The incidence of infants who are large-for-gestational-age (LGA) is on the rise in China, and its detrimental effects on health have received increasing attention. Diet-based interventions have the potential to reduce adverse birth outcomes, particularly in decreasing the occurrence of LGA infants. We aim to evaluate the effect of lipid-focused diet education based on the theories of behaviour change in pregnant women on maternal and offspring outcomes through a randomised controlled trial.

We have designed an open-label, parallel, multicentre randomised controlled trial in collaboration with three hospitals in Beijing, China.

Pregnant women will be recruited before reaching 12 weeks of gestation and will be randomised in a 1:1:1 ratio into three arms: (1) online education arm, (2) pregnancy nutrition checklist and ‘one-page flyer’ arm and (3) routine antenatal education. The primary outcome LGA will be recorded at birth. Demographic information, physical activity, sleep and medical history will be collected through questionnaires and case cards prior to enrolment. Questionnaires will also be used to collect dietary behaviours and psychosocial factors of pregnant women at enrolment, at 24–28 weeks and 34–36 weeks of gestation. Additionally, information on breastfeeding and complementary food supplementation for infants and young children will be obtained through questionnaires. Physical development indicators of children and taste tests will be assessed 3 years after delivery.

The study has received ethical approval from the Capital Medical University Ethics Committee and other collaborating study centres. Informed consent will be introduced to pregnant women, and their consent will be obtained. The findings will be reported in relevant national and international academic conferences and peer-reviewed publications.

ChiCTR2300071126.

Poor sleep quality adversely affects the overall well-being and outcomes of patients with chronic kidney disease (CKD). However, it has not been well studied in Africans with CKD. We determined the prevalence of poor sleep quality and associated factors among patients with CKD.

This was a cross-sectional study that involved patients with CKD .

The study was carried out in the outpatient clinic of nine hospitals in Nigeria.

Sleep quality, depressive and anxiety symptoms and quality of life (QoL) were assessed among 307 patients with CKD using Pittsburgh Sleep Quality Index Questionnaire, Hospital Anxiety Depression Scale Questionnaire and 12-item Short Form Health Survey Quality of Life Questionnaire, respectively. The prevalence of poor sleep quality and associated factors were determined. A p

The mean age of the study participants was 51.40±15.17 years. The male:female ratio was 1.5:1 One hundred and twenty-one (39.4%) of the patients were on maintenance haemodialysis (MHD). The prevalence of poor sleep quality, anxiety symptoms and depressive symptoms among the patients was 50.2%, 37.8% and 17.6%, respectively. The prevalence of poor sleep quality in the CKD stages 3, 4, 5 and 5D was 38.1%, 42.6%, 52.2% and 58.7%, respectively. The prevalence of poor sleep quality was significantly higher in MHD patients compared with predialysis CKD (59.5% vs 43.6%; p=0.008). Factors associated with poor sleep quality were CKD stage (p=0.035), anaemia (p=0.003), pruritus (p=0.045), anxiety symptoms (p≤0.001), depressive symptoms (p≤0.001) and reduced QoL (p≤0.001). On multivariate analysis, factors associated with poor sleep were anxiety (AOR 2.19; 95% CI 1.27 to 3.79; p=0.005), anaemia (AOR 5.49; 95% CI 1.43 to 21.00;p=0.013) and reduced physical component of QoL (AOR 4.11; 95% CI 1.61 to 10.47; p=0.003).

Poor sleep quality is common among patients with CKD especially in the advanced stage. The significant factors associated with poor sleep quality were QoL, anaemia and anxiety symptoms. These factors should be adequately managed to improve the overall outcomes of patients with CKD.

Imprecise nutritional recommendations due to a lack of diagnostic test accuracy are a frequent problem for individuals with adverse reactions to foods but no precise diagnosis. Consequently, patients follow very broad and strict elimination diets to avoid uncontrolled symptoms such as diarrhoea and abdominal pain. Dietary limitations and the uncertainty of developing gastrointestinal symptoms after the inadvertent ingestion of food have been demonstrated to reduce the quality of life (QoL) of affected individuals and subsequently might increase the risk of malnutrition and intestinal dysbiosis. This trial aims to investigate the effects of a tailored diet based on the confocal laser endoscopy (CLE) examination result to limit the side effects of unspecific and broad elimination diets and to increase the patient’s QoL.

The study is designed as a prospective, double-blind, monocentric, randomised and controlled trial conducted at the University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. One hundred seventy-two patients with non-IgE-related food allergies and positive CLE results will be randomised to either a tailored diet or a standard fivefold elimination diet. The primary endpoints are the difference between the end and the start of the intervention in health-related QoL and the sum score of the severity of symptoms after 12 weeks. Key secondary endpoints are changes in the severity of symptoms, further QoL measurements, self-assessed state of health and number of days with a pathologically altered stool. Microbiome diversity and metabolome of stool, urine and blood will also be investigated. Safety endpoints are body composition, body mass index and adverse events.

The study protocol was accepted by the ethical committee of the University of Lübeck (AZ: 22-111) on 4 May2022. Results of the study will be published in peer-reviewed journals and presented at scientific meetings.

German Clinical Trials Register (DRKS00029323).