Pilot and Feasibility Studies最新文献

{"title":"Feasibility and acceptability of a mixed methods within-subjects comparative design in dance movement therapy for adults with personality disorders.","authors":"S T Kleinlooh, R A Samaritter, B W Koes, R Hoekstra, J H Stubbe","doi":"10.1186/s40814-026-01816-8","DOIUrl":"10.1186/s40814-026-01816-8","url":null,"abstract":"<p><strong>Background: </strong>Dance Movement Therapy (DMT) is an established treatment for adults diagnosed with personality disorders (PD). A central component of DMT is the creation of improvised dance material, which supports emotional expression and may enhance autonomy, self-efficacy, and well-being. However, structured dance-based micro-interventions derived from this practice have not yet been systematically described or evaluated. This study was the first attempt to examine the feasibility of implementing a within-subjects comparative study protocol and the acceptability of a structured dance-based micro-intervention, with the aim of informing future controlled trials.</p><p><strong>Methods: </strong>We conducted a mixed-methods feasibility study comparing two DMT conditions delivered within ongoing open clinical groups: (a) DMT as Usual (DMT-AU) and (b) a structured dance-based micro-intervention (DMT-MI). Primary outcomes concerned the feasibility of the study protocol, assessed via recruitment, enrolment, retention, adherence, and questionnaire completeness, without evaluating intervention effects. Secondary outcomes concerned the acceptability of the DMT-MI, assessed through session ratings and semi-structured interviews with patients and dance movement therapists.</p><p><strong>Results: </strong>All feasibility indicators suggested that the comparative study protocol could be implemented in a real-world clinical setting and that the DMT-MI intervention was acceptable to both patients and therapists. Of the 27 eligible patients, 20 consented to participate (74.1%). Of these included patients19 completed the study (95.0%). Eighteen participants (90.0%) attended both intervention sessions, and 19 (95.0%) participated in the DMT-MI session. Questionnaire return was 100%, with 96% item-level completeness. Semi-structured interviews were completed with all patients (19/19) and both therapists (2/2).</p><p><strong>Conclusions: </strong>A within-subject comparative study protocol and structured DMT micro-intervention were feasible and acceptable when implemented within ongoing DMT group treatment for adults diagnosed with PD in a clinical setting. These findings can inform the design of future controlled trials. Future studies should address recruitment challenges arising from slow and unpredictable patient flow in long-term treatment programs and consider the high diagnostic heterogeneity and comorbidity within PD populations when planning sample sizes and study designs.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13185333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147639568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Equality Health-CVD intervention: protocol for a feasibility study of a home-based multi-component cardiovascular support intervention.","authors":"Anna Pennington, Kelly Morgan, Jonathan Hewitt, Tracy Daszkiewicz","doi":"10.1186/s40814-026-01819-5","DOIUrl":"10.1186/s40814-026-01819-5","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular diseases comprise a range of conditions affecting the heart and blood vessels, with numerous underlying modifiable determinants that raise the risk of heart disease, stroke, and peripheral vascular disease. Many of these risk factors could be mitigated through community-based health improvement interventions, which include physiological assessments, health behaviour coaching, psychosocial factors, and wider determinants of health support. Despite their potential, such interventions are seldom integrated into standard secondary care provision. This feasibility study aims to assess the feasibility and acceptability of the equality health-cardiovascular disease (Equality Health-CVD) intervention, a 12-week, place-based intervention for patients with vascular disease.</p><p><strong>Methods: </strong>The study will use a single-arm 12-week pilot study based in Wales, UK. A total of 20 participants will be recruited. Quantitative data (questionnaire and physical health assessments) will be collected at week 1 (baseline) and week 12. Questionnaires will include PROMIS 10, South Wales Social Wellbeing Scale and EuroQol-5D tools. Health assessments will collect data on body mass index, waist circumference, heart rate and blood pressure. One-to-one interviews will be conducted with a sub-sample of participants (n = 10-15) and intervention deliverers (n = 2). Data on participant recruitment and retention and the fidelity of intervention implementation will also be collected.