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 — 1.75★ (Critical), 0 critical, 6 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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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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86e5056f796ff33644b4fd726419432e311ca0e39d7f954e9fa3c19faf24d4f0

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Issued Aug 10, 2026Engine 7.29.0

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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 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

1.75 / 5

Critical — serious problems across many checks

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×5−2.5★
StatisticsPrinted percentage does not match its own count (capped)−0.25★
ReportingEthical approvals partially met−0.25★
ReportingStatistical analysis partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

References were not verified against Crossref/OpenAlex.

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%)”
Find in source

Findings by category

201ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 06Copyedit6 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.

The paper presents a well-designed RCT with adequate data sharing and reporting of methods, but contains several numerical inconsistencies in the Discussion (incorrect percentages, mismatched counts) and missing ethics details (informed consent, regulatory compliance). These issues are minor individually but collectively warrant a correction or erratum.

Two independent runs of the same model were synthesised; they agreed on most dimensions, diverging mainly on the statistical analysis dimension (one saw a pass, the other a warn due to a numerical error). The copyedit and integrity components confirmed the numerical inconsistencies. The statistics component checked only a subset of reported tests; no claim of overall correctness is made.

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 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks. 1 printed percentage that does not match its own count.

Overstated conclusions

1 finding · worst low

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.

Conclusions only partially backed by the presented evidenceAssessed

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

Data authenticity concerns

1 finding · worst low

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.

Methods and results do not matchAssessed

5 integrity concerns flagged (0 high).

Reporting gaps

2 findings · worst high

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.

Statistical reporting gaps (tests, assumptions, effect sizes)Assessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions5 pass · 2 warn

The introduction cites conflicting prior evidence and highlights the prepregnancy window as an opportunity, directly motivating the trial. The hypothesis is explicitly stated. Limitations of prior work (late intervention start, scarce prepregnancy data) are addressed.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The premise is well established through citation of prior trials (RADIEL, UPBEAT, LIMIT, Prepare) and a clear hypothesis is stated.

Evidence

“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 ¶2Find in source

“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

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

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

The introduction establishes a clear scientific foundation, citing both positive and negative prior trials and deriving a testable hypothesis.

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”

Introduction ¶2Find in source

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

Introduction ¶3Find in source

IntroductionFind in source

Randomisation used a computer random number generator (WebCRF3) with variable block sizes and stratification by prior GDM. The open-label design is explicitly stated. A priori sample size calculation is provided with effect size, SD, power, and alpha. Pre-specified inclusion/exclusion criteria and analysis population (ITT and per-protocol) are described.

Sub-criteria

controlsN/A

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

Randomisation, stratification, blinding status, sample size calculation, and inclusion/exclusion criteria are all adequately reported.

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· 80% conf

Core RCT design elements (randomisation, power calculation, inclusion/exclusion, ITT/per-protocol populations) are well described; the lack of masking is disclosed but no rationale is given.

Evidence

paraphrase[Methods, Randomisation and blinding]

“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.”

“Neither participants nor study personnel were masked.”

MethodsFind in source

All participants are female (pregnancy trial), so sex is effectively reported. Age, weight, BMI, and other health measures are in Table 1. Demographics (ethnicity, education) are also reported. Single-sex justification is inherent to the pregnancy context, so sex_justified is 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· 85% conf

Age, weight, BMI, ethnicity, and education are reported in baseline characteristics; sex is implicit (pregnancy trial).

Evidence

paraphrase[Table 1]

“Age, years | 30.3 (3.2) | 30.2 (3.1) | ... | Body mass index | 29.1 (4.5) | 29.2 (4.9)”

paraphrase[Table 1]

“Ethnic origin, n (%) | Europe | 74 (89) | 72 (87)”

paraphrase[Methods, Recruitment and participants]

“we sent electronic invitations to participate in the trial to all women aged 20-35 years in Trondheim”

PASSReviewer 2· 75% conf

Age, weight, health status and demographics (ethnicity, education, parity) are reported in a detailed baseline table; the single-sex population is inherent to the pregnancy-focused study question.

