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Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.

Name: Adcurare Rigor Record — Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.
Item: Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.
Rating: 96
Author: Adcurare

Jolly K, Clarke J, Crossland N, Dombrowski SU, Gkini E, Hoddinott P, Ingram J, Johnson D, MacArthur C, Mann M, McKell J, Moss N, Roberts T, Sanders J, Savory N, Sitch A, Taylor B, Tearne S, Thomson G, Williams E, Woolley R, ABA-feed study group

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Adcurare Rigor Review — 4.75★ (Strong), 0 critical, 3 high issues for “Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Not verified in this report

References were not verified against Crossref/OpenAlex.

Problems surfaced1 type

Data/code availability incomplete

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and transparently reported pragmatic RCT of a peer support intervention for breastfeeding. The main methodological strengths are the rigorous randomisation, pre-specified analysis plan, and comprehensive reporting of limitations. The primary weaknesses are minor reporting gaps: the absence of an explicit regulatory compliance statement in the ethics section, and the code being shared only as a supplementary file rather than in a version-controlled repository.

All three independent reviewers evaluated the full manuscript. The reviewers agreed on most dimensions; the main divergence was on ethical approvals (one reviewer flagged a missing regulatory compliance statement) and key resources (one reviewer considered it not applicable, but the intervention is a described resource). The statistics verification component checked 4 tests and found all consistent; coverage is limited to tests with a test statistic + df or an effect estimate + CI. No citation issues were flagged. The copyedit pass found one minor clarity issue.

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 4 tests: 4 consistent, 0 inconsistent, 4 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites a 2022 Cochrane review and other studies showing mixed evidence for peer support, identifies gaps in previous UK trials (low intensity, lack of proactive contact), and explains how ABA-feed addresses these limitations. The hypothesis follows logically from the cited evidence. Limitations of prior research are explicitly addressed (e.g., low intensity, need for parent to initiate contact).

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper establishes a clear scientific premise, citing prior research and providing a logical rationale for the study.

Evidence

direct quote[Introduction, paragraph 3-4]

“A 2022 Cochrane review reported moderate certainty evidence that interventions providing breastfeeding support...probably reduce the risk of women stopping any and exclusive breastfeeding...”

direct quote[Introduction, paragraph 5]

“Possible reasons include low intensity interventions, lack of timely support after the birth, and the need for a new parent to initiate contact.”

paraphrase[Introduction, paragraph 6]

“The ABA-feed intervention was developed to address these issues, drawing on best evidence, including a moderate to high number of proactive woman centered contacts.”

PASSReviewer 2· 90% conf

The scientific premise is well-established through citations of prior systematic reviews, UK trials, and WHO recommendations, with a clear rationale for the intervention and acknowledgment of limitations of previous work.

Evidence

direct quote[Introduction, paragraph 3]

“A 2022 Cochrane review reported moderate certainty evidence that interventions providing breastfeeding support... probably reduce the risk of women stopping any and exclusive breastfeeding...”

direct quote[Introduction, paragraph 4]

“Possible reasons include low intensity interventions, lack of timely support after the birth, and the need for a new parent to initiate contact. The ABA-feed intervention ... was developed to deal with these issues.”

direct quote[Introduction, final paragraph]

“We evaluated whether this novel, intensive peer support intervention for infant feeding could improve breastfeeding rates in a UK context.”

PASSReviewer 3· 95% conf

The paper establishes a clear scientific premise by citing prior research, including a Cochrane review, and provides a logical rationale for the study. Limitations of prior work are acknowledged and addressed in the intervention design.

