Contemporary clinical trials最新文献

{"title":"Personalising the management of obesity-related asthma using medical nutrition therapy and physical activity prescription: The IDEAL study protocol","authors":"Tamara Blickisdorf ,&nbsp;Lisa G. Wood ,&nbsp;Sarah R. Valkenborghs ,&nbsp;Anne E. Dixon ,&nbsp;Jay C. Horvat ,&nbsp;Natasha A. Weaver ,&nbsp;Serene Yoong ,&nbsp;Bronwyn S. Berthon ,&nbsp;Evan J. Williams ,&nbsp;Alexandra C. Brown ,&nbsp;Christine R. Jenkins ,&nbsp;Meagan L. Morrissey ,&nbsp;Peter A. Wark ,&nbsp;Katie Wynne ,&nbsp;Christopher L. Grainge ,&nbsp;Emad M. El-Omar ,&nbsp;Lily M. Williams ,&nbsp;John D. Brannan ,&nbsp;Liang De Wang ,&nbsp;Siu Ling Wong ,&nbsp;Hayley A. Scott","doi":"10.1016/j.cct.2025.108178","DOIUrl":"10.1016/j.cct.2025.108178","url":null,"abstract":"<div><h3>Background</h3><div>Obesity is associated with more severe asthma symptoms, more frequent exacerbations, and more frequent asthma-related hospitalisations compared to adults without obesity. Because the origins and expression of obesity varies between individuals, a one-size-fits-all approach to obesity management will not address the underlying cause(s), increasing the risk of treatment failure. We hypothesise that obesity-related asthma is driven by excess adiposity, poor diet quality, physical inactivity, and poor metabolic health, while an individualised obesity management intervention, utilising medical nutrition therapy and personalised physical activity prescription, will result in better asthma control.</div></div><div><h3>Methods</h3><div>The Individualised Diet and Exercise Intervention for Optimising Asthma Control and Lung Function (IDEAL) Study will test the first individualised obesity management approach for people with asthma. In this 16-week randomised controlled trial with 12-month follow-up, 102 adults with obesity and uncontrolled asthma will be randomised to either the IDEAL program or control group. Participants will be assessed for outcomes at baseline, 16 and 52 weeks. Participants randomised to the IDEAL Program will attend five sessions with a dietitian and physiotherapist/exercise physiologist during the 16-week intervention period. We will test the intervention effect on asthma (asthma control, lung function), inflammatory (e.g. sputum cell counts, plasma IL-6) and non-asthma outcomes (e.g. diet quality, physical activity levels, metabolic health), as well as the acceptability and cost of the intervention.</div></div><div><h3>Conclusion</h3><div>This trial aims to provide people living with asthma and obesity an effective and sustainable way to help control their asthma symptoms and will assess mechanisms responsible for any improvements observed.</div></div><div><h3>Ethics/Registrations</h3><div><strong>NSW REGIS ETHICS Reference:</strong> 2023/ETH00833.</div><div><strong>UoN IBC Reference No:</strong> SP-23-92.</div><div><strong>ANZCTR Reference No:</strong> ACTRN12623000979651.</div><div><strong>Universal Trial Number</strong>: U1111–1291–8501.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108178"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696106","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":"Analytical treatment interruption as a tool in the evaluation of immune-mediated interventions for long-term antiretroviral-free control of HIV-1 among people with HIV","authors":"Ana Gabriela Pires dos Santos ,&nbsp;Manal Abunimeh ,&nbsp;Beatriz Mothe ,&nbsp;Jean-Pierre Routy ,&nbsp;Jacob P. Lalezari ,&nbsp;Gary I. Sinclair ,&nbsp;Simiso M. Sokhela ,&nbsp;Ricardo Sobhie Diaz ,&nbsp;Siegfried Schwarze ,&nbsp;Jeff Berry ,&nbsp;Sharon R. Lewin ,&nbsp;Karine Dubé ,&nbsp;Preethi Krishnan ,&nbsp;Andrew Topp ,&nbsp;Sarah Gill ,&nbsp;Daniel Cohen","doi":"10.1016/j.cct.2025.108144","DOIUrl":"10.1016/j.cct.2025.108144","url":null,"abstract":"<div><h3>Background</h3><div>Immune-mediated interventions have the potential to induce long-term antiretroviral treatment (ART)-free viral suppression in people with HIV. However, in the absence of biomarkers of viral control, studies looking at immune interventions require a planned long-term analytical treatment interruption (ATI) that may bring risks to participants and challenges for data interpretation. Herein, we describe an ongoing, global, proof-of-concept, randomized, placebo-controlled, phase 2 clinical trial with a planned ATI and illustrate how those risks have been mitigated to safely evaluate the long-term durability of ART-free viral control.