Pilot and Feasibility Studies最新文献

{"title":"Nonpharmacological multicomponent intervention for mild cognitive impairment with a family-patient approach: protocol for the pilot clinical trial-INTERCOG study.","authors":"Diana Carolina Tiga-Loza, William Armando Álvarez-Anaya, Raquel Rivera-Carvajal, Ariel Calderón Ardila, Jhosman Alfonso Buitrago-Buitrago, Alexander Pabon, Álvaro Castañeda-Hernández, Mabel Margoth Reyes-Pulido, Katherine Prado Guzmán, Hadder Uriel Acosta Salazar, Edwing Alberto Urrea-Vega, Lina María Carreño-Parra, Paul Anthony Camacho","doi":"10.1186/s40814-026-01871-1","DOIUrl":"10.1186/s40814-026-01871-1","url":null,"abstract":"<p><strong>Background: </strong>Given the risk of progression to dementia ranging from 6 to 44.8% over approximately 4 years of follow-up, nonpharmacological multicomponent interventions are emerging as promising strategies to improve or maintain cognitive function and quality of life in individuals with mild cognitive impairment (MCI). This pilot study aims to evaluate the feasibility and potential efficacy of a multicomponent and transdisciplinary intervention focused on the dyad of older adults with MCI-family study partner to promote cognitive function in older adults.</p><p><strong>Methods: </strong>A pilot, randomized, controlled, and double-blind clinical trial will be conducted with 102 dyads consisting of an older adult with MCI and their family study partner. The participants will be randomly assigned to two groups: the intervention group (INTERCOG) and the control group. The INTERCOG group will receive a 12-week home-based intervention (twice weekly) with the support of a healthcare professional. The intervention components consist of cognitive training and stimulation, nutritional counseling, and physical exercises. Simultaneously, family members will participate in a training program on care and self-care. The control group will receive an Enhanced Standard of Care with educational messages on infection prevention. The feasibility of the study will be assessed through an analysis of recruitment, data collection, intervention acceptability, and implementation challenges; also, changes in global cognition and changes in specific cognitive domains will be measured as exploratory results. Secondary outcomes will include changes in health-related quality of life, caregiver burden, social support for family members, as well as changes in functional independence, frailty, physical capacity, family functioning, and nutritional status in patients, with follow-up at 3, 6, and 9 months. In a subsample of 40 participants, the diversity of the gut microbiota will be characterized, and the frequency of the APOE-ε4 allele will be determined.</p><p><strong>Discussion: </strong>Multicomponent and transdisciplinary interventions focused on the family member-patient dyad have the potential to optimize cognitive outcomes and quality of life. This pilot study will allow us to identify key aspects of the feasibility and potential efficacy of INTERCOG intervention, crucial information for the design of future larger-scale studies.</p><p><strong>Trial registration: </strong>NCT06408103. December 6, 2024, at clinicaltrials.gov. In recruitment.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13523507/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148339705","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 pilot study investigating the feasibility of a positive body image yoga intervention for men and women across adulthood.","authors":"Matthieu Dagenais, Shivani Mall, Sean Locke, Phillip Sullivan, Panagiota Klentrou, Kimberley L Gammage","doi":"10.1186/s40814-026-01869-9","DOIUrl":"10.1186/s40814-026-01869-9","url":null,"abstract":"<p><strong>Background: </strong>Yoga interventions have been shown to promote positive body image, although these studies have focused predominantly on young women. The purpose of this pilot study was to evaluate the feasibility and acceptability of a positive body image yoga intervention in a sample of men and women across the adult lifespan and to examine the potential changes in body image following the intervention.</p><p><strong>Methods: </strong>Sixty-two adults (≥18 years of age) who were not engaging in yoga and scored a 4 or lower on a measure of body appreciation (to avoid ceiling effects) were recruited from a small Canadian city. Participants were randomly assigned to an in-person 10-week yoga or waitlist control group. Participants self-reported demographic information; they completed body image measures online at baseline, 5 weeks, and program end. Study adherence, retention, and dropout rates were measured at program end to assess feasibility and acceptability.