Evidence

direct quote[Introduction, paragraph 3]

“A 2022 Cochrane review reported moderate certainty evidence that interventions providing breastfeeding support...probably reduce the risk of women stopping any and exclusive breastfeeding...Despite international evidence for the effectiveness of peer support...several large randomised controlled trials of peer support in the UK did not show a beneficial effect.”

direct quote[Introduction, paragraph 4]

“Possible reasons include low intensity interventions, lack of timely support after the birth, and the need for a new parent to initiate contact. The ABA-feed...intervention...was developed to deal with these issues...Novel aspects were its peer delivered contact post-birth that was proactive and daily...”

direct quote[Introduction, paragraph 4]

“A feasibility trial showed the acceptability and practicality of delivering the ABA-feed intervention.”

Randomisation used a secure web-based system with minimisation algorithm for site and age, ensuring allocation concealment. No blinding was possible due to the nature of the intervention, which is acknowledged. A power analysis with 90% power and 5% significance level was conducted, accounting for clustering. Inclusion/exclusion criteria are clearly stated. Pre-specified outlier and missing data handling were described. Controls (usual care) are appropriate. No independent replication is reported, which is expected for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsINADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study design is rigorous, with a well-described randomisation method, sample size calculation, and analysis plan, though blinding was not possible (open-label, justified).

Evidence

direct quote[Methods, Randomisation and masking, paragraph 1]

“the Birmingham Clinical Trials Unit used a secure, central, web based randomisation system to allocate women in a 1.43:1 ratio to receive intervention or usual care.”

direct quote[Methods, Sample size]

“Assuming 90% power and a two sided 5% significance level, with a control group rate of 44% for the primary outcome... a sample size of 2136 women (1068 in each group) was required to detect a risk ratio of 1.16 (ie, an increase of 7%).”

direct quote[Methods, Design and setting]

“We conducted a multicentre, parallel group, unblinded, randomised controlled trial”

PASSReviewer 2· 95% conf

The study design is rigorous for a pragmatic RCT: central randomisation with minimisation, a priori sample size calculation, pre-specified inclusion/exclusion criteria, and detailed handling of missing data and outliers. The unblinded design is appropriate for a behavioural intervention.

Evidence

direct quote[Methods: Randomisation and masking]

direct quote[Methods: Sample size]

“Assuming 90% power and a two sided 5% significance level, with a control group rate of 44% ... a sample size of 2136 women ... was required to detect a risk ratio of 1.16 (ie, an increase of 7%).”

direct quote[Methods: Recruitment and participants]

“women were eligible for recruitment if they were nulliparous, between 20 weeks and 35 weeks and six days gestation with a singleton pregnancy, aged 16 years or older, and lived in the study area.”

PASSReviewer 3· 95% conf

The study design is rigorous for a pragmatic RCT: randomisation method, allocation concealment, power analysis, inclusion/exclusion criteria, and handling of clustering are all adequately described.

Evidence

direct quote[Methods, Randomisation and masking]

“To ensure concealment of treatment allocation, the Birmingham Clinical Trials Unit used a secure, central, web based randomisation system to allocate women in a 1.43:1 ratio to receive intervention or usual care. A minimisation algorithm (with random element)...ensured balance...for study site and the woman’s age (<25, ≥25 years)...”

direct quote[Methods, Sample size]

“Assuming 90% power and a two sided 5% significance level, with a control group rate of 44%...a sample size of 2136 women...was required to detect a risk ratio of 1.16...To allow for potential clustering...the sample size required for the intervention arm was 1526...Allowing for a 5% loss to follow-up, 2730...”

direct quote[Abstract and Methods, Design and setting]

“UK based, multicentre, parallel group, unblinded, randomised controlled trial”

Participants are all women (sex reported), with age, ethnicity, education, relationship status, and deprivation index provided. Health status (e.g., gestation, nulliparity) is described. Species/strain/source and housing conditions are not applicable as this is a human RCT. Sex-justified is not applicable because both sexes were not enrolled (only women), but the study focuses on breastfeeding, making single-sex enrollment appropriate.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Human subject characteristics (age, sex, demographics) are adequately reported; species/strain and housing are not applicable.

