Pilot and Feasibility Studies最新文献

{"title":"Education and Music Intervention to Reduce Anxiety (EMIRA) in cardiac catheterization: intervention development.","authors":"Letícia de Carvalho Batista, Marina de Góes Salvetti, Rita de Cassia Gengo E Silva Butcher","doi":"10.1186/s40814-025-01663-z","DOIUrl":"10.1186/s40814-025-01663-z","url":null,"abstract":"<p><strong>Background: </strong>Anxiety related to cardiac catheterization (ARCC) is highly prevalent and most severe in the immediate preoperative period. ARCC is associated with increased myocardial oxygen consumption, blood pressure variability, and increased risk of arrhythmias, leading to higher rates of intraoperative complications and worse physical, emotional, and cognitive functioning.</p><p><strong>Objective: </strong>To describe a nurse-led complex intervention (CI) designed to reduce ARCC in adults before a cardiac catheterization (CC).</p><p><strong>Methods: </strong>To design the intervention, a concept analysis yielded the identification of ARCC antecedents and attributes, based on which CI components and objectives were determined. For each component, CI procedures, mode of delivery, and dose were established based on empirical evidence. The CI was reported according to the Template for Intervention Description and Replication checklist.</p><p><strong>Results: </strong>The Education and Music Intervention to Reduce Anxiety (EMIRA) consists of two components. The educational component provides the essential information regarding CC purpose, catheterization laboratory features, and what to expect before, during, and after the procedure. The musical component provides individuals with a feeling of comfort and relaxation. EMIRA is delivered in one 30-min session using an audiovisual format. EMIRA's expected primary outcome is a decreased state anxiety level. Additionally, EMIRA might reduce blood pressure, heart and respiratory rates, and chest pain.</p><p><strong>Conclusions: </strong>EMIRA is a CI developed with methodological rigor. Future studies should evaluate the acceptability, feasibility, and efficacy of EMIRA.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"80"},"PeriodicalIF":1.5,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12142818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144249236","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":"Infant Parent Support (IPS): a multidisciplinary intervention to improve the mental health of children with a social worker - a study protocol for a feasibility randomised controlled trial with embedded process evaluation.","authors":"Jaycee Pownall, Karen Crawford, Lindsay Dalgarno, Judith Fisher, Sharon Graham, Fiona Turner, Helen Minnis, Kathleen Boyd, Abril Seyahian, Alex McConnachie, Nicola Cosgrave, Matt Forde, Carol Atkinson, Janet McCullough, Kapil Sayal, Dennis Ougrin","doi":"10.1186/s40814-025-01616-6","DOIUrl":"10.1186/s40814-025-01616-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In many families where children have a social worker, parents have experienced challenges in their own childhoods or have neurodevelopmental conditions. These families often endure significant stress, which is frequently worsened by financial or housing challenges. This added pressure can strain relationships and increase the risk of child maltreatment, as well as contribute to mental health issues in children. Relationship-focused interventions show promise in preventing child maltreatment, although there are currently no interventions that simultaneously address neurodevelopmental conditions and the impact of poverty. We have co-produced, alongside parent experts-by-experience, local stakeholders, and infant mental health practitioners, a new service called Infant Parent Support (IPS). IPS will i) adopt a relationship-focused approach to comprehensive understanding of family functioning, ii) incorporate child and parent mental health and neurodevelopmental awareness, and iii) ensure a poverty aware approach throughout. The aim of this phase is to investigate the feasibility of a definitive Randomised Controlled Trial (RCT) of IPS compared with services-as-usual (SAU).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study settings are social care services in two local authorities: Glasgow City Council (Scotland) and the London Borough of Bromley (England). Our target population is children on a 'child in need' plan (or the Scottish equivalent) and eligible participants are families where i) the infant(s) are aged 0-5 years and ii) the family has an allocated social worker plus a multi-agency support plan. Thirty participants will be identified by social workers and randomised to receive either IPS or SAU. Families randomised to IPS will receive an intensive multidisciplinary attachment-focused assessment that provides a foundation for relationship-focused interventions. IPS will incorporate child and parent mental health and neurodevelopmental awareness and ensure a poverty aware