Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).

Name: Kaimen Rigor review — Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).
Item: Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).
Rating: 59
Author: Alpha1

Sujan MJ, Skarstad HM, Rosvold G, Fougner SL, Follestad T, Salvesen KÅ, Moholdt T

Paper source

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Kaimen Rigor review — 3.25★ (Adequate), 0 critical, 2 high issues for “Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).

Sujan MJ, Skarstad HM, Rosvold G, Fougner SL, Follestad T, Salvesen KÅ, Moholdt T

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DOI

10.1136/bmj-2024-083398

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).

Sujan MJ, Skarstad HM, Rosvold G, Fougner SL, Follestad T, Salvesen KÅ, Moholdt T

Paper source

Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
StatisticsPrinted percentage does not match its own count (capped)−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 12 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues

01Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
86% does not match the reported count 146/166
“146/166 participants (86%)”
DiscussionFind in source

Findings by category

201ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit7 minor suggestions

This Kaimen Rigor review uses Kaimen 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 randomised controlled trial of a prepregnancy lifestyle intervention. The main methodological strengths are the rigorous randomisation, pre-specified sample size, detailed statistical methods, and open data/code availability. The primary weakness is the lack of an explicit informed consent statement, and there are minor reporting and copyedit issues.

Both reviewers classified the study as interventional (RCT), so no divergence on study type. The statistics verification covered only 5 tests (those with test statistics/df or effect estimates with CIs); the remaining analyses (e.g., bootstrap, exact tests) were not machine-verified and should not be assumed correct. The citation check found no retracted or unresolved references. The reproducibility check confirmed the Zenodo link is live.

Numerical inconsistencies

2 findings · worst medium

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks. 1 printed percentage that does not match its own count.

Overstated conclusions

None found

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Checked — nothing surfaced.

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

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites multiple relevant studies (RADIEL, UPBEAT, LIMIT, Prepare) and systematic reviews, and it explicitly notes the lack of evidence on specific prepregnancy intervention components. The hypothesis follows logically from the cited evidence that prepregnancy lifestyle changes may improve glycaemic control. The paper also addresses limitations of prior research by highlighting the missed window of opportunity in pregnancy and the need for prepregnancy interventions.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior research on GDM risk factors, lifestyle interventions, and the rationale for a prepregnancy intervention, and it acknowledges gaps in existing evidence.

Evidence

“The Finnish Gestational Diabetes Prevention Study (RADIEL) showed that a diet and exercise intervention started before 20 weeks of gestation could reduce the incidence of GDM by 39% in those at high risk. In contrast, some large lifestyle intervention trials, such as the UPBEAT study and the LIMIT trial, did not show the effectiveness of a diet and exercise intervention in pregnancy for GDM prevention.”

Introduction ¶2Find in source

“However, evidence on the specific components of prepregnancy interventions and their effectiveness remains scarce.”

Introduction ¶4Find in source

“In the BEFORE THE BEGINNING trial, we hypothesised that combined time restricted eating and exercise training started before pregnancy and continued throughout pregnancy would improve maternal glucose tolerance by gestational week 28 in people at increased risk of GDM.”

IntroductionFind in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise, citing prior research on GDM risk factors, lifestyle interventions, and the rationale for a prepregnancy intervention.

Evidence

Introduction ¶2Find in source

IntroductionFind in source

“Most clinical trials of lifestyle interventions in pregnancy have started the intervention around 16-20 weeks of gestation, leaving a missed window of opportunity to implement lifestyle changes and improve glycaemic control.”

Introduction ¶3Find in source

Randomisation was computer-generated with concealed allocation and stratification by previous GDM. Blinding was not performed, but the paper explicitly states 'Neither participants nor study personnel were masked' and provides a rationale for an open-label design. A sample size calculation was performed and revised during the trial. Inclusion/exclusion criteria were pre-specified and modifications were documented. The analysis population (ITT) and missing-data handling are described. Controls (standard care) are appropriate. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial uses a robust randomised design with adequate randomisation, blinding rationale, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“The study personnel used WebCRF3, a computer random number generator developed and administered at the Clinical Research Unit (Klinforsk, NTNU/St Olav’s Hospital, Trondheim, Norway) to randomly allocate participants using various block sizes.”

MethodsFind in source

“Neither participants nor study personnel were masked.”

MethodsFind in source

“Sample size calculation for a two sided t test to detect a 1.0 mmol/L difference between the groups, using a standard deviation of 1.3, a power of 0.90, and a significance level of 0.05, yields 37 participants in each group at gestational week 28.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomised, stratified, with a computer-generated random sequence, concealed allocation, and a pre-specified sample size calculation. Blinding was not feasible but is stated.

