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Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN

Por: Greene · L. · Barber · R. · Bingham · A. · Connors · J. · Conroy · S. · Elkhafer · K. · Fox · C. · Goodwin · V. · Gordon · A. · Hall · A. J. · Harwood · R. H. · Hulme · C. · Jackson · T. · Litherland · R. · Morgan-Trimmer · S. · Pankiewicz · S. · Parry · S. W. · Sharma · A. · Ukoumunne · O.
Introduction

Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual’s overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia.

Method and analysis

This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes.

Ethics and dissemination

The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals.

Trial registration number

ISRCTN16413728.

Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study

Por: Jung · H. · Yun · Y.-R. · Hong · S. W. · Shin · S.
Objective

Previous animal studies have shown the anti-obesity effect of kimchi-derived probiotic lactic acid bacteria. However, only a few epidemiological studies have investigated the association between kimchi consumption and obesity. Therefore, we aim to assess this relationship in Korean adults.

Design

Cross-sectional study.

Setting

The Health Examinees study was conducted from 2004 to 2013.

Participants

This study analysed 115 726 participants aged 40–69 years enrolled in the Health Examinees study in Korea.

Primary and secondary outcome measures

Obesity was defined as body mass index ≥25 kg/m2, and abdominal obesity was defined as waist circumference ≥90 cm in men and ≥85 cm in women. Kimchi consumption was assessed by the validated food frequency questionnaire.

Results

In men, total kimchi consumption of 1–3 servings/day was related to a lower prevalence of obesity (OR: 0.875 in 1–2 servings/day and OR: 0.893 in 2–3 servings/day) compared with total kimchi consumption of

Conclusions and relevance

Consumption of 1–3 servings/day of total kimchi was associated with a lower risk of obesity in men. Baechu kimchi was associated with a lower prevalence of obesity in men, and kkakdugi was associated with a lower prevalence of abdominal obesity in both men and women. However, since all results showed a ‘J-shaped’ association, it is recommended to limit excessive kimchi intake.

Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial

Por: Li · M. C. M. · Cheng · Y. K. · Cui · C. · Chow · S. K. H. · Wong · R. M. Y. · Kwok · T. C. · Siu · P. M. · Yang · M. · Tian · M. · Rubin · C. · Welch · A. A. · Qin · L. · Law · S. W. · Cheung · W. H.
Introduction

Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.

Methods and analysis

In this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.

Ethics and dissemination

This study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.

Trial registration number

NCT05525039.

Interpregnancy weight change and risks of stillbirth and infant mortality: a protocol of a systematic review and meta-analysis

Por: Tang · Y. · Islam · N. · Luo · R. · Wen · S. W. · Guo · Y.
Introduction

Interpregnancy weight change may impact two important adverse perinatal outcomes: stillbirth and infant mortality. This systematic review aims to synthesise the existing evidence on the association between interpregnancy weight change and stillbirth and infant mortality.

Methods and analysis

This systematic review and meta-analysis will be conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols guidelines and has been registered in the International Prospective Register of Systematic Reviews (PROSPERO). A comprehensive literature search of four online databases (Embase, Cochrane Libraries, Web of Science and Medline) will be conducted from inception to October 2023. Observational (longitudinal, cohort, case–control) and randomised controlled trials will be included. Interpregnancy weight/body mass index change between two consecutive pregnancies will be the exposure. The primary outcomes will be the incidence of stillbirth and infant mortality in subsequent pregnancy. The Cochrane Risk of Bias tool will be used to assess the risk of bias in the randomised controlled studies and the Risk of Bias in Non-Randomised Studies of Interventions tool will be used for observational studies. If there are sufficient data, a meta-analysis will be conducted to estimate the pooled effect size. Otherwise, qualitative descriptions of individual studies will be summarised. The heterogeneity will be statistically assessed using a 2 test and I2 statistic.

Ethics and dissemination

Ethics approval is not required for this study as all results will be based on published papers. No primary data collection will be needed. Study findings will be presented at scientific conferences or published in a peer-reviewed scientific journal.

Trial registration number

A registration for this review has been submitted to PROSPERO under CRD42020222977.

Six month incidence of major adverse cardiovascular events among adults with HIV in northern Tanzania: a prospective observational study

Por: Stark · K. · O'Leary · P. R. E. · Sakita · F. M. · Ford · J. S. · Mmbaga · B. T. · Blass · B. · Gedion · K. · Coaxum · L. A. · Rutta · A. · Galson · S. W. · Rugakingira · A. · Manavalan · P. · Bloomfield · G. S. · Hertz · J. T.
Objectives

We aimed to prospectively describe incident cardiovascular events among people living with HIV (PLWH) in northern Tanzania. Secondary aims of this study were to understand non-communicable disease care-seeking behaviour and patient preferences for cardiovascular care and education.

Design

A prospective observational study.

Setting

This study was conducted at the Majengo HIV Care and Treatment Clinic, an outpatient government-funded clinic in Moshi, Tanzania

Participants

Adult patients presenting to an HIV clinic for routine care in northern Tanzania were enrolled from 1 September 2020 to 1 March 2021.

Interventions

At enrolment, participants completed a survey and a resting 12-lead ECG was obtained. At 6 month follow-up, a repeat survey regarding interim health events and repeat ECG was obtained.

Primary and secondary outcome measures

Interim major adverse cardiovascular events (MACE) were defined by: self-reported interim stroke, self-reported hospitalisation for heart failure, self-reported interim myocardial infarction, interim myocardial infarction by ECG criteria (new pathologic Q waves in two contiguous leads) or death due to cardiovascular disease (CVD).

Results

Of 500 enrolled participants, 477 (95.4%) completed 6 month follow-up and 3 (0.6%) died. Over the 6 month follow-up period, 11 MACE occurred (3 strokes, 6 myocardial infarctions, 1 heart failure hospitalisation and 1 cardiovascular death), resulting in an incidence rate of 4.58 MACE per 100 person-years. Of participants completing 6 month follow-up, 31 (6.5%) reported a new non-communicable disease diagnosis, including 23 (4.8%) with a new hypertension diagnosis.

Conclusions

The incidence of MACE among PLWH in Tanzania is high. These findings are an important preliminary step in understanding the landscape of CVD among PLWH in Tanzania and highlight the need for interventions to reduce cardiovascular risk in this population.

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