approach throughout. Families randomised to SAU will receive the assessment and support that social care services normally implement. We will utilise a pre-post and 3/6-month follow-up design with embedded mixed-method process evaluation and exploratory economic analysis. The primary objective is to assess if enough families can be recruited, randomised, and retained in the trial such that a full-scale RCT is likely to be feasible. The secondary objectives are to assess the acceptability and feasibility of the planned outcome measures and the IPS intervention to families and professionals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;A service like IPS, that uses a relationship-focused approach to child and parent mental health, neurodevelopmental and money/housing problems, has never previously been tested. Therefore, there are several areas of uncertainty that need to be addressed before moving onto a definitive RCT. TRIAL REGISTRATION {2A AND 2B}: Register","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"78"},"PeriodicalIF":1.5,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12139322/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144234735","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":"Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial.","authors":"Rachael Nugent, Caroline de Costa, Leonie Callaway, Shiv Erigadoo, Elise Gilbertson, Chris Brown, Joanna Perry-Keene, Rebekah Shakhovskoy, Lauren Kearney","doi":"10.1186/s40814-025-01645-1","DOIUrl":"10.1186/s40814-025-01645-1","url":null,"abstract":"<p><strong>Background: </strong>Obstructive sleep apnoea (OSA) is associated with increasing body mass index (BMI) and affects up to 15% of pregnant women. OSA in pregnancy can be associated with adverse maternal and neonatal outcomes. Continuous positive airway pressure (CPAP) may be an effective treatment for OSA during pregnancy.</p><p><strong>Aim: </strong>To examine the feasibility and acceptability of screening women with a BMI ≥ 35 kg/m² for OSA in pregnancy, followed by randomisation to treatment with CPAP or no CPAP for women diagnosed with moderate to severe OSA.</p><p><strong>Methods: </strong>This study was a single-centre, two-stage pilot study. Firstly, all consenting participants were screened for OSA and then, only if diagnosed with moderate to severe OSA (AHI ≥ 15), randomised to CPAP or no CPAP. The feasibility of the OSA screening was determined by recruitment rates. A priori criteria of > 20% recruitment to the sleep study were considered feasible. The acceptability of the sleep study was examined using the completion rate and reasons for withdrawal prior to the sleep study. The acceptability of CPAP randomisation was assessed by completion rates for women randomised, adherence to CPAP, reasons for withdrawal, and the review of quality-of-life measures over the course of pregnancy.</p><p><strong>Results: </strong>Ninety-six women with a BMI ≥ 35 kg/m² before 26 completed weeks of pregnancy were invited to participate from the Sunshine Coast University Hospital and Health Service. Overall, 36 women enrolled, giving a recruitment rate of 37%. A total of 75% (n = 26) of recruited women completed OSA screening (clinical history, questionnaires, and formal sleep study). Subsequently, six (6%) of invited women had an apnoea hypopnoea index (AHI) ≥ 15/h and were diagnosed with moderate to severe OSA and underwent randomisation to receive treatment with CPAP (n = 4) or no CPAP (n = 1) until birth. One woman withdrew after randomisation to treatment. Nine women withdrew prior to full completion of OSA screening and one following an inconclusive sleep study. Women who had a sleep study found it acceptable, and in women randomised to CPAP, adherence averaged 4.86 h/night. Quality-of-life measures were similar when measured over two time points in pregnancy.</p><p><strong>Discussion: </strong>A definitive trial screening women for OSA and subsequent randomisation to treatment or no treatment may be feasible. Future trials should be resourced to expand inclusion criteria, improve accessibility for participants, evaluate clinical and cost-effectiveness, and investigate partial treatment effects.</p><p><strong>Trial registration: </strong>ACTRN, ACTRN12621001523897. Registered 9 September 2021 - retrospectively registered, https://www.anzctr.org.au/Trial/Update/Step8_Update.aspx?id=382640.