</p><p><strong>Discussion: </strong>This study will provide important findings on the feasibility and acceptability of the Equality Health-CVD. Findings are critical for guiding future directions on intervention implementation and efficacy.</p><p><strong>Trial registration: </strong>ISRCTN11889657.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13185328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147639522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pre-SAFEx: protocol for a single-centre, randomised, unblinded feasibility trial of Simultaneous Application of Flow at Extubation (SAFEx) in patients requiring intubation and ventilation for the management of acute respiratory failure.","authors":"Duncan G Thomson, Glasiele C Alcala, Malcolm J Watson, Malcolm A B Sim","doi":"10.1186/s40814-026-01817-7","DOIUrl":"10.1186/s40814-026-01817-7","url":null,"abstract":"<p><strong>Background: </strong>Failed extubation within critical care is associated with increased morbidity and mortality. Although the role of high-flow nasal therapy (HFNT) has been established post-extubation, it is not clear whether the delay in establishing HFNT after extubation adversely affects lung physiology, resulting in an increased risk of extubation failure. Early administration of HFNT may prevent lung derecruitment and reduce the rate of extubation failure. Electrical impedance tomography (EIT) is a non-invasive, non-ionising imaging method that allows continuous real-time measurement of lung physiology.</p><p><strong>Methods: </strong>This is a single-centre, unblinded, randomised feasibility trial. Patients who have required intubation and ventilation for the management of acute respiratory failure will be recruited from the critical care unit at Queen Elizabeth University Hospital, Glasgow, Scotland. At the time of their planned extubation, patients will either be randomised to SAFEx extubation (where HFNT is established pre-extubation) or to standard care (where low-flow conventional oxygen therapy is established post-extubation). EIT will be used to compare the lung physiology of these two extubation strategies.</p><p><strong>Discussion: </strong>This randomised feasibility trial will provide the relevant information to determine whether a multi-centre feasibility study comparing a SAFEx extubation against standard care is viable. It will also determine the feasibility of using EIT as a measure of changes in lung physiology peri-extubation. As extubation failure remains a significant burden for critical care services, with an associated lack of evidence addressing the impact that the oxygen delivery device has on the outcome of extubation in high-risk patients, this study aims to take the first step in addressing this important research question.</p><p><strong>Trial registration: </strong>ClinicalTrials.Gov.</p><p><strong>Registration number: </strong>NCT05904652. Date of registration: 2023-06-15. https://clinicaltrials.gov/.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13185409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147639550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"m-Lifestyle Intervention for Employees (m-LIfE): protocol for a pilot cluster randomized controlled trial on cardiovascular disease prevention strategies.","authors":"Samina Akhtar, Zainab Samad, Gerald S Bloomfield, Khairulnissa Ajani, Salim S Virani, Safia Awan, Aysha Almas","doi":"10.1186/s40814-026-01815-9","DOIUrl":"10.1186/s40814-026-01815-9","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiovascular diseases (CVDs) are the leading cause of mortality globally. Developing countries, including Pakistan, face a significant burden of CVD risk factors. Mobile health (mHealth) interventions have shown potential in promoting physical activity (PA) and reducing sedentary behavior; however, their use in CVD risk prevention, particularly among high-risk, urban sedentary employees remains underexplored. This study aims to develop and evaluate the feasibility and potential efficacy of a mobile-based Lifestyle Intervention for Employees (m-LIfE) to improve PA among sedentary bank employees in Karachi, Pakistan.</p><p><strong>Methods and analysis: </strong>A multiphase-sequential design will be conducted in two phases across branches of three commercial banks (one public and two private) in Karachi. In phase 1, a cross-sectional study will be conducted to estimate 10-year and lifetime risk for CVD events among bank employees, followed by focus groups discussions and interviews to explore employees' awareness, perceptions, and preferences regarding CVD prevention. These findings will inform the development of the m-LIfE app using a human-centered design (HCD) approach. In phase 2, a pilot cluster randomized controlled trial will be conducted to assess the feasibility (primary outcome) and potential efficacy of m-LIfE on PA (secondary outcome) over 12 weeks, with a 4-week post-intervention follow-up. Bank branches will serve as clusters, with four randomized to m-LIfE and four to routine care. The m-LIfE app will deliver healthy lifestyle content for behavior change, and routine-care participants will receive paper-based educational pamphlets on CVD prevention.