Evidence

MethodsFind in source

“Neither participants nor study personnel were masked.”

MethodsFind in source

The study enrolled only women (sex is implied by the population and confirmed by the baseline table). Age, weight, BMI, and health status are reported in Table 1. Demographics including education, ethnicity, and parity are reported. Since the study is human, species/strain and housing conditions are not applicable. Sex justification is not applicable because the study is in pregnant people (both sexes not applicable).

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper reports sex (all female), age, weight, BMI, and other relevant characteristics; demographics are well described.

Evidence

“Age, years | 30.3 (3.2) | 30.2 (3.1) | | Weight, kg | 81.5 (13.2) | 81.1 (16) | | Body mass index | 29.1 (4.5) | 29.2 (4.9)”

Table 1Find in source

“Education level, n (%) | | Compulsory schooling | 0 (0) | 1 (1) | | Completed upper secondary school | 8 (10) | 10 (12) | | Completed university education, <4 years | 28 (34) | 23 (28) | | Completed university education, ≥4 years | 46 (56) | 47 (58)”

Table 1Find in source

PASSReviewer 2· 90% conf

Biological variables are well reported: sex (all female), age, weight, BMI, and health status are given. Demographics (education, ethnicity) are reported. Species/strain and housing are not applicable for a human trial.

Evidence

“Age, years | 30.3 (3.2) | 30.2 (3.1) | | Weight, kg | 81.5 (13.2) | 81.1 (16) | | Body mass index | 29.1 (4.5) | 29.2 (4.9)”

Table 1Find in source

The paper states 'The Regional Committees for Medical and Health Research Ethics in Norway approved the study (REK 143756)', which is a named ethics body with a protocol number. Informed consent is not explicitly described in the text, but it is standard for such trials and the paper mentions 'informed consent' in the context of the trial registration? Actually, the paper does not explicitly state that informed consent was obtained. However, the ethics approval implies consent was obtained. The paper also states compliance with the Declaration of Helsinki? It does not explicitly mention it, but the ethics approval is sufficient. Regulatory compliance is implied by the ethics approval.

Sub-criteria

iacuc statementN/A

informed consentINADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study has a named ethics approval and a data availability statement; informed consent is implied but not explicitly described.

Evidence

“The Regional Committees for Medical and Health Research Ethics in Norway approved the study (REK 143756).”

EthicsFind in source

absence[Ethics statements]

Informed consent is not explicitly described.

PASSReviewer 2· 95% conf

Ethical approval is explicitly stated with a named ethics committee and protocol number. Informed consent is implied but not explicitly described; however, the trial is registered and conducted in Norway, where consent is standard.

Evidence

“The Regional Committees for Medical and Health Research Ethics in Norway approved the study (REK 143756).”

EthicsFind in source

absence[Ethics statements]

Informed consent is not explicitly described.

The intervention components (time-restricted eating and exercise) are described in detail, including the PAI metric and smartwatches used. The glucose drink (Glucosepro) is identified with manufacturer. Statistical software (IBM SPSS Statistics 29.0 and STATA MP version 18) is identified. Antibodies, cell lines, and mycoplasma testing are not applicable as this is a clinical trial without wet-lab assays.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (lifestyle intervention) is described in detail, and the software used for analysis is identified.

Evidence

“participants consumed a premade drink of 75 g glucose diluted in 250 mL water (Glucosepro, Finnamedical, Finland)”

MethodsFind in source

“Statistical analyses were performed using IBM SPSS Statistics 29.0 and STATA MP version 18.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (lifestyle intervention) is described in detail, including the exercise metric (PAI) and time-restricted eating protocol. Software tools are identified. No antibodies, cell lines, or mycoplasma testing are applicable.

Evidence

“We counselled the participants in the intervention group to restrict their daily time window of energy intake to ≤10 hours, ending no later than 7 pm, for a minimum of five days per week throughout the study period.”

MethodsFind in source

“Statistical analyses were performed using IBM SPSS Statistics 29.0 and STATA MP version 18.”

Statistical analysisFind in source

The paper names the statistical tests (linear mixed models, Fisher's exact, chi-square, t-test) and describes how assumptions were checked (QQ plots, bootstrap for non-normal). Exact p-values are reported (e.g., P=0.08). Effect sizes with 95% CIs are reported throughout. Software is identified. Data presentation includes per-group n and error bars defined. Mathematical plausibility checks were not performed due to continuous data and large N.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well described, with exact p-values and confidence intervals reported; assumptions are checked.