</p><p><strong>Results: </strong>A total of 195 individuals contacted us with interest in the study, of which 82 (42%) were eligible. Fifty-seven participants were randomized (Mage of the sample was 52 years; 93% identified as White and 86% identified as a woman). Measures of feasibility (4.82/5 yoga, 3.42/5 control), acceptability (4.80/5 yoga, 3.33/5 control), and appropriateness (4.82/5 yoga, 3.35/5 control) supported the feasibility of the intervention condition. Secondary indicators of feasibility were also assessed. Twenty-one participants attended at least one yoga class, with mean attendance at the yoga classes 79%. All classes were delivered as intended. Sixteen (57%) and 18 (62%) participants in the yoga and control group, respectively, completed measures at all three time points. There was a total of 12 dropouts and 11 dropouts in the yoga and control group, respectively. There were improvements in functionality appreciation (η²_p = .168) and body satisfaction with body function (η²_p = .105) in favor of those in the yoga intervention group.</p><p><strong>Conclusions: </strong>This pilot study provided insight into conducting a fully randomized controlled trial of a yoga program to improve positive body image in men and women across the adult lifespan. Although some changes, particularly to the recruitment of men and younger individuals, are necessary in subsequent studies, in general the yoga program was feasible to deliver and acceptable to participants. Changes to the control group to make it more acceptable would be beneficial. Exploratory analysis indicated the program could improve positive body image facets.</p><p><strong>Trial registration: </strong>NCT05899881. First submitted on May 24, 2023. First posted on June 12, 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13573482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148339515","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 single-session consultation to enhance mental health treatment engagement in patients with comorbid physical and mental problems: study protocol for a pilot randomized controlled trial.","authors":"Jacqueline L Tilley, Jia Xin Choon, Sakura Ito, Behram A Khan, Konstadina Griva, Shannon Ang, Luke Kang-Kwong, Jessica L Schleider","doi":"10.1186/s40814-026-01870-2","DOIUrl":"10.1186/s40814-026-01870-2","url":null,"abstract":"<p><strong>Background: </strong>Individuals with chronic physical diseases are at elevated risk of developing mental health disorders. Comorbid chronic physical disease and mental health problems (CPDMHP) are associated with substantial societal and healthcare costs. Although enhancing mental healthcare for this population can improve outcomes, efforts to increase service engagement have had limited success. This study evaluates a Solution-Focused Single-Session Consultation (SF-SSC) as a brief, innovative approach to addressing structural and attitudinal barriers to treatment engagement.</p><p><strong>Methods/design: </strong>The study will comprise two phases: Phase 1 will consist of a prospective cross-sectional study of patients in an outpatient community health setting in Singapore. Participants will complete measures of their sociodemographic characteristics, physical and mental health status (e.g., current and past physical and mental health conditions, and service utilization), and psychosocial indicators (e.g., life satisfaction, hope, readiness for change). Phase 2 will involve a two-arm randomized controlled pilot trial that evaluates the feasibility, acceptability, and preliminary effectiveness of the SF-SSC compared with a single session of supportive therapy (SPT). Up to 60 participants from Phase 1 with elevated depression or anxiety symptoms (PHQ-9 or GAD-7 scores ≥ 5) will be randomized to receive the SF-SSC or SPT intervention. Phase 1 analyses will examine the associations among sociodemographic characteristics, physical and mental health factors, and psychological and psychosocial outcomes. The primary outcomes of Phase 2 will be the feasibility and acceptability of the SF-SSC, assessed by the completion of SF-SSC action plans (with a predefined ≥ 70% threshold) and participant-reported usefulness and satisfaction. The primary clinical/process outcome will be treatment engagement, operationalized as the willingness to be referred and attendance at a subsequent appointment. Exploratory secondary outcomes will include psychosocial constructs that are hypothesized to underlie intervention effects, such as hope, perceived agency, readiness to change, and life satisfaction. Given the pilot nature of the trial, clinical and psychosocial findings will be interpreted as preliminary indicators of potential benefit rather than confirmatory evidence of efficacy.