Does an infant feeding helper service increase infant feeding practices in firstborn babies?
| ISRCTN | ISRCTN17395671 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17395671 |
| Secondary identifying numbers | CPMS 46651 |
- Submission date
- 17/05/2021
- Registration date
- 24/05/2021
- Last edited
- 15/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Breastfeeding can improve the health of mothers and babies, but fewer women breastfeed in the UK compared to other European countries. Many women stop breastfeeding within the first 2 weeks. Most wish they had breastfed for longer, and would have liked more support to help them continue. Younger mothers and those from lower-income homes are less likely to breastfeed.
The aim of this study is to find out whether a promising ‘feeding helper’ service to support women to feed their babies helps them to breastfeed for longer, improves how babies are formula fed and whether it is good value for money.
Who can participate?
Women expecting their first baby up until they are 35 weeks pregnant
What does the study involve?
Mothers will be allocated by chance to either receive usual care for feeding or the additional new ‘feeding helper’ service. ‘Feeding helpers’ will respect women’s feeding choices. They will help mothers identify friends and family who may be able to help and will provide information about local groups, helplines and high-quality websites about infant feeding. They will provide a ‘listening ear’ when women have had their baby. All participants complete questionnaires at the start of the study and at 8, 16 and 24 weeks after the baby's birth.
What are the possible benefits and risks of participating?
Participants may have additional support in feeding their baby, and will at the same time be contributing to the design and delivery of services that could benefit other mothers in the future. As a thank you for taking part in the study and for completing the questionnaires, the researchers will send participants shopping vouchers after they have completed the follow-up questionnaires at 8 and 16 weeks. There are no known risks in taking part in the study.
Where is the study run from?
Birmingham Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
October 2020 to March 2025
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Prof. Kate Jolly, c.b.jolly@bham.ac.uk
Contact information
Scientific
University of Birmingham
Institute of Applied Health Research
Murray Learning Centre
Edgbaston
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-6224-2115 |
|---|---|
| Phone | +44 (0)121 414 7552 |
| c.b.jolly@bham.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Process of Care, Other |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation |
| Study acronym | ABA-feed |
| Study hypothesis | The aim of the ABA-feed trial is to assess the clinical and cost-effectiveness of the ABA-feed infant feeding intervention compared to usual care in first-time (nulliparous) mothers. |
| Ethics approval(s) | Approved 18/05/2021, East of Scotland Research Ethics Service REC 1 (Tayside Medical Science Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK; +44 (0)1382 383878; tay.eosres@nhs.scot), REC ref: 21/ES/0045 |
| Condition | Breastfeeding initiation and continuation |
| Intervention | The study design is a randomised controlled trial with women randomised to receive the additional ABA-feed intervention or usual feeding support. The researchers aim to recruit women, 2730 women aged at least 16 years, pregnant with their first baby, and not expecting a multiple pregnancy. Women will receive study information from 16 weeks gestation, with recruitment between 20 and 35+6 weeks gestation. They will be approached when attending their 20-week scan or at routine antenatal clinics to see whether they would be interested in taking part in the study. If COVID-19 restrictions are in place then processes are in place for entirely remote recruitment. Two weeks before they are due to give birth, participants will receive an SMS text to remind them to let the study team know when they have given birth. This can be by phone or text. This will enable the researchers to collect information about the initiation of breastfeeding at 3 days after their baby is born. At 3 days after their baby is born women will receive a text asking about how they have fed their baby. At 8 and 16 weeks postnatally, they will receive an email/text with a link to an online questionnaire, or a postal questionnaire (in line with request at recruitment). These questionnaires will ask about infant feeding. Women will receive a final text/weblink at 24 weeks asking about how they are feeding their baby. Women allocated to the ABA infant feeding team intervention will be offered information and support from about 30 weeks of pregnancy up until 8-weeks postnatally. Before the birth, women will be offered a face-to-face contact (in person or remotely) followed by texts