</p><p><strong>Discussion: </strong>m-LIfE will use an HCD approach to co-create the intervention with participants, ensuring contextual relevance and addressing barriers faced by sedentary employees. This approach complements global evidence while accounting for unique cultural, organizational, and individual factors shaping lifestyle behaviors in Pakistan.</p><p><strong>Trial registration: </strong>This trial was registered with ClinicalTrials.gov on 20th May 2025 (Identifier: NCT06981247).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13220611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147633528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Examining the feasibility and preliminary effects of eyes-open and eyes-closed backward treadmill training on balance, mobility, and fear of falling in sub-acute stroke survivors: a pilot randomized clinical trial.","authors":"Nawaj Mehtab Pathan, Rahul Saxena, Chandan Kumar","doi":"10.1186/s40814-026-01810-0","DOIUrl":"10.1186/s40814-026-01810-0","url":null,"abstract":"<p><strong>Background: </strong>Gait impairment among stroke survivors is a prevalent and significant issue that necessitates appropriate rehabilitation interventions to address multiple factors such as muscle strength, balance, and coordination. One recommended approach for improving gait function is physical therapy, which helps to improve strength, balance, and coordination by reducing muscle weakness, spasticity, and tone. Other intervention ns that have demonstrated efficacy in improving gait function and mobility among stroke survivors include task-specific, high-velocity gait training. The effects of backward treadmill training were comparable to or superior to those of forward treadmill training in improving balance, gait speed, and stride length. Backward treadmill training can be considered a potential rehabilitation intervention for stroke survivors with gait impairments.</p><p><strong>Methods: </strong>This study will be a two-arm, double-blinded, 4-week pilot, randomized clinical trial involving 4-week interventions and 2 weeks follow-up. Forty subacute stroke survivors will be recruited from a tertiary care hospital in India. The study participants will be randomized to either the eyes-open backward treadmill training group (EOBT; n = 20) or eyes-closed backward treadmill training group (n = 20). The participants in both groups will receive 4-week interventions in addition to standard care. Standard care consists of self-management exercises printed in a booklet.</p><p><strong>Discussions: </strong>The primary outcomes will include a series of feasibility assessments of the study protocols in relation to the study's methodological procedures, including subject recruitment and follow-up processes, completion of study protocols, and feasibility acceptability and safety of the intervention such as balance, gait, and fear of falling, which will be evaluated using the Berg Balance Scale, Timed Up and Go Test, and Fall Efficacy Scale.</p><p><strong>Trial registration: </strong>CTRI/2023/08/056653 (21/08/2023) Ethical approval was obtained from the Institutional Ethical Committee of Sharda University (Ref No-SU/SMS&R/76-A/2022/73). The results of this research will be presented at conferences and disseminated through scientific journals that are subject to peer review.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13182127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147632737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A machine learning approach to using ultrasound for body composition and nutritional status assessment in newborns: a pilot study protocol.","authors":"Bryan J Ranger, Marisa Albert, Ji In Kim, Hayoung Cho, Julie Hohenberg, Keshi He, Donglai Wei, Melkamu Berhane, Tsinuel Girma, Judy Estroff, Katherine A Bell, Jinhee Park","doi":"10.1186/s40814-026-01814-w","DOIUrl":"10.1186/s40814-026-01814-w","url":null,"abstract":"<p><strong>Background: </strong>Accurate assessment of infant body composition, specifically fat and fat-free mass, is crucial for evaluating growth and nutritional status. Existing methods, such as air displacement plethysmography and dual-energy X-ray absorptiometry, are expensive, require specialized facilities, and demand trained personnel. Ultrasound offers a promising alternative as a portable, low-cost tool capable of distinguishing adipose tissue from skeletal muscle. However, its feasibility for widespread use in diverse clinical settings remains uncertain. This pilot study aims to assess the feasibility, acceptability, and reliability of an ultrasound scanning protocol for measuring body composition in infants while establishing a foundation for artificial intelligence (AI)-enabled analysis to enable whole-body composition estimation from ultrasound images.