Contemporary clinical trials最新文献

{"title":"Exercise to enhance cardiovascular health among black men with prostate cancer with androgen deprivation therapy (the POWER trial): A study protocol","authors":"Dong-Woo Kang ,&nbsp;Salvatore Ficarra ,&nbsp;Rebekah L. Wilson ,&nbsp;Alicia K. Morgans ,&nbsp;Paul L. Nguyen ,&nbsp;Timothy R. Rebbeck ,&nbsp;David J. Einstein ,&nbsp;Hajime Uno ,&nbsp;Matthew Mossanen ,&nbsp;Danielle M. Hill ,&nbsp;Paola Gonzalo-Encabo ,&nbsp;Mary K. Norris ,&nbsp;John Gardiner ,&nbsp;Darryl Tjogas ,&nbsp;Jocelyn Greer ,&nbsp;Christina M. Dieli-Conwright","doi":"10.1016/j.cct.2025.107973","DOIUrl":"10.1016/j.cct.2025.107973","url":null,"abstract":"<div><h3>Background</h3><div>Black men in the US are 1.8 and 2.2 times more likely to develop and die from prostate cancer (PCa) than non-Hispanic White men, respectively, and have the highest incidence globally. Furthermore, Black men undergoing androgen deprivation therapy (ADT) for PCa face a higher risk of cardiovascular disease (CVD) compared to men of other racial groups. Therefore, we have designed a randomized controlled trial (RCT) to investigate the impact of exercise on CVD risk factors among Black man undergoing ADT.</div></div><div><h3>Methods</h3><div>The POWER trial is a dual-arm RCT designed to examine the effects of a 16-week, culturally tailored, remotely supervised cardiovascular and strength exercise program on Black men with PCa receiving ADT. Sixty-two patients will be randomized in a 1:1 allocation to either the exercise intervention or a waitlist control group. The patient population includes adult males who self-identify as Black, receiving ADT for at least four months prospectively at the time of recruitment. The primary outcome is the CVD risk assessed using the Framingham Risk Score. The secondary and exploratory outcomes include physical fitness and function, patient-reported outcomes, and clinical events at a one-year follow-up.</div></div><div><h3>Discussion</h3><div>The POWER Trial evaluates a culturally tailored exercise program for Black men with PCa undergoing ADT, focusing on improving cardiovascular health. The findings of the study are expected to inform a larger phase clinical trial to examine long-term CVD-related clinical outcomes. Ultimately, our findings and subsequent trials would narrow the gap in health disparities among the communities of Black men with PCa.</div><div><strong>Trial registration</strong>: <span><span>NCT05327465</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107973"},"PeriodicalIF":2.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"BREATHER Plus clinical trial design: A randomised non-inferiority trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily ART in virologically suppressed adolescents living with HIV aged 12 to <20 years in sub-Saharan Africa","authors":"Fredrick Katongole ,&nbsp;Tiyara Arumugam ,&nbsp;Angus Jennings ,&nbsp;Constantine Mutata ,&nbsp;Patrick Ssebunya ,&nbsp;Charity Wamboi ,&nbsp;Alexandra Green ,&nbsp;Mutsa Bwakura-Dangarembizi ,&nbsp;Cissy Kityo ,&nbsp;Abraham Siika ,&nbsp;Moherndran Archary ,&nbsp;Lungile Jafta ,&nbsp;Stella Namukwaya ,&nbsp;Janet Seeley ,&nbsp;Henry Mugerwa ,&nbsp;Simon Walker ,&nbsp;Naomi Apoto ,&nbsp;Margaret J. Thomason ,&nbsp;Deborah Ford ,&nbsp;Sarah L. Pett ,&nbsp;Eram David Williams","doi":"10.1016/j.cct.2025.107963","DOIUrl":"10.1016/j.cct.2025.107963","url":null,"abstract":"<div><h3>Background</h3><div>Novel strategies to improve ART adherence, retention in care and quality of life among adolescents living with HIV (ALHIV) are needed. Short-Cycle Therapy (SCT) with 4/5 sequential days on ART, 2/3 days off ART per week has shown non-inferior virological outcomes and high acceptability, but most data are in adults and are very limited for dolutegravir (DTG)-based SCT.