Complex Behaviour Change Intervention Research Articles

Designing a behaviour change intervention using COM-B and the Behaviour Change Wheel: Co-designing the Healthy Gut Diet for preventing gestational diabetes.

Evidence suggests that modulating the gut microbiota during pregnancy may help prevent gestational diabetes mellitus (GDM). The Healthy Gut Diet study is a complex behaviour change intervention co-designed with women who have a lived experience of GDM. The aim of the study was to describe the development of the behaviour change dietary intervention, the Healthy Gut Diet. This study followed the process for designing behaviour change interventions using the Behaviour Change Wheel. Six researchers and 12 women with lived experience participated in online workshops to co-design the Healthy Gut Diet intervention. This included "diagnosing" the barriers and enablers to two target behaviours: eating more plant foods and eating less ultra processed/saturated fat containing foods. Content analysis of the workshop transcripts and activities was undertaken, underpinned by the Capability, Opportunity, Motivation and Behaviour (COM-B) model and the Theoretical Domains Framework (TDF). Barriers and enablers to the target behaviours were described across all six COM-B components and 10 TDF domains. The intervention functions for the Healthy Gut Diet were education, enablement, environmental restructuring, persuasion and incentivisation. Forty behaviour change techniques were integrated into five modes of delivery for the Healthy Gut Diet intervention. The feasibility, acceptability and effectiveness of the Healthy Gut Diet is being tested within a randomised controlled trial. Using the Behaviour Change Wheel process in partnership with consumers resulted in a clearly described complex intervention targeting barriers and enablers of dietary behaviour change to improve the gut microbiota diversity in pregnant women.

A generic logic model for physical activity interventions for the cardiac population using intervention mapping

Abstract Introduction Regular physical activity is important in the secondary prevention of cardiovascular disease. But many cardiac patients have difficulty establishing lifelong physical activity habits, even after completion of an exercise-based cardiac rehabilitation programme. There is a need for effective interventions to support cardiac patients' physical activity. Such interventions are often complex behaviour change interventions whose design should be grounded in programme theory, i.e., a description of how the intervention is expected to lead to its effects and under what conditions. A logic model is often used to communicate programme theory [1]. Purpose The purpose of this work was to describe a generic logic model for behaviour change interventions to increase and maintain physical activity among patients who have had an acute cardiac event. Methods We applied the Intervention Mapping approach [2] to develop a generic logic model that is both data- and theory-driven, i.e. informed by research evidence and behaviour change theory. The at-risk behaviour for the individual cardiac patient was defined as "insufficient independent long-term maintenance of heart-healthy physical activity", compounded by the environmental factor "lack of support provision for long-term independent physical activity" from the healthcare providers and people in the patient’s interpersonal environment. We defined performance objectives by asking the questions: "What do people who had an acute cardiac event need to do to increase and maintain their heart-healthy physical activity?" and "What do the healthcare providers and people in the patient’s interpersonal environment need to do to encourage and support the patient in being physically active?" The performance objectives specify what actions are required of the individuals targeted in the intervention. We selected determinants corresponding to performance objectives based on empirical evidence from systematic reviews and based on behaviour change theory such as the Reasoned Action Approach (RAA) and the Health Action Process Approach (HAPA). Results Central elements of the logic model are presented in table 1. The logic model includes 18 performance objectives and 13 determinants, supported by empirical evidence from 40 scientific publications. Conclusion The generic logic model serves as a collection of current knowledge regarding increasing and maintaining physical activity among the cardiac population and can be used for a number of purposes: as a foundation for developing new interventions; as a blueprint against which to compare and/or solidify the programme theory of existing interventions; as a conceptual framework for designing evaluations of interventions; as a current evidence map from which to identify research gaps; and as a point of reference for reflecting on one’s own health behaviour.Table 1.Elements of the logic model.

Effectiveness of complex behaviour change interventions tested in randomised controlled trials for people with multiple long-term conditions (M-LTCs): systematic review with meta-analysis

IntroductionThe prevalence of multiple long-term conditions (M-LTCs) increases as adults age and impacts quality of life and health outcomes. To help people manage these conditions, complex behaviour change interventions are...

What influences stroke survivors with physical disabilities to be physically active? A qualitative study informed by the Theoretical Domains Framework.

