Cluster randomised controlled trial of a financial incentive for mothers to improve breast feeding in areas with low breastfeeding rates

The NOSH study protocol

Clare Relton, Mark Strong, Mary J. Renfrew, Kate Thomas, Julia Burrows, Barbara Whelan, Heather M. Whitford, Elaine Scott, Julia Fox-Rushby, Nana Anoyke, Sabina Sanghera, Maxine Johnson, Sue Easton, Stephen Walters

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Abstract

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.

Original languageEnglish
Article numbere010158
Pages (from-to)1-8
Number of pages8
JournalBMJ Open
Volume6
Issue number4
Early online date11 Apr 2016
DOIs
Publication statusPublished - Apr 2016

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Breast Feeding
Motivation
Randomized Controlled Trials
Mothers
Health
Health Personnel
Cost-Benefit Analysis
Economics
Health Behavior
Ethics
Health Care Costs
Parturition
Organizations
Interviews
Morbidity
Delivery of Health Care
Costs and Cost Analysis
Research

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Relton, Clare ; Strong, Mark ; Renfrew, Mary J. ; Thomas, Kate ; Burrows, Julia ; Whelan, Barbara ; Whitford, Heather M. ; Scott, Elaine ; Fox-Rushby, Julia ; Anoyke, Nana ; Sanghera, Sabina ; Johnson, Maxine ; Easton, Sue ; Walters, Stephen. / Cluster randomised controlled trial of a financial incentive for mothers to improve breast feeding in areas with low breastfeeding rates : The NOSH study protocol. In: BMJ Open. 2016 ; Vol. 6, No. 4. pp. 1-8.
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abstract = "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.",
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note = "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.",
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Relton, C, Strong, M, Renfrew, MJ, Thomas, K, Burrows, J, Whelan, B, Whitford, HM, Scott, E, Fox-Rushby, J, Anoyke, N, Sanghera, S, Johnson, M, Easton, S & Walters, S 2016, 'Cluster randomised controlled trial of a financial incentive for mothers to improve breast feeding in areas with low breastfeeding rates: The NOSH study protocol', BMJ Open, vol. 6, no. 4, e010158, pp. 1-8. https://doi.org/10.1136/bmjopen-2015-010158

Cluster randomised controlled trial of a financial incentive for mothers to improve breast feeding in areas with low breastfeeding rates : The NOSH study protocol. / Relton, Clare; Strong, Mark; Renfrew, Mary J.; Thomas, Kate; Burrows, Julia; Whelan, Barbara; Whitford, Heather M.; Scott, Elaine; Fox-Rushby, Julia; Anoyke, Nana; Sanghera, Sabina; Johnson, Maxine; Easton, Sue; Walters, Stephen.

In: BMJ Open, Vol. 6, No. 4, e010158, 04.2016, p. 1-8.

Research output: Contribution to journalArticle

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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

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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.

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