Evidence

“We used linear mixed models to estimate differences in primary and secondary continuous outcomes between groups, with time and the interaction between time and group as fixed effects variables, and subject (participant ID) as random effect.”

Statistical analysisFind in source

“mean difference 0.48 mmol/L, 95% confidence interval −0.05 to 1.01, P=0.08”

ResultsFind in source

“We checked the normality of residuals by visually inspecting QQ plots. For variables that were not normally distributed, bias corrected and accelerated bootstrap confidence intervals based on 3000 bootstrap samples were calculated.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described: linear mixed models, bootstrap for non-normal residuals, Fisher's exact and chi-square tests. Exact p-values are reported. Effect sizes with CIs are given. Software is identified. Data presentation is adequate for a clinical trial.

Evidence

Statistical analysisFind in source

“mean difference 0.48 mmol/L, 95% confidence interval −0.05 to 1.01, P=0.08”

ResultsFind in source

“0.48 (−0.05 to 1.01) | 0.08”

Table 2Find in source

The data availability statement names a specific repository (Zenodo) with a DOI, and states that individual deidentified participant data and statistical codes are available. This is reported_and_adequate. Repository deposit and accession numbers are covered by the Zenodo DOI. Code sharing is also covered by the statement that statistical codes are available on Zenodo.

Sub-criteria

code sharingADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are openly available on Zenodo with a DOI, and the data availability statement is concrete.

Evidence

paraphrase[Data availability statement]

“All individual deidentified participant data and statistical codes are available on Zenodo data repository. The data underlying the findings in this paper are openly and publicly available and can be found here: https://doi.org/10.5281/zenodo.15675472”

PASSReviewer 2· 95% conf

Data and code are openly available on Zenodo with a DOI. The data availability statement is concrete and adequate.

Evidence

“All individual deidentified participant data and statistical codes are available on Zenodo data repository. The code used to analyse the data in the paper can be found in the supplementary files. The data underlying the findings in this paper are openly and publicly available and can be found here: https://doi.org/10.5281/zenodo.15675472”

Data availabilityFind in source

The trial is registered at ClinicalTrials.gov (NCT04585581). Methods are detailed enough for replication. A reporting guideline (CONSORT) is not explicitly mentioned, but the paper follows a structured format typical of RCT reports. All pre-specified outcomes are not fully reported (some secondary outcomes deferred to separate publications), but the main ones are. Limitations are thoroughly discussed. Conclusions are proportional to the findings. Funding and COI are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedINADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“Trial registration ClinicalTrials.gov NCT04585581”

AbstractFind in source

“Most participants were well educated, potentially resulting in healthy volunteer bias as they were likely knowledgeable about their health and wellbeing.”

LimitationsFind in source

“The trial was funded by the Novo Nordisk Foundation (NNF19SA058975), the Liaison Committee for education, research, and innovation in Central Norway, and the Joint Research Committee between St Olav’s Hospital and the Faculty of Medicine and Health Sciences, NTNU (FFU).”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered (NCT04585581), methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. A reporting guideline is not explicitly mentioned, but the paper follows CONSORT-like structure.

Evidence

“Trial registration ClinicalTrials.gov NCT04585581 (https://clinicaltrials.gov/ct2/show/NCT04585581)”

AbstractFind in source

“Most participants were well educated, potentially resulting in healthy volunteer bias as they were likely knowledgeable about their health and wellbeing.”

LimitationsFind in source

FundingFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 65 references by DOI: 62 verified — 3 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

7 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 7 minor suggestions below.

7 copyedit issues flagged: mostly consistency, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and generally trustworthy, but an informed reader should weigh the minor reporting gaps: the absence of an explicit informed consent statement, the lack of an explicit CONSORT adherence statement, and a minor arithmetic inconsistency (146/166 reported as 86% instead of 88%). These do not undermine the main conclusions but would warrant a correction or clarification from the authors.

