Overweight and obesity impacts approximately 50% of pregnant women. Professional medical colleges worldwide recommend women with a higher body mass index (BMI) lose weight before conception. While diet and lifestyle interventions before pregnancy are associated with improvements in diet and modest weight loss, subsequent clinical pregnancy outcomes are poorly reported.

Our aim is to conduct a randomised controlled trial of a comprehensive lifestyle intervention for women with overweight or obesity who are planning pregnancy. We will evaluate the impact of this intervention on maternal health and well-being prior to conception; and pregnancy, birth and newborn health outcomes in a subsequent pregnancy.

Women with a BMI ≥25.0 kg/m² who plan to conceive within 2 years will be recruited.

Women randomised to the ‘Educational Control Group’ will attend a pre-conception health consultation with a research midwife, providing limited information about obesity and associated risks in pregnancy, nutrition, exercise and weight management.

Women randomised to the ‘Pre-pregnancy Lifestyle Intervention Group’ will attend a pre-conception health consultation with a research midwife, as above, and additionally consult with a research dietitian and trained health coaches throughout the 6-month intervention period. Women will also have access to a specifically designed mHealth application providing tailored content and interactive tasks delivered bi-weekly during this time.

Secondary outcomes will include a range of maternal pre-conception health outcomes; maternal and infant pregnancy and birth outcomes; diet and physical activity changes; and quality of life.

We estimate a mean birth weight z-score of 0.43 (SD 1.09) and will recruit 800 women to detect 0.4 SD difference (alpha 0.05 (two-tailed); power 80%). Analyses will be intention to treat with estimates reported as relative risks and 95% CIs.

The study protocol was approved by the Human Research and Ethics Committee of the Women’s and Children’s Hospital, Adelaide, South Australia (HREC/17/WCHN/177; 2020/HRE01445) on 17 August 2018. The first participant was recruited in June 2021, with recruitment anticipated through 2025. The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders.

ACTRN 12621000128897. This study has been registered at (https://www.anzctr.org.au/).

In 2022, the WHO conditionally recommended the use of treatment decision algorithms (TDAs) for treatment decision-making in children

Within the Decide-TB project (PACT ID: PACTR202407866544155, 23 July 2024), we aim to generate an individual-participant dataset (IPD) from prospective TB diagnostic accuracy cohorts (RaPaed-TB, UMOYA and two cohorts from TB-Speed). Using the IPD, we aim to: (1) assess the diagnostic accuracy of published TDAs using a set of consensus case definitions produced by the National Institute of Health as reference standard (confirmed and unconfirmed vs unlikely TB); (2) evaluate the added value of novel tools (including biomarkers and artificial intelligence-interpreted radiology) in the existing TDAs; (3) generate an artificial population, modelling the target population of children eligible for WHO-endorsed TDAs presenting at primary and secondary healthcare levels and assess the diagnostic accuracy of published TDAs and (4) identify clinical predictors of radiological disease severity in children from the study population of children with presumptive TB.

This study will externally validate the first data-driven WHO TDAs in a large, well-characterised and diverse paediatric IPD derived from four large paediatric cohorts of children investigated for TB. The study has received ethical clearance for sharing secondary deidentified data from the ethics committees of the parent studies (RaPaed-TB, UMOYA and TB Speed) and as the aims of this study were part of the parent studies’ protocols, a separate approval was not necessary. Study findings will be published in peer-reviewed journals and disseminated at local, regional and international scientific meetings and conferences. This database will serve as a catalyst for the assessment of the inclusion of novel tools and the generation of an artificial population to simulate the impact of novel diagnostic pathways for TB in children at lower levels of healthcare. TDAs have the potential to close the diagnostic gap in childhood TB. Further finetuning of the currently available algorithms will facilitate this and improve access to care.

If clinical trials measure and report the outcomes included in core outcome sets (COS) for a given condition/disease as a minimum, this has the potential to improve comparability between trials and prevent research waste. Until now, the uptake of the Bronchiectasis and Hidradenitis Suppurativa (HS) COS has not been assessed.

This study assessed the uptake of Bronchiectasis and HS COS using a review of trial registries, with entries taken from ClinicalTrials.gov and the WHO International Clinical Trial Registry Platform. This uptake assessment provides valuable information to inform COS refinement and uncover areas lacking uptake to inform further dissemination requirements.

For each trial, the outcomes included in the trial registry entry were extracted and compared with those included in the corresponding Bronchiectasis or HS COS. The Bronchiectasis COS consists of 18 outcomes, and the HS COS, 6.

Of the trials registered after both COS were developed in 2018, 63% (12/19) of HS trials planned to measure the full COS, whereas for Bronchiectasis, 0% (0/24) of trials planned to measure the full COS. However, of the five priority outcomes to be measured for Bronchiectasis, 4% (1/24) of trials planned to measure all five outcomes.

Both COS publications’ focus was to reach consensus on what outcomes should be measured. Despite both publications referring to the Core outcome Measures for Effectiveness Trials (COMET) Handbook, which discusses the importance of COS dissemination, implementation plans were not included in either publication.

The results suggest that uptake of the HS COS is relatively good, despite yearly fluctuations, whereas for Bronchiectasis, COS uptake is limited. Further research into standardised measurement tools for HS is expected to increase uptake. The focus for Bronchiectasis, however, will be to refine the COS for feasible application in clinical trials. Future COS development publications should use all resources from the COMET initiative to ensure feasible dissemination of the COS.