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"79"},"PeriodicalIF":1.5,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12139340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144234813","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":"Results from a randomized controlled pilot trial of a home-visiting intervention to reduce child maltreatment.","authors":"Joakim Finne, Anne Grete Tøge, Kjersti Stabell Wiggen, Maria Ekre, Ira Malmberg-Heimonen, Maiken Pontoppidan, Jacinthe Dion, Truls Tømmerås, Eirin Pedersen","doi":"10.1186/s40814-025-01659-9","DOIUrl":"10.1186/s40814-025-01659-9","url":null,"abstract":"<p><strong>Background: </strong>Child maltreatment has severe and lasting consequences, and evidence-based interventions are essential for its prevention. However, few randomized controlled trials (RCTs) have been conducted within child welfare settings in Norway. Pilot trials play an important part in assessing the acceptability and feasibility of such interventions prior to full scale evaluations. This study evaluated the acceptability and feasibility of conducting a full-scale RCT of the Family Partner home-visiting intervention, designed to reduce the risk of child maltreatment.</p><p><strong>Methods: </strong>Families from three child welfare offices in Norway with at least one child under the age of 12 were invited to participate in this pilot trial. A two-arm randomized design was used, with participants allocated in a 1:1 ratio to either the intervention or control group (n = 45). The intervention group received the home-visiting Family Partner intervention, while the control group received treatment as usual. A qualitative process evaluation was conducted alongside the trial, comprising 29 interviews with Family Partners, caseworkers, participating families, and other stakeholders. Statistical and qualitative analyses evaluated participant acceptability, adherence, and retention.</p><p><strong>Results: </strong>Qualitative findings indicate a high level of acceptability for the Family Partner intervention across all stakeholder groups. Adherence was strong, with no participants withdrawing consent and only two opting out of subsequent surveys. However, participant retention declined over time, with survey response rates dropping at each time point and only 42% completing the final assessment.</p><p><strong>Conclusions: </strong>This pilot trial provides preliminary evidence supporting the acceptability of the Family Partner intervention within child welfare services and highlights important considerations regarding the feasibility of conducting RCTs in this setting.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT04957394.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"77"},"PeriodicalIF":1.5,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144216597","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 co-creating and delivering a youth-led noncommunicable diseases risk reduction intervention in schools of slums in Karachi, Pakistan: protocol for a mixed-methods, pre- and post-intervention study.","authors":"Sabahat Naz, Munazzah Ilyas, Romaina Iqbal","doi":"10.1186/s40814-025-01662-0","DOIUrl":"10.1186/s40814-025-01662-0","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Adolescents are more susceptible to the shared risk factors of noncommunicable diseases (NCDs), including physical inactivity, tobacco use (smoking and smokeless), and unhealthy diets. However, there is limited literature from Pakistan that involves school-going adolescents in developing and delivering NCD risk-reduction interventions among their younger peers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to assess the feasibility of co-creating and delivering a youth-led NCD risk reduction intervention in schools of slums in Karachi, Pakistan.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using a mixed-methods, pre- and post-intervention design approach, we will conduct the study in 10 randomly selected schools (5 government and 5 private) in Azam Basti and Mehmoodabad, the urban slums in Karachi. The study comprises five sequential phases: Phase I involves identifying shared risk factors of NCDs among younger peers aged 9 to 12 (grades 5 and 6 students) (n = 100) using structured diaries, which will also serve as a pre-intervention assessment. Phase II entails conducting qualitative interviews with youth aged 14 to 16 (grades 9 and 10 students) (n = 40), their parents, school head teachers, class teachers, and canteen staff to discuss intervention components, materials, and delivery methods. In Phase III, workshops will be held to co-create the intervention with the help of youth. Phase IV will involve 3 days of comprehensive youth training by a qualified nutritionist on delivering the intervention to their younger peers. Finally, in Phase V, youth will deliver the intervention among all grades 5 and 6 students in their schools, followed by a post-intervention assessment, in which the younger peers will complete the structured diaries for the shared risk factors. Two independent data collectors will also perform fidelity checks of the intervention delivery using a checklist. The expected outcomes will include the feasibility of developing and implementing a culturally relevant youth-led NCD risk reduction intervention and youth training manual. The feasibility of the intervention will be assessed using the recruitment and retention rates for schools, youth, and younger peers, youth attendance at workshops and training sessions, structured diaries completion rates at pre- and post-intervention, the fidelity of delivering the intervention, and the preliminary change in the risk factors at post-intervention compared to the baseline.