A randomised controlled trial of the 'Health in Early Feeding Scheme' to improve breastfeeding in neighbourhoods with low 6 week breastfeeding rates

Breastfeeding helps prevent disease and promote health in both babies and mothers. It is clear that breastfed babies suffer less tummy upsets, less ear and chest infrections, less eczema, and are less likely to develop childhood cancers. It is also clear that mothers who breastfeed are less likely to get breast cancer. Breastfeeding may also reduce the risk of Type 2 diabetes, coeliac disease, obesity and cardiac disease for children. The World Health Organisation recommends that all babies are breastfed up to at least 6 months.
Despite many attempts by the government and the NHS, breastfeeding rates in the UK are among the lowest in the world. So in the UK many children and mothers have illnesses which would be prevented if more babies could be breastfed.
Lots of things have been (and are being) tried to encourage mothers to breastfed at birth and at 6 weeks and at 6 months. But despite these efforts breastfeeding rates in the UK are still very low. Breastfeeding rates are particularly low in more deprived areas and lower income communities, and these are often areas where people are less healthy generally. One possible approach is the use of financial incentives such as cash and voucher schemes.
There is a long history of taxes being applied to products that are harmful e.g. alcohol and tobacco. More recently cash and vouchers etc. are being paid to encourage healthy behaviours. For example, researchers have studied what happens if you pay some people take their medication or to help pregnant women stop smoking. More recently the government helped pregnant women eat healthy food by paying vouchers to women on Income Support and Job Seekers Allowance (Healthy Start Scheme).
Researchers at the University of Sheffield (working with researchers at the University of York and the University of Brunel) are exploring a new approach to encourage women to breastfeed - a 'Health in Early Feeding Scheme'. Researchers are studying the effect of offering an incentive 'paying' women to breastfeed. The researchers are particularly interested in studying the effect of this Scheme on women who live in areas with very low breastfeeding rates (40% or less babies being breastfed at 6 weeks). These areas also tend to be areas which are very deprived and low income areas.
The researchers hope that by offering women in these areas a 'Health in Early Feeding Scheme', that more babies will be breastfed at 6 weeks. They also hope this Health in Early Feeding Scheme (HEFS) will mean more babies will be breastfed when they leave hospital, at 10 days, at 12 weeks and at 26 weeks. If more babies are breastfed then many diseases will be prevented in both babies and mothers.

This study has three stages.
In the first stage the researchers will select 15 out of 30 neighbourhoods with the lowest breastfeeding rates in Sheffield. The researchers will then finalise the HEFS with pregnant mothers and their families from these neighbourhoods, as well as midwives, health visitors, peer supporters, and doctors. Together they will investigate any barriers, work out the best size of incentive, how often it should be paid to women, who are the best people (e.g. health visitors, peer supporters, midwives, GPs) to tell women about the scheme and to perform any checks that might be needed for this Health in Early Feeding Scheme.
In the second stage, the researchers will then test the HEFS in two of these 15 neighbourhoods. They will find out if it is feasible to offer the HEFS. They will also get a rough idea of the number of extra women who decide to (and do) breastfeed because of the offer of the HEFS.
In the third stage, the researchers will offer the HEF Scheme to all pregnant women in 15 of the 30 study neighbourhoods from areas with very low breastfeeding rates in Sheffield for one year (about 1,250 out of 2,500 women). They will then look at all the information they have to see what effect the HEF Scheme has on breastfeeding rates.

The overall purpose of this three stage study is to evaluate the clinical and cost effectiveness of the Health in Early Feeding Scheme (HEFS) designed to increase the prevalence of breastfeeding in neighbourhoods with low 6 week breastfeeding rates.

Prior to the first stage half the neighbourhoods will be randomly selected to the experimental intervention (Offer of HEFS).

The first stage (A) aims to develop the intervention. Focus groups with pregnant /post partum women from Offer neighbourhoods will provide preliminary ideas on key components of the interention. To estimate the optimum size of payments a discrete choice experiment will be conducted with pregnant and post partum mothers,. In order to finalise the key components of the intervention NGT workshops will be held with healthcare professionals and healthcare funders and commissioners.

The second stage (B) of the study will test the feasibility (acceptability and deliverability) of the intervention and obtain estimates of key parameters necessary for the main trial. This will be achieved by piloting the intervention in two neighbourhoods in the Offer Group for a period of 3 months (with 6-8 weeks post partum follow up). This stage will also seek to understand the accuracy and variability of both routine data and additional relevant resource use data for this sample at both a cluster and individual level.

The third (C) stage of this study evaluates the clinical and cost effectiveness of the intervention using a cluster (neighbourhood based) randomised controlled trial design with a mixed methods process/context evaluation. The intervention will be delivered to all neighbourhoods in the Offer Group for a duration of one year (with 6 months follow up). The results of the Offer Group and No Offer Group will be compared and the variability of the effectiveness of the intervention between cluster neighbourhoods using cluster-level process and context data

Whatever the outcome of the trial, this work will have an immediate and direct impact on policy and practice. Both infant feeding and the use of financial incentive schemes are high profile topics, and the impact on public policy as well as health service commissioning could be profound. There will be lessons for topic areas other than infant feeding (see academic beneficiaries). The health service - clinical, primary care and public health, and the wider range of health professionals involved in the field - will all have an interest, and it is likely to be used to update existing NICE guidance in this field.

If the intervention is shown to have a positive impact, the effect on the health of the public could be widespread and long-standing. Few health behaviours have the short, medium and long-term impact of infant feeding. If a single intervention is shown to make a positive difference to the complex socio-cultural problem of breastfeeding promotion, there would be immediate and active interest nationally and internationally.

If we identify a positive outcome of the intervention, there will be very important ongoing benefits in terms of information to be gained about health outcomes related to infant feeding. Because of the practical and ethical constraints on conducting randomised controlled trials of breast vs formula feeding, only one well-conducted RCT has measured health outcomes (Kramer et al 2001 and subsequent publications). This trial was conducted in Belarus, where the baseline breastfeeding rates are already fairly high, so the balance of risks is not directly comparable with the UK and other developed country settings with very low rates. This trial offers a vehicle for examining health outcomes in the context of a well-conducted RCT in a low income UK setting.