1.
HIGHethics
Add an explicit statement in the Ethics statements section describing how informed consent was obtained (e.g., written informed consent from all participants) or provide a waiver justification.
Informed consent is a required element for human research; its absence is a reporting gap that both reviewers flagged and that an informed reader would expect to see.
2.
HIGHreporting
Correct the arithmetic inconsistency in the Discussion: 146/166 is 88%, not 86%.
An incorrect percentage is a factual error that could mislead readers and warrants a correction.
3.
MEDIUMreporting
Add an explicit statement of adherence to the CONSORT reporting guideline in the Methods or a dedicated section, and indicate where the checklist is available.
Explicitly naming the reporting guideline improves transparency and is expected for RCT reports.
4.
MEDIUMreporting
Clarify in the Results or Discussion that some pre-specified secondary outcomes are deferred to separate publications, and consider providing a summary of all outcomes in the supplementary material.
Readers should know which outcomes are reported here and where to find the rest, to avoid selective reporting concerns.
5.
MEDIUMstatistics
In the Discussion, explicitly address the potential for type II error due to the reduced sample size (167 vs. planned 260) and its impact on the null result.
The trial was underpowered relative to the original plan; acknowledging this helps readers interpret the null findings appropriately.
6.
MEDIUMreporting
Add a note on the generalizability of the findings given the predominantly white, well-educated sample.
The sample is not representative of all at-risk populations; this limitation should be explicitly stated.
7.
MEDIUMdata code
Specify the license and any access conditions for the Zenodo data and code repository.
Clear licensing terms are important for reuse and reproducibility.
8.
LOWcopyedit
Clarify the abstract sentence about adherence: '31/83 participants (37%) in the intervention group adhered to prespecified criteria, whereas 24/55 participants (44%) in the intervention group who became pregnant fulfilled these criteria.'
The sentence is confusing because it is unclear that the first number refers to all intervention participants and the second to those who became pregnant.
9.
LOWcopyedit
Use consistent hyphenation in 'bias-corrected and accelerated' in the Methods, Statistical analysis section.
Minor typographical consistency improves readability.
10.
LOWcopyedit
Rephrase the sentence in Results, Participants: 'We ended inclusion of new participants when 47 participants in each group reached gestational week 12' to 'We stopped recruiting when 47 participants in each group had reached gestational week 12.'
The original phrasing is understandable but could be clearer.
11.
LOWcopyedit
Specify which residuals (e.g., from the linear mixed models) were checked for normality in the Methods, Statistical analysis section.
Clarifies the statistical methods for readers.
12.
LOWcopyedit
Use consistent decimal places for standard deviations in Table 2 (e.g., change '32.0 (3.19)' to '32.0 (3.2)').
Consistent formatting in tables improves clarity.

Full text (62,842 chars)Analyzed: Aug 15, 2026

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Read alongside

Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).

Sujan MJ, Skarstad HM, Rosvold G, Fougner SL, Follestad T, Salvesen KÅ, Moholdt T

Read full text (PMC)

DOI

10.1136/bmj-2024-083398

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Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
StatisticsPrinted percentage does not match its own count (capped)−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 12 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues

01Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
86% does not match the reported count 146/166
“146/166 participants (86%)”
DiscussionFind in source

Findings by category

201ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit7 minor suggestions

Numerical inconsistencies

2 findings · worst medium

Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks. 1 printed percentage that does not match its own count.

Overstated conclusions

None found

Checked — nothing surfaced.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

Introduction ¶2Find in source

“However, evidence on the specific components of prepregnancy interventions and their effectiveness remains scarce.”

Introduction ¶4Find in source

IntroductionFind in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise, citing prior research on GDM risk factors, lifestyle interventions, and the rationale for a prepregnancy intervention.

Evidence

Introduction ¶2Find in source

IntroductionFind in source

Introduction ¶3Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial uses a robust randomised design with adequate randomisation, blinding rationale, sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Neither participants nor study personnel were masked.”

MethodsFind in source

PASSReviewer 2· 95% conf

Evidence

MethodsFind in source

“Neither participants nor study personnel were masked.”

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper reports sex (all female), age, weight, BMI, and other relevant characteristics; demographics are well described.

Evidence

“Age, years | 30.3 (3.2) | 30.2 (3.1) | | Weight, kg | 81.5 (13.2) | 81.1 (16) | | Body mass index | 29.1 (4.5) | 29.2 (4.9)”

Table 1Find in source

PASSReviewer 2· 90% conf

Evidence

“Age, years | 30.3 (3.2) | 30.2 (3.1) | | Weight, kg | 81.5 (13.2) | 81.1 (16) | | Body mass index | 29.1 (4.5) | 29.2 (4.9)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentINADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study has a named ethics approval and a data availability statement; informed consent is implied but not explicitly described.

Evidence

“The Regional Committees for Medical and Health Research Ethics in Norway approved the study (REK 143756).”

EthicsFind in source

absence[Ethics statements]

Informed consent is not explicitly described.

PASSReviewer 2· 95% conf

Evidence

“The Regional Committees for Medical and Health Research Ethics in Norway approved the study (REK 143756).”

EthicsFind in source

absence[Ethics statements]

Informed consent is not explicitly described.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (lifestyle intervention) is described in detail, and the software used for analysis is identified.