</p><p><strong>Discussion: </strong>Findings from this study will inform future trials examining the large-scale and long-term impact of the intervention. The study will also inform the design of scalable approaches that can be integrated into existing mental healthcare systems to improve mental health service uptake and engagement among individuals with CPDMHP.</p><p><strong>Trial registration: </strong>The trial was retrospectively registered at Clinicaltrials.gov [NCT07116655] on August 11, 2025.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13556082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148331888","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":"Remote versus face-to-face delivery of the Group Triple P parenting programme: a feasibility non-randomised trial.","authors":"Elinor Coulman, Susan Channon, Lauren Copeland, Myrsini Gianatsi, Nina Jacob, Ben Karatas, Stavros Petrou, Rebecca Playle, Michael Robling, Elizabeth-Ann Schroeder, Rory Sheppard, Laura Winney-Jones, Linda Adara, Jeremy Segrott","doi":"10.1186/s40814-026-01861-3","DOIUrl":"10.1186/s40814-026-01861-3","url":null,"abstract":"<p><strong>Background: </strong>Many well-designed parenting interventions have demonstrated effectiveness in improving outcomes for parents and children. During the COVID pandemic, many group-based parenting interventions were rapidly transferred to remote delivery using online videoconferencing platforms. However, the evidence on the effectiveness of remotely delivered group-based parenting programmes, compared to face-to-face programmes, remains inconclusive. This trial aimed to assess the feasibility of delivering the Group Triple P intervention to parents/caregivers of young children to inform a potential, definitive trial of the effectiveness and cost-effectiveness of Group Triple P delivered remotely compared to face-to-face delivery.</p><p><strong>Methods: </strong>This study was a feasibility non-randomised trial, with embedded process evaluation. Parents/caregivers of a child (up to 12 years old) were recruited by Local Authority or independent provider research sites and self-selected remote or face-to-face delivery of the Group Triple P intervention. Data were collected at baseline and 16 weeks follow-up. The following feasibility outcomes were assessed: site recruitment, participant recruitment rates and retention at the 16-week follow-up, intervention adherence, fidelity and reach, feasibility of trial processes and outcome measures (including resource use, cost and health-related quality of life) and Local Authority and independent service provider willingness to participate in a definitive trial.</p><p><strong>Results: </strong>All sites utilised a multi-point participant recruitment strategy, relying on existing pathways to identify families. Only two sites reached participant recruitment targets. Participants' self-selected remote delivery (23 participants) or face-to-face delivery (19 participants) and baseline demographics, except for education level, were balanced across arms. A 66.7% retention rate was observed at 16 weeks. Most trial processes were acceptable to participants and site staff. However, randomisation was not considered acceptable to site staff or 37.5% of participants, due to the removal of participant choice. The intervention was delivered to high fidelity, except for some intervention adaptations. Participant engagement in the remote arm was hampered by inconsistent use of cameras and little interaction between parents and facilitators.</p><p><strong>Conclusions: </strong>A number of barriers to using a randomised trial design were identified. Ongoing research should consider a potential non-randomised definitive trial to assess the use of remotely delivered group-based parenting interventions and to overcome these barriers.</p><p><strong>Trial registration: </strong>ISRCTN81494090, 19/09/2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13374339/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148318536","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":"Weight management in obese cancer patients during curative active treatment: protocol for the CANOBESE feasibility study.","authors":"Aina Llenas-Bladé, Marta Puig Figueras, Carla Padilla Padilla, Anna Esteve, Raul Zamora-Ros, Mireia Daura I Vidal, Cristian Ochoa-Arnedo, Sonia Pernas, Cristina Santos Vivas, Jesús Brenes, Laura Jiménez-Colomo, Leyre Asiain, Ernest Nadal, Lorena Arribas","doi":"10.1186/s40814-026-01868-w","DOIUrl":"10.1186/s40814-026-01868-w","url":null,"abstract":"<p><strong>Background: </strong>Obesity is highly prevalent among patients with cancer and is associated with increased risks of treatment-related complications, poorer oncological outcomes, and long-term morbidity. Despite this, current oncology nutrition guidelines primarily address malnutrition and provide limited direction for clinical management of patients with obesity. Intentional weight loss interventions during cancer treatment are uncommon, partly due to concerns about safety and feasibility. The CANOBESE study aims to address this evidence gap by evaluating the feasibility of implementing a structured, multimodal weight management programme for patients with obesity undergoing curative oncological treatment.