Food, Pregnancy and Me: Exploring food insecurity in pregnancy in the UK
| ISRCTN | ISRCTN16655955 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16655955 |
| IRAS number | 326070 |
| Secondary identifying numbers | CPMS 60504 |
- Submission date
- 06/11/2024
- Registration date
- 07/11/2024
- Last edited
- 08/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
In the UK, we don’t have much information about what food is eaten and how it is accessed during pregnancy. We would like to find out more about the food you eat, how you access food, any barriers you face in accessing food, and your health and wellbeing during your pregnancy. This information will help us to better understand whether pregnant women and people need more support to access the food and nutrients they need.
Who can participate?
Women who are pregnant and in their third trimester (29-40 weeks’ gestation) may be invited to take part if they receive care at either Queen Elizabeth Hospital Gateshead or University Hospital Coventry and Warwickshire.
What does the study involve?
The first part of the study involves completing a questionnaire, either on paper or online. There are many things that affect what we eat and how we access food, lots of which are not in our control. For this research to find out what will help pregnant women and people who are struggling in the future, it is important that you answer the questionnaire honestly. We would like around 600 people to complete the questionnaire. To say thank you for your time, we will provide £20 supermarket gift vouchers.
We would also like to talk to around 40 people (20 each from Coventry and Gateshead maternity units) in more detail about their experiences accessing food during pregnancy. This is called a research interview. Participants in these interviews will receive an additional £25 voucher as a thank you for your time. When you complete your questionnaire for part one of this research, you will be asked if you are happy to be contacted about the interview.
What are the possible benefits and risks of participating?
There is no immediate benefit to you if you take part. However, you will receive a £20 voucher to thank you for taking the time to complete and return the questionnaire. You will need to complete the whole questionnaire to receive the voucher. If you miss any questions, the research team may contact you directly using the contact details you provide on the questionnaire, if you give permission for us to do so. There may be benefits to future pregnant people if this research helps to find out what support pregnant people need to access food. There are no anticipated risks to taking part in this study.
Where is the study run from?
Newcastle University, University of Birmingham & Lancaster University (UK)
When is the study starting and how long is it expected to run for?
January 2023 to October 2025
Who is funding the study?
This study has been funded by the National Institute for Health and Social Care Research, School for Public Health Research (UK)
Who is the main contact?
Professor Nicola Heslehurst, FPandMe@newcastle.ac.uk
Contact information
Principal Investigator
Population Health Sciences Institute
Newcastle University
Newcastle upon Tyne
NE24AX
United Kingdom
 ORCID ID |
0000-0001-8656-2319 |
|---|---|
| Phone | +44 191 2083823 |
| nicola.heslehurst@newcastle.ac.uk |
Scientific
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| ORCID ID |
0000-0002-5084-5410 |
|---|---|
| Phone | +44 7483331986 |
| k.hurley@bham.ac.uk |
Scientific
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| ORCID ID |
0000-0002-6224-2115 |
|---|---|
| Phone | +44 7745 914757 |
| c.b.jolly@bham.ac.uk |
Scientific
University of Lancaster
Lancaster
LA1 4YW
United Kingdom
| ORCID ID |
0000-0002-0067-991X |
|---|---|
| Phone | +44 1524 65201 |
| h.w.brown@lancaster.ac.uk |
Public
Population Health Sciences Institute
Newcastle University
Newcastle upon Tyne
NE24AX
United Kingdom
| ORCID ID |
0000-0001-8878-5970 |
|---|---|
| Phone | +44 1912083823 |
| zainab.akhter@newcastle.ac.uk |
Public
Population Health Sciences Institute
Newcastle University
Newcastle upon Tyne
NE24AX
United Kingdom
| ORCID ID |
0000-0002-4797-1459 |
|---|---|
| Phone | +44 1912083823 |
| eleanor.dyer@newcastle.ac.uk |
Study information
| Study design | Multi-centre observational cohort study and qualitative interview study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Other |
| Participant information sheet | 46350Participant Information Sheet.pdf |
| Scientific title | Food, Pregnancy and Me: Exploring food insecurity in pregnancy in the UK to inform future public health intervention needs |
| Study hypothesis | This study aims to explore the prevalence, experiences and health impact of FI in pregnancy in England to develop strategic recommendations for intervention strategies. |
| Ethics approval(s) |
Approved 04/04/2024, Newcastle & North Tyneside 1 Research Ethics Committee (2nd Floor, 2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 2071048384; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 24/NE/0027 |
| Condition | Food insecurity during pregnancy |
| Intervention | Questionnaires exploring diet quality, food security, mental health, and other health behaviours will be distributed to all women and pregnant people in their third trimester in two NHS Trusts in England |
| Intervention type | Other |
| Primary outcome measure | 1. Maternal antenatal depression measured using the Edinburgh Postnatal Depression Scale in the third trimester of pregnancy 2. Infant preterm delivery (less than 37 weeks gestation) will be obtained from routine maternity records after delivery 3. An understanding of the experiences and support needs of food insecure pregnant people collected during interviews in the third trimester or after delivery |
| Secondary outcome measures | 1. Maternal outcomes measured during pregnancy and delivery: gestational diabetes, preeclampsia, pregnancy induced hypertension, mode of delivery, induction, length of stay in maternity unit, maternal diet/nutrition measured using an adapted version of the Brief Diet Quality Assessment Tool 2. Child outcomes measured at birth and in the neonatal period: birthweight, large- and small-for gestational age, breastfeeding initiated/at discharge from maternity services, admission to special care baby units (and length of stay), Apgar score |
| Overall study start date | 01/01/2023 |
| Overall study end date | 31/10/2025 |
Eligibility
| Participant type(s) | Population, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | 605 |
| Participant inclusion criteria | 1. Women and pregnant people 2. Age 16 years and above 3. Pregnant and in their third trimester of a viable pregnancy (28-40 weeks gestation) 4. Registered for maternity services at Queen Elizabeth Hospital Gateshead or University Hospital Coventry |
| Participant exclusion criteria | 1. Under 16 years of age 2. Non-residents of the UK 3. Pregnant but less than 38 weeks gestation 4. Post-partum 5. Receiving care by maternity services other than those based at Queen Elizabeth Hospital Gateshead or University Hospital Coventry |
| Recruitment start date | 08/07/2024 |
| Recruitment end date | 30/04/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sherriff Hill
Gateshead
NE9 6SX
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor information
University/education
Faculty of Medical Sciences
Newcastle upon Tyne
NE1 7RU
England
United Kingdom
| Phone | +44 191 208 6338 |
|---|---|
| susanne.lewis@newcastle.ac.uk | |
| Website | https://www.ncl.ac.uk/ |
"ROR" |
https://ror.org/01kj2bm70 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- NIHR School for Public Health Research, NIHR SPHR, SPHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We plan to publish the study protocol in a peer-reviewed open access journal. We also plan to have five journal articles using reporting outputs from this study. All will be published open access. These will be: 1. Food insecurity prevalence 2. Food insecurityI impact on maternal nutrition and diet quality 3. Food insecurity impact on maternal and child health outcomes 4. Economic analysis 5. Qualitative research with women experiencing food insecurity |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 07/11/2024 | No | Yes | ||
| Protocol article | 07/05/2025 | 08/05/2025 | Yes | No |
Additional files
Editorial Notes
08/05/2025: Publication reference added.
04/02/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 01/02/2025 to 30/04/2025.
2. The overall study end date was changed from 01/07/2025 to 31/10/2025.
06/11/2024: Trial's existence confirmed by Newcastle & North Tyneside 1 Research Ethics Committee
