Acceptability of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial intervention: a qualitative study of perspectives of young people and school staff.

BACKGROUND: The Brushing RemInder 4 Good oral HealTh (BRIGHT) trial is investigating the clinical and cost-effectiveness of a multi-component behaviour change intervention to reduce the prevalence of dental caries in young people from deprived areas aged 11-13 years. Mobile health has gained popularity in delivering behaviour change interventions for improving oral health. The intervention, based on behaviour change theory, consists of two components; a single classroom-based session embedded in the school curriculum and a series of follow-up text messages (SMS) delivered twice daily to participants. This element of the process evaluation aimed to explore the acceptability of the BRIGHT intervention for pupils and school staff. METHODS: Qualitative study, based on the concept of acceptability. Focus groups were conducted with 50 pupils, from six secondary schools across the UK, who had received the intervention. Semi-structured interviews were conducted with 12 members of staff. Purposive maximum variation sampling was used. Interviews were transcribed verbatim and analysed using a framework approach. RESULTS: In line with the theoretical framework of acceptability, affective attitude, perceived effectiveness, ethicality, burden and self-efficacy were identified as factors that affect the acceptability of the BRIGHT intervention. Pupil participants appreciated learning about the consequences of inadequate brushing particularly the photographs of carious teeth during the classroom-based session. More detailed information on brushing techniques and follow-up lessons on oral health were recommended by pupils. In terms of the SMS, the data suggest that pupil participants found them to be helpful reminders for brushing their teeth. To further improve acceptability, more choice over the timing of the messages and greater interactivity to reduce tedium were suggested. Staff participants recognised the value of the lesson and reported that in general the content was suitable for their pupils. Having the lesson material prepared for them, having the necessary support and whether it was included in the curriculum, were factors that improved acceptability. CONCLUSION: Overall, pupils and staff found the BRIGHT intervention acceptable and made some suggestions which could be adopted in any subsequent implementation of the intervention.

Development of a secondary school-based digital behaviour change intervention to improve tooth brushing.

BACKGROUND: Dental caries in adolescents remains a significant public health problem with few oral health promotion interventions aimed at reducing dental caries in secondary school-aged students. Previous oral health and mobile health (mHealth) research has suggested the need for the development of a school-based behaviour change intervention incorporating a digital component. This study aimed to describe the development process of a behaviour change intervention to improve the oral health of students aged 11-16 years attending secondary schools in the UK. METHODS: A six-step process was used to develop the complex intervention informed by behaviour change theory and involving students, young people, parents and teachers in the process. The steps were: (1) identifying the target behaviours, namely tooth brushing with a fluoride toothpaste (2) identifying the theoretical basis and developing the causal model (3) reviewing the relevant literature and developing the logic model (4) designing the intervention with young people, parents and school staff (5) specifying the intervention content and (6) translating this content into features of the intervention and piloting. RESULTS: The resultant intervention included a quality-assured classroom-based session (CBS) (guided by a lesson plan and teaching resources), delivered by school teachers which was embedded within the school curriculum. This CBS was followed by a series of (Short Message Service) SMS texts delivered twice daily to student's mobile telephones with the content, duration and timing of the messages informed by involvement of students and young people. CONCLUSIONS: An intervention to improve the oral health of secondary school students through improved tooth brushing was rigorously developed based on behaviour change theory and work with young people, parents and school staff. Further research is needed to evaluate the outcomes and processes involved following the delivery of this intervention. BRIGHT Trial Trial Registration ISRCTN12139369.

Behaviour change intervention for toothbrushing (lesson and text messages) to prevent dental caries in secondary school pupils: The BRIGHT randomized control trial.

OBJECTIVES: This multicentre, assessor-blinded, two-arm cluster randomized trial evaluated the clinical and cost-effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in UK secondary schools. METHODS: Pupils aged 11-13 years with their own mobile telephone attending secondary schools with above average free school meals eligibility were randomized (at year-group level) to receive a lesson and twice-daily text messages or to usual care. Year-groups (n = 84) from 42 schools including 4680 pupils (intervention, n = 2262; control, n = 2418) were randomized. RESULTS: In 2383 participants with valid data at baseline and 2.5 years, the primary outcome of presence of at least one treated or untreated carious lesion (D4-6 MFT [Decayed, Missing and Filled Teeth] in permanent teeth using International Caries Detection and Assessment System) was 44.6% in the intervention group and 43.0% in control (odds ratio [OR] 1.04, 95% CI 0.85-1.26, p = .72). There were no statistically significant differences in secondary outcomes of presence of at least one treated or untreated carious lesion (D1-6 MFT), number of D4-6 MFT and D1-6 MFT, plaque and bleeding scores or health-related- (Child Health Utility 9D) or oral health-related- quality of life (CARIES-QC). However, twice-daily toothbrushing, reported by 77.6% of pupils at baseline, increased at 6 months (intervention, 86.9%; control, 83.0%; OR 1.30, 95% CI 1.03-1.63, p = .03), but returned to no difference at 2.5 years (intervention, 81.0%; control, 79.9%; OR 1.05, 95% CI 0.84-1.30, p = .69). Estimated incremental costs and quality-adjusted life-years (QALYs) of the intervention, relative to control, were £1.02 (95% CI -1.29 to 3.23) and -0.003 (95% CI -0.009 to 0.002), respectively, with a 7% chance of being cost-effective (£20 000/QALY gained threshold). CONCLUSION: There was no evidence of statistically significant difference for caries prevalence at 2.5-years. The intervention's positive 6-month toothbrushing behaviour change did not translate into caries reduction. (ISRCTN 12139369). COVID-19 pandemic adversly affected follow-up.

