UNASSIGNED: The presence of dental caries impacts on children\'s daily lives, particularly among those living in deprived areas. There are successful interventions across the United Kingdom for young children based on toothbrushing with fluoride toothpaste. However, evidence is lacking for oral health improvement programmes in secondary-school pupils to reduce dental caries and its sequelae.
UNASSIGNED: To determine the clinical and cost effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in secondary-school pupils.
UNASSIGNED: A multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot and embedded health economic and process evaluations.
UNASSIGNED: Secondary schools in Scotland, England and Wales with above-average proportion of pupils eligible for free school meals. Randomisation occurred within schools (year-group level), using block randomisation stratified by school.
UNASSIGNED: Pupils aged 11-13 years at recruitment, who have their own mobile telephone.
UNASSIGNED: Two-component intervention based on behaviour change theory: (1) 50-minute lesson delivered by teachers, and (2) twice-daily text messages to pupils\' mobile phones about toothbrushing, compared with routine education.
UNASSIGNED: Primary outcome: presence of at least one treated or untreated carious lesion using DICDAS4-6MFT (Decayed, Missing and Filled Teeth) in any permanent tooth, measured at pupil level at 2.5 years. Secondary outcomes included: number of DICDAS4-6MFT; presence and number of DICDAS1-6MFT; plaque; bleeding; twice-daily toothbrushing; health-related quality of life (Child Health Utility 9D); and oral health-related quality of life (Caries Impacts and Experiences Questionnaire for Children).
UNASSIGNED: Four thousand six hundred and eighty pupils (intervention, n = 2262; control, n = 2418) from 42 schools were randomised. The primary analysis on 2383 pupils (50.9%; intervention 1153, 51.0%; control 1230, 50.9%) with valid data at baseline and 2.5 years found 44.6% in the intervention group and 43.0% in control had obvious decay experience in at least one permanent tooth. There was no evidence of a difference (odds ratio 1.04, 95% confidence interval 0.85 to 1.26, p = 0.72) and no statistically significant differences in secondary outcomes except for twice-daily toothbrushing at 6 months (odds ratio 1.30, 95% confidence interval 1.03 to 1.63, p = 0.03) and gingival bleeding score (borderline) at 2.5 years (geometric mean difference 0.92, 95% confidence interval 0.85 to 1.00, p = 0.05). The intervention had higher incremental mean costs (£1.02, 95% confidence interval -1.29 to 3.23) and lower incremental mean quality-adjusted life-years (-0.003, 95% confidence interval -0.009 to 0.002). The probability of the intervention being cost-effective was 7% at 2.5 years. However, in two subgroups, pilot trial schools and schools with higher proportions of pupils eligible for free school meals, there was an 84% and 60% chance of cost effectiveness, respectively, although their incremental costs and quality-adjusted life-years remained small and not statistically significant. The process evaluation revealed that the intervention was generally acceptable, although the implementation of text messages proved challenging. The COVID-19 pandemic hampered data collection. High rates of missing economic data mean findings should be interpreted with caution.
UNASSIGNED: Engagement with the intervention and evidence of 6-month change in toothbrushing behaviour was positive but did not translate into a reduction of caries. Future work should include work with secondary-school pupils to develop an understanding of the determinants of oral health behaviours, including toothbrushing and sugar consumption, particularly according to free school meal eligibility.
UNASSIGNED: This trial is registered as ISRCTN12139369.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/166/08) and is published in full in Health Technology Assessment; Vol. 28, No. 52. See the NIHR Funding and Awards website for further award information.
Tooth decay has an impact on children and young people’s daily lives, particularly those living in deprived areas. For young children, programmes to improve toothbrushing with fluoride toothpaste help prevent tooth decay. The Brushing RemInder 4 Good oral HealTh trial (BRIGHT) investigated whether a secondary-school-based toothbrushing programme would work. We developed a new programme which included a lesson and twice-daily text messages sent to pupils’ phones. In total, 4680 pupils, aged 11–13 years, from 42 secondary schools in the United Kingdom took part in the trial. At each school, one year group was randomly selected to receive the programme, while the other year group did not receive it. All pupils were followed up for 2.5 years to see whether there were any differences in levels of tooth decay, frequency of toothbrushing, plaque or quality of life. We also considered the programme’s value for money and the views of pupils and school staff. We followed up 2383 pupils and found no difference in tooth decay, plaque or quality of life. We found those who had the programme were more likely to brush their teeth twice daily after 6 months than those who did not. The programme was not good value for money overall. However, the programme appeared to be of more benefit at preventing tooth decay in pupils eligible for free school meals compared to those not eligible. In the schools with more pupils eligible for free school meals, the chance of the programme representing good value for money increased. The programme was generally liked by the pupils and school staff. Some pupils found the text messages useful, although others said they were annoying. The programme helped pupils brush their teeth more frequently in the short term, but this did not lead to less tooth decay. Further research is needed to understand how to prevent tooth decay in secondary-school pupils.