Although the benefits of regular physical activity (PA) after stroke are well established, many stroke survivors do not achieve recommended PA levels. To date, studies exploring determinants to PA have not used a behaviour change theory and focused on stroke survivors with physical disabilities. As a precursor to an intervention development study, we aimed to use the Theoretical Domains Framework (TDF) to identify factors influencing PA in stroke survivors with physical disabilities in Singapore. Between November 2021 and January 2022, we conducted interviews with 19 community-dwelling stroke survivors with a weak arm and/or leg. An interview guide based on the TDF was developed. We analysed the data deductively by coding interview transcripts into the theoretical domains of the TDF, and then inductively by generating themes and belief statements. To identify relevant TDF domains, we prioritised the domains based on the frequencies of the belief statements, presence of conflicting belief statements and evidence of strong belief statements. Eight of the 14 TDF domains were relevant, and included environmental context and resources, knowledge, social influences, emotion, reinforcement, behavioural regulation, skills and beliefs about capabilities. The lack of access, suitable equipment and skilled help often limited PA participation at public fitness spaces such as parks, gyms and swimming pools (environmental context and resources). While a few stroke survivors expressed that they had the skills to engage in regular PA, most expressed not knowing how much and how hard to work, which exercises to do, which equipment to use and how to adapt exercises and equipment (knowledge and skills). This often left them feeling afraid to try new activities or venture out to new places for fear of the unknown or adverse events (e.g., falls) (emotion). For some, doing the activities in a group encourage them to get out and engage in PA (social influences). In stroke survivors with physical disabilities, environmental context and resources had a significant influence on PA participation, and this often had a spill over effect into other domains. Our results inform a complex behaviour change intervention to improve PA after stroke, and has implications for intervention design for people with physical disabilities.

Complex Behavior Change Interventions for Community Health

How can community health professionals connect with resident health consumers to encourage positive self care? This goes beyond encouraging physical activity to encompass a range of life style behavior changes with a tailored approach that engages those least engaged with health and wellness and potentially most at risk from acute health risks and longer term conditions such as Type 2 Diabetes. Is the answer purely digital, or does a network of health service managers help drive engagement and better outcomes?
 Objectives• Insight into own practices and the balance between acute and preventative care• Understand how smartphone technology, combined with incentives, can be used to engage community residents in their own self care• Learn how to baseline existing behavior and measure change over time• Gain insights from smartphone derived data and understand how it can be used to identify barriers to change

Health action process approach: promoting physical activity, and fruit and vegetable intake among Australian adults.

Based on the health action process approach (HAPA) this study examined whether changes in social cognition constructs could predict change in physical activity and fruit and vegetable intake for adult participants in My health for life, an Australian health promotion behaviour change program. Variance-based structural equation modelling was used to analyse data obtained from Australian adult program participants (n = 167) at baseline (T1), week 14 (T2), week 26 (T2), and 6-month post-program (T4). Change scores were calculated for the social cognition constructs and behaviour. Changes in action self-efficacy and outcome expectancies positively predicted changes in intentions. Action self-efficacy changes also predicted changes in maintenance self-efficacy which, in turn, mediated the effect of action self-efficacy on recovery self-efficacy and planning. Planning was predicted by changes in intentions and maintenance self-efficacy. Findings support the use of the HAPA model in designing complex health behaviour change interventions to achieve sustained behaviour change.

Developing and testing complex behaviour change interventions to support proactive deprescribing: A narrative review.

The authors declare that they do not have any conflict of interest.

Feasibility of a theoretically grounded, multicomponent, physiotherapy intervention aiming to promote autonomous motivation to adopt and maintain physical activity in patients with lower-limb osteoarthritis: protocol for a single-arm trial

