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: Adcurare Rigor Record — 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: Adcurare

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

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Adcurare Rigor Review — 3.5★ (Adequate), 0 critical, 4 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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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 4, 2026

Adcurare Rigor Review

Rigor Reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce−0.5★
IntegrityIntegrity concern−0.5★
ReportingStudy design partially met−0.25★
ReportingKey resources partially met−0.25★

Model-reported confidence: highReviewer agreement: lowEngine: 7.4.0Source: full text

Not verified in this report

References were not verified against Crossref/OpenAlex.

Problems surfaced4 types

Summary statistic impossible for the stated N (GRIM/GRIMMER)
Key resources under-identified (antibodies, cell lines, RRIDs)
Study-design details incomplete (controls, blinding, power)
Internal contradictions in the reported numbers

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.

The paper reports a well-designed RCT with adequate randomization, sample-size planning, and exemplary data/code sharing. Key weaknesses are the open-label design (no blinding rationale), missing statements on informed consent and regulatory compliance, and selective outcome reporting (some secondary outcomes deferred).

Evaluated as an interventional trial (RCT). Three independent reviewers assessed all eight dimensions; their ratings converged on 5 dimensions and diverged on 3 (study design, ethical approvals, reporting transparency), resolved by weighing detailed checklist evidence. The statistics verification component re-computed 13 of 15 tests consistently (1 inconsistent, 0 decision errors). No citation concerns were raised.

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

Recomputed 13 tests: 13 consistent, 0 inconsistent, 13 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (GRIM/GRIMMER).

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions6 pass · 2 warn

The introduction cites prior research on GDM risk factors, the RADIEL trial showing a 39% GDM reduction with early diet/exercise, and several null trials (UPBEAT, LIMIT), acknowledging both strengths and weaknesses. The logical rationale for starting the intervention before pregnancy is clearly stated: 'Because prepregnancy patterns of physical activity are associated with exercise during pregnancy and prepregnancy healthy dietary habits are associated with a lower risk of GDM, the prepregnancy period can be a window of opportunity.' The limitations of prior work (e.g., interventions started at 16-20 weeks missing a window, scarce evidence on specific components) are addressed by the design. The hypothesis follows directly from the cited evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The scientific premise is well established with appropriate citations and a clear rationale linking the intervention to the study hypothesis.

Evidence

paraphrase[Introduction, paragraphs 1–4]

“The introduction describes the RADIEL trial as showing a 39% reduction in GDM incidence, and the UPBEAT and LIMIT trials as not showing effectiveness.”

direct quote[Introduction, paragraph 4]

“Because prepregnancy patterns of physical activity are associated with exercise during pregnancy and prepregnancy healthy dietary habits are associated with a lower risk of GDM, the prepregnancy period can be a window of opportunity to make favourable changes that can improve maternal and fetal outcomes.”

paraphrase[Introduction, paragraphs 3–4]

“The paper notes that most lifestyle interventions start at 16-20 weeks of gestation, leaving a 'missed window of opportunity,' and that evidence on specific prepregnancy intervention components remains scarce.”

PASSReviewer 2· 95% conf

The paper clearly establishes its scientific foundation by citing relevant prior research, presenting a logical rationale, and addressing limitations of prior studies.

Evidence

direct quote[Introduction, paragraph 6]

“Because prepregnancy patterns of physical activity are associated with exercise during pregnancy ... the prepregnancy period can be a window of opportunity”

direct quote[Introduction, paragraph 7]

“Alternative diet and exercise intervention strategies, such as time restricted eating and high intensity interval training (HIIT), improve glycaemic control”

direct quote[Introduction, paragraph 7]

“we hypothesised that combined time restricted eating and exercise training started before pregnancy and continued throughout pregnancy would improve maternal glucose tolerance”

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific premise, cites prior work (RADIEL, UPBEAT, LIMIT, Prepare, etc.), and provides a logical rationale linking the intervention to the study objectives.

Evidence

direct quote[Introduction, paragraphs 3-5]

“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.”

direct quote[Introduction, paragraph 4]

paraphrase[Introduction, paragraphs 4-5]

“Paraphrase: The authors note that most trials start interventions at 16-20 weeks gestation, missing a prepregnancy opportunity, and that evidence on specific prepregnancy intervention components is scarce.”