Evidence

“Age, years | 30.3 (3.2) | 30.2 (3.1) | | Weight, kg | 81.5 (13.2) | 81.1 (16)”

Table 1Find in source

“Ethnic origin, n (%) | | Europe | 74 (89) | 72 (87)”

Table 1Find in source

“We also sent electronic invitations to participate in the trial to all women aged 20-35 years in Trondheim and the surrounding area”

MethodsFind in source

The ethics approval statement names the Regional Committees for Medical and Health Research Ethics in Norway and gives protocol number REK 143756. However, no informed consent is described, and no explicit regulatory compliance statement (e.g., Declaration of Helsinki) is present. These gaps are fixable reporting omissions.

Sub-criteria

iacuc statementN/A

informed consentNOT REPORTED

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

Ethics approval is reported with a named committee and protocol number, but informed consent and regulatory compliance statements are missing.

Evidence

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

EthicsFind in source

absence[Ethics statements]

No informed consent statement is present.

absence[Ethics statements]

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

WARNReviewer 2· 85% conf

A named ethics committee with protocol number is stated, but no informed-consent statement and no named regulatory-compliance framework appear anywhere in the manuscript.

Evidence

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

EthicsFind in source

absence[Ethics statements]

No informed consent statement found

absence[Ethics statements]

No named regulatory-compliance framework stated

The intervention is time-restricted eating and exercise, not a drug or device. The glucose drink and ELISA kits are measurement tools, not investigational products. Per the applicability guide, such trials are not_applicable for this dimension.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedN/A

Per reviewer (2) — the votes behind the verdict

N/AReviewer 1· 80% conf

This is a behavioural/dietary/exercise intervention trial with no drug, biologic, or device as investigational product; measurement reagents are identified but not scored as key resources.

Evidence

“The intervention consisted of exercise training and time restricted eating, started before pregnancy and continued throughout pregnancy.”

AbstractFind in source

N/AReviewer 2· 70% conf

This is a behavioural lifestyle-intervention trial (diet + exercise) with no investigational drug, biologic, device, or bench reagent central to the intervention, so no key biological/chemical resource criterion applies.

Evidence

“The intervention consisted of time restricted eating and exercise training, and spanned from inclusion before pregnancy and throughout pregnancy.”

MethodsFind in source

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

Statistical analysisFind in source

Tests are named (linear mixed models, Fisher's exact, chi-square, t-test), assumptions checked via QQ plots and bootstrap for non-normal residuals, software identified, and effect sizes with 95% CIs given throughout. The primary outcome p-value is consistent with its CI. The only issue is a percentage of 86% for 146/166, which should be 88%, a minor rounding discrepancy.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityWARN

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

Statistical methods are well described and effect sizes with CIs and exact p-values are reported, but a minor percentage rounding error (146/166 reported as 86%) is present.

Evidence

paraphrase[Methods, Statistical analysis]

“We used linear mixed models to estimate differences in primary and secondary continuous outcomes between groups... We checked the normality of residuals by visually inspecting QQ plots.”

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

ResultsFind in source

“146/166 participants (86%) having a body mass index greater than 25”

DiscussionFind in source

PASSReviewer 2· 80% conf

Statistical methods are named, assumptions checked via QQ plots, exact p-values and effect estimates with 95% CIs are reported, and software is identified; reporting follows the clinical-trial idiom appropriately.

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”

Statistical analysisFind 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

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

ResultsFind in source

The data availability statement specifies a public repository (Zenodo) with a DOI, and states that individual deidentified participant data and statistical codes are available. This satisfies all applicable criteria.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are deposited in 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· 90% conf

A concrete data-availability statement with a Zenodo DOI for deidentified participant data and statistical code is provided, satisfying open-science expectations.

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.”

Data availabilityFind in source

“https://doi.org/10.5281/zenodo.15675472”

Data availabilityFind in source

Trial registration is provided (NCT04585581). Methods are detailed. Limitations are discussed in a dedicated section. Funding and COI statements are present. However, no reporting guideline (e.g., CONSORT) is referenced, and the paper states that some secondary outcomes will be reported in separate publications.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedINADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Trial registration, methods, limitations, and funding/COI are well reported; the main gaps are no CONSORT checklist reference and deferral of some secondary outcomes.