</div></div><div><h3>Methods</h3><div>The trial evaluates an immunologic combination of low-dose budigalimab and trosunilimab administered during ATI. Adults aged 18–70 with confirmed HIV-1 on stable ART with viremia below the limit of detection and CD4+ counts &gt;500 cells/mL willing to undergo ATI are randomized to receive budigalimab, trosunilimab, both (at 2 different trosunilimab doses), or neither. The primary efficacy endpoint is the proportion of participants achieving viral control (HIV-1 RNA &lt;1000 copies/mL) without restarting ART at week 24. The planned ATI duration (≤112 weeks) evaluates the durability of off-ART viral control, long-term safety, and biomarkers. Key ATI elements align with published consensus recommendations [<span><span>1</span></span>] while incorporating feedback from members of the global HIV community.</div></div><div><h3>Conclusions</h3><div>By sharing this study design, we hope to inform on the lessons learned from operationalizing a global study evaluating durable ART-free viral control, including the critical role of engaging members of the HIV community during clinical trial design to ensure the success of an ATI-inclusive study.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108144"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494890","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":"Improving CDK4/6 inhibitors adherence in breast cancer using the CONnected CUstomized Treatment Platform (CONCURxP) mobile health intervention: Study protocol for ECOG-ACRIN EAQ221CD","authors":"Gelareh Sadigh ,&nbsp;Fenghai Duan ,&nbsp;Ilana F. Gareen ,&nbsp;Judy Hancock ,&nbsp;JoRean D. Sicks ,&nbsp;Maryanne Thangarajah ,&nbsp;Jane L. Meisel ,&nbsp;Mylin A. Torres ,&nbsp;Scott D. Ramsey ,&nbsp;Antonio C. Wolff ,&nbsp;Lynne I. Wagner ,&nbsp;Ruth C. Carlos ,&nbsp;Ilana Graetz","doi":"10.1016/j.cct.2025.108145","DOIUrl":"10.1016/j.cct.2025.108145","url":null,"abstract":"<div><h3>Background</h3><div>Cyclin-dependent kinase 4/6 inhibitors (CDKIs) improves survival when added to endocrine therapy in hormone receptor-positive (HR+), human epidermal growth factor receptor 2–negative (HER2-) breast cancer. However, their complex schedule, side effects, and cost contribute to non-adherence.</div></div><div><h3>Methods</h3><div>The EAQ221CD is a two-arm randomized controlled trial that evaluates the effectiveness of the CONnected CUstomized Treatment Platform (CONCURxP), a mobile health intervention, versus enhanced usual care (EUC) on CDKI adherence among 390 patients with breast cancer and a new CDKI prescription. Participants use a smart pouch (Wisebag) to monitor real-time adherence. CONCURxP arm patients: (1) receive text reminders for missed or extra doses; (2) receive text message surveys inquiring reasons for missed or extra doses; and (3) have access to their adherence history on a study web portal. Missed or double doses trigger alerts to the oncology team. Patients citing cost as a barrier are referred to a national non-profit financial navigation program. EUC arm patients receive educational materials on side effect management. Patients complete surveys at baseline, 3, 6, and 12 months after randomization. Our objectives are to: (1) compare 12-month CDKI adherence measured using Wisebag (primary outcome) between the two arms; (2) compare patient-reported outcomes at 12-months between the two arms, including symptom burden, quality of life, patient-provider communication, self-efficacy for managing symptoms, and financial worry; and (3) use mixed methods to describe patients' experience with the CONCURxP intervention. Our multilevel intervention will provide actionable results to improve adherence, health outcomes, and patients' experience.</div><div><strong>Trial registration:</strong> NCT06112613.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108145"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145563155","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":"Assessment of a novel functional food modulating the microbiota-inflammation-brain axis in patients with heart failure and/or /atrial fibrillation patients (the AMBROSIA study): Protocol for a randomized controlled trial","authors":"Simone Baldi ,&nbsp;Francesca Cuffaro ,&nbsp;Edda Russo ,&nbsp;Kate Porter ,&nbsp;William Cheung ,&nbsp;Maria Magdalena Coman ,&nbsp;Marco Garcia Vaquero ,&nbsp;Thomas Lingner ,&nbsp;Maria Cristina Verdenelli ,&nbsp;Gwendolyn Barceló-Coblijn ,&nbsp;Iain Brownlee ,&nbsp;Stefano Fumagalli ,&nbsp;Amedeo Amedei","doi":"10.1016/j.cct.2025.108170","DOIUrl":"10.1016/j.cct.2025.108170","url":null,"abstract":"<div><h3>Background and aims</h3><div>Atrial fibrillation (AF), heart failure (HF), and undernutrition represent a complex triad with major clinical and socioeconomic consequences in older adults, often predisposing to frailty. Undernutrition often remains underdiagnosed due to a reliance on weight-based measures and limited awareness of inflammation-related cachexia. The AMBROSIA study aims to fill these gaps by exploring the response of the microbiota–inflammation–brain axis to a targeted, fortified food product-based intervention, with comprehensive outcome assessments, alongside mechanistic/exploratory -omics analyses and gut microbiota (GM) functional profiling.