Contemporary clinical trials最新文献

{"title":"Trial of SiTes to IncreAse diversity in clinical TriaLs (TOTAL): A study protocol paper","authors":"Tenzin Yeshi Wangdak Yuthok ,&nbsp;Anny D. Rodriguez ,&nbsp;Victor Ritter ,&nbsp;Erin Rose Cruz ,&nbsp;Deidre A. Okeke ,&nbsp;Farmaan Judge ,&nbsp;Nicholas Vesom ,&nbsp;Sa Shen ,&nbsp;FeiFei Qin ,&nbsp;Cati G. Brown-Johnson ,&nbsp;Latha Palaniappan ,&nbsp;Anekwe Onwuanyi ,&nbsp;Eldrin Lewis","doi":"10.1016/j.cct.2025.108141","DOIUrl":"10.1016/j.cct.2025.108141","url":null,"abstract":"<div><div>The Trial Of Sites to Increase Diversity in Clinical Trials (TOTAL) addresses the critical issue of underrepresentation in cardiometabolic clinical trials. Despite existing initiatives, disparities in trial participant racial and ethnic diversity persist, limiting the generalizability of findings and health equity. This study aims to evaluate the effectiveness of three diversity-enhancing recruitment strategies (DERS)—virtual community ambassadors, population-based research registries, and social media ads—compared to usual recruitment methods.</div><div>A hybrid implementation-effectiveness cluster RCT design will randomize 36 cardiovascular clinical trial sites across the US to one of these 4 arms. The main outcome assessed is the proportion of underrepresented participants pre- and during the intervention. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, the study will assess recruitment effectiveness for historically underrepresented participants. Data collection includes de-identified demographic, screening, and enrollment information analyzed through robust statistical methods, including logistic regression and generalized estimating equations. Qualitative interviews with site teams will provide additional insights into implementation challenges and successes.</div><div>The study aims to identify the most effective recruitment methods, refine these strategies, and disseminate findings to enhance future clinical trial diversity. The TOTAL study's findings will provide evidence-based recommendations for increasing representation in trials, addressing a long-standing barrier to equitable healthcare innovation. By improving diversity, TOTAL will contribute to the broader goal of ensuring that treatments are effective and safe for all populations, fostering inclusivity in scientific research, and advancing precision medicine. This research is supported by the American Heart Association, underscoring its importance in achieving health equity.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108141"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494895","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":"Comparison of clopidogrel-based antiplatelet therapy versus warfarin as a secondary prevention strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE): Rationale and design of a prospective, randomized, open-label, blinded-endpoint trial","authors":"Wookjin Yang ,&nbsp;Hee-Kwon Park ,&nbsp;Seong-Ho Koh ,&nbsp;Seongheon Kim ,&nbsp;Yerim Kim ,&nbsp;Keun-Hwa Jung ,&nbsp;Hyun Goo Kang ,&nbsp;Jay Chol Choi ,&nbsp;Hahn Young Kim ,&nbsp;Hyo Suk Nam ,&nbsp;Hye Seon Jeong ,&nbsp;Joon-Tae Kim ,&nbsp;Young Seo Kim ,&nbsp;Sungwook Yu ,&nbsp;Kyung-Hee Cho ,&nbsp;Tae-Jin Song ,&nbsp;Sung Hyuk Heo ,&nbsp;Han-Jin Cho ,&nbsp;Sung-Il Sohn ,&nbsp;Yoonkyung Chang ,&nbsp;Seung-Hoon Lee","doi":"10.1016/j.cct.2025.108164","DOIUrl":"10.1016/j.cct.2025.108164","url":null,"abstract":"<div><h3>Background</h3><div>Antiphospholipid syndrome (APS) is closely associated with ischemic stroke. However, optimal treatment for APS-related stroke remains unestablished, as current guidelines are based on outdated studies and expert opinion rather than high-quality clinical trials. Evidence on antiplatelet agents other than aspirin, such as clopidogrel, in APS-related stroke is particularly limited. Given the relatively young age of patients with APS and the burden of warfarin use, verifying its necessity is crucial. This study compares clopidogrel-based antiplatelet therapy and warfarin for secondary prevention in APS-related stroke.</div></div><div><h3>Methods</h3><div>APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS and a history of ischemic stroke or transient ischemic attack (TIA) will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematosus, or other major indications for continued antiplatelet or anticoagulant therapy will be excluded. Participants will be randomized 1:1 to receive clopidogrel-based antiplatelet therapy or warfarin. More than 200 patients are planned for inclusion across 32 stroke centers. The primary endpoint is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during at least 4 years of follow-up. Secondary endpoints include major adverse cardiovascular events, ischemic stroke, any bleeding, major bleeding, intracranial bleeding, clinically relevant non-major bleeding, any death, and thrombosis-related death.