BackgroundLower-limb osteoarthritis (OA) causes high levels of pain and disability in adults over 45 years of age. Adopting and maintaining appropriate levels of physical activity (PA) can help patients with lower-limb OA self-manage their symptoms and reduce the likelihood of developing secondary noncommunicable diseases. However, patients with lower-limb OA are less active than people without musculoskeletal pain. This single-arm feasibility trial seeks to determine the feasibility and acceptability of a complex multicomponent physiotherapy behaviour change intervention that aims to aid patients with lower-limb OA to adopt and maintain optimal levels of PA.MethodsThis trial will be conducted at one site in a National Health Service physiotherapy outpatient setting in the West Midlands of England. Up to thirty-five participants with lower-limb OA will be recruited to receive a physiotherapy intervention of six sessions that aims to optimise their PA levels during phases of behavioural change: adoption, routine formation and maintenance. The intervention is underpinned by self-determination theory (and other motivational frameworks) and seeks to foster a motivationally optimal (empowering) treatment environment and implement behaviour change techniques (BCTs) that target PA behaviours across the three phases of the intervention. Physiotherapists (n = 5–6) will receive training in the why and how of developing a more empowering motivational environment and the delivery of the intervention BCTs. Participants will complete patient-reported and performance-based outcome measures at baseline and 3-month (to reflect behavioural adoption) and 6-month (maintenance) post-baseline. Feasibility and acceptability will be primarily assessed through semi-structured interviews (purposively recruiting participants) and focus groups (inviting all physiotherapists and research staff). Further evaluation will include descriptive analysis of recruitment rates, loss of follow-up and intervention fidelity.DiscussionA novel complex, multicomponent theoretical physiotherapy behaviour change intervention that aims to create a more empowering motivational treatment environment to assist patients with lower-limb OA to adopt and maintain optimal PA levels has been developed. Testing the feasibility and acceptability of the intervention and its associated physiotherapist training and related trial procedures is required to determine whether a full-scale parallel group (1:1) randomised controlled trial to evaluate the interventions effectiveness in clinical practice is indicated.Trial registrationTrial register: International Standard Randomised Controlled Trial identification number: ISRCTN12002764.Date of registration: 15 February 2022.

Earlier cancer diagnosis in primary care: a feasibility economic analysis of ThinkCancer!

UK cancer survival rates are much lower compared with other high-income countries. In primary care, there are opportunities for GPs and other healthcare professionals to act more quickly in response to presented symptoms that might represent cancer. ThinkCancer! is a complex behaviour change intervention aimed at primary care practice teams to improve the timely diagnosis of cancer. To explore the costs of delivering the ThinkCancer! intervention to expedite cancer diagnosis in primary care. Feasibility economic analysis using a micro-costing approach, which was undertaken in 19 general practices in Wales, UK. From an NHS perspective, micro-costing methodology was used to determine whether it was feasible to gather sufficient economic data to cost the ThinkCancer! Owing to the COVID-19 pandemic, ThinkCancer! was mainly delivered remotely online in a digital format. Budget impact analysis (BIA) and sensitivity analysis were conducted to explore the costs of face-to-face delivery of the ThinkCancer! intervention as intended pre-COVID-19. The total costs of delivering the ThinkCancer! intervention across 19 general practices in Wales was £25 030, with an average cost per practice of £1317 (standard deviation [SD]: 578.2). Findings from the BIA indicated a total cost of £34 630 for face-to-face delivery. Data collection methods were successful in gathering sufficient health economics data to cost the ThinkCancer! Results of this feasibility study will be used to inform a future definitive economic evaluation alongside a pragmatic randomised controlled trial (RCT).

Improving the diagnosis of cancer in primary care: a feasibility economic analysis of the ThinkCancer! study.

BackgroundCancer survival in the UK remains low compared to other Western countries including Australia, Canada and European countries. Delays in cancer diagnosis have an adverse impact on patient well-being and survival. Welsh Government outline a number of challenges with respect to earlier cancer diagnosis, including a lack of awareness of ‘red flag’ symptoms and difficulties among GPs and other healthcare professionals in identifying cancers that present with vague or non-specific symptoms. For some cancers, earlier diagnosis is associated with greater survival, better patient experience and quality of life, and lower healthcare costs.
 MethodsThe ThinkCancer! intervention is a complex behaviour change intervention, which aims to change the behaviours of primary care practice teams when thinking of and acting on clinical symptoms that could be cancer. From an NHS perspective, we conducted a feasibility economic analysis of the ThinkCancer! intervention. We used micro-costing methodology to determine whether it was feasible to gather sufficient economic data to cost the ThinkCancer! intervention. Due to the Covid-19 pandemic, the intervention was mostly delivered remotely in a digital format. Intervention deliverers completed data collection sheets (including forms recording materials used and intervention deliverer time) and provided information on primary care staff attendance at each of the ThinkCancer! workshops. Budget impact analysis and sensitivity analysis were conducted to explore the costs of face-to-face delivery of the ThinkCancer! intervention as intended pre-COVID-19.
 FindingsThe total costs of delivering the ThinkCancer! intervention across 19 general practices in Wales was £25,030. Costs per practice ranged from £431 to £2,498, with an average cost per practice of £1,311 (SD: 579.5). The potential budget impact if the intervention were to be delivered face-to-face across the 19 general practices would be £34,630. Sensitivity analysis revealed that if the intervention were to be delivered by one GP educator, the total estimated cost for face-to-face delivery would be £31,232. With the addition of one support role assisting the GP educator with the intervention delivery, the total cost of face-to-face delivery is estimated to be approximately £33,138.
 ConclusionsResults of this feasibility study are being used to inform a definitive economic evaluation alongside a pragmatic randomised controlled trial. Primary care interventions to expedite the diagnosis of symptomatic cancer have the potential to reduce large costs to the NHS and improve patient and carer outcomes as later stage cancer treatments are often longer, more aggressive to patients, with larger associated healthcare costs compared to earlier stage treatment.
 http://wicked.bangor.ac.uk/

