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.


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
23 Jul 2019
Historique:
received: 07 03 2019
accepted: 26 06 2019
entrez: 25 7 2019
pubmed: 25 7 2019
medline: 6 2 2020
Statut: epublish

Résumé

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. To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas. 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. 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. ISRCTN registry, ISRCTN12139369 . Registered on 10 May 2017.

Sections du résumé

BACKGROUND 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 OBJECTIVE
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 METHODS
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 CONCLUSIONS
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 BACKGROUND
ISRCTN registry, ISRCTN12139369 . Registered on 10 May 2017.

Identifiants

pubmed: 31337437
doi: 10.1186/s13063-019-3538-6
pii: 10.1186/s13063-019-3538-6
pmc: PMC6651965
doi:

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

452

Subventions

Organisme : Department of Health
ID : 15/166/08
Pays : United Kingdom
Organisme : Health Technology Assessment Programme
ID : 15/166/08

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Auteurs

Zoe Marshman (Z)

School of Clinical Dentistry, University of Sheffield, Claremont Crescent, Sheffield, S10 2TA, UK.

Hannah Ainsworth (H)

York Trials Unit, Department of Health Sciences, Faculty of Sciences ARRC Building, University of York, York, YO10 5DD, UK.

Ivor Gordon Chestnutt (IG)

Cardiff University School of Dentistry, Heath Park, Cardiff, CF14 4XY, UK.

Peter Day (P)

School of Dentistry, University of Leeds, Leeds, LS2 9LU, UK.

Donna Dey (D)

School of Education and Social Work, University of Dundee, Nethergate, Dundee, DD1 4HN, UK.

Sarab El Yousfi (S)

School of Clinical Dentistry, University of Sheffield, Claremont Crescent, Sheffield, S10 2TA, UK.

Caroline Fairhurst (C)

York Trials Unit, Department of Health Sciences, Faculty of Sciences ARRC Building, University of York, York, YO10 5DD, UK.

Fiona Gilchrist (F)

School of Clinical Dentistry, University of Sheffield, Claremont Crescent, Sheffield, S10 2TA, UK.

Catherine Hewitt (C)

York Trials Unit, Department of Health Sciences, Faculty of Sciences ARRC Building, University of York, York, YO10 5DD, UK.

Claire Jones (C)

Health information Centre, University of Dundee, (Main Level 5 Corridor), Second Floor (Level 7), Mail Box 15, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.

Ian Kellar (I)

School of Psychology, University of Leeds, Lifton Place, Leeds, LS2 9JT, UK.

Sue Pavitt (S)

Dental Translational & Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, LS2 9LU, UK.

Mark Robertson (M)

School of Dentistry, University of Dundee, Park Place, Dundee, DD6 8EF, UK. m.r.robertson@dundee.ac.uk.

Sarwat Shah (S)

Department of Health Sciences, Faculty of Sciences ARRC Building, University of York, York, YO10 5DD, UK.

Katherine Stevens (K)

Health Economics and Decision Science, School of Health and Related Research, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.

David Torgerson (D)

York Trials Unit, Department of Health Sciences, Faculty of Sciences ARRC Building, University of York, York, YO10 5DD, UK.

Nicola Innes (N)

School of Dentistry, University of Dundee, Park Place, Dundee, DD6 8EF, UK.

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Classifications MeSH