health and Social Care NHS Foundation Trust: Glenn
Waller (principal investigator). Kings College London: Paul McCrone (health
economist), Tiyi Morris (research assistant). University of Leicester: Charlotte
Edwardson (associate professor in physical activity, sedentary behaviour and
health), Kamlesh Khunti (professor of primary care diabetes and vascular
medicine), Melanie Davies (professor of diabetes medicine). University
Hospitals of Leicester: Marian Carey (director: structured education research
portfolio), Yvonne Doherty (consultant clinical psychologist), Alison Northern
(project manager), Janette Barnett (diabetes specialist nurse). Cornwall NHS
Trust: Richard Laugharne (principal investigator). Devon Partnership Trust:
Chris Dickens (principal investigator). Somerset Partnership Trust: Chris
Dickens (principal investigator). Sussex Partnership: Kathryn Greenwood
(principal investigator). South London and Maudsley NHS Foundation Trust:
Fiona Gaughran (co-principal investigator), Sridevi Kalidindi (co-principal
investigator). Southern Health NHS Foundation Trust: Shanaya Rathod
(principal investigator). Bradford District Care Trust: Najma Siddiqi (principal
investigator). Angela Etherington (independent service user consultant),
David Shiers (carer collaborator).
We also acknowledge and thank: research, managerial and clinical staff in
the ten participating NHS Trusts; the trial team at Sheffield Clinical Trials
Research Unit, Nicholas Bell, Director of Research and Development (Sheffield
Health and Social Care NHS Foundation Trust), as Research Sponsor. We
acknowledge advice and oversight from the independent members of the Trial
Steering Committee –especially service user representatives; and members of
the independent Data Monitoring Committee. We acknowledge Jonathan
Mitchell (Consultant Psychiatrist, Sheffield Health and Social Care NHS
Foundation Trust) as the PI of the intervention development study; and the
NIHR Clinical Research Network for supporting recruitment to the RCT, and
Tees Esk and Wear Valleys NHS Foundation Trust, which supported the study
from 1 October 2015.
Declarations
This article contains text reproduced from a study funded by the National
Institute for Health Research Health Technology Assessment (NIHR HTA) Holt
RIG, Hind D, Gossage-Worrall R, Bradburn M, Saxon D, McCrone P, et al.
Structured lifestyle education to support weight loss for people with
schizophrenia, schizoaffective disorder and first episode psychosis: the
STEPWISE RCT. Health Technol Assess 2018;22 (65).
Authors’contributions
RG-W, DH, KBK, DS, AE and RIGH conceived of and participated in the design
of the study. Participant and facilitator interviews were conducted by RGW;
and, DH conducted the interventionist interviews. RG-W and DH coded inter-
view transcripts and conducted qualitative data analysis and triangulation with
fidelity observations (data collected and analysed by researchers at Leicester
Diabetes Centre); and, RCT data (collected by 10 NHS mental health trusts and
analysed by the Trial Statistician). LS contributed to coding of interview tran-
scripts and together with RG-W, DH, KBK, DS, AE participated in discussions of
field notes and emerging themes. RG-W coordinated the study and drafted the
Gossage-Worrall et al. BMC Psychiatry (2019) 19:358 Page 12 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
initial manuscript. All authors contributed to revisions of, and approved, the final
manuscript.
Funding
This project was funded by the National Institute for Health Research (NIHR)
Health Technology Assessment programme (project number 12/28/05). The
funder took no part in the design collection, analysis, and interpretation of
data or writing the manuscript. The views expressed are those of the authors
and not necessarily those of the NHS, MRC, CCF, NIHR or the Department of
Health and Social Care. The views and opinions expressed by the interviewees
in this publication are those of the interviewees and do not necessarily
reflect those of the authors, those of the NHS, MRC, CCF, NIHR, NETSCC,
the Health Technology Assessment Programme or the Department of
Health and Social Care.
Availability of data and materials
The datasets generated and/or analysed during the current study are not
publicly available due to ensuring the confidentiality and anonymity of the
participants but are available from ctru@sheffield.ac.uk on reasonable request.
Ethics approval and consent to participate
The STEPWISE project received ethics approval from Yorkshire and Humber -
South Yorkshire NHS Research Ethics Committee (reference 14/YH/0019) on
4 February 2014. Written informed consent for study participation was obtained
from all service users as part of the consent process for the RCT. Service users
and facilitators provided verbal consent which was audio-recorded prior to
(and separately) from the telephone interviews and documented in writing
on NHS REC-approved consent forms. A copy of the consent form was
provided to all participants. Written informed consent for study participation for
interventionists was obtained. A copy of the consent forms for
service users, interventionists and facilitators are available for review by the
Editor of this journal.
Consent for publication
Written informed consent for study participation, and publication of direct
quotes, was obtained from all participants. A copy of the consent forms for
service users, interventionists and facilitators are available for review by the
Editor of this journal.
Competing interests
DS is expert advisor to the NICE centre for guidelines and a member of the
current NICE guideline development group for Rehabilitation in adults with
complex psychosis and related severe mental health conditions; Board member
of the National Collaborating Centre for Mental Health (NCCMH); Clinical
Advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP);
views are personal and not those of NICE, NCCMH or NCAP.
RIGH received fees for lecturing, consultancy work and attendance at
conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen,
Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD.
All remaining named authors did not disclose any declarations of interest.
Author details
1
Clinical Trials Research Unit, School of Health and Related Research, The
University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK.
2
Faculty of Health & Social Science, Bournemouth University, Poole, Dorset,
UK.
3
Honorary Research Consultant, Psychosis Research Unit, Greater
Manchester Mental Health NHS Foundation Trust and Honorary Reader in
Early Psychosis, School of Health Sciences, Division of Psychology and Mental
Health, University of Manchester, Manchester, UK.
4
Patient Representative,
Independent Service User Consultant, Manchester, UK.
5
Human Development
and Health, Faculty of Medicine, University of Southampton, Southampton,
UK.
6
University Hospital Southampton NHS Foundation Trust, Southampton,
UK.
Received: 7 January 2019 Accepted: 10 September 2019
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