Is fidelity to a complex behaviour change intervention associated with patient outcomes? Exploring the relationship between dietitian adherence and competence and the nutritional status of intervention patients in a successful stepped-wedge randomised clinical trial of eating as treatment (EAT)

BackgroundBehavioural medicine is characterised by findings for the effectiveness and efficacy of complex behaviour change interventions. Comparatively, scant attention has been paid to key intervention components or mechanisms of action. Evaluating relationships between process variables (fidelity) and intervention effects is central to addressing this imbalance. Accordingly, in the current study, we sought to explore the magnitude and direction of effect between fidelity predictors (dietitian adherence and competence) and intervention effects (patient nutritional status) during the intervention phase of a real-world, stepped-wedge evaluation of ‘EAT: Eating As Treatment’.MethodsThe EAT clinical trial was conducted within five major Australian hospitals located in Queensland, Western Australia, Victoria and South Australia between 2013 and 2016. EAT is a dietitian-delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Dietitian adherence and competence ratings were derived from a 20% random sample of audio-recorded dietetic consultations (n=194) conducted after dietitians (n=18) were trained in EAT. Sessions were coded by trained, independent, coders using a study checklist, the Behaviour Change Counselling Index (BECCI) and items from the Cognitive Therapy Scale-Revised (CTS-R). Patient nutritional status was measured using the Patient-Generated Subjective Global Assessment (PGSGA).ResultsDietitian adherence to a written nutrition plan (β=7.62, 95% CI=0.65 to 14.58, p=0.032), dietitian adherence to behaviour change counselling (β=0.69, 95% CI =0.02 to 1.38, p=0.045) and competence in delivering behaviour change counselling (β=3.50, 95% CI =0.47 to 6.53, p=0.024) were significant predictors of patient nutritional status. Dietitian adherence and competence ratings were higher during consultations with intervention patients at greater risk of malnutrition.ConclusionsThis study contributes new insights into the relationship between fidelity and treatment outcome by demonstrating that dietitian adherence and competence is greater when working with more challenging patients. This is likely central to the demonstrated success of the EAT intervention in reducing malnutrition and highlights the importance of ensuring that providers are adequately equipped to flexibly integrate intervention elements according to patient need.Trial registrationThis study is a process analysis of a stepped-wedge randomised controlled trial prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12613000320752; Date of registration 21/03/2013).

Assessing Adherence, Competence and Differentiation in a Stepped-Wedge Randomised Clinical Trial of a Complex Behaviour Change Intervention.

Background: A key challenge in behavioural medicine is developing interventions that can be delivered adequately (i.e., with fidelity) within real-world consultations. Accordingly, clinical trials should (but tend not to) report what is actually delivered (adherence), how well (competence) and the distinction between intervention and comparator conditions (differentiation). Purpose: To address this important clinical and research priority, we apply best practice guidelines to evaluate fidelity within a real-world, stepped-wedge evaluation of “EAT: Eating As Treatment”, a new dietitian delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Methods: Dietitians (n = 18) from five Australian hospitals delivered a period of routine care and following a randomly determined order each site received training and began delivering the EAT Intervention. A 20% random stratified sample of audio-recorded consultations (control n = 196; intervention n = 194) was coded by trained, independent, raters using a study specific checklist and the Behaviour Change Counselling Inventory. Intervention adherence and competence were examined relative to apriori benchmarks. Differentiation was examined by comparing control and intervention sessions (adherence, competence, non-specific factors, and dose), via multiple linear regression, logistic regression, or mixed-models. Results: Achievement of adherence benchmarks varied. The majority of sessions attained competence. Post-training consultations were clearly distinct from routine care regarding motivational and behavioural, but not generic, skills. Conclusions: Although what level of fidelity is “good enough” remains an important research question, findings support the real-world feasibility of integrating EAT into dietetic consultations with HNC patients and provide a foundation for interpreting treatment effects.

