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Background Households in areas of socio-economic deprivation are more likely to consume diets low in fruit and vegetables. Fresh Street is a place-based fruit and vegetable voucher scheme with vouchers redeemable with local independent (non-supermarket) vendors. Paper vouchers are offered to all households in a geographical area regardless of household type, size, or income with no requirement to demonstrate need. The regular shareable vouchers are combined with recipes and dietary information to increase exposure to healthy food prompts, reduce food insecurity, increase fruit and vegetable consumption, improve dietary quality, and support healthy dietary habits. This study aimed to inform a randomised controlled trial (RCT) to assess the impact of Fresh Street on a range of public health outcomes. Methods The pilot cluster RCT took place in three inner city areas of high socioeconomic deprivation in England (Tower Hamlets, Bradford, and Doncaster). New systems for managing vouchers and doorstep delivering weekly envelopes to households were developed. Weekly envelopes containing vouchers (5 x £1), a healthy seasonal recipe and brief nutritional information were offered to all households in nine intervention streets. Nine control streets received no intervention. Household surveys collected information on fruit and vegetable consumption, diet quality, and household characteristics. Results The household survey response rate was below the 50% target for progression to the main trial. Most local fruit and vegetable vendors accepted vouchers. Three quarters or more of households regularly accepted the envelopes. The scheme was well received by households, local vendors and local public health teams. Household uptake of the scheme was highest in Tower Hamlets (75%) and Bradford (83%). The mean weekly voucher redemption was highest in Tower Hamlets (£3.26) and Bradford (£2.82), where the scheme ran longest, and where vendors were nearby. Conclusions This was the first pilot RCT of a place-based, household voucher approach. The newly developed system for securely printing and redeeming the vouchers worked well and is potentially scalable. Future trials should consider alternative methods of assessing the impact on households and explore more efficient ways to deliver the intervention e.g. through collaborative working with local resources such as community centres.

To evaluate the feasibility and acceptability of a mobile-based brief intervention (BI), generate preliminary estimates of the impact of the BI and fine-tune the procedures for a definitive randomised controlled trial. Parallel three-arm single-blind individually randomised controlled pilot trial. Eligible and consenting participants were randomised to receive mobile-based BI, face-to-face BI and information leaflet. Educational institutions, workplaces and primary care centres. Adult hazardous drinkers. Seventy-four participants were randomised into the three trial arms; forty-eight (64·9 %) completed outcome evaluation. There were no significant differences between the three arms on change in any of the drinking outcomes. There were however in two-way comparisons. Face-to-face BI and mobile BI were superior to active control for percent days heavy drinking at follow-up, and mobile BI was superior to active control for mean grams ethanol consumed per week at follow-up. The encouraging findings about feasibility and preliminary impact warrant a definitive trial of our intervention and if found to be effective, our intervention could be a potentially scalable first-line response to hazardous drinking in low-resource settings.

Early Childhood Education and Care (ECEC) settings are important environments to support children’s physical activity (PA). In 2021, COVID-19 regulations recommended the provision of indoor–outdoor free-play programs in ECEC settings to reduce the transmission of COVID-19, resulting in an increased uptake of this practice. As the context has since changed, research suggests that ECEC services could cease the implementation of these practices. Therefore, this pilot randomised controlled trial (RCT) aims to examine the feasibility, acceptability, and impact of a sustainment strategy to ensure the ongoing implementation (sustainment) of ECEC-delivered indoor–outdoor free-play programs. Twenty ECEC services located in New South Wales, Australia that have implemented indoor–outdoor free-play programs since the release of COVID-19 guidelines will be recruited. The services will be randomly allocated either the sustainment strategy or usual care. The “Sustaining Play, Sustaining Health” program consists of eight strategies, developed to address key barriers against and facilitators of sustainment informed by the Integrated Sustainability Framework. The outcomes will be assessed via internal project records, staff surveys, and a self-reported measure of free play. This study will provide important data to support the performance of a fully powered trial within Australian ECEC settings and to inform the development of future sustainment strategies.

Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention ( n  = 24) or control group ( n  = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register ( NL6758/NTR7627 ).

Background: ‘We Can Quit2’ pilot randomised controlled trial determined the feasibility [of conducting a community-based trial of We Can Quit, a peer-delivered stop-smoking programme (group support, combination nicotine replacement therapy (NRT), and tailored individual support) for women living in socioeconomically disadvantaged areas in Ireland. Lessons from a knowledge exchange (KE) workshop that reengaged trial stakeholders are presented. Methods: The trial dissemination plan included invitation of community, regional and national stakeholders (n = 176) to a KE interactive workshop, who received an accessible brief beforehand. Trial findings were presented. Enhancements to community engagement, participants’ recruitment and retention, and policy priorities arising from the research were discussed. Field notes and responses to a post-event anonymous questionnaire were analysed using thematic content analysis. Results: Workshop attendees (41/176, 23%) recommended: dedicated additional time to engage community stakeholders; social prescribing pathways to enhance recruitment; more adaptation of trial-related information and assistance in completion of data forms for low literacy individuals; encouraging women to join healthy community programmes to facilitate retention and sustainability; removal of barriers to access NRT; and ongoing provision of cessation services tailored to disadvantaged groups. Conclusions: The findings are relevant to the implementation of other community-based health interventions for disadvantaged groups, to policy makers and to service providers.

Background/Objective: To test the feasibility of a mixed-phase, pilot, placebo-controlled, double-blind trial of mistletoe therapy (MT) with an embedded qualitative study in the UK National Health Service (NHS) setting. Methods: The aim was to recruit 45 patients via an NHS oncology centre with a diagnosis of early or locally advanced breast cancer. Participants were allocated to Iscador® Malus, Iscador® Pinus, or physiological saline (placebo). Diaries and quality-of-life questionnaires were administered. Qualitative interviews were conducted with participants, oncologists, and nurses. Feasibility was assessed by recruitment, retention, adherence, blinding, and safety. Results: Sixty-seven patients were approached between August 2019 and March 2020, 15 gave consent, 14 participants were randomised, and 2 withdrew during the trial. Ten participants and five staff were interviewed. Barriers to recruitment were the additional treatments/time, extra injections, and the possibility of placebo allocation. Adherence was very good whilst the participants were on the study therapy. Diaries and interviews indicated that 11/14 participants struggled with injections and skin reactions. There were 22 adverse events due to the MT, related to the injections or skin reactions. Conclusion: This pilot study examined the feasibility of conducting a randomised placebo-controlled, double-blind trial of mistletoe therapy for breast cancer patients within the UK NHS. The results describe the challenges and achievements of recruitment, retention, adherence, blinding, and safety in this context.

BackgroundNegative affect plays an important role in motivating problematic alcohol use. Consequently, training imagery-based adaptive responses to negative affect could reduce problematic alcohol use. The current study tested whether personalised online functional imagery training (FIT) to utilise positive mental imagery in response to negative affect would improve drinking outcomes in hazardous negative affect drinking students.MethodParticipants were 52 hazardous student drinkers who drink to cope with negative affect. Participants in the active group (n = 24) were trained online over 2 weeks to respond to personalised negative drinking triggers by retrieving a personalised adaptive strategy they might use to mitigate negative affect, whereas participants in the control group (n = 28) received standard risk information about binge drinking at university. Measures of daily drinking quantity, drinking motives, self-efficacy and use of protective behavioural strategies were obtained at baseline and 2 weeks follow-up.ResultsThere were three significant interactions between group and time in a per-protocol analysis: the active intervention group showed increased self-efficacy of control over negative affect drinking and control over alcohol consumption and decreased social drinking motives from baseline to 2-week follow-up, relative to the control intervention group. There were no effects on drinking frequency.ConclusionThese findings provide initial evidence that online training to respond to negative affect drinking triggers by retrieving mental imagery of adaptive strategies can improve drinking-related outcomes in hazardous, student, negative affect drinkers. The findings support the utility of FIT interventions for substance use.

