A preconception lifestyle intervention in women with obesity and cardiovascular health in their children

Harink, Tamara den; Schuppen, Joost van; Marciniak, Maciej; Voet, Karen A; Planken, R. Nils; Hoek, Annemieke; Groen, Henk; Gemke, Reinoud J. B. J.; Mol, Ben Willem J.; Blom, Nico A.; Lamata, Pablo; Roseboom, Tessa J.; Deutekom, Arend W van

doi:10.1038/s41390-022-02443-8

“…Of the eight studies published between 2015-2023 [14,15,[30][31][32][33][34][35], three were follow-up reports from the Lifestyle study [16,17,[31][32][33], two from UPBEAT (UK Pregnancies Better Eating and Activity Trial) [14,18,19,30], one from LiP (Lifestyle in Pregnancy) [22,35], one from ETIP (Exercise Training in Pregnancy) [20,21,34], and one pilot study from ENHANCED (Enhanced Neonatal Health and Neonatal Cardiac Effect Developmentally) [15]. Two RCTs studied 'the effect of antenatal exercise' [15,20], two studied 'the combined effect of antenatal physical activity and diet' [18,22], and one studied 'the combined effect of preconception physical activity and diet' [17].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…One study also randomised women with normal-weight, but separate analyses enabled examination of the effect of the intervention in women with overweight/obesity [15]. The offspring follow-up period varied between studies: two studies were within the first two months of life [15,34] and six were at three-to-seven-years-old [14,[30][31][32][33]35]. There were no studies of adolescent or adult offspring.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Five studies reported data on cardiac structure in 245 offspring [14,15,31,32,34]. RCTs appeared to limit cardiac structural remodelling in the intervention versus non-intervention group (Table 3).…”

Section: Cardiac Structural Remodellingmentioning

confidence: 99%

“…These results persisted after adjustment for child body surface area (BSA), age, and sex. A sub-sample of the echocardiography cohort also had cardiac magnetic resonance imaging (MRI) performed, but there were no differences in standard metrics of cardiac remodelling between groups using this method [32]. However, den Harink et al also undertook statistical shape modelling (SSM) of the cardiac MRI images, which provides novel insights into cardiac remodelling whereby standard metrics cannot.…”

Section: Cardiac Structural Remodellingmentioning

confidence: 99%

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Maternal obesity and offspring cardiovascular remodelling — the effect of preconception and antenatal lifestyle interventions: a systematic review

Burden,

Alshehri,

Lamata

et al. 2024

Int J Obes

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Background Preconception or antenatal lifestyle interventions in women with obesity may prevent adverse cardiovascular outcomes in the child, including cardiac remodelling. We undertook a systematic review of the existing data to examine the impact of randomised controlled trials of lifestyle interventions in pregnant women with obesity on offspring cardiac remodelling and related parameters of cardiovascular health. Methods This review was registered with PROSPERO (CRD42023454762) and aligns with PRISMA guidelines. PubMed, Embase, and previous reviews were systematically searched. Follow-up studies from randomised trials of lifestyle interventions in pregnant women with obesity, which included offspring cardiac remodelling or related cardiovascular parameters as outcome measures, were included based on pre-defined inclusion criteria. Results Eight studies from five randomised controlled trials were included after screening 3252 articles. Interventions included antenatal exercise (n = 2), diet and physical activity (n = 2), and preconception diet and physical activity (n = 1). Children were <2-months to 3–7-years-old, with sample sizes ranging between n = 18–404. Reduced cardiac remodelling, with reduced interventricular septal wall thickness, was consistently reported. Some studies identified improved systolic and diastolic function and a reduced resting heart rate. Risk of bias analyses rated all studies as ‘fair’ (some risk of bias). A high loss-to-follow-up was a common limitation. Conclusion Although there is some evidence to suggest that lifestyle interventions in women with obesity may limit offspring cardiac remodelling, further high-quality longitudinal studies with larger sample sizes are required to confirm these observations and to determine whether these changes persist to adulthood.

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“…'IUI in cervical factor 2007' [12] was the only trial classi ed as low risk, while no trial was classi ed as moderate risk. The TRACT lead developer coauthored 11 publications in the rst month of 2023 alone [13][14][15][16][17][18][19][20][21][22][23], leading us to consider the item "large number of RCTs published in a short time frame by one author/in one institute" to be ful lled in all reviewed trials. A total of 9 trials (56.25%) showed a discrepancy in reported ndings between the published abstract and the nal article [7][8][9][10][24][25][26][27][28].…”

Section: Tract Checklist Evidence Synthesismentioning

confidence: 99%

Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

Al-Inany

¹

2023

Preprint

0

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Randomized controlled trials (RCTs) are considered the gold standard study design in clinical effectiveness research, albeit some RCTs have been found to be fraudulent post-publication. The Trustworthiness in RAndomized Controlled Trials (TRACT) checklist examines RCT integrity through an assessment covering seven domains. While the authors claim that it can identify problematic trials, it has never been validated. A critical appraisal of the checklist highlights major failures in terms of health measurement methodology, including the arbitrary nature of items chosen. We applied the checklist to 16 RCTs coauthored by the checklist developer, and identified potential violations related to retrospective registration, ethical implications, authorship, methodology, implausible timeframes, zero participants to follow-up, implausible baseline characteristics, and excessive inter-group within trial as well as inter-trial similarities. In addition, we identified inconsistencies between the trials’ registration and data in the final published manuscripts. If we uncritically assume that the checklist is valid, then a formal institutional investigation into the trial portfolio its developer is warranted; especially targeting these 16 trials objectively shown to be problematic. The checklist should be considered as neither investigative nor conclusive of potential problems with RCTs until it is further refined and validated.

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Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

Al-Inany

¹

,

AbdelMonem

²

,

Abdelmeguid

³

et al. 2023

Preprint

0

View full text Add to dashboard Cite

Randomized controlled trials (RCTs) are considered the gold standard study design in clinical effectiveness research, albeit some RCTs have been found to be fraudulent post-publication. The Trustworthiness in RAndomized Controlled Trials (TRACT) checklist examines RCT integrity through an assessment covering seven domains. While the authors claim that it can identify problematic trials, it has never been validated. A critical appraisal of the checklist highlights major failures in terms of health measurement methodology, including the arbitrary nature of items chosen. We applied the checklist to 16 RCTs coauthored by the checklist developer, and identified potential violations related to retrospective registration, ethical implications, authorship, methodology, implausible timeframes, zero participants to follow-up, implausible baseline characteristics, and excessive inter-group within trial as well as inter-trial similarities. In addition, we identified inconsistencies between the trials’ registration and data in the final published manuscripts. If we uncritically assume that the checklist is valid, then a formal institutional investigation into the trial portfolio its developer is warranted; especially targeting these 16 trials objectively shown to be problematic. The checklist should be considered as neither investigative nor conclusive of potential problems with RCTs until it is further refined and validated.

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A preconception lifestyle intervention in women with obesity and cardiovascular health in their children

Cited by 6 publications

References 60 publications

Maternal obesity and offspring cardiovascular remodelling — the effect of preconception and antenatal lifestyle interventions: a systematic review

Maternal obesity and offspring cardiovascular remodelling — the effect of preconception and antenatal lifestyle interventions: a systematic review

Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

Could the Trustworthiness in RAndomized Controlled Trials (TRACT) checklist be trusted?

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