How to design a complex behaviour change intervention: experiences from a nutrition-sensitive agriculture trial in rural India.

Many public health interventions aim to promote healthful behaviours, with varying degrees of success. With a lack of existing empirical evidence on the optimal number or combination of behaviours to promote to achieve a given health outcome, a key challenge in intervention design lies in deciding what behaviours to prioritise, and how best to promote them. We describe how key behaviours were selected and promoted within a multisectoral nutrition-sensitive agriculture intervention that aimed to address maternal and child undernutrition in rural India. First, we formulated a Theory of Change, which outlined our hypothesised impact pathways. To do this, we used the following inputs: existing conceptual frameworks, published empirical evidence, a feasibility study, formative research and the intervention team’s local knowledge. Then, we selected specific behaviours to address within each impact pathway, based on our formative research, behaviour change models, local knowledge and community feedback. As the intervention progressed, we mapped each of the behaviours against our impact pathways and the transtheoretical model of behaviour change, to monitor the balance of behaviours across pathways and along stages of behaviour change. By collectively agreeing on definitions of complex concepts and hypothesised impact pathways, implementing partners were able to communicate clearly between each other and with intervention participants. Our intervention was iteratively informed by continuous review, by monitoring implementation against targets and by integrating community feedback. Impact and process evaluations will reveal whether these approaches are effective for improving maternal and child nutrition, and what the effects are on each hypothesised impact pathway.

Evidence, theory and context: using intervention mapping in the development of a community-based self-management program for chronic low back pain in a rural African primary care setting - the good back program

BackgroundRural Nigeria has one of the greatest burdens of low back pain but there are no effective evidence-based interventions to manage it in this population. This paper presents the application of the intervention mapping (IM) approach in the development of a complex behavior change intervention – The Good Back program, aimed at reducing non-specific chronic low back pain (CLBP) disability in rural Nigeria.MethodsThe first four steps of IM were applied. A critical review of the literature, 2 qualitative studies and a population-based cross-sectional study in rural Nigeria helped to identify two key program objectives in order to reduce CLBP disability in this population: reduce the impact of illness perceptions, fear avoidance beliefs, catastrophising, anxiety and depression by targeting maladaptive illness perceptions about CLBP; and facilitate the adoption of exercises and good posture to limit disability. A systematic review plus these studies, identified the personal and environmental determinants of the performance objectives including health literacy, self-awareness, self-efficacy, personal preference, health professional skills, health facility structure and family/community support. The theory, techniques and strategies for modifying personal and environmental determinants were also identified from these studies. Intervention components and materials were then produced for practical application. The initial developed intervention was described.ResultsThe feasibility and acceptability of the developed program was then tested using a small pragmatic non-randomised controlled study incorporating qualitative exit feedback interviews in a rural Nigerian primary health care centre. The program appeared feasible and acceptable when delivered by a highly trained physiotherapist. There were promising clinical outcomes in disability, pain intensity, illness perceptions, fear avoidance beliefs and pain medication use. Suggestions for program improvement included shorter but ongoing sessions, video demonstration of exercises/good posture, spacious exercise/demonstration rooms, and community legitimisation of exercise as treatment for back pain. Subsequent modifications to program content and delivery were then described. Theoretical modification included the addition of aspects of the social cognitive theory to the Leventhal’s self-regulatory model of illness cognitions.ConclusionsIM appears to be a suitable framework for designing complex behavior change interventions in rural Nigeria. The need for further testing of the intervention was highlighted.

Outcomes associated with scale-up of the Stepping On falls prevention program: A case study in redesigning for dissemination