with links to useful sources of infant feeding information and local social groups for mothers. After birth women will receive daily texts or calls for up to 2 weeks after birth, with reducing frequency to 8 weeks postnatally as participant preference. Once a mother is fully formula feeding and is confident in her ability to do this, the feeding team will cease to proactively contact the mother, but will be available for advice if it is required. The infant feeding team members will be trained peer supporters with additional training to include an assets-based approach. Some exemplar SMS texts were developed with input from women from socio-economically disadvantaged communities, to enhance their acceptability. The main outcome of the study is any breastfeeding at 8-weeks postnatally from self-report, or, in the case of non-response, from the routinely collected data by health visitors. The researchers will interview approximately 30 women in the intervention group to find out their experience of the ABA feeding support and to find out whether the ABA intervention was delivered as planned. Women will have the choice of where these interviews take place and whether they would prefer them to take place over the phone or by video call. The researchers will also interview key informants from five case recruiting centres (e.g. lead midwives, health visitors, Children’s Centre managers, and infant feeding leads) at the start and end of the study to ‘map’ the usual care pathway and at the end to find out whether there were any issues with referral or delivery or contamination and to explore differences in implementation between recruiting centres. At every recruiting centre the infant feeding helpers and their trainers will be asked to complete a brief questionnaire about the training and at the end of the study all infant feeding helpers will be invited to a focus group to explore their experience of delivering the intervention. Overall the study will take 38 months, with the training the trainers, training the peer supporters and the mapping of community assets taking place in the first six months. Recruitment will start from April 2021 in each locality and last for up to 14 months. Women will be followed up until 24 weeks after they have had their babies. After follow-up is finished there are 6 months to complete the analyses and to write the final report. There will be public involvement in the development of study materials, design of the study methods, advising during the study and contributing to how the researchers disseminate the findings of the study. One public involvement member is a study co-investigator. Two public partners will be members of the study management group and two lay members will sit on an oversight group to monitor the progress of the study. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 15/10/2024: Any breastfeeding at 8 weeks post birth, measured by self-report in the 8-week questionnaire (or subsequent text message for non-responders) with missing data supplemented from health visitor records _____ Previous primary outcome measure: Any breastfeeding at 8 weeks post birth, measured by self-report in the 8-week questionnaire (or subsequent text message for non-responders) |
| Secondary outcome measures | 1. Any breastfeeding measured using infant feeding status, self-reported formula feeding practices at 16 weeks post birth 2. Any breastfeeding measured using infant feeding status, self-reported formula feeding practices at 24 weeks post birth 3. Exclusive breastfeeding measured using infant feeding status, self-reported formula feeding practices at 16 weeks post birth 4. Exclusive breastfeeding measured using self-reported formula feeding practices at 24 weeks post birth 5. Time to cease exclusive feeding with breastmilk measured using infant feeding status, self-reported formula feeding practices up to 16 weeks 6. Time to cease feeding with any breastmilk measured using infant feeding status, self-reported formula feeding practices up to 16 weeks 7. Maternal anxiety measured using the Generalised Anxiety Disorder Assessment (GAD-7) at 8 weeks post birth 8. Maternal anxiety measured using the GAD-7 at 16-weeks post birth 9. Maternal health-related quality of life measured by the EuroQol (EQ-5D-5L) at 8 weeks 10. Maternal health-related quality of life measured by the EQ-5D-5L at 16 weeks 11. Maternal social support measured by Medical Outcomes Study (MOS) Emotional/Informational Support domain at 8-weeks post birth 12. Maternal social support measured by MOS Emotional/Informational Support domain at 16 weeks post birth 13. The following maternal formula feeding practices measured using infant feeding status, self-reported formula feeding practices at 8 and 16 weeks post birth: 13.1. Making one feed at a time 13.2. Correct water temperature 13.2. Adding formula powder before water 13.3. Making up formula when needed when out of the home 13.4. Keeping milk chilled when out of the home 13.5. Making formula with hot water when out of the home 13.6. Sterilising bottles using recommended methods 14. Maternal use of support for infant feeding (e.g. national breastfeeding helpline; peer support; breastfeeding groups) measured using infant feeding status, self-reported formula feeding practices, health and social resource use at 8 and 16 weeks post birth |