Behaviour change intervention (education and text) to prevent dental caries in secondary school pupils: BRIGHT RCT, process and economic evaluation.

Background: 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. Objectives: To determine the clinical and cost effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in secondary-school pupils. Design: A multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot and embedded health economic and process evaluations. Setting: 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. Participants: Pupils aged 11-13 years at recruitment, who have their own mobile telephone. Interventions: 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. Main outcome measures: 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). Results: 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. Conclusions: 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. Trial registration: This trial is registered as ISRCTN12139369. Funding: 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 11­13 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.

Set up and assessment of progression criteria for internal pilots: the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial example.

BACKGROUND: Dental caries is common in young people and has wide-ranging ramifications for health and quality of life. Text messaging interventions show promise as a means to promote oral health behaviour change among young people. This paper reports the internal pilot of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial, which is evaluating an intervention comprising an oral health classroom lesson and text messages about toothbrushing, on caries in young people. Pilot trial objectives were to evaluate the feasibility and appropriateness of recruitment and data collection methods, the randomisation strategy, and intervention delivery against progression criteria for the main trial. METHODS: This is an internal pilot trial embedded within an assessor-blinded, two-arm, cluster randomised controlled trial. Participants were pupils aged 11-13 years (in year 7/S1 or year 8/S2) in secondary schools in England, Scotland, and Wales with above average pupil eligibility for free school meals. Following completion of pupil baseline questionnaires and dental assessments, year groups within schools were randomised to the intervention or control arm. Approximately 12 weeks later, participants completed a follow-up questionnaire, which included questions about sources of oral health advice to assess intervention contamination between year groups. At the end of the pilot phase, trial conduct was reviewed against pre-specified progression criteria. RESULTS: Ten schools were recruited for the pilot, with 20 year groups and 1073 pupils randomised (average of 54 pupils per year group). Data collection methods and intervention delivery were considered feasible, the response rate to the follow-up questionnaire was over 80%, there was an indication of a positive effect on self-reported toothbrushing, and interest was obtained from 80% of the schools required for the main trial. Despite partial intervention contamination between year groups, within-school randomisation at the level of the year-group was considered appropriate for the main trial, and the sample size was revised to account for partial contamination. Facilitators and barriers to recruitment and data collection were identified and strategies refined for the main trial. CONCLUSIONS: Progression to the main trial of BRIGHT, with some design refinements, was concluded. The internal pilot was an efficient way to determine trial feasibility and optimise trial processes. TRIAL REGISTRATION: ISRCTN registry, ISRCTN12139369 , registered 10/05/2017.

The oral health of secondary school pupils: baseline data from the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial.

Background This paper describes the sociodemographics and oral health of UK secondary school pupils. They were participants of the BRIGHT trial, which was designed to evaluate the effectiveness of a toothbrushing intervention to reduce dental caries.Methods Overall, 4,680 pupils aged 11-13 years attending 42 secondary schools in England, Scotland and Wales with above average proportion of pupils eligible for free school meals, were recruited to the trial. Sociodemographic data were collected. Participants had a clinical assessment for caries, plaque and bleeding and completed measures of oral and general health-related quality of life and oral health behaviours (frequency of toothbrushing, dental attendance and cariogenic food/drinks consumed). Regression analyses were performed.Results Over one-third (34.7%) of participants had caries experience, with 44.5% reporting their oral health had an impact on their daily lives. Factors associated with a statistically significant increased likelihood of caries experience were older age, being female, eligibility for free school meals, worse oral health-related quality of life, higher cariogenic diet, less than twice-daily toothbrushing, living in a more deprived area and lower school attendance.Conclusions The prevalence and impact of dental caries on the lives of pupils remains high, with further oral health promotion activities needed in targeted secondary schools.

Brushing RemInder 4 Good oral HealTh (BRIGHT) trial: does an SMS behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas? A study protocol of a randomised controlled trial.

BACKGROUND: Almost one-half of 12-15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions such as short messaging service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention-classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS-to reduce the prevalence of dental caries in young people from deprived areas. OBJECTIVES: To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas. METHODS/DESIGN: This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5040 11-13 year olds in 42 schools with a 3-year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at 3 years. Secondary outcomes are: number of carious teeth, frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted. DISCUSSION: The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations. TRIAL REGISTRATION: ISRCTN registry, ISRCTN12139369 . Registered on 10 May 2017.