UNASSIGNED: This study describes the development and evaluation of a competency based training program in behaviour change counselling for obesity management. This was a real world study attempting to obtain evidence on the learning experience; specifically, achievement of level of competency as well as personal experiences of the integration of skills learned into practice.
UNASSIGNED: This was a training effectiveness study involving a total of 28 evaluable licenced healthcare providers providing obesity care services. The design for this study is pre-experimental; specifically a one-group post-test only quasi-experimental design.Based on previous work developing a competency-based model of behaviour change counselling (developing change-based relationships, assessing and promoting readiness to change, implementing behaviour modification when ready, and addressing psychosocial determinants of behaviour) we report on training outcomes; specifically, the level of competency achieved in the various skill components of the intervention model. The model of training was based on corrective feedback, the development of peer-based learning and the creation of a mindmap to guide adaptation of interventions to the unique characteristics of individuals with obesity. Quantitative data on competency of components skills and qualitative information on the experience of training were used to evaluate the program.
UNASSIGNED: Objective assessment of skill competency post training demonstrated moderate to high skill in all aspects of behaviour change counselling. Learners reported frequent use of skills in clinical practice, particularly change-based relationships and readiness assessment/intervention. Qualitative interviews confirmed the value to learners in creating a safe place for corrective feedback, the development of the mindmap concept and the opportunity to teach back learned skills to peers.
UNASSIGNED: Provision of competency-based behaviour change counselling in obesity management is critical to support the reformulation of obesity as a chronic disease and to be an important adjunct to medical/surgical interventions. In this paper, we have demonstrated the value of an intensive training program for obesity providers.

BACKGROUND: Sarcopenia leads to functional disability, dependence in activities of daily living (ADL), and is a key contributor to frailty. Reducing and breaking up sedentary time is associated with improved sarcopenia and frailty-related outcomes. The aim of this study was to determine the feasibility of delivering and evaluating a remote sedentary behaviour intervention to improve sarcopenia and independent living in older adults with frailty.
METHODS: A two-arm randomised controlled feasibility trial was conducted with a target of 60 older adults (mean age 74 ± 6 years) with very mild or mild frailty. Participants were randomised to the Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention or usual care control group for six months. The intervention included tailored feedback on sitting, standing and stepping; an education workbook that included goal setting and action planning; one-to-one health coaching; peer support; and a wearable device to self-monitor sedentary behaviour. Participant recruitment (percentage of eligible individuals recruited), retention and data completion rates were used to assess trial feasibility. Acceptability of the trial was explored through interviews and safety was evaluated via unplanned healthcare utilisation and number of falls. Sitting, standing, stepping and sarcopenia were measured to evaluate potential intervention effects.
RESULTS: Sixty participants were recruited. Recruitment and retention rates were 72% and 83%, respectively. Completion rates for outcome measures ranged from 70 to 100%. The trial was safe (< 1 fall per participant on average at each timepoint) and trial procedures were acceptable. Descriptive analysis (mean ± SD) showed that daily sitting was 25.1 ± 82.1 min/day lower in the intervention group, and 6.4 ± 60.5 min/day higher in the control group, at 6 months compared with baseline. Hand grip strength and sit-to-stand score were improved by 1.3 ± 2.4 kg and 0.7 ± 1.0, respectively, in the intervention group.
CONCLUSIONS: This study demonstrates the feasibility and safety of delivering and evaluating a remote intervention to reduce and break up sitting in older adults with frailty. The intervention showed evidence towards reducing daily sitting and improving sarcopenia, supporting its evaluation in a definitive randomised controlled trial.
BACKGROUND: ISRCTN registry (registration number: ISRCTN17158017). Registered 6th August 2021.