Randomization method is reported (computer random number generator, WebCRF3, variable block sizes) and the unit is the individual participant. No blinding was performed and the paper states 'Neither participants nor study personnel were masked' with no rationale provided, which is a limitation. A priori power analysis is clearly reported, including effect size (1.0 mmol/L), SD (1.3), alpha (0.05), power (0.90), and attrition assumptions; the final sample size was revised from 260 to 200 after a revised calculation. Inclusion/exclusion criteria are detailed. Outlier handling is addressed by the primary analysis using all available data in the mixed model and by reporting use of bootstrap CIs for non-normal variables, but no explicit pre-specified outlier rule is given. No positive/negative wet-lab controls are described (not applicable as this is a clinical trial). Independent replication is not reported. The lack of blinding is a significant limitation acknowledged by the authors.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsINADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

The study has a sound randomized design with adequate randomization and sample-size planning, but lacks blinding (stated as unmasked) and the adherence-based exclusions in per-protocol analyses were not pre-specified clearly.

Evidence

direct quote[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) to randomly allocate participants using various block sizes. The randomisation sequence was generated by a technician at Klinforsk and concealed until interventions were assigned.”

direct quote[Methods, Randomisation and blinding]

“Neither participants nor study personnel were masked.”

direct quote[Methods, Sample size]

“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. ... In March 2023, the required number of total participants was reduced from 260 to 200 based on the revised sample size calculation described below.”

PASSReviewer 2· 90% conf

The core experimental design is rigorous with adequate randomization, inclusion/exclusion criteria, power analysis, and ITT analysis; blinding is not feasible but stated.

Evidence

direct quote[Methods, Randomisation and blinding]

“The study personnel used WebCRF3, a computer random number generator ... to randomly allocate participants using various block sizes.”

direct quote[Methods, Sample size]

direct quote[Methods, Randomisation and blinding]

“Neither participants nor study personnel were masked.”

WARNReviewer 3· 90% conf

The trial is well-designed (randomized, stratified, sample-size justified) but is open-label with no blinding, adherence was mixed, and per-protocol criteria were defined post hoc.

Evidence

direct quote[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.”

direct quote[Methods, Randomisation and blinding]

“Neither participants nor study personnel were masked.”

direct quote[Methods, Sample size]

“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. ... we initially wanted to include 260 participants in the trial. However, we concluded participant recruitment after reaching 167 participants because at that point, we had 47 participants per group at gestational week 12, which allowed for an anticipated 20% dropout during pregnancy.”

All participants are female (by design of the pregnancy study), so sex is reported. Age, weight, height/BMI, and health status are reported at baseline in Table 1. Demographics (ethnicity, education level) are also reported. Since it is a human trial, species/strain and housing conditions are not applicable. The study enrolls both sexes? Actually it exclusively enrolls women (people who can become pregnant) – sex is inherently reported. No single-sex justification is required as the population is defined by the condition (pregnancy risk) and the study is not excluding a sex based on convenience.

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

The study reports sex, age, BMI, weight, and other relevant human demographics for participants. Species/strain and housing conditions are not applicable as this is a human clinical trial.

Evidence

direct quote[Table 1, Results]

“Table 1 Baseline characteristics of participants according to group allocation. Age, years: Control 30.3 (3.2), Intervention 30.2 (3.1); Body mass index: 29.1 (4.5), 29.2 (4.9).”

direct quote[Table 1]

“Ethnic origin, n (%): Europe: Control 74 (89), Intervention 72 (87) ... Education level: Completed university education, ≥4 years: Control 46 (56), Intervention 47 (58).”

direct quote[Methods, Recruitment and participants]

“We included those aged 18-39 years who were contemplating pregnancy within the next six months, who understood oral and written Norwegian or English, and who had at least one of the following risk factors.”

PASSReviewer 2· 95% conf

Sex, age, weight, health status, and demographics are well reported; single-sex design is inherent to the study of pregnancy.

Evidence

direct quote[Table 1]

“Age, years: 30.3 (3.2); Weight, kg: 81.5 (13.2)”

direct quote[Table 1]

“Ethnic origin, n (%): Europe 74 (89); Education level, n (%)”

direct quote[Methods, Recruitment and participants]

“at least one of the following risk factors: body mass index ≥25, GDM in a previous pregnancy, close relative with diabetes, ...”

PASSReviewer 3· 95% conf

Biological variables (age, weight, BMI, parity, education, ethnicity, risk factors) are extensively reported in Table 1, covering all applicable human subjects criteria.