</div></div><div><h3>Methods</h3><div>BREATHER Plus is an ongoing 96-week non-inferiority randomised trial evaluating efficacy, safety and acceptability of SCT (5 sequential days on, 2 days off at the weekend) with DTG/tenofovir (TNV)-based triple ART versus continuous (daily) therapy (CT) in ALHIV. Participants are aged 12 to &lt;20 years in Kenya/South Africa/Uganda/Zimbabwe, virologically suppressed (Viral Load (VL) &lt;50copies/mL) for ≥12 months at enrollment, with no prior treatment failure. Randomisation is 1:1 to SCT versus CT. VL monitoring for clinical management is 6–12 monthly aligning with standard-of-care. The primary outcome is confirmed virological rebound ≥50 copies/mL by 96 weeks. The trial employs the Smooth Away From Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event risk in the CT arm. Secondary outcomes include HIV resistance, toxicities, patient-reported outcomes and cost-effectiveness. Enrolment of 470 participants completed in June 2023.</div></div><div><h3>Discussion</h3><div>BREATHER Plus is the first randomised trial specifically evaluating DTG/TNV-triple based SCT. Rapid roll-out of DTG and a pragmatic approach to VL monitoring mean results will be generalisable to ALHIV across sub-Saharan Africa. If SCT provides non-inferior virological suppression to CT, it may offer choice for ALHIV on how they take their ART.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107963"},"PeriodicalIF":2.0,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Grief Navigation Trial: A multi-site pragmatic comparative effectiveness trial of two interventions to support parents after their child's unexpected or traumatic death","authors":"Elaf Agha ,&nbsp;Carolyn Sutter ,&nbsp;Ifeoluwadolapo Ojewuyi ,&nbsp;Emily M. Abramsohn ,&nbsp;Megan Andriano ,&nbsp;Christal Bell ,&nbsp;Anna L. Calix ,&nbsp;Jamie Lynn Cherry ,&nbsp;Kim Downing ,&nbsp;Tina Flower ,&nbsp;Michelle Halm ,&nbsp;Ashley Hayes ,&nbsp;Marie E. Heffernan ,&nbsp;JaShawn Hill ,&nbsp;C. Zoe Hoeppner ,&nbsp;Meghan Jacobson ,&nbsp;Jacquelyn Jennings ,&nbsp;Leslie Kula-Leitner ,&nbsp;SuYeon Lee ,&nbsp;Deborah R. Major ,&nbsp;Ryan Westerberg","doi":"10.1016/j.cct.2025.107962","DOIUrl":"10.1016/j.cct.2025.107962","url":null,"abstract":"<div><h3>Background</h3><div>In the US, ~60,000 people &lt;25 years old die annually. Forty-five percent of pediatric deaths occur traumatically, and the parents' or caregivers' (hereafter ‘parents’) sole contact with the healthcare system is often the coroner or medical examiner (ME). Parents experience mental and physical health problems following their child's death. There are no evidence-based interventions for MEs supporting bereaved parents. Scalable, systems-level interventions are needed to connect bereaved parents to grief and social care support. This research will build upon the experience of Missing Pieces, a community organization that supports families after pediatric death, and CommunityRX, an evidence-based social care intervention that supports patients and caregivers. This comparative effectiveness trial will test two strategies that help parents and caregivers find support after traumatic or unexpected pediatric death.</div></div><div><h3>Methods</h3><div>This pragmatic, comparative effectiveness randomized controlled trial uses a hybrid type 1 implementation-effectiveness design to compare: (1) CommunityRx-Bereavement (the “high touch” intervention), a personalized resource referral intervention involving Grief Navigator support; and (2) general bereavement support information (the “low touch” intervention), including community resources, shared by text message. Parents of deceased children (&lt;25 years old) are referred by MEs to Missing Pieces and cases are randomized. The primary outcomes are complicated grief and self-efficacy for finding resources, evaluated ~6.5 months post-child's death. By taking a community-engaged research approach, community collaborators were included to inform research methods, materials, and dissemination plans.</div></div><div><h3>Discussion</h3><div>This work fills a knowledge gap regarding evidence-based practices for supporting families after the traumatic or unexpected death of their child.</div></div><div><h3>Trial registration</h3><div><span><span>NCT06136260</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107962"},"PeriodicalIF":2.