</div></div><div><h3>Conclusion</h3><div>This study will provide valuable information on the optimal secondary prevention strategy for APS-related stroke.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov: NCT05995600; CRIS: KCT0008900.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108164"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630825","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":"Pilot randomized trial of cash transfer interventions to improve health outcomes in low income adults with poorly controlled type 2 diabetes: Study protocol and baseline characteristics","authors":"Jennifer A. Campbell,&nbsp;Rebekah J. Walker,&nbsp;Leonard E. Egede","doi":"10.1016/j.cct.2025.108171","DOIUrl":"10.1016/j.cct.2025.108171","url":null,"abstract":"<div><h3>Background</h3><div>Monetary interventions, such as cash transfers, have emerged as important intervention approaches to address the complex determinants at the structural and individual level impacting diabetes outcomes.</div></div><div><h3>Methods</h3><div>This NIH funded (K01DK131319), pilot randomized controlled trial (RCT) is an ongoing 5 year study to evaluate the efficacy of two diabetes-tailored cash transfer interventions in low-income adults in which 1) cash transfers are conditional on participating in nurse-led, telephone-delivered diabetes education/skills training and stress/coping intervention delivered every 2 weeks for 6 months (DM-CCT); or 2) cash transfers are unconditional (DM-UCT), on clinical outcomes (HbA1c and blood pressure), and quality of life among 100 African Americans aged 18+ years with T2DM and HbA1c ≥8 %. Assessments will be conducted at baseline, 3-, and 6-months with primary outcome at 6 months post-randomization.</div></div><div><h3>Discussion</h3><div>Recruitment began in March 2023 and was completed in February 2024. Average age was 51 years. Most participants were women (71.0 %). Mean HbA1c was 10.1±1.8 for DM-CCT group and 10.2±1.8 for DM-UCT group. Mean systolic and diastolic blood pressure was 128.0±22.7 mmHg and 80.2±13.7 mmHg for DM-CCT group and 133.5±22.2 mmHg and 83.7±13.7 mmHg for DM-UCT group. Mean BMI was 36.2±10.3 kg/m² for DM-CCT and 35.7±9.2 kg/m² for DM-UCT. This pilot RCT represents a promising intervention to address the underlying poverty driven social risk factors while simultaneously addressing diabetes specific behaviors to improve outcomes. Findings from this study will provide preliminary evidence on efficacy of cash transfer interventions to improve clinical outcomes in low-income adults with poorly controlled T2DM.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108171"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630892","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":"Protocol for a pilot RCT investigating a weight loss navigation program for adults","authors":"Hannah I. Silverstein ,&nbsp;Evan M. Forman ,&nbsp;Adam H. Gilden ,&nbsp;Charlotte J. Hagerman ,&nbsp;Brandy-Joe Milliron ,&nbsp;Fengqing (Zoe) Zhang ,&nbsp;Meghan L. Butryn","doi":"10.1016/j.cct.2025.108163","DOIUrl":"10.1016/j.cct.2025.108163","url":null,"abstract":"<div><div>Millions of adults in the U.S. with overweight or obesity would like to improve their health via weight loss, yet utilization of evidence-based weight loss interventions is low. Instead, adults commonly attempt self-guided weight loss, which has poor efficacy. When adults use evidence-based interventions (i.e., behavioral, dietary, commercial, surgical, and pharmacological options), long-term engagement is suboptimal. The proposed project is a pilot randomized clinical trial to test the use of patient navigators to increase uptake of and persistence with evidence-based weight loss interventions. Navigators have been successful in other areas of healthcare to facilitate engagement with various treatment and prevention services. However, little data are available on the feasibility, acceptability, or efficacy of a weight loss navigator program in adults. In the present study, participants (<em>N</em> = 68 adults with a BMI &gt;27 kg/m2 interested in weight loss) will be randomly assigned for a 12-month period to either usual care or the navigator condition. Participants in usual care will have no intervention contact, while participants in the navigator condition will attend individual sessions and receive personalized emails from a navigator to support uptake and persistence with an evidence-based weight loss intervention. Assessments will be conducted remotely at months 0, 6, and 12. The primary outcome for the preliminary test of efficacy is weight change after 12 months. This study will inform future iterations of a weight loss navigator program and could impact clinical practice and public health by enhancing the utilization of evidence-based weight loss interventions.