scholarly journals A Pilot Randomised Controlled Trial to Enhance Well-Being and Performance of Athletes in Para Sports

2019 ◽  
Vol 12 (2) ◽  
pp. 7-7 ◽  
Author(s):  
Hannah Macdougall ◽  
Paul O'Halloran ◽  
Emma Sherry ◽  
Nora Shields
BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e021891
Author(s):  
Heather Mitchell ◽  
Kathryn M Abel ◽  
Brendan James Dunlop ◽  
Tammi Walker ◽  
Sandeep Ranote ◽  
...  

IntroductionSelf-harm in prison is a major public health concern. Less than 5% of UK prisoners are women, but they carry out more than a fifth of prison self-harm. Scars resulting from self-harm can be traumatising and stigmatising, yet there has been little focus on recovery of women prisoners with self-harm scarring. Medical skin camouflage (MSC) clinics treat individuals with disfiguring skin conditions, with evidence of improved well-being, self-esteem and social interactions. Only one community study has piloted the use of MSC for self-harm scarring.Methods and analysisWe describe an acceptability and feasibility pilot randomised controlled trial; the first to examine MSC for women prisoners who self-harm. We aim to randomise 20–25 women prisoners to a 6-week MSC intervention and 20–25 to a waitlist control (to receive the MSC after the study period). We aim to train at least 6–10 long-term prisoners with personal experience of self-harm to deliver the intervention. Before and after intervention, we will pilot collection of women-centred outcomes, including quality of life, well-being and self-esteem. We will pilot collection of self-harm incidents during the intervention, resources used to manage/treat self-harm and follow-up of women at 12 weeks from baseline. Data on recruitment, retention and dropout will be recorded. We aim for the acceptability of the intervention to prison staff and women prisoners to be explored in qualitative interviews and focus groups.Ethics and disseminationEthical approval for COVER has been granted by the North East–York Research Ethics Committee (REC) for phases 1 and 2 (reference: 16/NE/0030) and West of Scotland REC 3 for phases 3 and 4 (reference: 16/WS/0155). Informed consent will be the primary consideration; it will be made clear that participation will have no effect on life in prison or eligibility for parole. Due to the nature of the study, disclosures of serious self-harm may need to be reported to prison officials. We aim for findings to be disseminated via events at the study prison, presentations at national/international conferences, journal publications, prison governor meetings and university/National Health Service trust communications.Trial registration numberNCT02638974; Pre-results.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042850
Author(s):  
Karin Leder ◽  
John J Openshaw ◽  
Pascale Allotey ◽  
Ansariadi Ansariadi ◽  
S Fiona Barker ◽  
...  

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.


Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 769
Author(s):  
Abrar M Babateen ◽  
Oliver M Shannon ◽  
Gerard M O’Brien ◽  
Edward Okello ◽  
Anmar A Khan ◽  
...  

Nitrate-rich food can increase nitric oxide production and improve vascular and brain functions. This study examines the feasibility of a randomised controlled trial (RCT) testing the effects of prolonged consumption of different doses of dietary nitrate (NO3-) in the form of beetroot juice (BJ) in overweight and obese older participants. A single-blind, four-arm parallel pilot RCT was conducted in 62 overweight and obese (30.4 ± 4 kg/m2) older participants (mean ± standard deviation (SD), 66 ± 4 years). Participants were randomized to: (1) high-NO3- (HN: 2 × 70 mL BJ/day) (2) medium-NO3- (MN: 70 mL BJ/day), (3) low-NO3- (LN: 70 mL BJ on alternate days) or (4) Placebo (PL: 70 mL of NO3--depleted BJ on alternate days), for 13 weeks. Compliance was checked by a daily log of consumed BJ, NO3- intake, and by measuring NO3- and NO2- concentrations in plasma, saliva, and urine samples. Fifty participants completed the study. Self-reported compliance to the interventions was >90%. There were significant positive linear relationships between NO3- dose and the increase in plasma and urinary NO3- concentration (R2 = 0.71, P < 0.001 and R2 = 0.46 P < 0.001, respectively), but relationships between NO3- dose and changes in salivary NO3- and NO2- were non-linear (R2 = 0.35, P = 0.002 and R2 = 0.23, P = 0.007, respectively). The results confirm the feasibility of prolonged BJ supplementation in older overweight and obese adults.


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