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

IntroductionBreast 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 analysisBased 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 disseminationParticipating organisations Research and Governance departments approved the study. Results will be published in peer-reviewed journals and at conference presentations.Trial registration numberISRCTN44898617; Pre-results.

Valuing breastfeeding: a qualitative study of women’s experiences of a financial incentive scheme for breastfeeding

“…This is the first study of women’s experiences of being offered a financial incentive to breastfeed. It was conducted alongside a large cluster randomised controlled trial of the financial incentive (details [ 11 ] and findings [ 12 ] are published elsewhere) to explore acceptability of the scheme in practice and to contextualise the trial findings [ 22 ].…”

“…Responses from the first stage (development) were used to inform the study design [ 9 ] which was tested in the second (feasibility) stage [ 10 ]. The purpose of this paper is to help interpret the results of the full trial (details [ 11 ] and findings [ 12 ] are published elsewhere). The trial reported a significant increase in breastfeeding at 6–8 weeks for those clusters where the NOSH Scheme was offered [ 12 ].…”

Cost-effectiveness of offering an area-level financial incentive on breast feeding: a within-cluster randomised controlled trial analysis

“…While data unavailability precluded estimating effectiveness at 6 months, total costs of vouchers were included in the analysis because the offer of vouchers up to 6 months was provided to participants at the outset of the trial and could therefore had impacted on the take up and duration of breast feeding. The protocol planned cost-effectiveness analysis10 was published prior to the analysis. The Trial Steering Committee approved changes from protocol to analyses.…”

Development of a biochemical marker to detect current breast milk intake

“…To overcome this perception, U.K. researchers have developed and trialled financial incentives for breastfeeding, in the form of shopping vouchers worth up to £200 in total (Relton et al, ). Results suggest that areas with low breastfeeding rates that offer financial incentives have significantly increased breastfeeding rates at 6–8 weeks post‐natal age (Relton et al, ).…”

“…Results suggest that areas with low breastfeeding rates that offer financial incentives have significantly increased breastfeeding rates at 6–8 weeks post‐natal age (Relton et al, ). Financial incentives were provided, on the basis of self‐report of breastfeeding corroborated by a confirmatory signature from an appropriate health care worker (Relton et al, ). This is the method by which infant feeding status is recorded for the purposes of routine data collection in the U.K.'s National Health Service: a healthcare professional's determination based on their interactions with the woman during routine visits (which may or may not include witnessing the woman breastfeed).…”