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Headline
This intervention was found to be feasible to deliver and was acceptable to women, infant feeding helpers and maternity services; a full trial would be feasible.
Abstract
Background:
The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory.
Objective:
To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial.
Design:
This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group.
Setting:
Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding.
Participants:
Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics.
Interventions:
Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally.
Main outcome measures:
The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity.
Results:
Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms.
Limitations:
Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely.
Conclusion:
It is feasible to deliver the intervention and trial.
Future work:
The intervention should be tested in a fully powered randomised controlled trial.
Trial registration:
Current Controlled Trials ISRCTN14760978.
Funding:
This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Introduction
- The benefits of breastfeeding for health and well-being
- Breastfeeding rates and duration in the UK
- Effectiveness of peer support for breastfeeding initiation and continuation
- Existing provision of breastfeeding support in the UK
- Information needs of and risks for mothers who feed their babies formula milk
- Assets-based approaches in public health
- Rationale for the ABA study
- Chapter 2. Methods
- Aim and objectives
- Setting
- Study design
- Study management
- Ethics approval and study registration
- Participant identification
- Inclusion and exclusion criteria
- Consent-taking process
- Randomisation
- Intervention design
- Recruitment of ABA infant-feeding helpers
- Training for ABA infant-feeding helpers
- Comparator group
- Outcome assessment
- Feasibility outcomes
- Assessment of feasibility outcomes
- Qualitative research
- Qualitative analysis
- Outcome measures for a future trial
- Assessment of outcomes
- Assessment of adverse events
- Sample size
- Statistical analysis
- Feasibility of data collection for a future economic evaluation
- Criteria for progression to a main trial
- Chapter 3. Results
- Feasibility of recruitment
- Reach of recruitment of women to reflect the required sociodemographic profile
- Baseline imbalances
- Birth notifications
- Feasibility of postnatal text at 3 days
- Follow-up rates
- Study withdrawals
- Characteristics of participants who were followed up compared with characteristics of those who were lost to follow-up or withdrew
- Qualitative study participants
- Women’s and maternity services providers’ views on recruitment and randomisation process
- Feasibility and process outcomes for the intervention
- Fidelity of delivery and whether or not woman-centred care was provided
- Fidelity of delivery: analysis of behaviour change techniques discussed in qualitative interviews
- Acceptability of the ABA intervention to women, infant-feeding helpers and maternity services
- Potential cases of intervention contamination in the usual care group
- Outcomes for a definitive trial
- Achievement of progression criteria
- Chapter 4. Discussion and conclusions
- Summary of findings of the feasibility study
- Interpretation of findings of the feasibility study
- Potential improvements for future intervention delivery
- Comparison of findings with those from other research
- Strengths and limitations
- Economic evaluation methods
- Patient and public involvement in the study
- Recommendations for future research
- Conclusions
- Acknowledgements
- References
- Appendix 1. Revisions to the ABA study protocol
- Appendix 2. Participant information leaflet (anonymised)
- Appendix 3. Consent form (anonymised)
- Appendix 4. Anonymised version of the ‘assets leaflet’ used in the ABA intervention
- Appendix 5. The ABA study text library
- Appendix 6. Example genogram
- Appendix 7. Fidelity checklist for ABA antenatal visit recordings
- Appendix 8. Semistructured interview schedules
- Appendix 9. Text message sent to women 2–3 days postnatally
- Appendix 10. Recruitment flow diagrams for sites A and B
- Appendix 11. Participant demographic and delivery characteristics by site
- Appendix 12. Data completeness
- Appendix 13. Estimates from feasibility study: any breastfeeding at 8 weeks and 6 months, by site
- Appendix 14. Estimates from feasibility study: exclusive breastfeeding at 8 weeks and 6 months, by site
- Appendix 15. Estimates from feasibility study: breastfeeding initiation and feeding status at 3 days postnatally, by site
- Appendix 16. Estimates from feasibility study: ceased breastfeeding at 8 weeks and 6 months
- Appendix 17. Estimates from feasibility study: serious adverse events (hospital admissions for feeding-related problems)
- Appendix 18. Self-reported use of health and feeding support services at 8 weeks for advice on infant feeding
- Appendix 19. Use of child care
- Appendix 20. Receipt of benefits
- List of abbreviations
About the Series
Article history
The research reported in this issue of the journal was funded by the PHR programme as project number 15/53/04. The contractual start date was in November 2016. The final report began editorial review in November 2018 and was accepted for publication in May 2019. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors
Kate Jolly reports grants from the National Institute for Health Research (NIHR), local authority funding for the intervention and part-funding by NIHR Collaborative Leadership for Applied Health Research and Care West Midlands during the conduct of the study. Alongside her Cardiff University role, Heather Trickey worked part time as a senior researcher for NCT (London, UK) during the period in which the research was conducted. NCT provides breastfeeding peer support services. NCT volunteers were not included in this study. Pat Hoddinott is a member of the Health Technology Assessment Commissioning Board (March 2014 to present). She is working on a funding application to take forward the FEeding Support Team (FEST) feasibility trial that she led and that is cited in this report. The FEST feasibility trial informed parts of the design of the Assets-based feeding help Before and After birth study. Alice Sitch is supported by the NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, UK.
Last reviewed: November 2018; Accepted: May 2019.
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