Translating complex behavior change interventions into practice can be accompanied by a loss of fidelity and effectiveness. We present the evaluation of two sequential phases of implementation of a complex evidence-based community workshop to reduce falls, using the Replicating Effective Programs Framework. Between the two phases, workshop training and delivery were revised to improve fidelity with key elements. Stepping On program participants completed a questionnaire at baseline (phase 1: n = 361; phase 2: n = 2219) and 6 months post-workshop (phase 1: n = 232; phase 2: n = 1281). Phase 2 participants had an additional follow-up at 12 months (n = 883). Outcomes were the number of falls in the prior 6 months and the Falls Behavioral Scale (FaB) score. Workshop participation in phase 1 was associated with a 6% reduction in falls (RR = 0.94, 95% CI 0.74-1.20) and a 0.14 improvement in FaB score (95% CI, 0.11- 0.18) at 6 months. Workshop participation in phase 2 was associated with a 38% reduction in falls (RR = 0.62, 95% CI 0.57-0.68) and a 0.16 improvement in FaB score (95% CI 0.14-0.18) at 6 months, and a 28% reduction in falls (RR = 0.72, 95% CI 0.65-0.80) and a 0.19 score improvement in FaB score (95% CI 0.17-0.21) at 12-month follow-up. Effectiveness can be maintained with widespread dissemination of a complex behavior change intervention if attention is paid to fidelity of key elements. An essential role for implementation science is to ensure effectiveness as programs transition from research to practice.

Addressing fidelity within complex health behaviour change interventions: A protocol of a scoping review of intervention fidelity frameworks and models.

Intervention fidelity is crucial to facilitate accurate interpretation of research outcomes, but has been inadequately addressed within complex health behaviour change interventions. Recent research has highlighted a need for practical guidance to improve understanding and use of existing fidelity frameworks and models within complex health behaviour change intervention research. The aim of this paper is to present a protocol for a scoping review of existing intervention fidelity frameworks and models. In accordance with scoping review guidelines, the following stages will be conducted: (1) identifying the research question, (2) identifying potentially relevant studies of fidelity frameworks and models, (3) study screening and selection, (4) charting and extracting data from identified frameworks and models, (5) collating, summarising and reporting the results and (6) consultation with stakeholders. Two reviewers will independently conduct the screening and extraction stages. Identified frameworks will be collated, summarized and categorized iteratively by one reviewer in consultation with the review team. The findings of this review will provide a useful resource by identifying and comparing existing fidelity frameworks and models. It is intended that increased clarity and understanding in this area will facilitate the appropriate selection and application of fidelity frameworks for complex health behaviour change interventions, inform areas for future research, and ultimately contribute towards improving how intervention fidelity is addressed in this area.

Development of an intervention to expedite cancer diagnosis through primary care: a protocol.

BackgroundGPs can play an important role in achieving earlier cancer diagnosis to improve patient outcomes, for example through prompt use of the urgent suspected cancer referral pathway. Barriers to early diagnosis include individual practitioner variation in knowledge, attitudes, beliefs, professional expectations, and norms.AimThis programme of work (Wales Interventions and Cancer Knowledge about Early Diagnosis [WICKED]) will develop a behaviour change intervention to expedite diagnosis through primary care and contribute to improved cancer outcomes.Design & settingNon-experimental mixed-method study with GPs and primary care practice teams from Wales.MethodFour work packages will inform the development of the behaviour change intervention. Work package 1 will identify relevant evidence-based interventions (systematic review of reviews) and will determine why interventions do or do not work, for whom, and in what circumstances (realist review). Work package 2 will assess cancer knowledge, attitudes, and behaviour of GPs, as well as primary care teams’ perspectives on cancer referral and investigation (GP survey, discrete choice experiment [DCE], interviews, and focus groups). Work package 3 will synthesise findings from earlier work packages using the behaviour change wheel as an overarching theoretical framework to guide intervention development. Work package 4 will test the feasibility and acceptability of the intervention, and determine methods for measuring costs and effects of subsequent behaviour change in a randomised feasibility trial.ResultsThe findings will inform the design of a future effectiveness trial, with concurrent economic evaluation, aimed at earlier diagnosis.ConclusionThis comprehensive, evidence-based programme will develop a complex GP behaviour change intervention to expedite the diagnosis of symptomatic cancer, and may be applicable to countries with similar healthcare systems.

Embedding a user-centred approach in the development of complex behaviour change intervention to improve outcomes for young adults living with type 1 diabetes: The D1 Now Study.

