title: Cluster randomised controlled trial of a financial incentive for mothers to improve breast feeding in areas with low breastfeeding rates: the NOSH study protocol.
abstract: Breast feeding can promote positive long-term and short-term health outcomes in infant and mother. The UK has one of the lowest breastfeeding rates (duration and exclusivity) in the world, resulting in preventable morbidities and associated healthcare costs. Breastfeeding rates are also socially patterned, thereby potentially contributing to health inequalities. Financial incentives have been shown to have a positive effect on health behaviours in previously published studies.
  
  
  
  Based on data from earlier development and feasibility stages, a cluster (electoral ward) randomised trial with mixed-method process and content evaluation was designed. The 'Nourishing Start for Health' (NOSH) intervention comprises a financial incentive programme of up to 6 months duration, delivered by front-line healthcare professionals, in addition to existing breastfeeding support. The intervention aims to increase the prevalence and duration of breast feeding in wards with low breastfeeding rates. The comparator is usual care (no offer of NOSH intervention). Routine data on breastfeeding rates at 6-8 weeks will be collected for 92 clusters (electoral wards) on an estimated 10,833 births. This sample is calculated to provide 80% power in determining a 4% point difference in breastfeeding rates between groups. Content and process evaluation will include interviews with mothers, healthcare providers, funders and commissioners of infant feeding services. The economic analyses, using a healthcare provider's perspective, will be twofold, including a within-trial cost-effectiveness analysis and beyond-trial modelling of longer term expectations for cost-effectiveness. Results of economic analyses will be expressed as cost per percentage point change in cluster level in breastfeeding rates between trial arms. In addition, we will present difference in resource use impacts for a range of acute conditions in babies aged 0-6 months.
  
  
  
  Participating organisations Research and Governance departments approved the study. Results will be published in peer-reviewed journals and at conference presentations.
  
  
  
  ISRCTN44898617; Pre-results.
authors.affiliation: Public Health Section, School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Relton
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Strong
authors.affiliation: Mother and Infant Research Unit, School of Nursing and Health Sciences, University of Dundee, Dundee, UK.
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Renfrew
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Thomas
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Burrows
authors.affiliation: Public Health Section, School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Barbara
authors.initials: B
authors.lastname: Whelan
authors.affiliation: Mother and Infant Research Unit, School of Nursing and Health Sciences, University of Dundee, Dundee, UK.
authors.forename: Heather M
authors.initials: HM
authors.lastname: Whitford
authors.affiliation: Public Health Section, School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Elaine
authors.initials: E
authors.lastname: Scott
authors.affiliation: Health Economics Research Group, Brunel University London, Uxbridge, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Fox-Rushby
authors.affiliation: Health Economics Research Group, Brunel University London, Uxbridge, UK.
authors.forename: Nana
authors.initials: N
authors.lastname: Anoyke
authors.affiliation: Health Economics Research Group, Brunel University London, Uxbridge, UK.
authors.forename: Sabina
authors.initials: S
authors.lastname: Sanghera
authors.affiliation: Public Health Section, School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Maxine
authors.initials: M
authors.lastname: Johnson
authors.affiliation: Public Health Section, School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Easton
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Walters
mesh_terms: D000293:Adolescent; D000328:Adult; D001942:Breast Feeding / Q000191:economics* / Q000523:psychology / Q000706:statistics & numerical data*; D016000:Cluster Analysis; D003362:Cost-Benefit Analysis; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009035:Mothers; D009042:Motivation; D012201:Reward; D006113:United Kingdom; D055815:Young Adult
keywords: Breastfeeding; cluster RCT; financial incentives; protocol