NOurishing Start for Health (NOSH)

ISRCTN	ISRCTN44898617
DOI	https://doi.org/10.1186/ISRCTN44898617
Secondary identifying numbers	V1.1

Submission date: 11/02/2014
Registration date: 12/03/2014
Last edited: 11/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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
c.relton@sheffield.ac.uk

Study website

Contact information

Dr Clare Relton
Scientific

30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone	+44 (0)114 222 0796
Email	c.relton@sheffield.ac.uk

Study information

Study design	Parallel cluster randomised controlled trial (RCT) with a mixed methods process and context evaluation and a pre-trial feasibility stage
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Other
Participant information sheet	http://www.noshvouchers.org/#!about-nosh/cjg9
Scientific title	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).
Study acronym	NOSH
Study objectives	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.
Ethics approval(s)	NHS Research Ethics Committee, 26/07/2013, ref: 13/WM/0299
Health condition(s) or problem(s) studied	Neighbourhood levels of breastfeeding at 6-8 weeks
Intervention	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.
Intervention type	Behavioural
Primary outcome measure	Change in neighbourhood level 6-8 week breastfeeding rate from the baseline (previous 12 months breastfeeding) rate
Secondary outcome measures	Area level 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) Individual level 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 study start date	01/07/2014
Completion date	01/07/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	956 babies per group (1,912 in total)
Key inclusion criteria	All neighbourhoods in Chesterfield, Rotherham and Sheffield which report mean 6-8 week breastfeeding rates of ≤40% in the previous four quarters
Key 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
Date of first enrolment	01/07/2014
Date of final enrolment	01/07/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Sheffield

Sheffield
S1 4DA
United Kingdom

Sponsor information

University of Sheffield (UK)
University/education

Kirsty Woodhead
School of Health and Related Research (ScHARR)
Regent Court
30 Regent Street
Sheffield
S1 4DA
England
United Kingdom

Phone	+44 (0)114 222 5453
Email	k.woodhead@sheffield.ac.uk
Website	http://www.sheffield.ac.uk/
"ROR"	https://ror.org/05krs5044

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) - National Prevention Research Initiative (NPRI) Phase 4 Grant number R-129897
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	11/04/2016		Yes	No
Results article	qualitative study results	08/01/2018		Yes	No
Results article	results	05/02/2018		Yes	No
Results article	cost-effectiveness results	01/02/2020	11/05/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

11/05/2020: Publication reference added.
14/02/2018: Publication references added.
14/04/2016: Publication reference added.