The burden of depression is a public health concern, and traditional treatment approaches to mental health alone may be insufficient. The effects of contact with nature on wellbeing have been shown to reduce stress and improve mood, emotional wellbeing and mental health difficulties. Thus, self-guided nature-based interventions (NBIs) present a promising approach to improving mental health and wellbeing. However, there is limited evidence on the development of such interventions. This two-armed pilot randomised controlled trial aimed at determining the feasibility, acceptability and preliminary efficacy of a novel, 4-week, self-help NBI (Roots and Shoots©). Forty-seven participants were randomised (1:1) to either receive the Roots and Shoots intervention or a waitlist control. Participants in both conditions completed measures including wellbeing (primary outcome) and depressive symptoms, rumination, sleep and nature relatedness (secondary outcomes) at three timepoints: baseline (T0), 2 weeks (T1) and 4 weeks (T2). Those who completed the intervention period reported high acceptability and satisfaction with the intervention. The findings from this pilot study indicate potential for improvements in wellbeing following the intervention, which appears reasonably feasible and acceptable. Future research is warranted to further investigate the efficacy of this novel NBI in a larger, powered clinical trial.

Pressure injuries affect 1 to 46% of residents in aged care (long term) facilities and cause a substantial economic burden on health care systems. Remote expert wound nurse consultation has the potential to improve pressure injury outcomes; however, the clinical and cost effectiveness of this intervention for healing of pressure injuries in residential aged care require further investigation. We describe the remote expert wound nurse consultation intervention and the method of a prospective, pilot, cluster randomised controlled trial. The primary outcome is number of wounds healed. Secondary outcomes are wound healing rate, time to healing, wound infection, satisfaction, quality of life, cost of treatment and care, hospitalisations, and deaths. Intervention group participants receive the intervention over a 12‐week period and all participants are monitored for 24 weeks. A wound imaging and measurement system is used to analyse pressure injury images. A feasibility and fidelity evaluation will be concurrently conducted. The results of the trial will inform the merit of and justification for a future definitive trial to evaluate the clinical and cost effectiveness of remote expert wound nurse consultation for the healing of pressure injuries in residential aged care.

Introduction This pilot trial reports the findings of Randomized controlled trial (RCT) investigating the initial estimates of the effects of spinal manipulations on systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation (SpO2) in patients suffering from functional scoliosis as well as determine the feasibility and acceptability of spinal manipulation in the management of Functional scoliosis for full trial and to obtain pilot data to perform sample size calculation for full trial. Material and methods A Single –blinded trial was done in accordance with CONSORT guidelines 2010. Thirty patients of functional scoliosis with ‘Intention to treat Analysis’ were recruited. The participants were randomly allocated into experimental (n=15) and Control group (n=15). Experimental group received spinal manipulations with Grade 5 high velocity thrust and Schroth exercise whereas Control group received only Schroth exercise. Feasibility and acceptability were assessed by number of participants completing the baseline and post-intervention data of treatment process. Results Experimental group showed a statistically significant improvement in SBP (MD=10.73; 95% CI= 4.63, 7.49), DBP (MD=10.13; 95% CI= 5.80, 8.06) and SpO2 (MD=-7.2; 95% CI= -5.55, -3.51) as compared to control group in terms of SBP (MD=4.66; 95% CI= 3.63, 5.50), DBP (MD=3.2; 95% CI= 3.20, 4.01) and SpO2 (MD=-2.7; 95% CI= -3.55, -2.50). Results suggested that outcome measures were feasible and acceptable. Conclusions This pilot study is feasible and acceptable to do a fully powered randomised controlled trial. This study also concluded that spinal manipulations combined with Schroth exercises may significantly reduce the blood pressures and improve the oxygen saturation levels.