</div></div><div><h3>Methods and results</h3><div>This single-center, prospective, parallel-group randomized controlled trial aims to enroll 120 older adults with confirmed AF and/or HF. Participants will be randomized 1:1 into an intervention group (<em>n</em> = 60) or control group (n = 60). All participants receive individualized dietary counseling; the intervention group additionally consumes one AMBROSIA nutritional bar daily for six months. The bar contains hydrolyzed proteins, inulin, CoQ₁₀, and probiotics (<em>L. rhamnosus</em> IMC 501® and L. <em>paracasei</em> IMC 502®) in a flavonoid-rich chocolate matrix. Clinical, cognitive, and nutritional data, along with blood, saliva, urine, and stool samples, will be collected at baseline, 3, and 6 months. The primary endpoint is the change in skeletal muscle mass, physical function and frailty, while secondary endpoints include changes in nutritional status, inflammation, GM, metabolomics, and quality of life.</div></div><div><h3>Conclusion</h3><div>By integrating cutting-edge omics tools and a multidimensional nutritional strategy, AMBROSIA aims to uncover mechanisms driving undernutrition and identify biomarkers to support personalized interventions for older patients with AF and HF.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108170"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145654007","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 effectiveness and engagement strategies for asynchronous, messaging, trauma-focused therapy for posttraumatic stress disorder: Study design and methodology for a hybrid effectiveness-implementation randomized controlled trial","authors":"Katherine A. Dondanville ,&nbsp;Amber Calloway ,&nbsp;Elizabeth C. Stade ,&nbsp;Thomas D. Hull ,&nbsp;Booil Jo ,&nbsp;Szu-chi Huang ,&nbsp;Brittany N. Hall-Clark ,&nbsp;Stefanie T. LoSavio ,&nbsp;Bailee Schuhmann ,&nbsp;Sohayla Elhusseini ,&nbsp;Nicole Fridling-Cook ,&nbsp;Cyrus Pattee ,&nbsp;Aarthi Padmanabhan ,&nbsp;Shannon Wiltsey Stirman","doi":"10.1016/j.cct.2025.108149","DOIUrl":"10.1016/j.cct.2025.108149","url":null,"abstract":"<div><div>Posttraumatic stress disorder (PTSD) can be a chronic and debilitating condition with significant individual and societal costs. Despite the availability of effective, trauma-focused treatments like Cognitive Processing Therapy (CPT), access and sustained engagement remain limited due to logistical, financial, and stigma-related barriers. The current study utilized a hybrid effectiveness-implementation randomized control trial (<em>N</em> = 300) to evaluate the clinical effectiveness and feasibility of <em>CPT-Text</em>, an asynchronous, therapist-delivered messaging version of CPT, compared to culturally informed treatment-as-usual (CI-TAU) delivered via secure text on the Talkspace platform. Participants were also randomized to receive either standard engagement reminders (RAU) or a novel engagement incentive (RAU + I), which encourages altruism by offering participants the opportunity to “pay forward” credits for free therapy to another PTSD-affected individual through their continued participation. Primary outcomes include PTSD symptom severity (PCL-5) and engagement (e.g., treatment completion and messaging frequency), with secondary outcomes assessing depression, functioning, satisfaction, substance use. We hypothesize that CPT-Text will outperform CI-TAU in symptom reduction, and that RAU + I will enhance engagement and outcomes. Exploratory analyses will examine individual-level moderators and motivation as a mechanism of change. A novel component of this trial includes development of a large language model–based fidelity assessment tool for CPT-Text, allowing scalable evaluation of treatment delivery. Findings will inform scalable, effective, and accessible PTSD interventions that meet the needs of individuals underserved by traditional mental health care, and provide insight into how human-delivered, technology-mediated therapy can be both clinically robust and broadly accessible. Evaluating Asynchronous Messaging Therapy for PTSD.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108149"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145570300","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":"Corrigendum to “Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial,” [Contemp Clin Trials 101 (2021) 106253]","authors":"Rachel C. Whooten ,&nbsp;Gracia M. Kwete ,&nbsp;Haley Farrar-Muir ,&nbsp;Rachel N. Cournoyer ,&nbsp;Elizabeth A. Barth ,&nbsp;Milton Kotelchuck ,&nbsp;Elsie M. Taveras","doi":"10.1016/j.cct.2025.108181","DOIUrl":"10.1016/j.cct.2025.108181","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108181"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780456","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":"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}