Evidence

“participants consumed a premade drink of 75 g glucose diluted in 250 mL water (Glucosepro, Finnamedical, Finland)”

MethodsFind in source

“Statistical analyses were performed using IBM SPSS Statistics 29.0 and STATA MP version 18.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

Evidence

MethodsFind in source

“Statistical analyses were performed using IBM SPSS Statistics 29.0 and STATA MP version 18.”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well described, with exact p-values and confidence intervals reported; assumptions are checked.

Evidence

Statistical analysisFind in source

“mean difference 0.48 mmol/L, 95% confidence interval −0.05 to 1.01, P=0.08”

ResultsFind in source

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Evidence

Statistical analysisFind in source

“mean difference 0.48 mmol/L, 95% confidence interval −0.05 to 1.01, P=0.08”

ResultsFind in source

“0.48 (−0.05 to 1.01) | 0.08”

Table 2Find in source

Sub-criteria

code sharingADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are openly available on Zenodo with a DOI, and the data availability statement is concrete.

Evidence

paraphrase[Data availability statement]

PASSReviewer 2· 95% conf

Data and code are openly available on Zenodo with a DOI. The data availability statement is concrete and adequate.

Evidence

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedINADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“Trial registration ClinicalTrials.gov NCT04585581”

AbstractFind in source

“Most participants were well educated, potentially resulting in healthy volunteer bias as they were likely knowledgeable about their health and wellbeing.”

LimitationsFind in source

FundingFind in source

PASSReviewer 2· 90% conf

Evidence

“Trial registration ClinicalTrials.gov NCT04585581 (https://clinicaltrials.gov/ct2/show/NCT04585581)”

AbstractFind in source

“Most participants were well educated, potentially resulting in healthy volunteer bias as they were likely knowledgeable about their health and wellbeing.”

LimitationsFind in source

FundingFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 65 references by DOI: 62 verified — 3 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

7 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 7 minor suggestions below.

7 copyedit issues flagged: mostly consistency, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHethics
Add an explicit statement in the Ethics statements section describing how informed consent was obtained (e.g., written informed consent from all participants) or provide a waiver justification.
Informed consent is a required element for human research; its absence is a reporting gap that both reviewers flagged and that an informed reader would expect to see.
2.
HIGHreporting
Correct the arithmetic inconsistency in the Discussion: 146/166 is 88%, not 86%.
An incorrect percentage is a factual error that could mislead readers and warrants a correction.
3.
MEDIUMreporting
Add an explicit statement of adherence to the CONSORT reporting guideline in the Methods or a dedicated section, and indicate where the checklist is available.
Explicitly naming the reporting guideline improves transparency and is expected for RCT reports.
4.
MEDIUMreporting
Clarify in the Results or Discussion that some pre-specified secondary outcomes are deferred to separate publications, and consider providing a summary of all outcomes in the supplementary material.
Readers should know which outcomes are reported here and where to find the rest, to avoid selective reporting concerns.
5.
MEDIUMstatistics
In the Discussion, explicitly address the potential for type II error due to the reduced sample size (167 vs. planned 260) and its impact on the null result.
The trial was underpowered relative to the original plan; acknowledging this helps readers interpret the null findings appropriately.
6.
MEDIUMreporting
Add a note on the generalizability of the findings given the predominantly white, well-educated sample.
The sample is not representative of all at-risk populations; this limitation should be explicitly stated.
7.
MEDIUMdata code
Specify the license and any access conditions for the Zenodo data and code repository.
Clear licensing terms are important for reuse and reproducibility.
8.
LOWcopyedit
Clarify the abstract sentence about adherence: '31/83 participants (37%) in the intervention group adhered to prespecified criteria, whereas 24/55 participants (44%) in the intervention group who became pregnant fulfilled these criteria.'
The sentence is confusing because it is unclear that the first number refers to all intervention participants and the second to those who became pregnant.
9.
LOWcopyedit
Use consistent hyphenation in 'bias-corrected and accelerated' in the Methods, Statistical analysis section.
Minor typographical consistency improves readability.
10.
LOWcopyedit
Rephrase the sentence in Results, Participants: 'We ended inclusion of new participants when 47 participants in each group reached gestational week 12' to 'We stopped recruiting when 47 participants in each group had reached gestational week 12.'
The original phrasing is understandable but could be clearer.
11.
LOWcopyedit
Specify which residuals (e.g., from the linear mixed models) were checked for normality in the Methods, Statistical analysis section.
Clarifies the statistical methods for readers.
12.
LOWcopyedit
Use consistent decimal places for standard deviations in Table 2 (e.g., change '32.0 (3.19)' to '32.0 (3.2)').
Consistent formatting in tables improves clarity.

Full text (62,842 chars)Analyzed: Aug 15, 2026