TY - JOUR
T1 - Cluster randomised controlled trial of a financial incentive for mothers to improve breast feeding in areas with low breastfeeding rates
T2 - The NOSH study protocol
AU - Relton, Clare
AU - Strong, Mark
AU - Renfrew, Mary J.
AU - Thomas, Kate
AU - Burrows, Julia
AU - Whelan, Barbara
AU - Whitford, Heather M.
AU - Scott, Elaine
AU - Fox-Rushby, Julia
AU - Anoyke, Nana
AU - Sanghera, Sabina
AU - Johnson, Maxine
AU - Easton, Sue
AU - Walters, Stephen
N1 - This research was funded by the Medical Research Council (MR/J000434/1) via the National Prevention Research Initiative Phase 4 Awards. Funding for the costs of the intervention (shopping vouchers) for the trial is supported by NHS Public Health England (PHE). The NOSH Trial Steering Committee provides overall supervision of the trial and monitors trial progress and conducts and advises on scientific credibility. The Trial Steering Committee (TSC) carries the responsibility for deciding whether the trial
needs to be stopped. The members are listed as follows: Dr Andrew Furber, Director of Public Health, Wakefield (Chair); Professor Andrew Briggs, Professor of Health Economics and Health Technology Assessment, Glasgow University; Professor David Tappin, Professor of Clinical Trials for Children, School of Medicine, University of Glasgow; CR, Principle Investigator (NOSH), Senior Research Fellow, ScHARR, University of Sheffield; MJR (Co-investigator), Professor of Mother and Infant Health, University of Dundee; Gavin Malloch, MRC Observer; Professor Jon Nicholl, Representative of host institution, Dean of ScHARR, Professor of Health Services Research, University of Sheffield. Director NIHR School for Public Health Research.
PY - 2016/4
Y1 - 2016/4
N2 - Introduction: 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.Methods and analysis: 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.Ethics and dissemination: Participating organisations Research and Governance departments approved the study. Results will be published in peer-reviewed journals and at conference presentations.Trial registration number: ISRCTN44898617; Preresults.
AB - Introduction: 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.Methods and analysis: 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.Ethics and dissemination: Participating organisations Research and Governance departments approved the study. Results will be published in peer-reviewed journals and at conference presentations.Trial registration number: ISRCTN44898617; Preresults.
UR - http://www.scopus.com/inward/record.url?scp=84992234300&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2015-010158
DO - 10.1136/bmjopen-2015-010158
M3 - Article
C2 - 27067889
AN - SCOPUS:84992234300
SN - 2044-6055
VL - 6
SP - 1
EP - 8
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e010158
ER -