</p><p><strong>Methods: </strong>We will recruit 50 infants (20 preterm and 30 full-term infants) from two sites: Brigham and Women's Hospital (Boston, MA, USA) and Jimma Medical Center (Jimma, Ethiopia). Feasibility will be assessed through metrics such as recruitment rates, scan completion, and session duration. Acceptability will be measured using clinician feedback, and reliability will be evaluated using intra-class correlation coefficients (ICCs) for ultrasound image acquisition. A comprehensive database of ultrasound images and corresponding body composition metrics will be developed, forming the foundation for training AI models. Preliminary machine learning (ML) models, including convolutional neural networks (CNN), will be developed to predict body composition. The accuracy of these models will be evaluated using metrics such as root mean squared error (RMSE), mean absolute percent error (MAPE), mean absolute error (MAE), and mean squared error (MSE).</p><p><strong>Discussion: </strong>This study will determine the feasibility of integrating ultrasound-based body composition assessment into neonatal clinical workflows as a potential future application. We will evaluate protocol adherence, scan reliability, and clinician and family acceptability to guide further protocol optimization. Findings will inform the design of a larger-scale study and contribute to refining AI models for clinical use. Ultimately, this approach aims to improve the accessibility, accuracy, and efficiency of body composition assessments, particularly in low-resource settings, where it could enable frontline healthcare workers to perform these assessments without specialized training, improving care for vulnerable infants.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13188397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147623612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A feasibility randomised controlled trial of Empowered Conversations: training family carers to enhance their relationships and communication with people living with dementia.","authors":"Lydia Morris, Cassie Eastham, Chris Sutton, Yeliz Prior, Yvonne Sylvestre, Gemma Shields, John Keady, Cathy Riley, Mal Walters, Warren Mansell","doi":"10.1186/s40814-026-01799-6","DOIUrl":"10.1186/s40814-026-01799-6","url":null,"abstract":"<p><strong>Background: </strong>The primary objective of this UK-based trial was to investigate the feasibility of conducting a multi-centre randomised controlled evaluation trial of Empowered Conversations (EC). EC is a 6-session group psychosocial intervention for informal (family) care partners of people living with dementia. The two key feasibility objectives were to establish whether recruitment levels and retention to follow-up were sufficient for a multi-centre evaluation trial to be feasible. Secondary objectives were as follows: to estimate potential effectiveness on a range of candidate primary outcome measures and their standard deviations; to identify the most appropriate primary outcome measure for a multi-centre evaluation trial; to obtain additional evidence regarding proof of concept; to establish the optimum way of evaluating cost-effectiveness in the evaluation trial.</p><p><strong>Methods: </strong>The feasibility trial used a pragmatic data-collector blind parallel two-group RCT design with two arms (EC intervention plus treatment as usual, and treatment as usual waitlist control). There was a 2:1 allocation in favour of the EC arm. Participants completed baseline outcome measures including measures of their psychological health, quality of life and service use. These were repeated after 6 months.</p><p><strong>Results: </strong>Seventy-five care partners were recruited. The average number of people randomised per month was 8.9, consistent with the pre-specified average recruitment rate of 6 to 10 carers per month sufficient for proceeding to a multi-centre trial. A total of 58 (77%) participants were retained at 6 months follow-up meeting the amber stop-go criterion (65%-<80%; green ≥ 80% retention).</p><p><strong>Conclusion: </strong>The trial indicated the feasibility of progressing to an evaluation trial of EC. Recruitment was at a sufficient level for a multi-centre trial across three proposed sites. Retention to follow-up was close to the green criterion, and ways of increasing retention in the evaluation trial have been identified.</p><p><strong>Trial registration: </strong>ISRCTN15261686; Registered 02/03/2022 https://www.isrctn.com/ISRCTN15261686.