</p><p><strong>Methods: </strong>This single-arm feasibility trial will recruit 50 adult patients with a BMI ≥ 30 kg/m² and newly diagnosed stage II-IV solid tumours receiving chemotherapy, radiotherapy, immunotherapy, targeted therapy alone, or in combination with curative intent. The intervention includes a personalized hypocaloric and high-protein diet, a supervised home-based aerobic and resistance exercise programme, and integrated behavioural support delivered throughout the programme, with psycho-oncological input when more intensive individualized support is needed. Follow-up will continue for the duration of active treatment (3-9 months). The study will evaluate feasibility by examining key aspects such as recruitment and retention rates, intervention adherence and fidelity, participant acceptability, and the completeness of data collection throughout the intervention period. Secondary outcomes include exploratory changes in weight, body composition, physical performance, dietary intake, quality of life, and inflammatory biomarkers. The broad eligibility criteria were selected to evaluate feasibility in a pragmatic real-world oncology setting, while predefined exclusions were used to reduce baseline nutritional risk and improve safety.</p><p><strong>Discussion: </strong>The CANOBESE study represents one of the first efforts to assess whether a comprehensive lifestyle intervention can be effectively delivered to patients with obesity during curative cancer treatment. This protocol incorporates patient and public involvement, a multidisciplinary team approach, and real-world implementation considerations. Findings will inform the scalability of the intervention, characterize implementation challenges across a pragmatic oncology population, and guide the design of a future randomized controlled trial. The study is not intended to provide subgroup-specific clinical recommendations, but to generate feasibility data that may help refine tailored approaches to intentional weight management in oncology settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT07058207. Registered on 9 July 2025. https://clinicaltrials.gov/study/NCT07058207 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13551854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148318518","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 'Nature Impact' feasibility study protocol: a mixed methods feasibility study of a group- and nature-based health intervention for adults experiencing mild to moderate anxiety, depression and/or stress.","authors":"Signe Salanson Jensen-Smidt, Louise Sofia Madsen, Lisa Gregersen Oestergaard, Dorthe Varning Poulsen, Knud Ryom, Nanna Holt Jessen","doi":"10.1186/s40814-026-01875-x","DOIUrl":"10.1186/s40814-026-01875-x","url":null,"abstract":"<p><strong>Background: </strong>Anxiety, depression and stress-related conditions are prevalent and growing public health challenges, impacting individuals' quality of life and placing significant strain on healthcare systems globally. These complex conditions rarely respond to a single mode of treatment, underscoring the importance of diverse and complementary approaches. Nature-based health interventions (NBHIs) represent one such perspective, offering novel opportunities to address mental health by engaging with natural environments. While international interest in NBHIs is growing, evidence on how these interventions can be systematically developed and implemented remains limited. The aim of this study protocol is to report the planned Nature Impact Feasibility Study.