| Overall study start date | 01/10/2020 |
| Overall study end date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 2730; UK Sample Size: 2730 |
| Participant inclusion criteria | 1. Pregnant with their first child 2. Singleton pregnancy 3. Aged 16 years or over 4. Provided informed consent 5. Gestation age from 20+0 to 35+6 (inclusive) weeks gestation |
| Participant exclusion criteria | 1. Women who have had a previous live birth 2. Non-English speaking pregnant women with no Infant Feeding Helper in their locality able to speak their language are not eligible to be randomised into the ABA-feed Trial |
| Recruitment start date | 10/01/2022 |
| Recruitment end date | 12/01/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Town Lane
Southport
PR8 6PN
United Kingdom
Hollins Park House
Hollins Lane
Warrington
WA2 8WA
United Kingdom
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Glasbury House
Bronllys Hospital
Brecon
LD3 0LS
United Kingdom
Albert Road
Pontypridd
CF37 1 LB
United Kingdom
The Crichton
Bankend Road
Dumfries
DG1 4ZG
United Kingdom
Bristol
BS8 1NU
United Kingdom
Stirling
FK9 4LA
United Kingdom
Lancaster
PR1 2HE
United Kingdom
Cardiff
CF14 4XN
United Kingdom
Edgbaston
Birmingham
B15 2TT
United Kingdom
Dudley
DY1 1HQ
United Kingdom
Glasgow
G75 8NH
United Kingdom
SA12 7BR
United Kingdom
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Derby Road
Birkenhead
CH42 0LQ
United States of America
Sponsor information
University/education
Room 117, Aston Webb Building
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 415 8011 |
|---|---|
| researchgovernance@contacts.bham.ac.uk |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers plan to publish the protocol in the future. The chief investigator will coordinate dissemination of results. Results of this trial will be submitted for publication in a peer-reviewed journal. The manuscript will be prepared by CI or delegate and authorship will be determined by mutual agreement. A publication policy will be developed and approved by the CIG and TSC. Any secondary publications and presentations prepared by Investigators must be reviewed by the CIG. Manuscripts must be submitted to the NIHR in a timely fashion and in advance of being submitted for publication, to allow time for review and resolution of any outstanding issues. The authors must acknowledge that the trial was performed with the support of the NIHR and the University of Birmingham. Intellectual property rights will be addressed in the project agreement between the University of Birmingham and collaborating universities. A plain English summary will be sent to participants and available via the study website. |
| IPD sharing plan | The datasets generated during the current study will be available upon reasonable request from Professor Kate Jolly (c.b.jolly@bham.ac.uk) after the study is completed and the findings published. The anonymised quantitative data and transcribed qualitative transcripts from participants who have given consent to their anonymised data being stored for use in future ethically approved research will be available. Data requests will be considered by the research team and Birmingham Clinical Trials Unit, who will hold the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 15/11/2023 | 16/11/2023 | Yes | No |
Editorial Notes
15/10/2024: the primary outcome measure was changed.
10/10/2024: The following changes were made to the trial record:
1. A contact was removed.
2. The recruitment end date was changed from 30/09/2023 to 12/01/2024.
3. The country of recruitment United States was removed (this was added in error).
16/11/2023: Publication reference added.
15/09/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The intention to publish date was changed from 31/03/2025 to 30/06/2025.
30/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2023 to 30/09/2023.
2. The overall end date was changed from 30/11/2023 to 31/03/2025.
3. The intention to publish date was changed from 30/11/2024 to 31/03/2025.
4. The plain English summary was updated to reflect these changes.
30/12/2021: The recruitment start date has been changed from 01/12/2021 to 10/01/2022.
18/10/2021: The recruitment start date was changed from 01/10/2021 to 01/12/2021.
19/08/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 15/08/2021 to 01/10/2021.
2. Trial participating centres were added.
3. The contact email was changed.
19/07/2021: The recruitment start date was changed from 01/07/2021 to 15/08/2021.
17/05/2021: Trial's existence confirmed by the NIHR.