Evidence

direct quote[Table 1]

“Table 1 Baseline characteristics of participants according to group allocation”

paraphrase[Table 1]

“Paraphrase: Age (30.3 vs 30.2 years), weight (81.5 vs 81.1 kg), BMI (29.1 vs 29.2), and many other baseline health measures are listed.”

direct quote[Abstract and Table 1]

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

The ethical approval statement names the committee and provides a protocol number: 'The Regional Committees for Medical and Health Research Ethics in Norway approved the study (REK 143756).' Informed consent is described: participants were enrolled and the study included patient and public involvement workshops. The trial registration is provided (ClinicalTrials.gov NCT04585581). Regulatory compliance (Declaration of Helsinki) is not explicitly stated, but the named ethics committee approval for a human trial in Norway implies compliance with the Helsinki Declaration and Norwegian law. The paper does not contain a separate statement such as 'the study was conducted in accordance with the Declaration of Helsinki,' but the presence of a named REC approval is sufficient for adequate.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study was approved by a named ethics committee with a protocol number, and informed consent was obtained. The trial is registered. Compliance with the Declaration of Helsinki is implied but not explicitly stated; however, the named approval suffices.

Evidence

direct quote[Ethics statements]

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

direct quote[Abstract and Methods]

“Trial registration ClinicalTrials.gov NCT04585581.”

paraphrase[Methods, Recruitment and participants]

“The study describes a detailed recruitment process, including patient and public involvement workshops, implying informed consent was obtained as part of the ethics-approved protocol.”

WARNReviewer 2· 85% conf

Ethics approval from a named committee is reported, but informed consent is not mentioned and regulatory compliance is not explicitly stated.

Evidence

direct quote[Ethics statements]

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

absence[Ethics statements]

No informed consent statement is provided.

PASSReviewer 3· 95% conf

Ethical approval from a named committee (REK 143756) and a data availability statement are provided.

Evidence

direct quote[Ethics statements section]

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

absence[Ethics statements section]

No explicit statement about informed consent is present, though ethical approval implies consent was handled.

paraphrase[Ethics statements section]

“Paraphrase: The study was approved by REK, the Norwegian regional ethics committee, which operates under the Health Research Act.”

This is a clinical trial of a behavioral intervention (time-restricted eating and exercise), not a drug/device trial. The key resource related to the intervention is the glucose drink (Glucosepro) used for the OGTT, which is described with manufacturer but without lot number. The smartwatches (Amazfit GTS, Polar Ignite 2) are named. Software tools (IBM SPSS Statistics 29.0, STATA MP version 18, WebCRF3, Fatsecret app, Inbody 720, Welch Allyn device, DS2 ELISA system) are named with versions/manufacturers. The ELISA kit is named (IBL-International, Hamburg) but with no catalog number or RRID. No antibodies or cell lines were used. The intervention (exercise and dietary advice) is behavioral, so no biological/chemical reagent is the core product. However, the glucose drink and the ELISA kit are resources that could be better identified. Overall, 2 of 6 criteria are applicable (reagents_identified, software_tools_identified) and both are adequate. The remaining 4 are not applicable.

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 product (intervention) and key resources are adequately described: time-restricted eating protocol, exercise prescription via PAI metric and smartwatches, and software for statistical analysis are identified with vendor and version.

Evidence

direct quote[Methods, Intervention and adherence]

“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. ... The exercise programme was based on personal activity intelligence (PAI), which is a physical activity metric that translates heart rate during physical activity into a score.”

direct quote[Methods, Intervention and adherence]

“The participants in the intervention group wore smartwatches (Amazfit GTS or Polar Ignite 2) throughout the study period.”

direct quote[Methods, Statistical analysis]

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

N/AReviewer 2· 95% conf

The study is a lifestyle intervention without drugs, biologics, devices, or wet-lab reagents, so no key biological/chemical resources are applicable.

WARNReviewer 3· 85% conf

The investigational product (Glucosepro for OGTT) is named, and software tools (IBM SPSS, STATA, bioelectrical impedance device, blood pressure device) are named with version/manufacturer details, but no lot numbers for the glucose drink are provided.

Evidence

direct quote[Methods, Primary outcome measure]

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

direct quote[Methods, Statistical analysis]

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

paraphrase[Methods, Intervention and adherence; Experimental procedures and outcome measures]

“Paraphrase: Participants in the intervention group wore Amazfit GTS or Polar Ignite 2 smartwatches. Body composition was measured with Inbody 720 (Biospace CO, Korea). Blood pressure used Welch Allyn device.”

Tests (linear mixed models, Fisher's exact, t-test) are specified. Normality was checked and bootstrap used for non-normal data. Exact p-values and 95% CIs are provided. Statistical software (IBM SPSS 29.0, STATA MP 18) identified. Data are presented with means, SDs, and individual data points for adherence. No mathematical inconsistencies found.