</p><p><strong>Methods: </strong>The Nature Impact Feasibility Study is a one-armed, mixed methods feasibility study aiming to evaluate a complex, group-based NBHI developed using the Medical Research Council framework for complex interventions. The intervention will be conducted across three sites in Denmark: Glostrup outpatient clinic, Kolding and Silkeborg municipality centres. The intervention consists of group-based NBHI programmes delivered weekly over 10 consecutive weeks, facilitated by experienced health professionals. The feasibility evaluation will examine three core domains. These include (1) the implementation process, including fidelity, dose, reach, adaptations and acceptability; (2) mechanisms of change and (3) contextual factors influencing implementation and intervention processes. Data will be collected through participant observations, focus group interviews, registration forms and participant questionnaires assessing mental health outcomes and the participants' relationship to nature. Data will be analysed using a mixed methods convergent design. Quantitative and qualitative data will be analysed separately and then integrated thematically during interpretation.</p><p><strong>Discussion: </strong>By reporting the study protocol for the Nature Impact Feasibility Study in advance, the project enhances transparency, allows for critical appraisal of the planned design and methods and strengthens the foundation for the subsequent feasibility evaluation and future large-scale trials. The Nature Impact Feasibility Study will provide valuable insight into delivering NBHIs for adults experiencing mild to moderate anxiety, depression and/or stress, while informing intervention refinement, outcome measures and future research aimed at investigating the potential of integrating NBHIs into existing practices for treating anxiety, depression and stress.</p><p><strong>Trial registration: </strong>NCT06981000. Registered on March 13, 2025.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13536583/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148296090","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":"Co-development of a protocol for a randomised controlled feasibility trial of CIRCuiTS™ cognitive remediation therapy for people with multiple sclerosis.","authors":"Rebecca J Thomas, Matteo Cella, Peter A Brex, Eli Silber, Kate Fifield, Patrick Burke, Mary Summers, Sara Simblett, Til Wykes","doi":"10.1186/s40814-026-01862-2","DOIUrl":"10.1186/s40814-026-01862-2","url":null,"abstract":"<p><strong>Background: </strong>Cognitive difficulties are common in people with multiple sclerosis (MS) and predict poorer quality of life, yet effective treatment is lacking. Cognitive remediation therapy (CRT) improves functioning in individuals with severe mental health conditions and could benefit people with MS if adequately adapted. Recognising patient and public involvement (PPI) benefits in developing acceptable interventions, this study engaged people with MS to develop a protocol to assess the feasibility of delivering a computerised, therapist-assisted CRT programme (CIRCuiTS™) to people with MS. This paper describes this process and presents the trial protocol, highlighting how PPI informed the study design and treatment implementation.</p><p><strong>Methods: </strong>Protocol co-development involved three phases of consultation with people with MS. First, the PPI lead, who has MS, contributed along with mental health professionals to the design draft. Second, co-development using an observational qualitative design was conducted with people with MS in a structured 2-day workshop. Workshop discussions were recorded, transcribed, and analysed thematically to arrive at 24 specific, actionable recommendations. These recommendations, alongside statistical input, guided the trial design. Finally, a separate PPI group provided feedback on the trial documents. The proposed trial will recruit 24 people with MS experiencing cognitive difficulties from a UK NHS service, randomly assigning them to receive a 12-week CIRCuiTS™ MS programme immediately or after a 13-week wait. This relatively short waiting period was recommended as likely to maintain engagement. Standard CIRCuiTS™ delivery will be adapted to MS needs by offering remote sessions, dexterity tailoring and MS-specific therapist training. Primary outcomes are feasibility and acceptability. Guided by PPI-anticipated benefits, the secondary outcomes will be goal attainment, cognition, fatigue, mood, and daily functioning. Two people with MS continue to guide the study in the oversight group and a PPI Advisory group will provide ongoing advice on trial management.</p><p><strong>Discussion: </strong>PPI, as recommended in the new CONSORT 2025 statement, strengthened the feasibility and acceptability of the trial by addressing challenges and shaping the protocol. This collaboration enhances the evaluation of CRT for people with MS and provides a model for transparent PPI reporting in trial development.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID NCT06877273, 14th March 2025.