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108163"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615979","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":"Agile by adaptive design: An algorithm for decentralized trials","authors":"K. Shuvo Bakar","doi":"10.1016/j.cct.2025.108169","DOIUrl":"10.1016/j.cct.2025.108169","url":null,"abstract":"<div><div>Decentralized Clinical Trials (DCTs) represent a significant advancement in clinical research, offering greater accessibility, flexibility, and participant engagement through the use of telemedicine, mobile health technologies, and remote data capture. However, the decentralized nature of data collection introduces challenges related to data reliability and variability, which are often inadequately addressed by conventional statistical methods at the design stage of the trial.</div><div>This study presents an agile Bayesian design framework tailored to the specific needs of DCTs, integrating adaptive data reliability directly into trial design and analysis. Our approach is based on Bayesian decision rules to guide interim sample size adjustments. By treating data reliability as a model parameter rather than an external factor, our method accounts for uncertainty and improves the robustness of power calculations.</div><div>Simulation studies demonstrate the effectiveness of this strategy. The proposed framework enables a flexible and agile approach to DCT design that can adapt to varying data quality conditions. This work offers a foundation for extending the proposed adaptive method to other trial contexts, including time-to-event endpoints, and supports the broader adoption of DCTs in real-world clinical research.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108169"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615991","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":"Strategies and challenges for the recruitment of young healthy participants in the dietary approaches to longevity and health (DiAL health) pilot trial","authors":"Hannah E. Cabre ,&nbsp;Courtney M. Peterson ,&nbsp;Gareth R. Dutton ,&nbsp;Kimberly L. Drews ,&nbsp;Stephanie T. Broyles ,&nbsp;Robert Dubin ,&nbsp;Laura Q. Rogers ,&nbsp;Catherine Champagne ,&nbsp;Dennis T. Villareal ,&nbsp;Daniel S. Hsia ,&nbsp;Leanne M. Redman ,&nbsp;Corby K. Martin","doi":"10.1016/j.cct.2025.108143","DOIUrl":"10.1016/j.cct.2025.108143","url":null,"abstract":"<div><h3>Background</h3><div>Understanding the impact of nutrition on human aging requires long-term trials in young, healthy, unmedicated adults. As part of the Dietary Approaches for Longevity and Health (DiAL Health) pilot project, we evaluated strategies for recruiting this population for aging-related dietary intervention studies.</div></div><div><h3>Methods</h3><div>We analyzed recruitment costs to enroll 70 participants (ages 25–49, BMI 22.0–29.9 kg/m²) across two DiAL Health sites and used NHANES data (2017–March 2020) to estimate the proportion of U.S. adults meeting partial trial eligibility. Additionally, a formative study surveyed 492 U.S. adults (≥18 years) to assess interest in aging-focused dietary trials.</div></div><div><h3>Results</h3><div>Of 2049 applicants screened, 70 were enrolled (3.4 %), with recruitment costs of $1572 per participant at site 1 and $625 at site 2. NHANES data revealed only 3.6 % (555/15,560) of adults met partial eligibility criteria, while 2.2 % (11/492) of formative survey respondents met full eligibility. DiAL Health eligible participants were willing to participate in dietary interventions like time-restricted eating or caloric restriction, but willingness declined for longer or more burdensome trials.</div></div><div><h3>Conclusions</h3><div>Recruiting young, healthy, unmedicated individuals for aging-focused dietary intervention trials is challenging due to low rates of eligibility and enrollment (∼3–4 % of initial applicants enrolled). Longer trials with stricter eligibility are likely to face greater recruitment barriers, highlighting the need for targeted strategies to engage, recruit, and retain this population effectively.