Plain English Summary
Background and study aims
Breastfeeding helps prevent disease and promote the health of both mum and baby. However, breastfeeding rates in the UK are among the lowest worldwide. The impact of offering financial support to mums for breastfeeding is a new area. This study aims to test the impact of offering financial support in the form of shopping vouchers in areas with low 6-8 week breastfeeding rates. It is hoped that the scheme will increase the numbers of mums who breastfeed and how long they breastfeed for.
Who can participate?
Neighbourhoods in South Yorkshire and Derbyshire where less than 2 babies out of 5 are breastfed when they are 6-8 weeks old are eligible to participate. Mums are eligible for the scheme if they have babies born between 01/09/2014 and 01/09/2015.
What does the study involve?
Neighbourhoods in South Yorkshire and Derbyshire are randomly allocated to either offer the scheme (shopping vouchers) to mums with new babies, or to not offer the scheme. Changes in neighbourhood breastfeeding rates are measured.
What are the possible benefits and risks of participating?
Mums who are in the study neighbourhoods where the scheme is offered have the opportunity to participate in the scheme. By taking part in this study there are no risks of physical injury or psychological harm or distress to mums or their partners or healthcare providers involved in helping deliver the scheme.
Where is the study run from?
The study is being run by researchers at the University of Sheffield (ScHARR). They are working with researchers at Brunel University and the University of Dundee (UK)
When is the study starting and how long is it expected to run for?
July 2014 to July 2016
Who is funding the study?
Medical Research Council (MRC) (UK)
Who is the main contact?
Dr Clare Relton
Dr Clare Relton
30 Regent Street
+44 (0)114 222 0796
The clinical and cost effectiveness of a financial incentive scheme to improve 6-8 week breastfeeding in neighbourhoods with low breastfeeding rates (cluster randomised controlled trial with pre-trial feasibility stage).
The offer of a structured financial incentive to mums living in areas with low breastfeeding rates will increase the proportion of babies being breastfed at 6-8 weeks.
NHS Research Ethics Committee, 26/07/2013, reference: 13/WM/0299
Parallel cluster randomised controlled trial (RCT) with a mixed methods process and context evaluation and a pre-trial feasibility stage
Primary study design
Secondary study design
Cluster randomised trial
Patient information sheet
Neighbourhood levels of breastfeeding at 6-8 weeks
Neighbourhoods in South Yorkshire and Derbyshire will be randomly assigned to one of two conditions:
1. Neighbourhoods offer NOSH scheme to new mums
2. Neighbourhoods do not offer NOSH scheme to new mums
A neighbourhood level behaviour change intervention in the form of the offer of a structured financial incentive (shopping vouchers each worth £40 x 5) for mums which is designed to increase breastfeeding rates at 6-8 weeks in neighbourhoods with low breastfeeding rates.
Duration of follow up is 12 months (as the primary outcome measure will be the change in neighbourhood level 6-8 week breastfeeding rate from the baseline (previous 12 months breastfeeding) rate.
Primary outcome measures
Change in neighbourhood level 6-8 week breastfeeding rate from the baseline (previous 12 months breastfeeding) rate.
Secondary outcome measures
1. Duration of breastfeeding (BF), BF intention, BF initiation, BF at discharge, BF at 3/12, BF at 6/12 (any BF vs exclusive BF where available)
2. Hospital visits: in-patient days, out-patient visits
3. Conditions: SIDs, coeliac, otitis media, necrotizing enterocolitis (NEC)
1. Healthcare providers/ commissioners/ funders/ policy makers views on the intervention and the completeness and accuracy of 6-8 week BF data
2. Eligible mums in study neighbourhoods - their Health Related Quality of life (as measured by EQ-5D), Life satisfaction score and their awareness of the intervention (NOSH Scheme) and their views on & experience of the intervention.
3. Eligible babies in study neighbourhoods: the incidence of infections (ear, chest, GI), eczema, constipation.
4. Delivery of the intervention: Number of enquiries, applications, claims, concerns.
Overall trial start date
Overall trial end date
Participant inclusion criteria
All neighbourhoods in Chesterfield, Rotherham and Sheffield which report mean 6-8 week breastfeeding rates of ≤40% in the previous four quarters
Target number of participants
956 babies per group (1,912 in total)
Participant exclusion criteria
All neighbourhoods in Chesterfield, Rotherham and Sheffield which report mean 6-8 week breastfeeding rates greater than 40% in the previous four quarters
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Sheffield
Medical Research Council (MRC) (UK) - National Prevention Research Initiative (NPRI) Phase 4 Grant number R-129897
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27067889