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13527947/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148284097","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 feasibility of a novel exercise therapy and activity modification intervention for patients with Sever's disease.","authors":"Shawn L Hanlon, Kayla D Seymore, Morgan N Potter, Bradley C Bley, Karin Grävare Silbernagel","doi":"10.1186/s40814-026-01850-6","DOIUrl":"10.1186/s40814-026-01850-6","url":null,"abstract":"<p><strong>Background: </strong>Sever's disease (calcaneal apophysitis) is a common cause of heel pain in physically active youth. Evidence-based treatment options are limited, with no consensus for the standard of care. This study aimed to assess the feasibility of delivering an intervention comprising exercise therapy and pain-guided activity modification for youth patients with Sever's disease and to describe patient symptoms, functional limitations, psychosocial factors, and ultrasound imaging findings to inform future clinical trials.</p><p><strong>Methods: </strong>This single-cohort study enrolled patients between 7 and 17 years old with Sever's disease. Participants received a comprehensive 12-week intervention combining daily Achilles-tendon loading exercises, activity modification using a pain-monitoring model, and patient education. Training diaries were provided to monitor adherence, daily activities, and pain. Feasibility was assessed via recruitment and retention rates, daily activity modification adherence, rehabilitation adherence, and safety. Secondary outcomes (patient-reported outcome measures, functional test battery, and ultrasound imaging) were collected at baseline and at 4-, 8-, and 12 weeks and were reported descriptively to characterize the biopsychosocial burden of the condition and inform selection of outcomes and hypotheses for future clinical trials.</p><p><strong>Results: </strong>Of the 13 participants enrolled (7F/6 M, (mean ± SD) age 11.5 ± 2.5 years, BMI 21.6 ± 4.6 kg/m²), recruitment and retention rate was 65% and 69%, respectively. Activity modification adherence was 91 ± 28% (range 37-100%), and rehabilitation adherence was 91 ± 25% (range 25-100%). Three adverse events occurred and each was unrelated to participation. All participants expressed satisfaction with the intervention (75% [10/10] very satisfied).</p><p><strong>Conclusions: </strong>Our findings support that this exercise therapy and activity modification intervention is feasible, safe, and appropriate for the treatment of Sever's disease. Intervention satisfaction ratings and favorable global rating of change scores reported imply that educating patients to use a pain-monitoring model, allowing for modified physical activity, is not detrimental to patients with Sever's disease. A larger randomized controlled trial is warranted to evaluate the effectiveness of this intervention.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04816188. Registered 18th of March, 2021 retrospectively.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13520403/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148278369","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":"Digital personalized trials of a multicomponent behavioral change intervention for increasing habitual low-intensity physical activity in middle-aged and older healthcare workers: results of a feasibility study.","authors":"Mark J Butler, Jerry Suls, Ciaran P Friel, Joan Duer-Hefele, Patrick L Robles, Frank Vicari, Thevaa Chandereng, Ying Kuen Cheung, Karina W Davidson","doi":"10.1186/s40814-026-01865-z","DOIUrl":"10.1186/s40814-026-01865-z","url":null,"abstract":"<p><strong>Background: </strong>Prior research has shown that multi-component behavior change technique (BCT) interventions can potentially increase physical activity (PA) in middle-aged and older adults and thereby reduce risk of cardiovascular disease (CVD) and mortality. However, habit formation theory suggests that the PA is most likely to be sustained when the behavior involves high levels of automaticity for walking. Therefore, PA behavior such as walking must be automatic to be sustainable. The current National Institutes of Health (NIH) Stage Model of Behavioral Intervention Stage 1B trial examines the feasibility of a digital, personalized, multi-component BCT intervention to increase the automaticity with which participants execute a walking routine to ultimately reduce likelihood of future CVD and mortality.