Condition category
Pregnancy and Childbirth
Date applied
11/02/2014
Date assigned
12/03/2014
Last edited
14/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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. We are calling this the NOurishing Start for Health (NOSH) scheme. It is hoped that the NOSH 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 having breast milk when they are 6-8 weeks old are eligible to participate. Mums will be eligible for the NOSH Scheme if they have babies born between September 1st 2014 and September 1st 2015.

What does the study involve?
Neighbourhoods in South Yorkshire and Derbyshire will be randomly allocated to either offer the NOSH scheme (shopping vouchers) to mums with new babies, or to not offer the NOSH scheme.

What are the possible benefits and risks of participating?
Mums who are in the study neighbourhoods where the NOSH scheme is offered will have the opportunity to participate in the NOSH 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 NOSH 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

Trial website

http://www.shef.ac.uk/scharr/sections/ph/research/breastmilk

Contact information

Type

Scientific

Primary contact

Dr Clare Relton

ORCID ID

Contact details

30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 0796
c.relton@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1.1

Study information

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).

Acronym

NOSH

Study hypothesis

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

NHS Research Ethics Committee, 26/07/2013, reference: 13/WM/0299

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

Trial setting

Other

Trial type

Other

Patient information sheet

http://www.noshvouchers.org/#!about-nosh/cjg9

Condition

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

Phase

Drug names

Primary outcome measures

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 & accuracy of 6-8 wk 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

01/07/2014

Overall trial end date

01/07/2016

Reason abandoned

Eligibility

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 are eligible for participation.

Participant type

Patient

Age group

Adult

Gender

Female

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 are ineligible for participation.

Recruitment start date

01/07/2014

Recruitment end date

01/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Kirsty Woodhead
School of Health and Related Research (ScHARR)
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 5453
k.woodhead@sheffield.ac.uk

Sponsor type

University/education

Website

http://www.sheffield.ac.uk/

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27067889

Publication citations

Additional files

Editorial Notes

14/04/2016: Publication reference added.