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108143"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145511947","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 Diet Guidelines: 3 Diets (DG3D) study protocol of a behavioral teaching kitchen intervention for type-2 diabetes prevention among African American adults","authors":"Shiba Bailey ,&nbsp;Gabrielle M. Turner-McGrievy ,&nbsp;Enid A. Keseko ,&nbsp;Taylor Duncan ,&nbsp;Denine Ward-Johnson ,&nbsp;Briana Davis ,&nbsp;Sara Wilcox ,&nbsp;Daniela B. Friedman ,&nbsp;Mark A. Sarzynski ,&nbsp;Angela D. Liese","doi":"10.1016/j.cct.2025.108109","DOIUrl":"10.1016/j.cct.2025.108109","url":null,"abstract":"<div><h3>Background</h3><div>The U.S. Dietary Guidelines (USDG) serve as a foundational public health resource, yet their cultural applicability to underserved populations, including Black and African American (AA) adults, remains limited. The AA population is disproportionately affected by obesity and type 2 diabetes mellitus (T2DM), highlighting the need for culturally tailored interventions.</div></div><div><h3>Objectives</h3><div>To describe the design and methodology of the Dietary Guidelines: 3 Diets (DG3D) study, aimed at evaluating the effectiveness of culturally adapted USDG dietary patterns in improving diet quality and reducing risk factors associated with T2DM among AA adults. The intervention focuses on nutritional education and the promotion of healthy eating behaviors to support sustainable dietary change.</div></div><div><h3>Methods</h3><div>The DG3D study is a 12-month, single-masked, three-arm randomized behavioral nutrition intervention designed to evaluate three culturally adapted USDG dietary patterns: Healthy US, Mediterranean, and Vegetarian. The study recruited AA adults with overweight or obesity and at least three additional risk factors for T2DM. Participants were randomized to one of three dietary patterns and received group-based classes, cooking demonstrations, and web-based educational content. Primary outcomes include changes in diet quality (Healthy Eating Index [HEI]), body weight, and hemoglobin A1c (HbA1c), assessed at baseline, 6 months, and 12 months.</div></div><div><h3>Conclusion</h3><div>The DG3D study is a novel and comprehensive randomized trial evaluating culturally tailored dietary patterns in the AA population, a high-risk population. Findings are expected to inform inclusive dietary policy and contribute to reducing health disparities related to obesity and T2DM.</div><div>Trial registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> identifier <span><span>NCT05254496</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108109"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145279189","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":"Assessing the feasibility, acceptability, and efficacy of a pragmatic pilot and full-scale trial to improve care for older adults with complex care needs: The SPIRE study","authors":"Thomas G. Travison ,&nbsp;Edward Pham ,&nbsp;Karen Donelan ,&nbsp;Stephen J. Bartels ,&nbsp;Jocelyn A. Carter ,&nbsp;Kathryn Corelli ,&nbsp;Steven R. Counsell ,&nbsp;Maggie Crean ,&nbsp;Ellen Flaherty ,&nbsp;Carie Michael ,&nbsp;Daniel S. Moran ,&nbsp;Harvey J. Murff ,&nbsp;Jennifer Perloff ,&nbsp;Christine S. Ritchie","doi":"10.1016/j.cct.2025.108072","DOIUrl":"10.1016/j.cct.2025.108072","url":null,"abstract":"<div><div>Older adults with complex health and social care needs comprise some 5% of the United States population but contribute roughly half of healthcare costs. Patient and caregiver perspectives in qualitative studies emphasize care fragmentation in traditional care delivery models. The need for more streamlined and personalized care for these older adults is acute, particularly in value-based care systems such as Accountable Care Organizations (ACOs). Prior studies suggest that older adults with complex health needs are best cared for through person-centered care plans conducted by interdisciplinary teams of healthcare professionals, but adoption remains suboptimal. In this study, we compare two different geriatric-focused approaches to care for older adults: Annual Wellness Visits (AWV) and/or AWV augmented with GRACE (Geriatric Resources for Assessment and Care of Elders). AWVs are a Medicare benefit with a brief geriatric assessment; GRACE is a geriatric model of care that uses a home-based geriatric assessment, structured protocols, team-based care planning and primary care co-management to support older adults with complex care needs. The two-phase study includes a Phase 1 feasibility pilot, conducted in two primary care practices in one health system; and a Phase 2 cluster-randomized trial conducted in 32 primary care practices in four ACOs. Phase 2 assesses the comparative effectiveness of AWVs vs. AWV with GRACE, with primary outcomes of hospitalizations and patient experience, and secondary outcomes of caregiver strain and clinician professional fulfillment. Results will help inform personalized care among older adults with complex health needs.