Clinical trials

Vascular Ehlers-Danlos syndrome (vEDS) is a rare, life-threatening connective tissue disorder. People with vEDS have often been advised to limit physical activity, yet the safety and feasibility of structured exercise in this group is poorly understood. This study works with people with vEDS, their families and clinicians to co-design a safe, tailored physical activity programme, then tests it in a 12-week randomised feasibility study comparing the programme with usual care. The aim is to find out whether the intervention and the trial procedures are safe, acceptable and practical, in order to inform a future full-scale trial. Outcomes focus on recruitment, retention, adherence, acceptability and safety, alongside exploratory measures of physical function, quality of life and microvascular health.

This study aims to explore the context of how children aged 3-5 use interactive electronic devices like tablets or smartphones in their everyday home environment. The researchers will look at the social, family, and environmental factors that shape this use. This study will use a qualitative ethnographic approach to explore how young children aged 3-5 use interactive electronic devices (IEDs) in the home. Data will be collected through questionnaires, exploring parent and child IED use, and video recordings of children in their natural home environment over one week, with three recording sessions of approximately four hours each. Following the recording period, selected clips will be reviewed with parents during a semi-structured interview to reflect on behaviours, routines, and context. These videos will help capture not just what children do, but also how they interact with others while using the devices - like gestures, facial expressions, and conversations. The researchers will process the data and extract some video clips. These clips will be used to discuss with parents what they saw in the videos during 60-90-minute interviews to get their insights and giving us a deeper understanding of the child's behaviour and communication. Data analysis will involve inductive thematic analysis of interview transcripts to identify patterns and themes in parental reflections and experiences. To support and accelerate this process, video analysis will be used to extract key moments and behaviours from the recordings, helping to contextualise and enrich the thematic findings. This combined approach will allow for a deep understanding of the social and environmental factors shaping children's technology use. The study will include families from a range of socioeconomic backgrounds, with children aged 3-5 years of age. Participants will be recruited through early years settings, as well as via flyers distributed across family hubs, community centres, libraries and on social media throughout Yorkshire.

Interactive electronic devices (IEDs) have become a common part of young children's lives, yet research on this topic remains limited. Most studies utilise cross-sectional designs and present inconsistent evidence regarding the benefits and harms of IED use. Some findings suggest that IEDs may negatively impact sleep quality, be linked to visual impairment, and lead to reduced and more negative interactions between parents and children. However, it might also have a positive effect in helping language learning in young children when IEDs are co-viewed with parents and improving literacy, mathematics and science skills. Due to this conflicting evidence, health guidelines for young children do not provide specific recommendations on using these devices, leading policymakers to request more information in this area. In conversation with parents and nursery practitioners, they told us they were confused about the benefits and hams of using these devices and wanted further guidance. The primary aim of this study is to investigate the long-term association between IED use (duration and mode) and development outcomes in 3-to-5-year-old children. The researchers will also explore the longitudinal association between IED use (duration) and other outcomes, including BMI z-score, movement behaviour, motor skills, parent-child interaction and school readiness. Children and their parents or caregivers from both low, mid and high-income areas in England will be invited to take part. Children can participate if they are between 3 and 4 years old when they join the study, have received consent from their parent or caregiver, and have provided verbal agreement to participate. However, children will not be eligible if their parents or caregivers do not speak or understand English or if the child has been diagnosed with a developmental disorder by a medical professional before the baseline or follow-up measurements. Data collection will occur at the start of the study and one year later when children are 4 to 5 years old. Parents will be asked to download an app called EARS on the smartphone and/or tablet that the child uses. The app will measure how long they use the device (IED duration) and the specific apps accessed during device usage (IED mode). Child development will be assessed through the following measures: 1) working memory, including visual-spatial and phonological aspects; 2) ability to control, referred to as inhibition; 3) the ability to control and redirect attention, defined as shifting; 4) self-regulation; 5) social development; 6) numeracy skills; and 7) expressive vocabulary. Child development will be measured using the Early Years Toolbox app and recorded on an iPad. The researchers will also measure a set of secondary outcomes, including 1) BMI z-score; 2) 24-hour movement behaviour (i.e. physical activity, sedentary behaviour and sleep); 3) motor development (i.e., gross motor skills and fine motor skills); 4) parent-child interaction; 5) school readiness. The researchers will also measure other things that might influence IED use or emerging abilities, such as participants' demographics (i.e., sex, age, ethnicity and caregiver education), parenting styles, parents' smartphone addiction, the presence of screen viewing policy at the early year's settings. To thank the early years settings for participating, each will receive £100 for every data collection session. Parents will receive a £30 high street e-voucher for each data collection session in which they participate. There are no risks of physical injury or harm involved in this study. All researchers entering the nursery will have been subject to an enhanced Disclosure and Barring Service (DBS) check and are permitted to engage in controlled activity. If the research team observes a significant developmental delay in the child while conducting the health and development measures, they will notify the nursery staff, who will then communicate this information to the parents. Parents may feel uncomfortable downloading the app (EARS) onto their electronic devices to track how long the device is being used and the type of apps in use. The app has been designed for research purposes and approved by Sheffield Hallam University Digital Technology Services. Participants will download the app through the official Apple or Google Stores, which offers additional security and convenience. Participants will be advised to delete the app after each data collection point. The investigators will have regular group meetings throughout the project with parents, carers, nursery teachers and policymakers to gather ideas and opinions and share our findings. These discussions will help researchers improve the project. The findings will help inform public health guidance on children's device usage. The researchers will share the knowledge gained from this study with all participants, write policy briefs and scientific papers, and present the findings at conferences.

The purpose of this study is to evaluate the effects of kefir on gastrointestinal health, sleep quality, and biochemical parameters in adults who have sleep problems. Further measurements of cognitive function, arterial stiffness and blood pressure will also be assessed. The following questions will be addressed during the study: 1. What effect does repeated ingestion of kefir have on the gut microbiome and can this positively influence sleep performance (quality and duration) in adults with sleep problems? 2. Does repeated ingestion of kefir impact LDL, triacyglycerols and non-HDLc in adults with sleep problems? 3. What effect does repeated ingestion of kefir have on cognitive function and mood? 4. What effect does repeated ingestion of kefir have on vascular function, inflammation and markers of immunity in adults with sleep problems? In a randomised, crossover design study, participants will consume 250 ml of kefir (original flavour) or milk for 4 weeks with a 4-week washout.

Osteoporosis is a major contributor to loss of independence due to bone fractures and resulting hospital treatments lead to significant morbidity. While pharmacological treatments can reduce consequences of osteoporosis, there is a pressing need for non-pharmacological interventions to improve bone health across the life-course and to reduce likelihood of age-related bone disease. This study will allow us to determine whether synergistic potentiating effects on bone metabolism are observed in humans in relation to the timing of food ingestion and what recommendations can be made to people with respect to food ingestion and exercise to obtain the maximal bone benefits from aerobic exercise. Furthermore, if we can identify interventions that potentiate bone's response to aerobic exercise in younger adults, then such interventions may have the ability to maximise bone mass in younger adults so that with ageing, the additional bone mineral density and improved bone microarchitecture would extend the time before osteoporotic "fracture thresholds" are reached. Therefore, understanding the bone metabolic response to exercise following fasting and feeding in younger adults is important.

The purpose of this randomised control trial is to determine whether consuming PulseOn enriched crackers for breakfast influences post-prandial glycaemic response and markers of appetite (hunger, fullness, desire to eat) over 4 hours, and energy intake at an ad libitum lunch meal on the same day. Healthy individuals with no underlying metabolic disease will be recruited to take part in this study.