scholarly journals Effect of solar ultraviolet radiation exposure on serum 25(OH)D concentration: a pilot randomised controlled trial

2018 ◽  
Vol 17 (5) ◽  
pp. 570-577 ◽  
Author(s):  
Shanchita R. Khan ◽  
David C. Whiteman ◽  
Michael G. Kimlin ◽  
Monika Janda ◽  
Michael W. Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Ultraviolet Radiation ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Solar Ultraviolet Radiation ◽  
Pilot Randomised Controlled Trial ◽  
Ultraviolet Radiation Exposure ◽  
Solar Uv ◽  
Randomised Controlled ◽  
Solar Ultraviolet

A pilot trial investigated the change in serum 25(OH)D concentration induced by deliberate exposure to one SED of solar UV radiation. This will inform the methods of a fully powered trial.

scholarly journals Acceptability and Feasibility of a 13-Week Pilot Randomised Controlled Trial Testing the Effects of Incremental Doses of Beetroot Juice in Overweight and Obese Older Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 769
Author(s):  
Abrar M Babateen ◽  
Oliver M Shannon ◽  
Gerard M O’Brien ◽  
Edward Okello ◽  
Anmar A Khan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Beetroot Juice ◽  
Obese Adults ◽  
Pilot Randomised Controlled Trial ◽  
Brain Functions ◽  
Linear Relationships ◽  
Trial Testing ◽  
Pilot Rct ◽  
Randomised Controlled

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.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048178
Author(s):  
Katie Mellor ◽  
Saskia Eddy ◽  
Nicholas Peckham ◽  
Christine M Bond ◽  
Michael J Campbell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Pilot Trial ◽  
Public Library ◽  
Feasibility Studies ◽  
Methodological Review ◽  
Pilot Trials ◽  
Trial Protocols ◽  
Randomised Controlled

ObjectivesPrespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports.Study designMethodological review.MethodsWe searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics.ResultsWe included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified.ConclusionsMany external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.

Low‐cost local food supplements could improve maternal and birth outcomes in Indonesia: A pilot randomised controlled trial

2021 ◽  
Vol 46 (3) ◽  
pp. 321-331
Author(s):  
Kun A. Susiloretni ◽  
Dyah Nur Subandriani ◽  
Elisa Ulfiana ◽  
Sunarto Sunarto ◽  
Trina Astuti ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Birth Outcomes ◽  
Local Food ◽  
Low Cost ◽  
Controlled Trial ◽  
Food Supplements ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

scholarly journals Pharmacist-led management of chronic pain in primary care: costs and benefits in a pilot randomised controlled trial

BMJ Open ◽  
2015 ◽  
Vol 5 (4) ◽  
pp. e006874-e006874 ◽  
Author(s):  
A. R. Neilson ◽  
H. Bruhn ◽  
C. M. Bond ◽  
A. M. Elliott ◽  
B. H. Smith ◽  
...  
Keyword(s):  
Primary Care ◽  
Chronic Pain ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Costs And Benefits ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled ◽  
Care Costs

scholarly journals Fluids in Sepsis and Septic Shock (FISSH): protocol for a pilot randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (7) ◽  
pp. e017602 ◽  
Author(s):  
Bram Rochwerg ◽  
Tina Millen ◽  
Peggy Austin ◽  
Michelle Zeller ◽  
Frédérick D’Aragon ◽  
...  
Keyword(s):  
Septic Shock ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled ◽  
Sepsis And Septic Shock
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