Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0)

Joanne Clarke; Stephan U Dombrowski; Eleni Gkini; Pat Hoddinott; Jenny Ingram; Christine MacArthur; Ngawai Moss; Laura Ocansey; Tracy Roberts; Gillian Thomson; Julia Sanders; Alice J Sitch; Clive Stubbs; Beck Taylor; Sarah Tearne; Rebecca Woolley; Kate Jolly

doi:10.1136/bmjopen-2023-075460

Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0)

Joanne Clarke, Stephan U Dombrowski, Eleni Gkini, Pat Hoddinott, Jenny Ingram, Christine MacArthur, Ngawai Moss, Laura Ocansey, Tracy Roberts, Gillian Thomson, Julia Sanders, Alice J Sitch, Clive Stubbs, Beck Taylor, Sarah Tearne, Rebecca Woolley, Kate Jolly^*

^*Corresponding author for this work

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Abstract

INTRODUCTION: Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.

METHODS AND ANALYSIS: A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become 'infant feeding helpers' in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle.

ETHICS AND DISSEMINATION: The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences.

TRIAL REGISTRATION NUMBER: ISRCTN17395671.

Original language	English
Article number	e075460
Number of pages	13
Journal	BMJ open
Volume	13
Issue number	11
DOIs	https://doi.org/10.1136/bmjopen-2023-075460
Publication status	Published - 15 Nov 2023

Bibliographical note

Funding:
This work was supported by the National Institute for Health Research (NIHR) Public Health Research grant number NIHR129182. KJ and CM are part-funded by the NIHR Applied Research Collaboration West Midlands. AJS is supported by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham.

Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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The effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA) for improving breastfeeding initiation and continuation
Sitch, A., Hardy, P., Jolly, K., MacArthur, C., Roberts, T. & Tearne, S.
NIHR EVALUATION, TRIALS AND STUDIES COORDINATING CENTRE
1/10/20 → 31/03/25
Project: Other Government Departments

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Clarke, J., Dombrowski, S. U., Gkini, E., Hoddinott, P., Ingram, J., MacArthur, C., Moss, N., Ocansey, L., Roberts, T., Thomson, G., Sanders, J., Sitch, A. J., Stubbs, C., Taylor, B., Tearne, S., Woolley, R., & Jolly, K. (2023). Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0). BMJ open, 13(11), Article e075460. https://doi.org/10.1136/bmjopen-2023-075460

@article{cbed99f80da44cbc81d1354e4fb37980,

title = "Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0)",

abstract = "INTRODUCTION: Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.METHODS AND ANALYSIS: A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become 'infant feeding helpers' in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle.ETHICS AND DISSEMINATION: The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences.TRIAL REGISTRATION NUMBER: ISRCTN17395671.",

author = "Joanne Clarke and Dombrowski, {Stephan U} and Eleni Gkini and Pat Hoddinott and Jenny Ingram and Christine MacArthur and Ngawai Moss and Laura Ocansey and Tracy Roberts and Gillian Thomson and Julia Sanders and Sitch, {Alice J} and Clive Stubbs and Beck Taylor and Sarah Tearne and Rebecca Woolley and Kate Jolly",

note = "Funding: This work was supported by the National Institute for Health Research (NIHR) Public Health Research grant number NIHR129182. KJ and CM are part-funded by the NIHR Applied Research Collaboration West Midlands. AJS is supported by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. Copyright: {\textcopyright} Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

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language = "English",

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Clarke, J, Dombrowski, SU, Gkini, E, Hoddinott, P, Ingram, J, MacArthur, C, Moss, N, Ocansey, L, Roberts, T, Thomson, G, Sanders, J, Sitch, AJ, Stubbs, C, Taylor, B, Tearne, S, Woolley, R & Jolly, K 2023, 'Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0)', BMJ open, vol. 13, no. 11, e075460. https://doi.org/10.1136/bmjopen-2023-075460

Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0). / Clarke, Joanne; Dombrowski, Stephan U; Gkini, Eleni et al.
In: BMJ open, Vol. 13, No. 11, e075460, 15.11.2023.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation

T2 - protocol for a multicentre randomised controlled trial (Version 3.0)

AU - Clarke, Joanne

AU - Dombrowski, Stephan U

AU - Gkini, Eleni

AU - Hoddinott, Pat

AU - Ingram, Jenny

AU - MacArthur, Christine

AU - Moss, Ngawai

AU - Ocansey, Laura

AU - Roberts, Tracy

AU - Thomson, Gillian

AU - Sanders, Julia

AU - Sitch, Alice J

AU - Stubbs, Clive

AU - Taylor, Beck

AU - Tearne, Sarah

AU - Woolley, Rebecca

AU - Jolly, Kate

N1 - Funding: This work was supported by the National Institute for Health Research (NIHR) Public Health Research grant number NIHR129182. KJ and CM are part-funded by the NIHR Applied Research Collaboration West Midlands. AJS is supported by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2023/11/15

Y1 - 2023/11/15

N2 - INTRODUCTION: Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.METHODS AND ANALYSIS: A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become 'infant feeding helpers' in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle.ETHICS AND DISSEMINATION: The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences.TRIAL REGISTRATION NUMBER: ISRCTN17395671.

AB - INTRODUCTION: Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.METHODS AND ANALYSIS: A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become 'infant feeding helpers' in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle.ETHICS AND DISSEMINATION: The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences.TRIAL REGISTRATION NUMBER: ISRCTN17395671.

U2 - 10.1136/bmjopen-2023-075460

DO - 10.1136/bmjopen-2023-075460

M3 - Article

C2 - 37968005

SN - 2044-6055

VL - 13

JO - BMJ open

JF - BMJ open

IS - 11

M1 - e075460

ER -

Clarke J, Dombrowski SU, Gkini E, Hoddinott P, Ingram J, MacArthur C et al. Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0). BMJ open. 2023 Nov 15;13(11):e075460. doi: 10.1136/bmjopen-2023-075460

Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0)

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Bibliographical note

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The effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA) for improving breastfeeding initiation and continuation

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