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;The study was approved by the Ethical Review Committee of the Aga Khan University (ref.: 2024-9763-29,256). If the intervention proves feasible, we will disseminate our findings to both academic and nonacademic audiences. Additionally, we will implement a definitive trial across various slum settings in Karachi, Pakistan.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov, NCT06465771. Registered 20 June 2024-prospectively registered,  h","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"76"},"PeriodicalIF":1.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131587/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209169","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":"EmpowerHer-a smoke-free future: a feasibility study examining the feasibility and acceptability of a culturally concordant tobacco treatment intervention in African American women.","authors":"Lisa Carter-Bawa, Julia Binstock, Ana Guadalupe Vielma, Elan N Shoulders, Lucile Adams-Campbell","doi":"10.1186/s40814-025-01664-y","DOIUrl":"10.1186/s40814-025-01664-y","url":null,"abstract":"<p><strong>Background: </strong>Tobacco use remains the leading preventable cause of disease and death in the USA. African Americans face a higher cancer mortality rate and disease burden due to modifiable health behaviors. Effective tobacco treatment programs must transition from research to accessible community settings, particularly targeting African American women who smoke. Research supports using motivational interviewing and cognitive-behavioral therapy alongside nicotine replacement therapy for effective tobacco cessation. Culturally tailored interventions can enhance risk perception, readiness to quit, and knowledge about smoking risks.</p><p><strong>Methods: </strong>We piloted the EmpowerHer: A Smoke-Free Future intervention in New Jersey among African American women (N = 22), which involved motivational interviewing, combination nicotine replacement therapy, at-home carbon monoxide testing, and culturally tailored newsletters.</p><p><strong>Results: </strong>The intervention showed high acceptability and satisfaction, with participants scoring a mean of 56.08 (SD = 5.14) out of a maximum possible score of 68 on the acceptability and satisfaction questionnaire, indicating strong endorsement of the intervention's usefulness, relevance, and cultural fit. Participants demonstrated reduced nicotine dependence and carbon monoxide levels, indicating promising reductions in smoking behavior. Median cigarettes smoked per day decreased from 15 to 3, highlighting substantial progress in reducing smoking behavior.</p><p><strong>Conclusions: </strong>This community-based, culturally tailored intervention shows promise in reducing tobacco use among at-risk African American women, filling a critical gap in tobacco treatment options. The positive outcomes suggest increased potential for successful future tobacco cessation efforts in this population.</p><p><strong>Trial registration: </strong>The trial was registered with ClinicalTrials.gov (NCT05878990) on 18 May 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"75"},"PeriodicalIF":1.5,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12125939/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144192068","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":"Development of an intervention to increase HPV vaccine uptake in Colombia.","authors":"Veronica Cordoba-Sanchez, Mariantonia Lemos, Sherri Sheinfeld Gorin","doi":"10.1186/s40814-025-01609-5","DOIUrl":"10.1186/s40814-025-01609-5","url":null,"abstract":"<p><strong>Background: </strong>The Global Strategy for the Elimination of Cervical Cancer as a Public Health Problem proposed a goal of 90% coverage for HPV vaccination in girls between 9 and 14 years of age by 2030. However, despite the efficacy and safety of the vaccine, its coverage in Colombia remains low. The aim of this paper is to provide a detailed description of the creation of a protocol for an intervention to increase HPV vaccine uptake among vaccine-eligible children and adolescents in a school setting.</p><p><strong>Methods: </strong>This intervention development protocol was co-created with nine teachers, five nurses, nine parents, and seven girls in two workshops. Using structured worksheets, the transcripts of the workshops were integrated with the behavioral diagnosis resulting from the COM-B model and the intervention options from the Behavior Change Wheel.</p><p><strong>Results: </strong>The findings suggest that participants want to receive information through different means, according to their age, such as messages and videos from experts on viruses for parents, games and workshops for girls, and testimonials for all. The protocol \"Superprotegidas\" integrates such strategies.