Evidence

“Trial registration ClinicalTrials.gov NCT04585581”

AbstractFind in source

“Here we report the main secondary maternal cardiometabolic outcomes and will report the remaining secondary outcomes in separate publications.”

MethodsFind in source

paraphrase[Discussion, Strengths and limitations]

“Most participants were well educated, potentially resulting in healthy volunteer bias... Most of our participants were also white and so it is difficult to generalise our findings to other ethnicities.”

PASSReviewer 2· 75% conf

Methods are detailed, the trial is registered, limitations and funding/COI are thoroughly reported, and conclusions are proportional; however, no reporting guideline (e.g., CONSORT) is referenced and some secondary outcomes are deferred to later publications.

Evidence

paraphrase[Methods, Study design]

“The trial was registered in ClinicalTrials.gov ( NCT04585581 ) on 25 September 2020.”

“Here we report the main secondary maternal cardiometabolic outcomes and will report the remaining secondary outcomes in separate publications.”

MethodsFind in source

paraphrase[Funding / Competing interests]

“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).”

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.

2 data/code links checked; 2 live.

Copyediting

6 minor

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

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly consistency, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

In this post-publication audit, the paper is robust in design and data sharing, but the numerical inconsistencies in the Discussion (incorrect percentages, mismatched counts) and missing informed consent statement are concrete issues that an informed reader should weigh. The authors should consider issuing a correction or erratum for the numerical errors and adding the missing ethics details to the published version if possible.

1.
HIGHstatistics
Correct the percentage in Discussion: '146/166 participants (86%)' to 88% (146/166 = 87.9%).
This is a demonstrable numerical error that could mislead readers.
2.
HIGHstatistics
Correct the statement '148/166 (89%) being white' to match Table 1 Europe sum (146/166 = 88%).
Inconsistent counts between text and table undermine data integrity.
3.
HIGHethics
Add an informed consent statement to the Ethics statements section, detailing how consent was obtained (written/oral) or why it was waived.
Missing informed consent is a reporting gap that could raise ethical concerns.
4.
HIGHethics
Add a regulatory compliance statement (e.g., 'conducted in accordance with the Declaration of Helsinki') to the Ethics statements section.
The absence of a compliance framework is a standard reporting omission.
5.
HIGHstatistics
Reconcile the HOMA2-B control baseline mean/SD between Table 1 (168.2 (59.2)) and Table 2 (167.8 (58.9)) and explain the discrepancy.
Minor numeric differences between tables may indicate data handling issues.
6.
HIGHstatistics
Verify the chi-square test for the week-28 GDM comparison (8/49 vs 6/52, reported P=0.57) and correct if the p-value is inaccurate (recomputed ~0.49).
An inconsistent p-value could affect the interpretation of a secondary outcome.
7.
MEDIUMreporting
Reference the CONSORT reporting checklist in the Methods or a dedicated section.
Adherence to reporting guidelines is expected for RCTs and improves transparency.
8.
MEDIUMreporting
Provide a clear statement of which secondary outcomes are deferred and where they will be reported, with reference to the registered protocol.
Selective outcome reporting is a potential bias; transparency is needed.
9.
MEDIUMother
Add a brief rationale for the open-label design (e.g., infeasibility of masking a lifestyle intervention) to the Methods.
Justifying the lack of blinding helps readers assess potential bias.
10.
LOWcopyedit
Remove the duplicated page/article identifier string from the header/abstract (BMJ template artifact).
Minor formatting artifact that does not affect content but should be cleaned.
11.
LOWcopyedit
Remove the unrelated DOI (10.3390/ijerph18094582) appended after the Zenodo DOI in the Data Availability Statement.
Copy-paste artifact that does not belong in the data availability statement.

Full text (62,842 chars)Analyzed: Aug 10, 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.

Read full text (PMC)

DOI

10.1136/bmj-2024-083398

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Record fingerprint

86e5056f796ff33644b4fd726419432e311ca0e39d7f954e9fa3c19faf24d4f0

Verify via API

Issued Aug 10, 2026Engine 7.29.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

1.75 / 5

Critical — serious problems across many checks

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×5−2.5★
StatisticsPrinted percentage does not match its own count (capped)−0.25★
ReportingEthical approvals partially met−0.25★
ReportingStatistical analysis partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

References were not verified against Crossref/OpenAlex.