Evidence

direct quote[Methods, Recruitment and participants]

“women were eligible for recruitment if they were nulliparous, between 20 weeks and 35 weeks and six days gestation”

direct quote[Results, paragraph 1 and Table 1]

“Mean age of the participants was 30 years, and most described their ethnicity as white (2132; 86.5%)”

direct quote[Methods, Recruitment and participants]

“nulliparous, between 20 weeks and 35 weeks and six days gestation with a singleton pregnancy”

PASSReviewer 2· 95% conf

All applicable biological variables for a human RCT are adequately reported: sex (all female), age, and detailed demographics including ethnicity, education, and deprivation index.

Evidence

direct quote[Results, Table 1]

“Mean (SD) age (years) | 30.6 (4.7) | 30.6 (4.8)”

direct quote[Results, Table 1]

“Ethnic group: White British 1180 (81.3) ... Highest level of qualification: Degree level or above 1013 (70.2) ... Deprivation index fifth: 1 (most deprived) 285 (19.6)”

direct quote[Methods: Recruitment and participants]

“nulliparous women between 20 and 35 weeks of gestation”

PASSReviewer 3· 95% conf

Demographic and biological variables relevant to the human study are well reported, including age, sex, ethnicity, education, deprivation, and feeding intentions. Species/housing are not applicable.

Evidence

direct quote[Results, Table 1]

“Mean age of the participants was 30 years, and most described their ethnicity as white (2132; 86.5%)...education to degree level (1726; 70.2%).”

direct quote[Methods, Recruitment and participants]

“Women were eligible for recruitment if they were nulliparous, between 20 weeks and 35 weeks and six days gestation with a singleton pregnancy, aged 16 years or older...”

direct quote[Results, Table 1]

“What milk do you want to give baby during the first six months of his/her life?...Breast milk only...Mainly breast milk...”

The paper reports ethical approval from the East of Scotland Research Ethics Committee (21/ES/0045). Informed consent procedures are detailed, including in-person, telephone, video, and e-consent options. Regulatory compliance with the Declaration of Helsinki is implied through ethics approval. IACUC is not applicable (human trial).

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from a named ethics committee is reported, and informed consent procedures are described.

Evidence

direct quote[Ethics statements]

“This trial was approved by the East of Scotland Research Ethics Committee (21/ES/0045).”

direct quote[Methods, Recruitment and participants]

“Informed consent was obtained from each participant in person or by telephone or video call.”

direct quote[Abstract]

“ISRCTN Registry ISRCTN17395671.”

WARNReviewer 2· 90% conf

Ethics approval from a named REC and informed consent are adequately reported, but the paper does not explicitly state compliance with a recognized regulatory framework (e.g., Declaration of Helsinki), which is a minor reporting gap.

Evidence

direct quote[Ethics statements]

“This trial was approved by the East of Scotland Research Ethics Committee (21/ES/0045).”

direct quote[Methods: Recruitment and participants]

“Informed consent was obtained from each participant in person or by telephone or video call. ... When in-person consent or e-consent was not possible, the researcher initialled, signed, and dated the consent form during a telephone discussion, with a copy sent to the woman.”

absence[Ethics statements]

No explicit regulatory compliance statement (e.g., Declaration of Helsinki).

PASSReviewer 3· 100% conf

The trial has a named ethics committee approval and informed consent is described.

Evidence

direct quote[Ethics statements section after Discussion]

“This trial was approved by the East of Scotland Research Ethics Committee (21/ES/0045).”

direct quote[Methods, Recruitment and participants]

“Informed consent was obtained from each participant in person or by telephone or video call.”

The paper describes the ABA-feed intervention and usual care in detail, including training, frequency, mode, and content. The statistical software is identified (SAS 9.4, Stata 18). As a non-drug/non-device trial for a complex intervention, the criteria for antibodies, cell lines, mycoplasma, and specific organisms are not applicable. The 'reagents_identified' criterion is applied to the investigational product (the peer support intervention), which is described with sufficient detail for replication.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational intervention (ABA-feed peer support) is described, and software tools are identified with versions; other bench resources are not applicable.

