NOurishing Start for Health (NOSH)
| ISRCTN | ISRCTN44898617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44898617 |
| Protocol serial number | V1.1 |
| Sponsor | University of Sheffield (UK) |
| Funder | Medical Research Council (MRC) (UK) - National Prevention Research Initiative (NPRI) Phase 4 Grant number R-129897 |
- 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
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
Contact information
Scientific
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 222 0796 |
|---|---|
| c.relton@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel cluster randomised controlled trial (RCT) with a mixed methods process and context evaluation and a pre-trial feasibility stage |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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(s) |
Change in neighbourhood level 6-8 week breastfeeding rate from the baseline (previous 12 months breastfeeding) rate |
| Key secondary outcome measure(s) |
Area level |
| Completion date | 01/07/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 1912 |
| 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
- United Kingdom
- England
Study participating centre
S1 4DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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 |
| Protocol article | protocol | 11/04/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/05/2020: Publication reference added.
14/02/2018: Publication references added.
14/04/2016: Publication reference added.