Background: Type 1 diabetes (T1D) is an auto-immune condition which requires intensive self-management. Diabetes self-management is challenging, especially during young adulthood. Effective interventions to improve outcomes for young adults with T1D are needed. This paper describes the development of the D1 Now intervention, employing a user-centred approach to engage with stakeholders in parallel with the application of theory. Methods: Intervention development consisted of 4 phases: 1) the formation of a public and patient involvement (PPI) Young Adult Panel (YAP); 2) a systematic review to synthesise evidence regarding the effectiveness of interventions aimed at improving outcomes for young adults with T1D; 3) understand young adults' diabetes self-management behaviour through engagement with key stakeholders; and 4) an expert consensus meeting to discuss self-management strategies identified in Phase 1 and 3 that would form the core components of the D1 Now intervention. Results: The YAP resulted in meaningful involvement between young adults, researchers and service providers. The systematic review highlighted a lack of quality intervention studies. Qualitative findings highlighted how young adult self-management is driven by complex interactions between external resources, which influence capability, and motivation. The expert panel in Phase 4 highlighted focus areas to improve outcomes for young adults and implementation strategies. Subsequent to these 4 phases, 3 intervention components have been identified: 1) a key worker to liaise with the young adult; 2) an online portal to facilitate relationship building between staff and young adults; and 3) an agenda setting tool to facilitate joint decision-making. Conclusions: This study described the systematic development of an intervention underpinned by theoretical frameworks and PPI, and has identified components for the D1 Now intervention. The resulting intervention content will now be subject to an intervention optimisation process.

Embedding a user-centred approach in the development of complex behaviour change intervention to improve outcomes for young adults living with type 1 diabetes: The D1 Now Study

Background: Type 1 diabetes (T1D) is an auto-immune condition which requires intensive self-management. Diabetes self-management is challenging, especially during young adulthood. Effective interventions to improve outcomes for young adults (18-30 year olds) with T1D are needed. This paper describes the development of the D1 Now intervention, employing a user-centred approach to engage with stakeholders in parallel with the application of theory. Methods: Intervention development consisted of 4 phases: 1) the formation of a public and patient involvement (PPI) Young Adult Panel (YAP); 2) a systematic review to synthesise evidence regarding the effectiveness of interventions aimed at improving outcomes for young adults with T1D; 3) understand young adults’ diabetes self-management behaviour through engagement with key stakeholders; and 4) an expert consensus meeting to discuss self-management strategies identified in Phase 1 and 3 that would form the core components of the D1 Now intervention. Results: The YAP resulted in meaningful involvement between young adults, researchers and service providers. The systematic review highlighted a lack of quality intervention studies. Qualitative findings highlighted how young adult self-management is driven by complex interactions between external resources, which influence capability, and motivation. The expert panel in Phase 4 highlighted focus areas to improve outcomes for young adults and implementation strategies. Subsequent to these 4 phases, 3 intervention components have been identified: 1) a key worker to liaise with the young adult; 2) an online portal to facilitate relationship building between staff and young adults; and 3) an agenda setting tool to facilitate joint decision-making. Conclusions: This study described the systematic development of an intervention underpinned by theoretical frameworks and PPI, and has identified components for the D1 Now intervention. The resulting intervention content will now be subject to an intervention optimisation process.

Embedding a user-centred approach in the development of complex behaviour change intervention to improve outcomes for young adults living with type 1 diabetes: The D1 Now Study

Background: Type 1 diabetes (T1D) is an auto-immune condition which requires intensive self-management. Diabetes self-management is challenging, especially during young adulthood. Effective interventions to improve outcomes for young adults with T1D are needed. This paper describes the development of the D1 Now intervention, employing a user-centred approach to engage with stakeholders in parallel with the application of theory. Methods: Intervention development consisted of 4 phases: 1) the formation of a public and patient involvement (PPI) Young Adult Panel (YAP); 2) a systematic review to synthesise evidence regarding the effectiveness of interventions aimed at improving outcomes for young adults with T1D; 3) understand young adults' diabetes self-management behaviour through engagement with key stakeholders; and 4) an expert consensus meeting to discuss self-management strategies identified in Phase 1 and 3 that would form the core components of the D1 Now intervention. Results: The YAP resulted in meaningful involvement between young adults, researchers and service providers. The systematic review highlighted a lack of quality intervention studies. Qualitative findings highlighted how young adult self-management is driven by complex interactions between external resources, which influence capability, and motivation. The expert panel in Phase 4 highlighted focus areas to improve outcomes for young adults and implementation strategies. Subsequent to these 4 phases, 3 intervention components have been identified: 1) a key worker to liaise with the young adult; 2) an online portal to facilitate relationship building between staff and young adults; and 3) an agenda setting tool to facilitate joint decision-making. Conclusions: This study described the systematic development of an intervention underpinned by theoretical frameworks and PPI, and has identified components for the D1 Now intervention. The resulting intervention content will now be subject to an intervention optimisation process.