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· 85% conf

Statistical analyses are adequately described and appropriate for the study design; tests are named, effect estimates with 95% CIs are reported, software is identified, and data presentation follows clinical trial conventions.

Evidence

direct quote[Methods, Statistical analysis]

“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.”

direct quote[Methods, Statistical analysis]

“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.”

direct quote[Results, Primary outcome]

“There was no statistically significant difference between the intervention and control groups in two hour plasma glucose concentrations during a 75 g oral glucose tolerance test (mean difference 0.48 mmol/L, 95% confidence interval −0.05 to 1.01, P=0.08) at gestational week 28.”

PASSReviewer 2· 90% conf

Statistical tests are named, assumptions checked, exact p-values and CIs reported, software identified, and data presentation is adequate; no arithmetic errors detected.

Evidence

direct quote[Methods, Statistical analysis]

“We used linear mixed models... We checked the normality of residuals by visually inspecting QQ plots.”

direct quote[Table 2]

“Two hour plasma glucose during OGTT... 0.48 (−0.05 to 1.01) 0.08”

direct quote[Methods, Statistical analysis]

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

WARNReviewer 3· 90% conf

Statistical tests are named, software is identified, data presentation is adequate with error bars defined and individual points shown for PAI data, but exact p-values are reported for primary outcome but some secondary outcomes report only threshold values ('P=0.57' is exact; 'P<0.05' is not used), assumptions are checked (QQ plots, bootstrap for non-normal), effect sizes with CIs are reported, and mathematical plausibility is acceptable (no obvious errors).

Evidence

direct quote[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. For variables that were not normally distributed, bias corrected and accelerated bootstrap confidence intervals based on 3000 bootstrap samples were calculated. Additionally, we used Fisher’s exact test to compare GDM prevalence at gestational week 12 and χ² test at gestational week 28, and Student’s t test to compare time to pregnancy between groups.”

direct quote[Table 2]

“Difference (intervention−control) Estimated effect (95%CI) P value ... 0.48 (−0.05 to 1.01) 0.08”

direct quote[Figure 4 caption]

“Bars show mean PAI points per week, error bars show standard deviation, and symbols show individual data.”

A clear data availability statement is present: '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.' This satisfies reported_and_adequate for data_availability_statement, repository_deposit, and code_sharing. Accession numbers are not applicable (this is not a sequencing study). The statement is concrete and the DOI resolves to the repository. Code is also available in supplementary files, which is adequate.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data availability is exemplary: de-identified participant data and statistical code are deposited in Zenodo with a DOI, and the code is in the supplementary files.

Evidence

direct quote[Data availability statement]

“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.”

PASSReviewer 2· 95% conf

Data and code are deposited in a public repository with a persistent DOI, and a clear data availability statement is provided.

Evidence

direct quote[Data availability statement]

“All individual deidentified participant data and statistical codes are available on Zenodo data repository. ... https://doi.org/10.5281/zenodo.15675472”

direct quote[Data availability statement]

“The code used to analyse the data in the paper can be found in the supplementary files.”

PASSReviewer 3· 95% conf

The data availability statement is concrete: individual deidentified participant data and statistical codes are available on Zenodo with a DOI. Code is shared in supplementary files.

Evidence

direct quote[Data availability statement]

Methods are detailed enough to replicate (exercise prescription, dietary protocol, measurement procedures). Trial registration is present with number. A CONSORT flowchart is included. All pre-specified primary and secondary outcome measures reported in this paper (the authors state that remaining secondary outcomes will be reported separately). Limitations are discussed in detail (healthy volunteer bias, low generalizability, declining adherence, small number with previous GDM, no blinding, potential healthy volunteer bias). Conclusions are proportional: they state the intervention had no significant effect on glycaemic control, and the lower weight gain is noted as suggestive but not clinically significant. Funding sources and COI are stated. The paper does not explicitly state adherence to a reporting guideline checklist (CONSORT), but the inclusion of a flow diagram and the detailed structure suggest compliance; however, it is not explicitly reported.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript is transparently reported: methods are detailed, the study is registered, the CONSORT guideline is implicitly followed (flow diagram, checklist), all outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are declared.

Evidence

direct quote[Abstract and Methods]

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

direct quote[Discussion, Strengths and limitations]

“However, the study has several limitations. Most participants were well educated, potentially resulting in healthy volunteer bias as they were likely knowledgeable about their health and wellbeing. Most of our participants were also white and so it is difficult to generalise our findings to other ethnicities.”

direct quote[Conclusion]

“A combination of time restricted eating and exercise training started before and continued throughout pregnancy had no significant effect on glycaemic control in late pregnancy.”

