The global prevalence of type 2 diabetes (T2D) is rising and disproportionately affects South Asian adults, including those in the United Kingdom. South Asians develop T2D at a higher rate and at a younger age than their white British counterparts, at a lower body mass index. Active efforts to reduce adiposity can improve glycaemic control and in some cases achieve T2D remission. However, a substantial proportion of lean mass is lost while achieving weight loss, which may have physiological and metabolic consequences, affecting long-term health outcomes and quality of life for people living with T2D and obesity. We are examining the impact of a combined low energy diet and supervised exercise intervention versus a low energy diet alone for the preservation of lean mass in an understudied South Asian population living with T2D and excess adiposity.

This prospective, randomised, two-arm parallel-group, open-label, blinded-endpoint trial is being conducted in Leicester, UK. 36 South Asian adults aged 40–65 years within 10 years of T2D diagnosis and not on insulin therapy will be enrolled. Both intervention arms will receive an 800–900 kcal/day low energy diet for 12 weeks. Those randomised to the exercise group will additionally receive a mixture of supervised and home-based resistance and aerobic exercise training three times per week. The primary outcome is the difference in the change of lean mass between groups measured using dual-energy X-ray absorptiometry at baseline and 12 weeks and will be analysed using linear regression modelling.

The trial was approved by the NHS research ethics service (23/WM/0201). All participants will provide informed consent prior to enrolment, and the study will be conducted in accordance with the Declaration of Helsinki. Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial.

ISRCTN11175684.

Poor sleep is common among patients with heart failure (HF) and is associated with adverse cardiovascular outcomes. The utility of actigraphy in sleep assessment, especially among older adults, remains underexplored. This study aimed to assess sleep health among older adults with HF using actigraphy and explore associations between sleep parameters and cardiac biomarkers, functional performance and quality of life (QoL).

A cross-sectional study.

The study was conducted at an outpatient HF clinic within a tertiary cardiology service in a National Health Service hospital in the UK between March and October 2023.

A total of 150 older adults aged ≥65 years with a diagnosis of HF were enrolled.

Participants were given a wrist-accelerometer to wear for 7 days. On Day 0, patients completed a 4-metre walk test (4MWT), handgrip strength test (HGST), Timed Up and Go test (TUGT), Barthel Index (BI), Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and frailty assessment (Clinical Frailty Scale, CFS). Subsequently, they were fitted with an accelerometer, with the device configured to start recording the following day (Day 1). Sleep outcomes were calculated after a 7-day wear period and averaged across valid nights (minimum 3 nights of recording, noon-to-noon with ≥16 hours wear-time). Sleep parameters studied include average sleep efficiency, sleep period time window, sleep duration, sleep onset and wake up time, wake after sleep onset (WASO), sleep interruptions and Sleep Regularity Index (SRI). Inefficient sleep was defined as sleep efficiency

The primary outcome measure was sleep efficiency; all other sleep parameters were classified as secondary or exploratory outcomes.

Accelerometry data from 145 participants were analysed; 42% had inefficient sleep based on average sleep efficiency across valid nights. These patients had significantly higher plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (p=0.044). No statistically significant difference was noted in 4MWT, HGST, TUGT, BI, KCCQ-12 and CFS between patients with sleep efficiency

Older adults with HF who had inefficient sleep had significantly higher NT-proBNP levels. Lower sleep efficiency was associated with higher functional dependence and frailty. Sleep irregularity was linked to HF symptom load, frailty, functional performance and QoL, while sleep fragmentation was associated with impaired gait speed.

To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.

Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.

SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient’s response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies. A comprehensive assessment of SMART reporting practices is lacking and necessary for developing standardised SMART-specific reporting guidelines.

We systematically searched multiple databases for SMART-related protocol and primary analysis papers published between January 2009 and February 2024. Title, abstract and full-text screenings were performed by pairs of reviewers, with disagreements resolved by consensus. Data extraction included study characteristics, design elements and analytical approaches for embedded or tailored DTRs. Results were synthesised qualitatively and presented descriptively.

From 5486 screened studies, 103 (59 protocol papers, 16 primary analysis papers, 14 protocol papers with corresponding primary analysis papers) met the inclusion criteria. Most studies targeted adults (62.7% protocols, 62.5% primary analyses, 42.9% protocol+primary analyses) and were primarily conducted in the USA. Behavioural and mental health constituted the most frequent therapeutic domain. While intervention descriptions and re-randomisation criteria were consistently reported, operational characteristics such as blinding (protocols: 64.4%, primary analyses: 62.5%, protocols+primary analyses: 71.4%) and randomisation details (protocols: 55.9%, primary analyses: 37.5%, protocols+primary analyses: 50.0%) were inconsistently documented. Only 46.7% of primary analyses evaluated embedded DTRs, and none explored deeply tailored DTRs.

Despite the increased adoption of SMART designs, substantial reporting variability persists. Most primary analyses underuse the capability of SMARTs to generate data for developing DTRs. SMART-specific standardised reporting guidelines can help accelerate the scientific and clinical impact of SMARTs.

There are more than 10 million deaf or hard of hearing people in the UK. While the deaf and hard of hearing population is heterogeneous, many of those with profound hearing loss are part of deaf communities (UK estimate around 120 000) which are defined minority communities. Many members of deaf communities are sign language users. Studies have shown that health behaviour and knowledge and health-related attitudes and beliefs are suboptimal among deaf and hard of hearing individuals, with reasons not well understood. This qualitative study aimed to explore the effectiveness of delivery of public health messages to sign language users and the potential methods of delivering public health messages beyond direct translation.

Qualitative study, using a phenomenological research approach and using interviews and focus groups. Interviews and focus groups were conducted initially between January and March 2019 and again between September and October 2022. Groups were held where logistically possible. The sessions followed a topic guide developed following review of the literature and discussion with the research team and with patient and public involvement input and pilot testing, but allowed for deviation for discussion depending on the responses given. Interviews took place in either British Sign Language (BSL) or English, depending on the language preference of the participants. Transcripts were analysed using thematic analysis.

Deaf community and associated stakeholders in Northern Ireland.

Participants were recruited from members of the deaf community and associated stakeholders across Northern Ireland and sampled purposively to ensure variation in age, sex, language, profession, educational level and region.

There were 16 one-to-one interviews and 5 focus groups held, in total involving 28 participants; 23 females and 5 males. 13 participants used BSL and 15 used English. Ages ranged from 23 to 77 years old. Participants included deaf community members (all BSL users and four English users) and key stakeholders involved in sign language and Healthcare. Interview duration ranged from 21 to 82 min. A number of themes were identified from the transcript analysis. These were broadly categorised into (1) current levels of awareness of public health messages, (2) barriers to accessing public health messages and (3) suggestions for facilitating improvement.

Participants reflected that, as with any heterogeneous population, levels of awareness of public health messages vary widely across Deaf communities. Overall levels of awareness were felt to be generally low and certainly much lower when compared with the hearing population. Particular difficulties were noted with regard to mental health, more abstract health-related concepts and preventative health measures. Participants identified not only communication barriers but also systemic, cultural and attitudinal barriers as contributing to this. Suggested next steps involve implementing legislative reforms to address systemic barriers, conducting awareness training to tackle attitudinal barriers, and launching culturally appropriate public health campaigns, all of which should be deaf-led to ensure the expertise and lived experiences of Deaf people guide the process.