Hartmannsmart3738
Gestational diabetes (GDM) causes various adverse short-term and long-term consequences for the mother and child, and its incidence is increasing globally. So far, the most promising digital health interventions for GDM management have involved healthcare professionals to provide guidance and feedback. The principal aim of this study is to evaluate the effects of comprehensive and real-time self-tracking with eMOM GDM mobile application (app) on glucose levels in women with GDM, and more broadly, on different other maternal and neonatal outcomes.
This randomised controlled trial is carried out in Helsinki metropolitan area. We randomise 200 pregnant women with GDM into the intervention and the control group at gestational week (GW) 24-28 (baseline, BL). The intervention group receives standard antenatal care and the eMOM GDM app, while the control group will receive only standard care. Participants in the intervention group use the eMOM GDM app with continuous glucose metre (CGM) and activity bracelet for 1 week every month until delivery and an electronic 3-day food record every month until delivery. The follow-up visit after intervention takes place 3 months post partum for both groups. Data are collected by laboratory blood tests, clinical measurements, capillary glucose measures, wearable sensors, air displacement plethysmography and digital questionnaires. The primary outcome is fasting plasma glucose change from BL to GW 35-37. Secondary outcomes include, for example, self-tracked capillary fasting and postprandial glucose measures, change in gestational weight gain, change in nutrition quality, change in physical activity, medication use due to GDM, birth weight and fat percentage of the child.
The study has been approved by Ethics Committee of the Helsinki and Uusimaa Hospital District. The results will be presented in peer-reviewed journals and at conferences.
NCT04714762.
NCT04714762.
To determine the agreement between the cardiovascular disease (CVD) risk predictions computed with the WHO non-laboratory-based model and laboratory-based model in a nationally representative sample of Peruvian adults.
Cross-sectional analysis of a national health survey.
Absolute CVD risk was computed with the 2019 WHO laboratory-based and non-laboratory-based models. The risk predictions from both models were compared with Bland-Altman plots, Lin's concordance coefficient correlation (LCCC), and kappa statistics, stratified by sex, age, body mass index categories, smoking and diabetes status.
663 people aged 30-59 years were included in the analysis. Overall, there were no substantial differences between the mean CVD risk computed with the laboratory-based model 2.0% (95% CI 1.8% to 2.2%) and the non-laboratory-based model 2.0% (95% CI 1.8% to 2.1%). In the Bland-Altman plots, the limits of agreement were the widest among people with diabetes (-0.21; 4.37) compared with people without diabetes (-1.17; 0.95). The lowest agreement as per the LCCC was also seen in people with diabetes (0.74 (95% CI 0.63 to 0.82)), the same was observed with the kappa statistic (kappa=0.36). ABBV-075 molecular weight In general, agreement between the scores was appropriate in terms of clinical significance.
The absolute cardiovascular predicted risk was similar between the laboratory-based and non-laboratory-based 2019 WHO cardiovascular risk models. Pending validation from longitudinal studies, the non-laboratory-based model (instead of the laboratory-based) could be used when assessing CVD risk in Peruvian population.
The absolute cardiovascular predicted risk was similar between the laboratory-based and non-laboratory-based 2019 WHO cardiovascular risk models. Pending validation from longitudinal studies, the non-laboratory-based model (instead of the laboratory-based) could be used when assessing CVD risk in Peruvian population.
Adolescent onset substance use is associated with neurodevelopmental, social and psychological harms. Thus, alcohol and other drug prevention programmes are essential to promote health and well-being during this period. Schools are uniquely positioned to deliver such prevention programmes. The last decade has seen a large expansion of school-based alcohol and drug prevention programmes in Australia, warranting an update of the comprehensive review conducted by Teesson
in 2012. This proposed review aims to (1) identify school-based substance use prevention programmes that have been trialled in Australia since 2011, (2) evaluate their efficacy and (3) identify intervention components associated with effectiveness. This will assist schools in identifying and adopting effective evidence-based programmes and inform future programme development, evaluation and policy.
Studies published from 2011 will be identified by searching the electronic databases PubMed, PsycINFO, Medline, Embase, ProQuest and Cochrane t conferences.
CRD42021272959.
CRD42021272959.
Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma.
TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial.Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen (
21%) that ensures an SpO
of 94%. The liberal group receives 12-15 L O
/min or FiO
=0.6-1.0.The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome).With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group.
TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website (www.traumox2.org) is available for updates and study results will be published in an international peer-reviewed scientific journal.
EudraCT 2021-000556-19; NCT05146700.
EudraCT 2021-000556-19; NCT05146700.
Dietary and/or physical activity interventions are often recommended for women with overweight or obesity as the first step prior to fertility treatment. However, randomised controlled trials (RCTs) so far have shown inconsistent results. Therefore, we propose this individual participant data meta-analysis (IPDMA) to evaluate the effectiveness and safety of dietary and/or physical activity interventions in women with infertility and overweight or obesity on reproductive, maternal and perinatal outcomes and to explore if there are subgroup(s) of women who benefit from each specific intervention or their combination (treatment-covariate interactions).
We will include RCTs with dietary and/or physical activity interventions as core interventions prior to fertility treatment in women with infertility and overweight or obesity. The primary outcome will be live birth. We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials and trial registries to identify eligible studies. We will approach authors of eligible trials to contribute individual participant data (IPD). We will perform risk of bias assessments according to the Risk of Bias 2 tool and a random-effects IPDMA. We will then explore treatment-covariate interactions for important participant-level characteristics.
Formal ethical approval for the project (Venus-IPD) was exempted by the medical ethics committee of the University Medical Center Groningen (METc code 2021/563, date 17 November 2021). Data transfer agreement will be obtained from each participating institute/hospital. Outcomes will be disseminated internationally through the collaborative group, conference presentations and peer-reviewed publication.
CRD42021266201.
CRD42021266201.
The International Consortium for Pooled Studies on Subsequent Malignancies after Childhood and Adolescent Cancer was established in 2018 to address gaps in knowledge of risk and risk factors for breast cancer subsequent to childhood/adolescent cancer by pooling individual patient data from seven cohorts. Initially, the pooled cohort will focus on three clinically relevant questions regarding treatment-related subsequent breast cancer risk in female survivors, which are the risk related to low-dose radiotherapy exposure to the chest, specific chemotherapy agents and attained age.
The consortium database includes pooled data on 21 892 female survivors from seven cohorts in North America and Europe with a primary cancer diagnosis at <21 years of age, and survival ≥5 years from diagnosis.
This is a newly established pooled study. The cohort profile summarised the data collected from each included cohort, including childhood cancer diagnosis information and treatment details (ie, radiotherapy fields and cand robust source of childhood/adolescent cancer survivor data for elucidating other knowledge gaps on subsequent breast cancer risk, and risk of other subsequent malignancies (including data on males) in the future.
The consortium is intended to serve as a model and robust source of childhood/adolescent cancer survivor data for elucidating other knowledge gaps on subsequent breast cancer risk, and risk of other subsequent malignancies (including data on males) in the future.
Premenopausal and postmenopausal osteoporosis and associated fragility fractures are major public health problems. Exercise, especially moderate-to-high-intensity impact exercise, has been recommended as an effective, low-cost non-pharmacological strategy for bone strength improvement; however, evidence on fracture risk is limited. In addition, maintaining regular training is currently a problem. Therefore, this study aims to conduct a randomised controlled trial of moderate-to-high-intensity tele-exercise intervention using a tele-rehabilitation app and quantify its effects on vertical fracture and fall prevention in women at high risk of osteoporotic fractures.
In this multicentre, randomised controlled trial, 794 women at high risk of osteoporotic fractures will be recruited and randomised into either the tele-exercise rehabilitation or control group. Participants in the control group will receive routine remote rehabilitation, while those in the intervention group will be provided with a 6-month tele-s registered with the Chinese Clinical Trial Registry (ChiCTR2200058780) prior to recruitment (May 2022).
Pandemics negatively impact healthcare workers' (HCW's) mental health and well-being causing additional feelings of anxiety, depression, moral distress and post-traumatic stress. A comprehensive review and evidence synthesis of HCW's mental health and well-being interventions through pandemics reporting mental health outcomes was conducted addressing two questions (1) What mental health support interventions have been reported in recent pandemics, and have they been effective in improving the mental health and well-being of HCWs? (2) Have any mobile apps been designed and implemented to support HCWs' mental health and well-being during pandemics?
A narrative evidence synthesis was conducted using Cochrane criteria for synthesising and presenting findings when systematic review and pooling data for statistical analysis are not suitable due to the heterogeneity of the studies.
Evidence summary resources, bibliographic databases, grey literature sources, clinical trial registries and protocol registries were searched.