BACKGROUND: Population mail-out bowel cancer screening programs save lives through prevention and early detection; however, their effectiveness is constrained by low participation rates. Many non-participants are \"intenders\"; that is, they intend to screen but fail to do so, often forgetting or procrastinating. This study aimed to co-design interventions to increase screening participation among intenders in the Australian National Bowel Cancer Screening Program.
METHODS: Three semi-structured interviews, and one online cross-sectional survey, were conducted between August 2021 and December 2022. Interviews with people who had completed and returned their latest screening kit (\"completers\") were first conducted to identify the planning strategies they had used. Using survey data, logistic regressions were conducted to analyse strategies predictive of participants having returned their latest bowel cancer screening kit. Then, intenders were interviewed to explore their opinions of these strategies and worked with researchers to adapt these strategies into prototype interventions to facilitate screening participation. All interviews were analysed using the framework approach of codebook thematic analysis.
RESULTS: Interview participants who returned their kit shared their effective planning strategies, such as putting the kit in a visible place or by the toilet, planning a time at home to complete the kit, and using reminders. Survey participants who reported using such strategies were more likely to have completed their screening kit compared to those who did not. Prototype interventions developed and endorsed by intenders included providing a prompt to place the kit or a sticker near the toilet as a reminder, a deadline for kit return, the option to sign up for reminders, and a bag to store the sample in the fridge.
CONCLUSIONS: These novel, consumer-led interventions that are built upon the needs and experience of screening invitees provide potential solutions to improve participation in population bowel cancer screening.

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how future implementation of NICE recommendations within the NHS was explored during complex intervention development to enable evaluation of a lifestyle intervention.
METHODS: Two stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored barriers and facilitators for embedding SLI into the context of the NHS, with delivery partner Nuffield Health, in the future.
RESULTS: Workshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI including patients (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of the SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner.
CONCLUSIONS: Application of NPT within two stakeholder workshops enhanced complex intervention development. Context-specific strategies to support implementation of SLI within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT.
BACKGROUND: (ISRCTN: 46385239 ). Registered on July 30, 2020.

Motivational interviewing (MI) is a common approach for smoking cessation counselling, yet little is known about the use of MI techniques in practice. This qualitative content analysis applied a published classification of content and relational MI techniques to a sample of 30 Quitline transcripts (January-March 2019) from Queensland, Australia. Overall, 36 MI techniques (94.7%) were identified at least once within the total sample. On average, 20 techniques (52.6%) were used in an individual conversation with a small difference observed between initial and follow-up calls. Techniques most frequently applied across conversations were largely relational, while techniques addressing client ambivalence/resistance were less frequently/never applied. Variability in techniques between individual initial and follow-up calls highlights the high degree of personalisation when applying MI to smoking cessation. Further investigations exploring associations of individual techniques and cessation outcomes are warranted. The classification may prove useful for assessments of fidelity for training and monitoring activities.