Evidence

direct quote[Methods, Statistical analysis]

“Statistical analysis was undertaken using the statistical software packages SAS version 9.4 and Stata version 18.”

direct quote[Methods, Outcomes]

“anxiety using the GAD-7 (generalised anxiety disorder 7 item) scale, health related quality of life using the EQ-5D-5L (EuroQol 5-dimension 5 level questionnaire), social support (Medical Outcomes Study)”

N/AReviewer 2· 100% conf

The study is a behavioural intervention trial with no drug, biologic, device, or bench reagent; hence no key biological or chemical resources are applicable.

Evidence

direct quote[Methods: ABA-feed intervention]

“The ABA-feed intervention was peer delivered using in-person and remote methods (SMS text, WhatsApp, and telephone calls)”

PASSReviewer 3· 95% conf

The key resources (intervention, usual care, software) are adequately identified. The study is a pragmatic trial comparing a complex intervention to usual care, not a typical drug/device trial, but the intervention is described in detail.

Evidence

direct quote[Methods, ABA-feed intervention]

“The ABA-feed intervention was peer delivered using in-person and remote methods (SMS text, WhatsApp, and telephone calls)...underpinned by behaviour change theory and an assets based approach.”

direct quote[Methods, Statistical analysis]

“Statistical analysis was undertaken using the statistical software packages SAS version 9.4 and Stata version 18.”

The primary analysis uses mixed effects log binomial regression with adjustment for minimisation variables; secondary outcomes use Cox regression, mixed effects linear regression, and bootstrapping for skewed data. All tests are named with effect estimates and 95% CIs. Exact p-values are reported (e.g., P=0.69, P=0.13, P=0.04). Statistical software (SAS 9.4, Stata 18) is identified. Data presentation includes tables with n, percentages, means, medians, and IQRs. The mathematical plausibility of reported numbers is consistent (e.g., primary outcome denominators align with randomized minus missing).

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are well described, with named tests, handling of assumptions, exact p-values, effect sizes with CIs, and software identified.

Evidence

direct quote[Results, Breastfeeding outcomes, Table 3]

“69.8% v 68.8%; risk difference 0.01, 95% CI −0.03 to 0.04, P=0.69”

direct quote[Methods, Statistical analysis]

“Missing data were imputed as formula feeding for the primary outcome... Sensitivity analyses (ie, complete case analysis, worst case scenario, best case scenario, and tipping point approach)”

direct quote[Methods, Statistical analysis]

“Time-to-cease outcomes were analysed using Cox proportional hazards models adjusting for the minimisation variables according to the primary outcome.”

PASSReviewer 2· 95% conf

Statistical methods are appropriate and well-described: tests named, exact p-values and effect sizes with CIs reported, software identified, and data presentation includes per-group n and dispersion measures. Missing data and outlier handling are pre-specified.

Evidence

direct quote[Methods: Statistical analysis]

“The primary outcome ... was binary, and the planned analysis was to use a mixed effects log binomial regression model ... Time-to-cease outcomes were analysed using Cox proportional hazards models ... For continuous secondary outcomes ... we used mixed effects linear regression methods.”

direct quote[Table 3]

“Risk difference 0.01 (95% CI −0.03 to 0.04; P=0.69)”

direct quote[Methods: Statistical analysis]

“Statistical analysis was undertaken using the statistical software packages SAS version 9.4 and Stata version 18.”

PASSReviewer 3· 95% conf

Statistical methods are detailed, with named tests, handling of assumptions, sensitivity analyses, and appropriate data presentation. Exact p-values and confidence intervals are reported for primary and key secondary outcomes.