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%)”
Find in source

Findings by category

201ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 06Copyedit6 minor suggestions

Numerical inconsistencies

2 findings · worst medium

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

Recomputed 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks. 1 printed percentage that does not match its own count.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

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

Data authenticity concerns

1 finding · worst low

Methods and results do not matchAssessed

5 integrity concerns flagged (0 high).

Reporting gaps

2 findings · worst high

Statistical reporting gaps (tests, assumptions, effect sizes)Assessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions5 pass · 2 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The premise is well established through citation of prior trials (RADIEL, UPBEAT, LIMIT, Prepare) and a clear hypothesis is stated.

Evidence

Introduction ¶2Find in source

IntroductionFind in source

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

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

The introduction establishes a clear scientific foundation, citing both positive and negative prior trials and deriving a testable hypothesis.

Evidence

Introduction ¶2Find in source

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

Introduction ¶3Find in source

IntroductionFind in source

Sub-criteria

controlsN/A

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

Randomisation, stratification, blinding status, sample size calculation, and inclusion/exclusion criteria are all adequately reported.

Evidence

MethodsFind in source

“Neither participants nor study personnel were masked.”

MethodsFind in source

PASSReviewer 2· 80% conf

Core RCT design elements (randomisation, power calculation, inclusion/exclusion, ITT/per-protocol populations) are well described; the lack of masking is disclosed but no rationale is given.

Evidence

paraphrase[Methods, Randomisation and blinding]

“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· 85% conf

Age, weight, BMI, ethnicity, and education are reported in baseline characteristics; sex is implicit (pregnancy trial).

Evidence

paraphrase[Table 1]

“Age, years | 30.3 (3.2) | 30.2 (3.1) | ... | Body mass index | 29.1 (4.5) | 29.2 (4.9)”

paraphrase[Table 1]

“Ethnic origin, n (%) | Europe | 74 (89) | 72 (87)”

paraphrase[Methods, Recruitment and participants]

“we sent electronic invitations to participate in the trial to all women aged 20-35 years in Trondheim”

PASSReviewer 2· 75% conf

Age, weight, health status and demographics (ethnicity, education, parity) are reported in a detailed baseline table; the single-sex population is inherent to the pregnancy-focused study question.

Evidence

“Age, years | 30.3 (3.2) | 30.2 (3.1) | | Weight, kg | 81.5 (13.2) | 81.1 (16)”

Table 1Find in source

“Ethnic origin, n (%) | | Europe | 74 (89) | 72 (87)”

Table 1Find in source

“We also sent electronic invitations to participate in the trial to all women aged 20-35 years in Trondheim and the surrounding area”

MethodsFind in source

Sub-criteria

iacuc statementN/A

informed consentNOT REPORTED

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

Ethics approval is reported with a named committee and protocol number, but informed consent and regulatory compliance statements are missing.

Evidence

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

EthicsFind in source

absence[Ethics statements]

No informed consent statement is present.

absence[Ethics statements]

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

WARNReviewer 2· 85% conf

A named ethics committee with protocol number is stated, but no informed-consent statement and no named regulatory-compliance framework appear anywhere in the manuscript.

Evidence

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

EthicsFind in source

absence[Ethics statements]

No informed consent statement found

absence[Ethics statements]

No named regulatory-compliance framework stated

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedN/A

Per reviewer (2) — the votes behind the verdict

N/AReviewer 1· 80% conf

This is a behavioural/dietary/exercise intervention trial with no drug, biologic, or device as investigational product; measurement reagents are identified but not scored as key resources.

Evidence

“The intervention consisted of exercise training and time restricted eating, started before pregnancy and continued throughout pregnancy.”

AbstractFind in source

N/AReviewer 2· 70% conf

Evidence

“The intervention consisted of time restricted eating and exercise training, and spanned from inclusion before pregnancy and throughout pregnancy.”