</p><p><strong>Methods: </strong>A personalized, single-arm, in 44 participants involving digital recruitment and intervention delivery was delivered to adults ages 45 to 75 who worked in Northwell Health system. Participants continuously wore a Fitbit activity tracker during a 2-week baseline and a 10-week intervention. During intervention, participants received five daily BCT associated with habit formation (i.e., goal-setting, action-planning, self-monitoring of behavior, behavioral practice/rehearsal, and behavioral repetition) to follow to execute a walking plan. Participants rated their satisfaction with personalized trial components at the conclusion of the intervention and made ratings of the walking plan's hypothesized mechanism of action-automaticity-over the course of the intervention phase. Step counts, adherence to the walking plan, adherence to step-count monitoring of step count, and attitudes about personalized trial implementation were also collected.</p><p><strong>Results: </strong>Half of the participants acquired automaticity of their daily walking routine in this virtual trial, but there was considerable heterogeneity across participants. Satisfaction with personalized trial elements was consistently high (rated as \"satisfied\" to \"very satisfied\" for most items). Adherence to the walking routine and self-monitoring of steps was moderate to good, with participants adhering to their walking plan for 55% of days. Eight of 34 participants achieved an increase of 2000 steps from baseline.</p><p><strong>Conclusions: </strong>This stage 1b study found that patients were satisfied with personalized trial components and implementation. Furthermore, half of the participants in the trial reached the hypothesized automaticity criterion over the course of intervention (albeit at different rates). This preliminary evidence suggests that personalized BCT interventions to initiate a walking habit among middle-aged and older adults are both feasible and acceptable.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13520397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148278387","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":"Introducing a group antenatal care model at the health post level in Ethiopia: a qualitative pilot study.","authors":"Solomon Getachew Alem, Walelegn Worku Yallew, Della Berhanu, Konjit Wolde, Dedefo Teshite, Pooja Sripad, Lisa Noguchi, Stephanie Suhowatsky, Anne Hyre, Alemayehu Worku","doi":"10.1186/s40814-026-01864-0","DOIUrl":"10.1186/s40814-026-01864-0","url":null,"abstract":"<p><strong>Background: </strong>Group antenatal care (G-ANC) is an alternative model of antenatal care that incorporates clinical assessment and care, participatory learning, and peer support. It gives expectant mothers the opportunity to discuss and share experiences with a group of women of similar gestational age throughout the pregnancy. This pilot study aimed to explore the feasibility of introducing a six-meeting G-ANC model in health posts, the most basic level of the health system in Ethiopia.</p><p><strong>Methods: </strong>A qualitative study of G-ANC was conducted at five purposively selected health posts in two zones in the Amhara region of Ethiopia, involving 54 pregnant women aged 15 years and older with a gestational age of less than 20 weeks. Trained research staff moderated 13 in-depth and 7 key informant interviews that were conducted after the second of the six G-ANC meetings. All interviews and discussions were recorded with consent from participants. Transcribed interviews were translated and thematically analyzed using a framework with open code qualitative data analysis software aiding in data sorting, categorization, and coding.</p><p><strong>Results: </strong>An adequate number of pregnant women were identified early in pregnancy and recruited to form G-ANC groups for this study. Pregnant women were willing to be enrolled and participate in G-ANC meetings and indicated interest in attending future meetings. Health extension workers (HEWs) demonstrated the ability to facilitate G-ANC meetings effectively.</p><p><strong>Conclusion: </strong>Introduction of G-ANC at the health post level appears feasible. None of the major anticipated feasibility challenges, adequate enrollment of eligible women, women's willingness to participate in successive meetings, and HEW capacity to facilitate, were encountered. Existing community structures were instrumental in achieving adequate enrollment. The training and G-ANC meeting guides enabled HEWs to effectively facilitate the meetings. Preliminary results from this pilot study informed the design of a stepped-wedge cluster randomized trial to evaluate the acceptability and effectiveness of G-ANC at the health post level on increased coverage of antenatal care and facility-based delivery.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13508501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148265620","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}