</p><p><strong>Discussion: </strong>The co-creation workshop identified the unique information sources and messages among stakeholders in this community. Basing the behavioral analysis on the COM-B model and the interventions on the Behavior Change Wheel undergirds the planned subsequent randomized clinical trial in a larger population.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"74"},"PeriodicalIF":1.5,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12125825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144192067","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 self-care and informal support intervention targeting women with gestational diabetes mellitus in northern Vietnam (VALID-II): a protocol for a two-arm non-randomised feasibility study.","authors":"Ditte S Linde, Hieu M Le, Dung T K Vu, Ngoc-Anh T Dang, Ai T Nguyen, Tuc P Vu, Xuan-Bai Nguyen, Cuong D Nguyen, Dan W Meyrowitsch, Jens Søndergaard, Christina A Vinter, Ib C Bygbjerg, Vibeke Rasch, Thanh D Nguyen, Tine M Gammeltoft, Dang K Nguyen","doi":"10.1186/s40814-025-01657-x","DOIUrl":"10.1186/s40814-025-01657-x","url":null,"abstract":"<p><strong>Background: </strong>Gestational diabetes mellitus (GDM) is a transitory form of diabetes that presents during pregnancy with frequent adverse maternal and neonatal health consequences if left untreated. The prevalence of GDM is rapidly increasing in low- and middle-income countries such as Vietnam, and early sustainable interventions are important. The overall aim of this study-henceforth referred to as VALID-II-is to assess the feasibility of a co-created self-care and informal support intervention targeted at pregnant women with GDM. Further, the aim is to assess the potential efficacy of the intervention in reducing maternal and neonatal health complications compared with standard care.</p><p><strong>Methods: </strong>VALID-II is a two-site, two-arm, non-randomised feasibility intervention study in Thai Binh Province in northern Vietnam with a delayed start for the intervention group. The intervention study is nested in a larger cohort. In total, 2000 pregnant women will be screened for GDM, with an estimated 400 women screening positive according to the World Health Organisation-International Association of Diabetes and Pregnancy Study Group diagnostic criteria. First, 200 women who screen positive for GDM will be assigned to a control group that will receive standard care. Among the 200 women, 20 will take part in an in-depth ethnographic study along with their family members, and the intervention will be co-created with them. Second, once the intervention has been created, 200 women will be assigned to the intervention group, which will receive the intervention plus standard care. Twenty women and their families from the intervention group will also take part in an ethnographic study. The primary outcome is to evaluate how feasible the self-care intervention is (composite outcome: recruitment, retention, and acceptability). Other secondary outcomes include the number of new-borns born large for gestational age, prevalence and risk factors for GDM, self-care agency, self-care, and breastfeeding practices.</p><p><strong>Discussion: </strong>This study provides knowledge of the feasibility of informal/self-care and social support interventions and their preliminary impact on maternal and child health outcomes among women with GDM in northern Vietnam. Furthermore, it will inform parameters such as effect size and variance, which are essential for calculating the sample size needed to achieve the desired power in a future full-scale trial. This may guide decision makers in how to optimise the management of GDM in low- and middle-income contexts.</p><p><strong>Trial registration: </strong>NCT05744856.</p><p><strong>Trial status: </strong>Recruiting.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"73"},"PeriodicalIF":1.5,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12121233/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144182253","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 Prostate cancer-Exercise and Metformin randomised controlled feasibility Trial (Pre-EMpT) in men following active surveillance, radical prostatectomy and radiotherapy.","authors":"Luke A Robles, Lucy McGeagh, Jonathan Aning, Amit Bahl, Amarnath Challapalli, Anthony Koupparis, Raj Persad, Edward Rowe, Constance Shiridzinomwa, Richard M Martin, J Athene Lane","doi":"10.1186/s40814-025-01654-0","DOIUrl":"10.1186/s40814-025-01654-0","url":null,"abstract":"<p><strong>Background: </strong>Moderate to vigorous physical activity and metformin are associated in epidemiological studies with reduced biochemical recurrence and mortality in men with prostate cancer. This study assessed the feasibility of a home-based physical activity and/or metformin intervention in men with non-metastatic prostate cancer following radical treatment (surgery or radiotherapy) or active surveillance.