Evidence

direct quote[Methods, Statistical analysis]

“The primary outcome...analysis was to use a mixed effects log binomial regression model...The treatment effect was expressed as an adjusted risk ratio and a risk difference with associated 95% CIs.”

direct quote[Methods, Statistical analysis]

“Various prespecified analyses were undertaken: a per protocol analysis...and missing data assumptions (eg, complete case analysis, imputing the missing responses using a tipping point analysis)...”

direct quote[Methods, Statistical analysis]

“to assess the impact of outliers or skewed data, we conducted sensitivity analyses either by excluding the outliers or by using bootstrapping methods to estimate unadjusted median differences in cases of skewed data.”

A data availability statement is present: 'Deidentified individual participant data stored at https://edata.bham.ac.uk/1555/ and are fully accessible for ethically approved research after registration with UBIRA eData.' This names a repository (UBIRA eData) with a persistent URL and a managed-access procedure (registration), which is adequate for controlled patient data. The statistical analysis code is included as a supplementary file, which is adequate. No accession numbers for other data (e.g., sequencing) are applicable. However, the data URL points to a generic repository page and does not specify whether the data are actually deposited under that URL; the statement is adequate but the practical access is unclear, so a cautious 'warn' is appropriate.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositINADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

Data availability statement is present but uses a vague 'on request' approach; code is shared as supplementary; no accession numbers for data are provided.

Evidence

direct quote[Data availability statement]

“Deidentified individual participant data stored at https://edata.bham.ac.uk/1555/ and are fully accessible for ethically approved research after registration with UBIRA eData.”

direct quote[Data availability statement]

“The SAS version 9.4 and Stata version 18 statistical analysis code is included in the supplementary file.”

WARNReviewer 2· 85% conf

Data availability statement and repository deposit are adequate, but the statistical analysis code is provided only in supplementary files rather than in a version-controlled public repository, which is a partial gap.

Evidence

direct quote[Data availability statement]

“Deidentified individual participant data stored at https://edata.bham.ac.uk/1555/ and are fully accessible for ethically approved research after registration with UBIRA eData.”

direct quote[Data availability statement]

“The SAS version 9.4 and Stata version 18 statistical analysis code is included in the supplementary file.”

PASSReviewer 3· 95% conf

The paper provides a data availability statement with a concrete access route (repository), and analysis code is shared. The individual patient data are in a controlled-access repository but with a stated mechanism.

Evidence

direct quote[Data availability statement]

“Deidentified individual participant data stored at https://edata.bham.ac.uk/1555/ and are fully accessible for ethically approved research after registration with UBIRA eData.”

direct quote[Data availability statement]

“The SAS version 9.4 and Stata version 18 statistical analysis code is included in the supplementary file.”

Methods are sufficiently detailed for replication. Trial registration number (ISRCTN17395671) is provided. No specific reporting guideline (e.g., CONSORT) is mentioned in the methods, but the structure follows CONSORT implicitly; a reference to CONSORT would strengthen this. All pre-specified outcomes are reported, including null results (primary outcome negative). Limitations section is thorough and balanced. Conclusions are appropriately cautious. Funding and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent: methods are detailed, trial is registered, negative outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI is declared.

Evidence

direct quote[Abstract]

“ISRCTN Registry ISRCTN17395671.”

direct quote[Results, Breastfeeding outcomes]

“Rates of any breastfeeding at eight weeks were similar between the intervention group and usual care group (69.8% v 68.8%; risk difference 0.01, 95% CI −0.03 to 0.04, P=0.69).”

direct quote[Discussion, Strengths and limitations]

“A limitation was that we did not fully achieve recruitment numbers to reach 90% power but did exceed the target for 80% power... our sample showed evidence of recruitment bias, with educated women over-represented”

direct quote[Funding section and Competing interests]

“This trial was funded by the National Institute for Health and Care Research (NIHR) Public Health Research Programme (project No NIHR129182).”

PASSReviewer 2· 90% conf

Reporting is comprehensive: methods are detailed, trial registration is provided, all outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are stated. The only gap is the absence of a reference to a reporting guideline (e.g., CONSORT), but this is offset by the overall quality.

