More than 170 countries have implemented disability-targeted social protection programmes, although few have been rigorously evaluated. Consequently, a non-randomised controlled trial is being conducted of a pilot ‘cash-plus’ programme implemented by UNICEF Laos and the Laos government for children with disabilities in the Xiengkhouang Province in Laos. The intervention combines a regular cash transfer with provision of assistive devices and access for caregivers to a family support programme.

The non-randomised controlled trial will involve 350 children with disabilities across 3 districts identified by programme implementers as eligible for the programme (intervention arm). Implementers have also identified approximately 180 children with disabilities in neighbouring districts, who would otherwise meet eligibility criteria but do not live in the project areas (control arm). The trial will assess the impact of the programme on child well-being (primary outcome), as well as household poverty, caregiver quality of life and time use (secondary outcomes). Baseline data are being collected May–October 2023, with endline 24 months later. Analysis will be intention to treat. A complementary process evaluation will explore the implementation, acceptability of the programme, challenges and enablers to its delivery and mechanisms of impact.

The study has received ethical approval from the London School of Hygiene and Tropical Medicine and the National Ethics Committee for Health Research in Laos. Informed consent and assent will be taken by trained data collectors. Data will be collected and stored on a secure, encrypted server and its use will follow a detailed data management plan. Findings will be disseminated in academic journals and in short briefs for policy and programmatic actors, and in online and in-person events.

ISRCTN80603476.

A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.

A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.

The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.

NCT05430152.

Childhood obesity rates in the UK are high. The early years of childhood are critical for establishing healthy behaviours and offer interventional opportunities. We aimed to identify studies evaluating the impact of UK-based obesity interventions in early childhood.

Systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Nine databases were searched in March 2023. Eligibility criteria: We included UK-based obesity intervention studies delivered to children aged 6 months to 5 years that had diet and/or physical activity components and reported anthropometric outcomes. The primary outcome of interest was z-score Body Mass Index (zBMI) change (within and between subjects). Studies evaluating the effects of breastfeeding interventions were not included as obesity prevention interventions, given that best-practice formula feeding is also likely to encourage healthy growth. The publication date for studies was limited to the previous 12 years (2011–23), as earlier reviews found few evaluations of interventions in the UK.

The reviewers worked independently using standardised approach to search, screen and code the included studies. Risk of bias was assessed using Cochrane tools (ROB 2 or ROBINS-I).

Six trials (five studies) were identified, including two randomised controlled trials (RCT), one cluster randomised trial (CRT), two feasibility CRTs and one impact assessment. The total number of participants was 566. Three trials focused on disadvantaged families and two included high-risk children categorised as having overweight or obesity. Compared with baseline, five interventions reported reductions in zBMI, three of which were statistically significant (p

UK evidence was limited but some interventions showed promising results in promoting healthy growth. As part of a programme of policies, interventions in the early years may have an important role in reducing the risk of childhood obesity.

CRD42021290676

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

ClinicalTrials.gov, NCT05968794.

To conduct an overview of systematic reviews that explore the effectiveness of interventions to enhance medical student well-being.

Overview of systematic reviews.

The Cochrane Library of Systematic Reviews, MEDLINE, APA PsychInfo, CINAHL and Scopus were searched from database inception until 31 May 2023 to identify systematic reviews of interventions to enhance medical student well-being. Ancestry searching and citation chasing were also conducted.

The Assessing the Methodological Quality of Systematic Reviews V.2 tool was used to appraise the quality of the included reviews. A narrative synthesis was conducted, and the evidence of effectiveness for each intervention was rated.

13 reviews (with 94 independent studies and 17 616 students) were included. The reviews covered individual-level and curriculum-level interventions. Individual interventions included mindfulness (n=12), hypnosis (n=6), mental health programmes (n=7), yoga (n=4), cognitive and behavioural interventions (n=1), mind-sound technology (n=1), music-based interventions (n=1), omega-3 supplementation (n=1), electroacupuncture (n=1) and osteopathic manipulative treatment (n=1). The curriculum-level interventions included pass/fail grading (n=4), problem-based curriculum (n=2) and multicomponent curriculum reform (n=2). Most interventions were not supported by sufficient evidence to establish effectiveness. Eleven reviews were rated as having ‘critically low’ quality, and two reviews were rated as having ‘low’ quality.