</div><div><span><span>NCT06287801</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108072"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999810","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":"Effects of soy foods on urinary sex steroid excretion and metabolic and cognitive health: The plants optimizing development study (PODS) protocol","authors":"Ajla Bristina ,&nbsp;Ilber E. Manavbasi ,&nbsp;Sharon M. Donovan ,&nbsp;Naiman A. Khan","doi":"10.1016/j.cct.2025.108110","DOIUrl":"10.1016/j.cct.2025.108110","url":null,"abstract":"<div><div>Soy foods are a dietary source of high-quality protein, essential micronutrients, and isoflavones with the potential to contribute to numerous health benefits. Previous research has examined the effects of soy isoflavones on health in adults, but comparatively little is known regarding the health effects of isoflavones in childhood. The Plants Optimizing Development Study (PODS) seeks to address this significant research gap. Children (<em>N</em> = 96) between the ages of 8–11 years will be recruited to participate in a 3-month randomized-controlled clinical trial. Treatment group participants will receive daily, a mix of soy foods with the target total isoflavone (i.e., daidzein, genistein, and glycitein) intake of 50 mg/d. The control group will consume isocaloric soy-free alternatives. The primary outcomes are sex steroids excreted in urine. Secondary outcomes include Android:Gynoid fat ratio, bone mineral density (BMD), blood lipids and fasting glucose, fecal microbial α-diversity, β-diversity, microbial taxa relative abundance, and cognition. Dual-energy X-ray absorptiometry will assess BMD and Android:Gynoid fat ratio. Urine samples will be analyzed for sex steroids using Liquid chromatography-mass spectrometry and adjusted for urinary creatinine. Stool and venous blood samples will assess gut microbiota and metabolic marker analyses, respectively. Cognitive assessments will include the Woodcock-Johnson Tests of Cognitive Abilities and Academic Achievement IV, a spatial memory task, and a modified Eriksen flanker task. The central hypothesis is that greater soy isoflavone consumption will not alter sex steroid levels but will be associated with beneficial outcomes on body composition, metabolic health, and the gut-brain axis in pre- and early adolescents.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108110"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145370126","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":"Protocol for a randomized clinical trial to evaluate the effectiveness of a technology-assisted motivational interviewing (TAMI) chatbot on smoking cessation","authors":"Brian Borsari ,&nbsp;Meredith C. Meacham ,&nbsp;Ahson Saiyed ,&nbsp;Tatyana Kanzaveli ,&nbsp;Maksim Tsvetovat ,&nbsp;Jing Cheng ,&nbsp;Anita S. Hargrave-Bouagnon ,&nbsp;Isaac A. Mirzadegan ,&nbsp;Faris Omeragic ,&nbsp;John Layton ,&nbsp;Jason Satterfield","doi":"10.1016/j.cct.2025.108111","DOIUrl":"10.1016/j.cct.2025.108111","url":null,"abstract":"<div><h3>Background</h3><div>The current project builds on our successful pilot work to develop a Technology-Assisted Motivational Interviewing (TAMI) chatbot and tobacco smoking cessation coach. TAMI is a highly scalable and easily accessible digital-coaching intervention that promotes readiness to change, provides compelling and accessible smoking cessation tools, and develops a tailored quit plan addressing social barriers to treatment initiation and sustainment.</div></div><div><h3>Methods</h3><div>The TAMI chatbot and associated digital architecture were optimized prior to the RCT using generative AI and incorporating feedback from both patients and experts. The resulting “TAMI 2.0” to be used in the RCT further supports smoking cessation by adding a nested, second chatbot that delivers education about evidence-based cessation tools, and a third nested chatbot that builds patient self-efficacy. The effectiveness of TAMI 2.0 will be determined by a 6-month, parallel 2-arm RCT comparing TAMI 2.0 to enhanced usual care. Adults who smoke (Target <em>N</em> = 440) recruited from primary care clinics will be randomized to (1) TAMI 2.0 or (2) usual care (UC). The primary outcome will be biochemically verified 7-day point prevalence abstinence from tobacco at 6 months with a secondary, self-reported, timepoint at 3 months. Other outcomes will include changes in readiness for cessation, smoking reduction, cessation outcome expectancies, smoking self-efficacy, and treatment initiation and sustainment.</div></div><div><h3>Conclusions</h3><div>If TAMI 2.0 is found to be an effective smoking cessation tool, this fully automated, patient-centered chatbot could be scaled to all communities greatly improving reach and access. NCT# <span><span>NCT06713603</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108111"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145360722","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}