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169528/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147593834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility and signals of efficacy of the Type 1 Diabetes Education and Support (T1DES) intervention to improve diabetes distress and glycemic levels among Black young adults with type 1 diabetes compared to standard diabetes education: study protocol for a randomized pilot trial.","authors":"Teaniese L Davis, Courtney McCracken, Lawrence Fisher, Ilana Graetz, Joshua Barzilay, Priyathama Vellanki, J Sonya Haw, Laura Gonzalez Paz, Rachel Wolf, Mackenzie Crawford, Marsha Wright, Fiona Bock, Swathi Sekar","doi":"10.1186/s40814-026-01776-z","DOIUrl":"10.1186/s40814-026-01776-z","url":null,"abstract":"<p><strong>Background: </strong>Diabetes distress, the negative emotional impact of living with diabetes, is associated with suboptimal outcomes, including higher HbA_1c, poorer self-management, and reduced quality of life, and contributes to disparities between Black and White patients with type 1 diabetes (T1D). Young adults may be particularly vulnerable to diabetes distress. Young Black adults therefore may benefit from tailored, representative, and inclusive interventions. Yet, few interventions have been designed to center the experiences of diabetes distress among Black young adults with T1D.</p><p><strong>Methods: </strong>OnTrack, an evidence-based diabetes distress group intervention, was adapted with input from an advisory board comprised of Black young adults to be culturally appropriate for Black young adults (ages 18-30 years) with T1D. The adapted intervention, called Type 1 Diabetes Education and Support (T1DES), will be tested in this pilot randomized trial to assess the feasibility of T1DES in two distinct healthcare systems: an integrated care system and a safety net care system. Participants will be stratified by site and randomized into the intervention condition (T1DES, n = 40, 20 per site) or an attention control condition providing a traditional diabetes education program not focused on distress (StreamLine, n = 40, 20 per site). Both conditions will include five workshop sessions over 3 months. Feasibility outcomes will include an assessment of intervention acceptability, demand, practicality, fidelity, and economic feasibility. Signals of efficacy will be assessed by changes in diabetes distress (self-reported), diabetes management skills (self-reported), and glycemic control (HbA_1c) between study arms, which will be collected at baseline and 3 months post intervention and 6 months post intervention.</p><p><strong>Discussion: </strong>Black young adults with T1D face unique needs and challenges that need to be considered when providing diabetes support. Interventions that tailor content to represent the experiences of Black young adults have the potential to reduce diabetes distress and HbA_1c and improve diabetes management. If successful, the T1DES intervention could be disseminated to support the long-term goal of improving diabetes outcomes and reducing healthcare disparities in this population.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05735340. Registered on 2023-2-9.</p><p><strong>Clinicaltrials: </strong>gov NCT06494722. Registered on 2024-7-9.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147593847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A co-created randomised controlled feasibility trial of a peer-led complex oral health intervention in UK secondary schools: the RAISED In Yorkshire RiY study protocol.","authors":"Yasmen Elsadek, Aruche-A-Noor Hamid, Poonam Anand, Lucy Simpson, Holly Davis, Flavian Kow, Neha Mehta, Nina Fraser, Abigail Turner, Minnie Lyons-Coleman, David Cooper, Sue H Pavitt","doi":"10.1186/s40814-026-01804-y","DOIUrl":"10.1186/s40814-026-01804-y","url":null,"abstract":"<p><strong>Background: </strong>Tooth decay in secondary school children is one of the most prevalent non-communicable diseases in the UK and globally. Whilst almost entirely preventable, oral health inequalities remain a significant public health problem to reach and manage those most vulnerable. School-based prevention strategies targeted to localities with oral health inequality, and incorporating peer-to-peer interventions warrant further evaluation. These peer-to-peer interventions have a bidirectional benefit and are proposed to positively influence both the 'peer leader' and 'peer recipient'; they rely on shared cultural backgrounds and relatability to reach students that may be missed by typical healthcare professional-led interventions. This protocol describes a feasibility trial which aims to establish RAISED in Yorkshire with its peer-to-peer delivery model within the secondary school setting supported by newly qualified dentists as an effective and sustainable approach to improve oral health awareness, skills (toothbrushing) and behaviours in adolescents from underserved at-risk communities.