Study protocol: can a school gardening intervention improve children's diets?

BACKGROUND: The current academic literature suggests there is a potential for using gardening as a tool to improve children's fruit and vegetable intake. This study is two parallel randomised controlled trials (RCT) devised to evaluate the school gardening programme of the Royal Horticultural Society (RHS) Campaign for School Gardening, to determine if it has an effect on children's fruit and vegetable intake. METHOD/DESIGN: Trial One will consist of 26 schools; these schools will be randomised into two groups, one to receive the intensive intervention as "Partner Schools" and the other to receive the less intensive intervention as "Associate Schools". Trial Two will consist of 32 schools; these schools will be randomised into either the less intensive intervention "Associate Schools" or a comparison group with delayed intervention. Baseline data collection will be collected using a 24-hour food diary (CADET) to collect data on dietary intake and a questionnaire exploring children's knowledge and attitudes towards fruit and vegetables. A process measures questionnaire will be used to assess each school's gardening activities. DISCUSSION: The results from these trials will provide information on the impact of the RHS Campaign for School Gardening on children's fruit and vegetable intake. The evaluation will provide valuable information for designing future research in primary school children's diets and school based interventions. TRIAL REGISTRATION: ISRCTN11396528

Optimising care for patients with cognitive impairment and dementia following hip fracture

The global shift in demographics towards aging populations is leading to a commensurate increase in age-related disease and frailty. It is essential to optimise health services to meet current needs and prepare for anticipated future demands. This paper explores issues impacting on people living with cognitive impairment and/or dementia who experience a hip fracture and are cared for in acute settings. This is important given the high mortality and morbidity associated with this population. Given the current insufficiency of clear evidence on optimum rehabilitation of this patient group, this paper explored three key themes namely: recognition of cognitive impairment, response by way of training and education of staff to optimise care for this patient group and review of the importance of outcomes measures. Whilst there is currently insufficient evidence to draw conclusions about the optimal ways of caring for patients living with dementia following hip fracture, this paper concludes that future research should improve understanding of healthcare staff education to improve the outcomes for this important group of patients

A positron emission tomography imaging study to confirm target engagement in the lungs of patients with idiopathic pulmonary fibrosis following a single dose of a novel inhaled αvβ6 integrin inhibitor

Background Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease with poor prognosis and a significant unmet medical need. This study evaluated the safety, pharmacokinetics (PK) and target engagement in the lungs, of GSK3008348, a novel inhaled alpha-v beta-6 (αvβ6) integrin inhibitor, in participants with IPF. Methods This was a phase 1b, randomised, double-blind (sponsor unblind) study, conducted in the UK (two clinical sites, one imaging unit) between June 2017 and July 2018 (NCT03069989). Participants with a definite or probable diagnosis of IPF received a single nebulised dose of 1000 mcg GSK3008348 or placebo (ratio 5:2) in two dosing periods. In period 1, safety and PK assessments were performed up to 24 h post-dose; in period 2, after a 7-day to 28-day washout, participants underwent a total of three positron emission tomography (PET) scans: baseline, Day 1 (~ 30 min post-dosing) and Day 2 (~ 24 h post-dosing), using a radiolabelled αvβ6-specific ligand, [18F]FB-A20FMDV2. The primary endpoint was whole lung volume of distribution (VT), not corrected for air volume, at ~ 30 min post-dose compared with pre-dose. The study success criterion, determined using Bayesian analysis, was a posterior probability (true % reduction in VT > 0%) of ≥80%. Results Eight participants with IPF were enrolled and seven completed the study. Adjusted posterior median reduction in uncorrected VT at ~ 30 min after GSK3008348 inhalation was 20% (95% CrI: − 9 to 42%). The posterior probability that the true % reduction in VT > 0% was 93%. GSK3008348 was well tolerated with no reports of serious adverse events or clinically significant abnormalities that were attributable to study treatment. PK was successfully characterised showing rapid absorption followed by a multiphasic elimination. Conclusions This study demonstrated engagement of the αvβ6 integrin target in the lung following nebulised dosing with GSK3008348 to participants with IPF. To the best of our knowledge this is the first time a target-specific PET radioligand has been used to assess target engagement in the lung, not least for an inhaled drug

Interventions to prevent obesity in children and adolescents: a systematic literature review.

Objective: Preventive measures to contain the epidemic of obesity have become a major focus of attention. This report reviews the scientific evidence for medical interventions aimed at preventing obesity during childhood and adolescence. Design: A systematic literature review involving selection of primary research and other systematic reviews. Articles published until 2004 were added to an earlier ( 2002) review by the Swedish Council on Technology Assessment in Health Care. Methods: Inclusion criteria required controlled studies with follow-up of at least 12 months and results measured as body mass index, skinfold thickness or the percentage of overweight/obesity. Children could be recruited from normal or high-risk populations. Results: Combining the new data with the previous review resulted in an evaluation of 24 studies involving 25 896 children. Of these, eight reported that prevention had a statistically significant positive effect on obesity, 16 reported neutral results and none reported a negative result ( sign test; P = 0.0078). Adding the studies included in five other systematic reviews yielded, in total, 15 studies with positive, 24 with neutral and none with negative results. Thus, 41% of the studies, including 40% of the 33 852 children studied, showed a positive effect from prevention. These results are unlikely to be a random chance phenomenon ( P = 0.000061). Conclusion: Evidence shows that it is possible to prevent obesity in children and adolescents through limited, school-based programs that combine the promotion of healthy dietary habits and physical activity

A comparison of static and dynamic cerebral autoregulation during mild whole-body cold stress in individuals with and without cervical spinal cord injury: a pilot study

This paper was published in the journal Spinal Cord and the definitive published version is available at https://doi.org/10.1038/s41393-017-0021-7.Study design: Experimental study. Objectives: To characterize static and dynamic cerebral autoregulation (CA) of individuals with cervical spinal cord injury (SCI) compared to able-bodied controls in response to moderate increases in mean arterial pressure (MAP) caused by mild whole-body cold stress. Setting: Japan Methods: Five men with complete autonomic cervical SCI (sustained>5y) and six age-matched able-bodied men participated in hemodynamic, temperature, catecholamine and respiratory measurements for 60 min during three consecutive stages: baseline (10 min; 330C water through a thin-tubed whole-body suit), mild cold stress (20 min; 250C water) and post-cold recovery (30 min; 330C water). Static CA was determined as the ratio between mean changes in middle cerebral artery blood velocity and MAP, dynamic CA as transfer function coherence, gain and phase between spontaneous changes in MAP to middle cerebral artery blood velocity. Results: MAP increased in both groups during cold and post-cold recovery (mean differences: 5 to 10 mm Hg; main effect of time: p=0.001). Static CA was not different between the able-bodied vs the cervical SCI group (mean [95% CI] of between-group difference: -4 [-11 to 3] and -2 [-5 to 1] cm/s/mmHg for cold (p=0.22) and post-cold (p=0.24), respectively). At baseline, transfer function phase was shorter in the cervical SCI group (mean [95% CI] of between-group difference: 0.6 [0.2 to 1.0] rad; p=0.006), while between-group differences in changes in phase were not different in response to the cold stress (interaction term: p=0.06). Conclusions: This pilot study suggests that static CA is similar between individuals with cervical SCI and able-bodied controls in response to moderate increases in MAP, while dynamic CA may be impaired in cervical SCI due to disturbed sympathetic control