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementing individualised physiotherapy using the Specific Treatment of Problems of the Spine (STOPS) approach for chronic low back pain in Bangladesh: Protocol for a prospective sequential comparison clinical trial","authors":"Mohammad Ali ,&nbsp;Jon J. Ford ,&nbsp;Ahmed Hossain ,&nbsp;Musa Sani Danazumi ,&nbsp;Andrew J. Hahne","doi":"10.1016/j.cct.2025.107960","DOIUrl":"10.1016/j.cct.2025.107960","url":null,"abstract":"<div><h3>Background</h3><div>Chronic low back pain (CLBP) is a major global health issue, with a particularly high burden in low- and middle-income countries (LMICs) due partly to inadequate evidence-based management. The Specific Treatment of Problems of the Spine (STOPS) approach offers individualised, biopsychosocial-based physiotherapy shown to be effective in Australia. This trial aims to evaluate the implementation, effectiveness, and cost-effectiveness of the STOPS approach to individualised physiotherapy compared to usual physiotherapy care in Bangladesh.</div></div><div><h3>Methods</h3><div>A three-phase prospective sequential comparison trial will be conducted with eligible participants aged 18–65 years presenting for physiotherapy with CLBP at two centres in Bangladesh. Phase 1 will evaluate the usual physiotherapy care, and Phase 3 will evaluate individualised physiotherapy according to the STOPS approach. Phase 2 involves training physiotherapists and assistants in STOPS. Patients in Phases 1 &amp; 3 will undergo 10 sessions of physiotherapy over 10 weeks, with an 11th booster session at 6 months. Primary outcomes are activity limitation (Oswestry Disability Index) and pain intensity (Numerical Rating Scales for back and leg pain) at 5, 10, 26 and 52 weeks. Secondary outcomes include global effect, patient satisfaction, work interference, psychosocial risk factors, quality of life, mental health, sleep, catastrophizing and self-efficacy. Qualitative interviews will explore patient and therapist experiences.</div></div><div><h3>Results</h3><div>Quantitative and qualitative data will be analysed to assess implementation feasibility, cost-effectiveness, and treatment outcomes.</div></div><div><h3>Conclusion</h3><div>Individualised physiotherapy using the STOPS approach could improve treatment outcomes for CLBP in Bangladesh.</div></div><div><h3>Clinical trial registration</h3><div><span><span>NCT05880212</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107960"},"PeriodicalIF":2.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144132243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating brain mechanisms of combined vagus nerve stimulation and mindfulness training for migraine: A randomized 2 × 2 factorial clinical trial protocol","authors":"Zev Schuman-Olivier ,&nbsp;Frances Marin ,&nbsp;Lillian D. Kinder ,&nbsp;Michael Datko ,&nbsp;Kassandra Round ,&nbsp;Sarasa Tohyama ,&nbsp;Ronald G. Garcia ,&nbsp;Randy L. Hirschtick ,&nbsp;Robert R. Edwards ,&nbsp;Rebecca Erwin Wells ,&nbsp;Hsinlin T. Cheng ,&nbsp;Riccardo Barbieri ,&nbsp;Nouchine Hadjikhani ,&nbsp;Marco L. Loggia ,&nbsp;Ted J. Kaptchuk ,&nbsp;Timothy T. Houle ,&nbsp;Bruce R. Rosen ,&nbsp;Vitaly Napadow","doi":"10.1016/j.cct.2025.107947","DOIUrl":"10.1016/j.cct.2025.107947","url":null,"abstract":"<div><h3>Background</h3><div>Migraine is a major cause of disability and efficacious interventions are needed. In this mechanistic study, we investigate the combined, and potentially synergistic, effects of a multimodal intervention combining Mindfulness-Based Stress Reduction (MBSR) and transcutaneous auricular Vagal Nerve Stimulation (taVNS) for migraine.</div></div><div><h3>Methods</h3><div>We utilize a modified double-blinded, placebo-controlled, 2 × 2 factorial randomized longitudinal design to assess the effects of an 8-week MBSR intervention with concomitant Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) taVNS on migraine pathophysiology primary outcomes. We will enroll 150 patients with migraine (4–20 headache days/month). After a run-in month of daily diaries, we expect to randomly assign <em>N</em> <em>=</em> <em>96</em> participants to one of four treatment groups: (1) MBSR+RAVANS taVNS, (2) MBSR+Sham taVNS, (3) Nature Education Control (NEC) + RAVANS taVNS, or (4) NEC + Sham taVNS. Before and after intervention, participants have three in-person assessments (a 7 T MRI scan, an autonomic/sensory testing (AST) visit, and a 3 T PET-MRI scan). The primary outcomes for this study assess (1) central sensitization (brainstem/cortical response to trigeminal sensory afference), (2) autonomic dysfunction (High Frequency-Heart Rate Variability (HF-HRV) response to stressors), and (3) neuroinflammation (PET[¹¹<em>C</em>]PBR28 signal).