</p><p><strong>Methods: </strong>This is a UK school-based, assessor-blinded, parallel two-arm randomised controlled feasibility trial with a preliminary interim assessment in advance of progression to a larger scale trial in the future. The trial aims to recruit n = ~240 11-13-year-old participants and n = ~50 16-18-year-old peer leaders across five schools/colleges in West Yorkshire. The primary outcomes are related to feasibility in terms of recruitment and retention of participants, and the ability to deliver the intervention. The secondary outcomes include the oral health of participants (knowledge, attitudes and behaviour, plaque and gingival index) and process evaluation.</p><p><strong>Discussion: </strong>The findings of the feasibility trial will dictate whether the project is scalable and can be delivered to multiple schools regionally and nationally. The findings will also show whether it is an effective method to provide oral health education for 11-13-year-old adolescents when delivered collaboratively by trained 16-18-year-old peer leaders.</p><p><strong>Trial registration: </strong>ISRCTN registry, ISRCTN83511912. Registered on 8 August 2024, https://www.isrctn.com/ISRCTN83511912 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13162352/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147593813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of high-intensity interval training in older adults with HIV and co-occurring hypertension.","authors":"Michael J Hankes, Taylor L Taylor, Emily L Zumbro, Ene M Enogela, Fitzgerald Dodds, McKenna Tharpe, Silvienne C Sint Jago, Burel R Goodin, Amanda L Willig, Thomas W Buford, Raymond Jones","doi":"10.1186/s40814-026-01812-y","DOIUrl":"10.1186/s40814-026-01812-y","url":null,"abstract":"<p><strong>Background: </strong>As life expectancy for people living with HIV (PWH) has increased, there has been a rise in age-related comorbidities such as hypertension. Exercise is an important nonpharmacological strategy to counter such adverse effects of chronic HIV infection. High-intensity interval training (HIIT) has been demonstrated to be safe and efficacious in improving health outcomes in individuals with chronic illness, but data are limited in older PWH and co-morbid conditions. The primary objective of this pilot feasibility study was to assess the feasibility, efficacy, and safety of a 6-week HIIT intervention among older PWH and co-occurring hypertension.</p><p><strong>Methods: </strong>PWH were recruited from a local HIV/AIDS Clinic for a 6-week, center-based HIIT exercise intervention involving twice-weekly aerobic exercise on an upright cycle ergometer, monitored by exercise physiologists. The primary endpoint of the study was the feasibility (e.g., consent rate, attendance, adherence, dropout rate) and participant perceived benefits and barriers assessed via the Exercise Benefits and Barriers Scale. Additional endpoints included cardiorespiratory fitness (6-min walk test [6MWT]), changes in blood pressure (BP), anthropometrics (body mass index [BMI]), and ratings of pain.</p><p><strong>Results: </strong>A total of 26 PWH were contacted, and 13 agreed to participate and were enrolled in the study. Ten of the 13 participants (76.9%) completed the study, and, on average, the completers were 60.5 years old, 50% Black, and 60% male. Reasons for dropping out of the study include the following: (1) foot pain; (2) distance; and (3) time commitment. Feasibility outcomes were as follows: 50% consent rate; 86.7% attendance rate, 100% protocol adherence; 23.1% dropout rate. The participants perceived exercise more positively and perceived fewer barriers to exercise following the exercise intervention. BP and BMI both decreased following the intervention, while distance walked during the 6MWT declined following the intervention.</p><p><strong>Conclusions: </strong>Overall, this pilot feasibility study suggests that a short-term exercise program is feasible for older PWH and co-occurring hypertension and may improve BP, BMI, and perceptions of exercise. While the program was safe and participants showed some improvements, incorporating approaches to enhance recruitment and adherence is critical. These preliminary findings are exploratory and descriptive in nature and support the need for larger, randomized trials with longer follow-up.</p><p><strong>Trial registration: </strong>The trial is registered on ClinicalTrials.gov (NCT06888596). Retrospectively registered March 13, 2025.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13162456/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147593864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}