OBJECTIVE: From the perspectives of healthcare professionals (HCPs) and people with chronic obstructive pulmonary disease (COPD) known to tertiary care, what influences successful referrals to a pulmonary rehabilitation program (PRP)?
METHODS: This cross-sectional qualitative study was informed by a critical realist perspective. We purposively sampled people with COPD and HCPs who deliver COPD care and used semi-structured interviews and focus groups to explore determinants of a successful referral to a PRP. Interviews were recorded, transcribed verbatim and analysed using reflexive thematic analysis.
RESULTS: Data were available on 38 HCPs and 15 people with COPD. We generated three core themes pertaining to successful referrals. The first theme was that HCPs should be mindful of how professional responsibilities (such as their personal value and interest in a PRP, their degree of understanding of PRPs, and the organisational culture the PRPs are embedded within) shape decision-making during a therapeutic interaction. The second theme, there\'s more to me than my COPD, characterised psychological perceptions that shape a person\'s readiness to engage in a PRP. The third theme, communication is a two-way street that requires careful navigation, characterised the interpersonal dynamic between HCP and patient, and how dedicated conversations about PRPs can encourage successful referrals.
CONCLUSIONS: Therapeutic interactions that include dedicated conversations about PRPs can foster successful referrals among people with COPD. During these interactions, HCPs should take the time to understand and carefully unpack psychological perceptions whilst imparting value, interest and enthusiasm for PRPs. Doing so can shape patient engagement toward referral success.

BACKGROUND: Multiple sclerosis (MS) is a complex immune-mediated disease with no currently known cure. There is growing evidence to support the role of diet in reducing some of the symptoms and disease progression in MS, and we previously developed and tested the feasibility of a digital nutrition education program for people with MS.
OBJECTIVE: The aim of this study was to explore factors that influenced engagement in the digital nutrition education program, including features influencing capability, opportunity and motivation to change their dietary behaviours.
METHODS: Semi-structured interviews were conducted with people who had MS, and who completed some or all of the program until data saturation was reached. Interviews were analysed inductively using thematic analysis. Themes were deductively mapped against the COM-B (Capability, Opportunity, Motivation, Behaviour) behaviour change model.
RESULTS: Sixteen interviews were conducted with participants who completed all (n = 10) or some of the program (n = 6). Four themes emerged: (1) acquiring and validating nutrition knowledge; (2) influence of time and social support; (3) getting in early to improve health and (4) accounting for food literacy experiences.
CONCLUSIONS: This is the first online nutrition program with suitable behavioural supports for people with MS. It highlights the importance of disease-specific and evidence-based nutrition education to support people with MS to make dietary changes. Acquiring nutrition knowledge, coupled with practical support mechanisms, such as recipe booklets and goal setting, emerged as crucial for facilitating engagement with the program.
CONCLUSIONS: When designing education programs for people with MS and other neurological conditions, healthcare professionals and program designers should consider flexible delivery and building peer support to address the needs and challenges faced by participants.
UNASSIGNED: Members of the MS Nutrition Research Program Stakeholder Reference Group, which includes people with MS and MS health professionals, provided input during the development of the nutrition education program and study design stages.

Background: Investigating and enhancing the effectiveness of behaviour change interventions requires detailed and consistent specification of all aspects of interventions. We need to understand not only their content, that is the specific techniques, but also the source, mode, schedule, and style in which this content is delivered. Delivery style refers to the manner by which content is communicated to intervention participants. This paper reports the development of an ontology for specifying the style of delivery of interventions that depend on communication. This forms part of the Behaviour Change Intervention Ontology, which aims to cover all aspects of behaviour change intervention scenarios. Methods: The Style of Delivery Ontology was developed following methods for ontology development used in the Human Behaviour-Change Project, with seven key steps: 1) defining the scope of the ontology, 2) identifying key entities and developing their preliminary definitions by reviewing 100 behaviour change intervention evaluation reports and existing classification systems, 3) refining the ontology by piloting the ontology through annotations of 100 reports, 4) stakeholder review by eight behavioural science and public health experts, 5) inter-rater reliability testing through annotating 100 reports using the ontology, 6) specifying ontological relationships between entities, and 7) disseminating and maintaining the ontology. Results: The resulting ontology is a five-level hierarchical structure comprising 145 unique entities relevant to style of delivery. Key areas include communication processes, communication styles, and attributes of objects used in communication processes. Inter-rater reliability for annotating intervention evaluation reports was α=0.77 (good) for those familiar with the ontology and α=0.62 (acceptable) for those unfamiliar with it. Conclusions: The Style of Delivery Ontology can be used for both annotating and describing behaviour change interventions in a consistent and coherent manner, thereby improving evidence comparison, synthesis, replication, and implementation of effective interventions.

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