scholarly journals A pilot randomised controlled trial investigating a Mediterranean diet intervention in pregnant women for the primary prevention of allergic diseases in infants

2017 ◽  
Vol 30 (5) ◽  
pp. 604-614 ◽  
Author(s):  
D. A. Sewell ◽  
V. S. Hammersley ◽  
A. Robertson ◽  
G. Devereux ◽  
A. Stoddart ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Mediterranean Diet ◽  
Controlled Trial ◽  
Allergic Diseases ◽  
Pilot Randomised Controlled Trial ◽  
Diet Intervention ◽  
Randomised Controlled

scholarly journals Prevention of Gestational Diabetes in Pregnant Women with Obesity: Protocol for a Pilot Randomised Controlled Trial

2021 ◽  
Author(s):  
Ola Quotah ◽  
Glen Nishku ◽  
Jessamine Hunt ◽  
Paul T Seed ◽  
Carolyn Gill ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Risk Stratification ◽  
Antenatal Care ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Lifestyle Advice ◽  
Targeted Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract BackgroundObesity in pregnancy increases the risk of gestational diabetes mellitus (GDM) and associated adverse outcomes. Despite metabolic differences, all pregnant women with obesity are considered to have the same risk of developing GDM. Improved risk stratification is required to enable targeted intervention in women with obesity who would benefit the most. The aim of this study is to identify pregnant women with obesity at higher risk of developing GDM and in a pilot randomised controlled trial (RCT), show efficacy of a lifestyle intervention and/or metformin to improve glycaemic control.MethodsWomen aged 18 years or older with a singleton pregnancy and body mass index (BMI) ≥30kg/m2 will be recruited from one maternity unit in London, UK. Risk of GDM will be assessed using a multivariable GDM prediction model combining maternal age, mid-arm circumference, systolic blood pressure, serum triglycerides and whole blood HbA1c. Women identified at higher risk of developing GDM will be randomly allocated to one of two intervention groups (lifestyle advice with or without metformin) or standard antenatal care. Primary outcome; reduction in mean glucose/24hr of 0.5mmol/l as assessed by continuous glucose monitoring. A sample of 60 high risk women is required.DiscussionEarly risk stratification of GDM in pregnant women with obesity and targeted intervention using lifestyle advice with or without metformin could improve glucose tolerance compared to standard antenatal care. If successful, an adequately powered RCT will be performed to investigate whether this strategy is effective in preventing GDM in women with obesity. Ethics and trial registrationThis study has been approved by the NHS Research Ethics Committee (UK IRAS integrated research application system; reference 18/LO/1500). EudraCT Number 2018-000003-16.

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.

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