</p><p><strong>Methods: </strong>A 2 × 2 factorial design randomised men into one of four groups for 6 months: (1) physical activity (defined as brisk walking ≥ 30 min for ≥ 5 days per week, aiming for ≥ 10,000 steps a day); (2) metformin (one 500 mg slow-release tablet daily); (3) physical activity and metformin; and (4) control. Men were recruited from a single tertiary referral centre in the South West of England, UK, (September 2018-March 2020 which terminated slightly early due to the COVID-19 pandemic). Co-primary outcomes were rates of randomisation and adherence which was defined as men brisk walking ≥30 minutes on at least 5 days with 10,000 steps daily (measured over one week 6-months after randomisation) with ≥ 60% adherence to metformin between 3- and 6 months post-randomisation using returned pill count. Secondary outcomes included self-reported adverse events and physical activity, feasibility of wearing activity monitors and questionnaire completion.</p><p><strong>Results: </strong>In total, 295 men were eligible and 110 were randomised (37.3%, 95% confidence interval [CI] 31.8 to 43.1). Adherence to the physical activity and metformin interventions was 46.9% (95% CI 32.5 to 62.0) and 47.1% (95% CI 32.9 to 61.5) respectively. Adherence was > 60% for both the physical activity and metformin interventions on a complete case basis. Adverse events were infrequent (n = 7) across randomised groups. Completion of self-reported measures of physical activity, urinary incontinence, sexual function, quality of life and stages of change was over 80%. Step counts were not higher in men wearing activity monitors that alerted them about their step counts and sedentary behaviour. Retention over 6 months was 91.3% (95% CI 84.2 to 96.0). Follow up and intervention prompts were impacted by the pandemic.</p><p><strong>Conclusion: </strong>Home-based physical activity and metformin interventions show some promise for men with prostate cancer following radical treatment or active surveillance.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN13543667. Registered 2 August 2018, https://www.isrctn.com/ISRCTN13543667.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"71"},"PeriodicalIF":1.5,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12103774/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143384","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":"Flash glucose monitoring for Indigenous Australians with type 2 diabetes: a randomised pilot and feasibility study.","authors":"Audrey S Eer, Mariam Hachem, Tracey Hearn, Digsu N Koye, Sharon Atkinson-Briggs, Jessica Jones, Sandra Eades, Sabine Braat, Stephen M Twigg, Ashim Sinha, Anna McLean, Richard C O'Brien, Phillip Clarke, David O'Neal, David Story, Jeffrey D Zajac, Raymond J Kelly, Luke Burchill, Elif I Ekinci","doi":"10.1186/s40814-025-01607-7","DOIUrl":"10.1186/s40814-025-01607-7","url":null,"abstract":"<p><strong>Background: </strong>Flash glucose monitoring (FGM) can improve diabetes management, but no randomised controlled trials (RCTs) of FGM have been undertaken in Indigenous Australian populations. This study aimed to assess the feasibility of performing a RCT of FGM in Indigenous Australians with type 2 diabetes.</p><p><strong>Methods: </strong>In this open-labelled pilot RCT, Indigenous adults with type 2 diabetes were randomised to FGM or standard care for 6 months. Eligible participants were being treated with injectable diabetes medications and had a glycosylated haemoglobin (HbA1c) ≥ 7.0%. The feasibility outcome was the proportion of participants completing the trial, and the primary outcome for the future trial was change in HbA1c from baseline to 6 months. Secondary outcomes included change in time spent in target blood glucose (4.0-10.0 mmol/L), safety (hypoglycaemic episodes), and quality of life (EuroQol 5-dimension 3-level (EQ-5D-3L) score).</p><p><strong>Results: </strong>Of 126 screened individuals, 74 were eligible, 40 (54%) were randomised, and 39 (97.5%) completed the study. Participants' baseline characteristics were similar between the FGM and usual care groups, except for sex and body mass index. No between-group differences were observed for the following: change in HbA1c; percentage of time spent in target blood glucose (4.0-10.0 mmol/L), low glucose (< 3.9 mmol/L), and high glucose (> 15.0 mmol/L); or EQ-5D-3L scores. No severe hypoglycaemic episodes occurred.</p><p><strong>Conclusions: </strong>This is the first pilot RCT of FGM in Indigenous Australians with type 2 diabetes. The results support a larger RCT.</p><p><strong>Trial registration: </strong>Australian New Zealand Clinical Trials Registry (ANZCTR12621000021875), retrospectively registered on 14 January 2021.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"72"},"PeriodicalIF":1.5,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12103807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143383","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}