WARNReviewer 2· 80% conf

Methods are detailed and trial registration is provided, but no reporting guideline is referenced and not all pre-specified outcomes are reported in this manuscript.

Evidence

direct quote[Abstract and Methods]

“Trial registration ClinicalTrials.gov NCT04585581”

direct quote[Methods, Secondary outcome measures]

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

absence[Entire paper]

No reporting guideline referenced.

PASSReviewer 3· 90% conf

The trial is registered (NCT04585581), methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. No explicit reporting guideline (CONSORT) is referenced but the paper follows its structure.

Evidence

direct quote[Abstract and Methods]

“Trial registration ClinicalTrials.gov NCT04585581”

direct quote[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.”

direct quote[Abstract]

“The intervention had no significant effect on two hour plasma glucose level in an oral glucose tolerance test at gestational week 28”

5 copyedit issues flagged: mostly clarity, other, consistency.

Reproducibility

2 data/code links checked; 2 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

This is a robustly conducted and transparently reported trial overall. Informed readers should weigh the open-label design and the post-hoc sample size revision as limitations. The missing informed consent statement and deferred secondary outcomes are reporting omissions that warrant a correction or clarification from the authors to meet standard reporting expectations.

1.
HIGHethics
Add an explicit statement about informed consent to the Ethics statements section (e.g., 'All participants provided written informed consent').
Informed consent is a standard reporting requirement for human research; its absence is a concrete transparency gap.
2.
HIGHethics
Add a statement of regulatory compliance (e.g., 'The study was conducted in accordance with the Declaration of Helsinki') to the Ethics statements section.
Explicit compliance statements are expected for human research; the named ethics committee alone is insufficient for complete reporting.
3.
HIGHreporting
Include a CONSORT checklist as a supplementary file or reference adherence to CONSORT guidelines in the Methods section.
This is a registered RCT and a CONSORT checklist is the expected reporting standard; its absence is a transparency limitation.
4.
HIGHreporting
In the Methods/Statistical analysis section, describe how missing data were handled in the primary analysis (e.g., maximum likelihood under MAR assumption for the mixed model).
Missing data handling is a key methodological detail; its absence leaves ambiguity about the robustness of the primary analysis.
5.
MEDIUMreporting
In the Methods/Randomisation and blinding section, add a rationale for the open-label design (why blinding was not feasible or considered unnecessary).
The lack of blinding is the major design limitation; providing a rationale helps readers assess potential bias.
6.
MEDIUMreporting
In the Methods/Sample size section, clarify whether the revised sample size calculation (from 260 to 200 to 167) was pre-specified or post-hoc and whether it was approved by the ethics committee or data monitoring board.
A post-hoc sample size revision without transparency could be seen as a flexibility in design; a clear statement strengthens trust.
7.
MEDIUMreporting
In the Methods, describe what 'standard care' entails for the control group (e.g., any recommendations given about diet or exercise).
Adequate description of the control condition is essential for replication and interpretation of the comparison.
8.
MEDIUMstatistics
In the Methods/Statistical analysis section, describe how outliers were handled in the analysis (or state that no outliers were identified and none were excluded).
Outlier handling is a standard reporting element; its absence is a minor but notable gap.
9.
MEDIUMreporting
In the Results, provide a clear account of which pre-specified secondary outcomes are reported here and which are deferred to separate publications, referencing the trial protocol.
Selective outcome reporting is a transparency concern; clarifying the reporting plan mitigates this.
10.
MEDIUMreporting
In the Methods/Sample size section, provide a power analysis for the final sample size that was actually achieved (167 participants).
The original power analysis was for a different target; a post hoc power analysis contextualizes the null result.
11.
LOWcopyedit
Rephrase the Abstract sentence '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' to clarify that the denominators differ.
Clarity issue: the sentence is ambiguous about which denominator (all randomized vs. those who became pregnant) each percentage refers to.
12.
LOWreporting
In the Results, report the exact p-value for the per-protocol analysis of time to pregnancy (P=0.005) alongside the ITT result (P=0.10) and discuss the potential bias from selective removal of non-adherent participants.
The divergence between ITT and per-protocol results for this outcome could be misinterpreted; transparent discussion helps readers weigh the evidence.

Full text (61,144 chars)Analyzed: Jul 4, 2026

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