</div></div><div><h3>Results</h3><div>Funded by NIH (P01AT009965), registered (<span><span>NCT03592329</span><svg><path></path></svg></span>). Final longitudinal outcomes will be collected by May 2025.</div></div><div><h3>Conclusion</h3><div>This mechanistic study is designed to investigate both independent and synergistic neurobiological effects of MBSR and RAVANS taVNS interventions on three distinct pathophysiological mechanisms of migraine. This research will elucidate the mechanistic and potentially synergistic effects of behavioral interventions (e.g., mindfulness) and device-based treatments (e.g., taVNS) for migraine.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107947"},"PeriodicalIF":2.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144123423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating","authors":"Wai Sze Chan,&nbsp;Wing Yee Cheng","doi":"10.1016/j.cct.2025.107955","DOIUrl":"10.1016/j.cct.2025.107955","url":null,"abstract":"<div><h3>Background</h3><div>Negative emotional eating (NEE) refers to overeating in response to negative emotions. The efficacy of cue exposure therapy (CET) for treating NEE has not been evaluated in a full-scale randomized controlled trial (RCT). Moreover, previously tested CET did not fully utilize theory-informed intervention strategies. Hence, an enhanced version of CET (<em>E</em>-CET) is here developed and evaluated. <em>E</em>-CET will integrate theory-informed intervention strategies including (1) exposures that incorporate food cues, emotional cues, and idiosyncratic contextual cues, (2) homework exposures, and, (3) explicit instructions to violate the conditioned stimulus-unconditioned stimulus (CS-US) expectancies maintaining NEE. <em>E</em>-CET is hypothesized to promote greater reductions in NEE than an active control, behavioral lifestyle intervention (BLI), and its efficacy will be mediated by the reduction in the believability of CS-US expectancies.</div></div><div><h3>Methods</h3><div>This is a parallel-group RCT. One-hundred-and-thirty-eight participants with recurring NEE will be randomly assigned to <em>E</em>-CET or BLI, and attend six individual sessions. The primary outcome is the change in the emotional eating subscale score measured by the Dutch Eating Behavior Questionnaire at posttreatment, 3-month, and 12-month follow-up from baseline. Secondary and mechanistic outcomes include changes in NEE measured by ecological momentary assessments, caloric consumption, and the believability in CS-US expectancies.</div></div><div><h3>Discussion</h3><div>If shown to be efficacious, <em>E</em>-CET can be implemented to reduce NEE. This study will be the first experimental evaluation of the mediating effects of CS-US expectancy violation in the working of <em>E</em>-CET for NEE to inform developments of the theories on CET and NEE.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107955"},"PeriodicalIF":2.0,"publicationDate":"2025-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144107486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Subgroup differences in calcium metabolism in response to dietary sodium: Rationale, design, and methods of a randomized, controlled, crossover dietary intervention in healthy adults","authors":"Sisi Cao ,&nbsp;Christina Vialva ,&nbsp;Shirin Hooshmand ,&nbsp;Mark Kern ,&nbsp;Gina N. Woods ,&nbsp;Scott Roesch ,&nbsp;Connie M. Weaver","doi":"10.1016/j.cct.2025.107956","DOIUrl":"10.1016/j.cct.2025.107956","url":null,"abstract":"<div><div>The growing interest in personalized nutrition stems from a deeper understanding of subgroup differences in response to environmental