Individual-level interventions (mindfulness and mental health programmes) and curriculum-level interventions (pass/fail grading) can improve medical student well-being. These conclusions should be tempered by the low quality of the evidence. Further high-quality research is required to explore additional effective interventions to enhance medical student well-being and the most efficient ways to implement and combine these for maximum benefit.

Based on the available evidence, cognitive stimulation is recommended as an intervention for people with dementia (PwD). Currently, cognitive stimulation is regularly offered as a group programme in care facilities. However, some residents, such as those who are bedridden, cannot participate. Furthermore, group programmes were not feasible during the pandemic. A concept that accompanies everyday life and enables cognitive stimulation in everyday communication (ie, ‘24/7’) has been missing. Therefore, this feasibility study aims to (1) assess the feasibility of a new continuous 24/7 cognitive stimulation programme (CogStim24) based on a process evaluation and (2) examine the possible effects of CogStim24 on the primary outcome of global cognition in PwD and further PwD-related and staff-related outcomes.

The complex CogStim24 programme is developed to be conducted as an everyday intervention during routine care including cognitively stimulating techniques, such as reminiscence therapy, multisensory stimulation and physical activity. In this unblinded single-arm study with pre-assessments and post-assessments, four nursing homes with a total of N=20 nursing and care staff will participate in an 11-week CogStim24 training programme. The intervention will be conducted to N=60 PwD. Neuropsychological assessments will be conducted pre-staff and post-staff training, as well as after a 6-week implementation phase. A process evaluation will be performed.

Ethics approval was obtained from the ethics committee of the Faculty of Medicine of the University of Cologne, Cologne, Germany. Although cognitive stimulation is known to be effective for enhancing global cognition and quality of life in PwD, it is currently undersupplied to PwD. Therefore, CogStim24 has the potential to reach many more PwD. This study has the potential to serve as a basis for a large multicentre cluster randomised controlled trial. An interdisciplinarity team and mixed-methods approach will help generate information on the practicality and mechanisms of impact of CogStim24. This is important for the further development of the intervention and for facilitating its implementation. The study results will be disseminated via presentations at scientific conferences and meetings for healthcare professionals and PwD and their relatives. Several manuscripts presenting results of the different study parts will be published in peer-reviewed journals.

DRKS00024381.

Pregnancy and the postpartum period are increasingly recognised as sensitive windows for cardiometabolic disease risk. Growing evidence suggests environmental exposures, including endocrine-disrupting chemicals (EDCs), are associated with an increased risk of pregnancy complications that are associated with long-term cardiometabolic risk. However, the impact of perinatal EDC exposure on subsequent cardiometabolic risk post-pregnancy is less understood. The Environmental Reproductive and Glucose Outcomes (ERGO) Study was established to investigate the associations of environmental exposures during the perinatal period with post-pregnancy parental cardiometabolic health.

Pregnant individuals aged ≥18 years without pre-existing diabetes were recruited at

We enrolled 653 unique pregnancies and retained 633 through delivery. Participants had a mean age of 33 years, 10% (n=61) developed gestational diabetes and 8% (n=50) developed pre-eclampsia. Participant pregnancy and postpartum urinary phthalate metabolite concentrations and postpartum glycaemic biomarkers were quantified. To date, studies within ERGO found higher exposure to phthalates and phthalate mixtures, and separately, higher exposure to radioactive ambient particulate matter, were associated with adverse gestational glycaemic outcomes. Additionally, certain personal care products used in pregnancy, notably hair oils, were associated with higher urinary phthalate metabolite concentrations, earlier gestational age at delivery and lower birth weight.

Future work will leverage the longitudinal data collected on pregnancy and cardiometabolic outcomes, environmental exposures, questionnaires, banked biospecimens and paediatric data within the ERGO Study.

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.

Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.

Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.

A total of 74 individuals with cardiovascular diseases.

Risk and time preferences.

The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.

The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.