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 plausibilityWARN

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

Statistical methods are well described and effect sizes with CIs and exact p-values are reported, but a minor percentage rounding error (146/166 reported as 86%) is present.

Evidence

paraphrase[Methods, Statistical analysis]

“We used linear mixed models to estimate differences in primary and secondary continuous outcomes between groups... We checked the normality of residuals by visually inspecting QQ plots.”

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

ResultsFind in source

“146/166 participants (86%) having a body mass index greater than 25”

DiscussionFind in source

PASSReviewer 2· 80% conf

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”

Statistical analysisFind in source

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

ResultsFind in source

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are deposited in Zenodo with a DOI, and the data availability statement is concrete.

Evidence

paraphrase[Data availability statement]

PASSReviewer 2· 90% conf

A concrete data-availability statement with a Zenodo DOI for deidentified participant data and statistical code is provided, satisfying open-science expectations.

Evidence

Data availabilityFind in source

“https://doi.org/10.5281/zenodo.15675472”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedINADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Trial registration, methods, limitations, and funding/COI are well reported; the main gaps are no CONSORT checklist reference and deferral of some secondary outcomes.

Evidence

“Trial registration ClinicalTrials.gov NCT04585581”

AbstractFind in source

“Here we report the main secondary maternal cardiometabolic outcomes and will report the remaining secondary outcomes in separate publications.”

MethodsFind in source

paraphrase[Discussion, Strengths and limitations]

PASSReviewer 2· 75% conf

Evidence

paraphrase[Methods, Study design]

“The trial was registered in ClinicalTrials.gov ( NCT04585581 ) on 25 September 2020.”

“Here we report the main secondary maternal cardiometabolic outcomes and will report the remaining secondary outcomes in separate publications.”

MethodsFind in source

paraphrase[Funding / Competing interests]

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.

2 data/code links checked; 2 live.

Copyediting

6 minor

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

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly consistency, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHstatistics
Correct the percentage in Discussion: '146/166 participants (86%)' to 88% (146/166 = 87.9%).
This is a demonstrable numerical error that could mislead readers.
2.
HIGHstatistics
Correct the statement '148/166 (89%) being white' to match Table 1 Europe sum (146/166 = 88%).
Inconsistent counts between text and table undermine data integrity.
3.
HIGHethics
Add an informed consent statement to the Ethics statements section, detailing how consent was obtained (written/oral) or why it was waived.
Missing informed consent is a reporting gap that could raise ethical concerns.
4.
HIGHethics
Add a regulatory compliance statement (e.g., 'conducted in accordance with the Declaration of Helsinki') to the Ethics statements section.
The absence of a compliance framework is a standard reporting omission.
5.
HIGHstatistics
Reconcile the HOMA2-B control baseline mean/SD between Table 1 (168.2 (59.2)) and Table 2 (167.8 (58.9)) and explain the discrepancy.
Minor numeric differences between tables may indicate data handling issues.
6.
HIGHstatistics
Verify the chi-square test for the week-28 GDM comparison (8/49 vs 6/52, reported P=0.57) and correct if the p-value is inaccurate (recomputed ~0.49).
An inconsistent p-value could affect the interpretation of a secondary outcome.
7.
MEDIUMreporting
Reference the CONSORT reporting checklist in the Methods or a dedicated section.
Adherence to reporting guidelines is expected for RCTs and improves transparency.
8.
MEDIUMreporting
Provide a clear statement of which secondary outcomes are deferred and where they will be reported, with reference to the registered protocol.
Selective outcome reporting is a potential bias; transparency is needed.
9.
MEDIUMother
Add a brief rationale for the open-label design (e.g., infeasibility of masking a lifestyle intervention) to the Methods.
Justifying the lack of blinding helps readers assess potential bias.
10.
LOWcopyedit
Remove the duplicated page/article identifier string from the header/abstract (BMJ template artifact).
Minor formatting artifact that does not affect content but should be cleaned.
11.
LOWcopyedit
Remove the unrelated DOI (10.3390/ijerph18094582) appended after the Zenodo DOI in the Data Availability Statement.
Copy-paste artifact that does not belong in the data availability statement.

Full text (62,842 chars)Analyzed: Aug 10, 2026