factors, including diet. Preliminary evidence in Black and White adolescent girls showed that Black girls retain more calcium and excrete more sodium compared to White girls on a high sodium diet. However, little is known about calcium absorption efficiency across other races or age groups. This report outlines the rationale and design of a planned randomized controlled trial aimed at investigating calcium absorption and calcium and sodium excretion in response to diets high (typical Western diet) and low (recommended) in sodium in Black, White, Hispanic, and Asian adults. It is hypothesized that fractional calcium absorption and urinary sodium excretion will vary by subgroup, with Blacks predicted to have the highest rates and Whites the lowest, and intermediate responses in Hispanics and Asians. Participants will undergo two 2-day dietary intervention arms, with biospecimen collection following each arm. Primary outcomes include fractional calcium absorption and urinary calcium excretion, and secondary outcomes comprise urinary sodium excretion and blood pressure. Findings from this study could advance precision nutrition by informing strategies to alleviate osteoporosis and cardiovascular diseases risks across different race/ethnicity groups.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107956"},"PeriodicalIF":2.0,"publicationDate":"2025-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A visual safety risk evaluation tool in early clinical phases","authors":"Kathrin Wawra-Hehenberger ,&nbsp;Vanessa Pencelli ,&nbsp;January Anne Pardo ,&nbsp;Lothar Tremmel ,&nbsp;Quazi Ataher ,&nbsp;Max Waschbusch","doi":"10.1016/j.cct.2025.107953","DOIUrl":"10.1016/j.cct.2025.107953","url":null,"abstract":"<div><div>Dynamic evaluation of safety risks across all stages of clinical development, including early trial phases, has become the norm with the evolution of risk management in pharmacovigilance. The need for practical tools directly applicable to early clinical assessment prompted the authors to pilot the customization of a common risk matrix to support proactive safety risk evaluation based on multiple dimensions. Once defined for their research area, the tailored safety risk matrix was applied to visualize a series of known risk profiles and examples, along with projected risk mitigation effects. This two-fold visualization on one simple graph (risks positioning, and effect of risk mitigation of those positions) was found to be particularly relevant in multi-disciplinary safety discussions during early clinical development stages. The visual tool provides useful snapshots of projected safety risk profiles, facilitating communication with multiple stakeholders involved in decisions throughout early clinical development. With the prospect of a simple visual instrument to add to their existing risk management toolbox and processes, clinical teams are also provided with a basic blueprint to apply and tailor based on risk dimensions related to their own research area.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107953"},"PeriodicalIF":2.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A brief online tool to increase behavioral weight loss treatment initiation: Protocol for a cluster randomized trial","authors":"Megan A. McVay ,&nbsp;Wendy S. Moore ,&nbsp;Dieulerne Deceus ,&nbsp;Savannah B. Townsend ,&nbsp;Eric I. Rosenberg ,&nbsp;Sofia Muenyi ,&nbsp;XiangYang Lou ,&nbsp;Fern J. Webb ,&nbsp;Luis D. Diaz ,&nbsp;Meena N. Shankar ,&nbsp;Jaime Ruiz ,&nbsp;Corrine I. Voils ,&nbsp;Kathryn M. Ross","doi":"10.1016/j.cct.2025.107948","DOIUrl":"10.1016/j.cct.2025.107948","url":null,"abstract":"<div><h3>Background</h3><div>Comprehensive behavioral weight loss treatments are the first-line approach for obesity in adults. However, only a small portion of eligible individuals will initiate treatment, even when available at low or no cost. To address low uptake, we developed the MyHealthPath Tool, a single-session, online, interactive tool designed to be completed prior to a primary care appointment. MyHealthPath Tool includes questions and automated personalized feedback to increase motivation to initiate a behavioral weight loss treatment.