Evidence

direct quote[Abstract]

“Trial registration ISRCTN Registry ISRCTN17395671.”

direct quote[Discussion: Strengths and limitations of this study]

“A limitation was that we did not fully achieve recruitment numbers to reach 90% power but did exceed the target for 80% power.”

absence[Methods]

No reference to CONSORT or other reporting guideline.

PASSReviewer 3· 95% conf

The reporting is transparent: trial registration, methods, limitations, and funding/COI are all adequately reported. Conclusions are proportional to the evidence.

Evidence

direct quote[Abstract]

“Trial registration ISRCTN Registry ISRCTN17395671.”

direct quote[Discussion, Strengths and limitations of this study]

“A limitation was that we did not fully achieve recruitment numbers...our sample showed evidence of recruitment bias...Our inability to include women regardless of their spoken language...”

direct quote[Abstract]

“The ABA-feed peer support intervention did not improve breastfeeding rates compared with usual breastfeeding support in a UK context.”

1 copyedit issue flagged: mostly clarity.

Reproducibility

1 data/code link checked; 1 live.

Registered (1 ID: ISRCTN). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is ready for submission after addressing the minor reporting gaps: add a regulatory compliance statement, deposit the analysis code in a public repository, and mention adherence to CONSORT guidelines. These are low-effort fixes that will strengthen the paper's transparency.

1.
HIGHethics
Add an explicit regulatory compliance statement in the Ethics section, e.g., 'The trial was conducted in accordance with the Declaration of Helsinki and the UK Policy Framework for Health and Social Care Research.'
The paper currently lacks an explicit statement of compliance with a recognized regulatory framework, which is a standard reporting requirement for human trials.
2.
HIGHdata code
Deposit the SAS and Stata analysis code in a version-controlled public repository (e.g., GitHub or Zenodo) with a persistent DOI, and update the data availability statement to reference the repository URL.
Sharing code only as a supplementary file is considered inadequate; a public repository with a permanent identifier ensures long-term accessibility and reproducibility.
3.
HIGHreporting
Add a statement in the Methods section that the trial is reported in accordance with the CONSORT 2010 statement, and consider submitting the CONSORT checklist as a supplementary file.
Explicitly mentioning adherence to a reporting guideline is a standard expectation for RCTs and improves transparency.
4.
MEDIUMreporting
Simplify the Table 4 footnote as suggested by the copyedit pass: 'Risk ratios and risk differences were adjusted for minimisation variables (age as fixed effect, site as random effect; infant feeding helper was removed due to convergence). For breastfeeding initiation, site was also removed.'
The current footnote contains nested parentheses that reduce clarity; a simplified version improves readability.
5.
MEDIUMreporting
In the Methods, explicitly state that assumptions for the mixed effects models (e.g., normality of residuals, proportional hazards) were checked and met, or describe any deviations.
While sensitivity analyses cover many scenarios, explicitly stating that model assumptions were verified strengthens the statistical reporting.
6.
MEDIUMreporting
Add a brief rationale in the Abstract or Methods for the unblinded design, e.g., 'due to the nature of the peer support intervention, blinding was not feasible'.
Although the unblinded design is transparent, a brief justification preempts potential reviewer criticism.
7.
LOWreporting
Clarify in the Data availability statement whether the data are already deposited at the provided URL or whether registration is needed to access the deposit; specify the conditions and timeline for access.
Providing more detail on the access process increases transparency and usability for other researchers.
8.
LOWreporting
Consider including a brief justification for the 1.43:1 randomisation ratio beyond accounting for clustering (e.g., to save costs or improve power?).
While the ratio is explained by clustering, a brief additional rationale would be informative.

Full text (63,826 chars)Analyzed: Jul 6, 2026

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Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial.

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Journal

DOI

10.1136/bmj-2025-086558

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