</div></div><div><h3>Method/Design</h3><div>In this cluster randomized controlled trial, primary care practitioners (PCPs; target <em>N</em> = 36) are being recruited from primary care clinics across multiple sites of a single academic-affiliated health care system, then randomized to the MyHealthPath Tool or Control condition. Patients (target <em>N</em> = 828) who have upcoming appointments with enrolled PCPs are recruited prior to their PCP appointment. Patients in both conditions are given information about and free access to two behavioral weight loss treatments. Participants in the MyHealthPath Tool condition also receive the tailored interactive tool and the option to share a summary of their responses with their PCP prior to their appointment. The primary outcome is the initiation of behavioral weight loss treatment within 2 months of the patient's PCP appointment. Secondary outcomes include treatment attendance and weight change over 6 months. Implementation-related outcomes (e.g., indicators of reach) are also being measured.</div></div><div><h3>Conclusion</h3><div>If effective, MyHealthPath could serve as a low-touch method for improving uptake of behavioral weight loss treatment in adults receiving primary care.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107948"},"PeriodicalIF":2.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Coenrollment in a critical care trial: Characteristics and consequences","authors":"France Clarke ,&nbsp;Lori Hand ,&nbsp;Adam Deane ,&nbsp;Nicole Zytaruk ,&nbsp;Miranda Hardie ,&nbsp;Yaseen Arabi ,&nbsp;Abdulrahman Al-Fares ,&nbsp;Diane Heels-Ansdell ,&nbsp;William Dechert ,&nbsp;Marlies Ostermann ,&nbsp;Irene Watpool ,&nbsp;Tina Millen ,&nbsp;John Muscedere ,&nbsp;Shane English ,&nbsp;Gordon Boyd ,&nbsp;Stephanie Sibley ,&nbsp;Leah Peck ,&nbsp;Glenn Eastwood ,&nbsp;Erick Duan ,&nbsp;Mark Soth ,&nbsp;Deborah Cook","doi":"10.1016/j.cct.2025.107938","DOIUrl":"10.1016/j.cct.2025.107938","url":null,"abstract":"<div><h3>Background</h3><div>Objectives of this study were to determine the characteristics of patients, centers and studies involved in coenrollment, and the association of coenrollment with trial metrics and patient outcomes.</div></div><div><h3>Methods</h3><div>This pre-planned study within a stress ulcer prophylaxis trial testing pantopazole used descriptive analyses and multilevel regression analysis to examine patterns and predictors of coenrollment among patients in an intensive care unit (ICU).</div></div><div><h3>Results</h3><div>Among 4821 trial participants, 1719 (35.7 %) were coenrolled in at least one of 145 unique studies. There were 2167 coenrollment events. The most common design of coenrolled studies were individual-patient randomized trials, followed by cluster randomized trials and platform trials. Most coenrollment involved investigator-initiated studies (1924, 88.8 %). Patients with SARS-CoV-2 infection were more likely to be coenrolled than others (odds ratio 1.85 (95 % confidence interval, 1.50, 2.29), <em>p</em> &lt; 0.001). Research coordinators with mid-senior trial experience were more likely to coenrol than others. Coenrolled patients were more likely to miss study drug (median 1 dose, IQR 1–2 doses) compared to others (202 (11.8 %) versus 221 (7.1 %), p &lt; 0.001). Coenrollment did not influence the effect of pantoprazole on gastrointestinal bleeding or 90-day mortality.</div></div><div><h3>Conclusions</h3><div>In the REVISE trial, one-third of participants were coenrolled, primarily into another academic randomized trial. Patients with SARS-CoV-2 were more likely to be coenrolled than other patients. Experienced research coordinators were more likely to coenrol than other personnel. Coenrollment did not modify the treatment effect of pantoprazole on the primary trial outcomes.</div></div><div><h3>Clinical trial registration</h3><div><span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT03374800</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107938"},"PeriodicalIF":2.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}