Contemporary clinical trials最新文献

{"title":"The long-term effectiveness of the anti-obesity medication phentermine (LEAP) trial: Rationale, design, and baseline characteristics","authors":"Caroline Blackwell Young ,&nbsp;Emily Rives ,&nbsp;Kimberly A. Gudzune ,&nbsp;Byron C. Jaeger ,&nbsp;Courtney G. Simmons ,&nbsp;Brian N. White ,&nbsp;Stephanie A. Hooker ,&nbsp;Deborah B. Horn ,&nbsp;Deborah R. Young ,&nbsp;Jennifer Vesely ,&nbsp;Amanda Velazquez ,&nbsp;Catherine Price ,&nbsp;Shelly D. Cook ,&nbsp;Katy Martin-Fernandez ,&nbsp;Galina Inzhakova ,&nbsp;Nicholas M. Pajewski ,&nbsp;Jamy D. Ard ,&nbsp;Kristina H. Lewis","doi":"10.1016/j.cct.2026.108219","DOIUrl":"10.1016/j.cct.2026.108219","url":null,"abstract":"<div><h3>Background</h3><div>Current clinical practice guidelines support the long-term use of pharmacotherapy for obesity treatment. Historically, phentermine has been one of the most prescribed obesity medications (OMs), however, its long-term efficacy and safety have never been evaluated in a randomized trial as its market approval predates such requirements. Here we describe the design, rationale, and baseline characteristics for a 24-month, double-blind, randomized controlled trial evaluating the efficacy, cardiovascular risk, and safety of phentermine in adults with overweight or obesity.</div></div><div><h3>Methods</h3><div>This multicenter trial will compare outcomes among participants randomized to phentermine 24 mg daily versus placebo for 24 months. All participants also receive an online lifestyle intervention. A total of 870 participants with body mass index of 27–44.9 kg/m² were randomized across six sites in North Carolina (2), Minnesota, Texas, and California (2). Primary outcomes are 24-month mean percent weight loss (efficacy), 24-month mean change in systolic blood pressure (cardiometabolic risk), and overall rates of adverse events and serious adverse events (safety). Secondary outcomes include changes in resting energy expenditure/resting metabolic rate, cardiac autonomic function measured using heart rate variability with electrocardiogram, and a self-reported measure of phentermine dependence.</div></div><div><h3>Conclusions</h3><div>The safety and efficacy of long-term phentermine remains a pressing, unanswered question, particularly given its low cost and high availability when compared to newer OMs that are highly effective but often associated with significant costs. This study will impact clinical practice regardless of result – either providing evidence to support use of an available low-cost option or prioritizing the use of other OMs.</div><div><strong>Trial Registration:</strong> Clinicaltrials.gov, NCT05176626.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108219"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948659","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":"Addressing social needs to improve health in adults with multiple chronic conditions: A comparative effectiveness trial of two real-world social needs interventions","authors":"Emma L. Tucher ,&nbsp;Allison L. Steele ,&nbsp;Connie S. Uratsu ,&nbsp;Leah K. Hamilton ,&nbsp;Meagan C. Brown ,&nbsp;Joshua R. Nugent ,&nbsp;Danielle Hessler Jones ,&nbsp;Laura M. Gottlieb ,&nbsp;Richard W. Grant","doi":"10.1016/j.cct.2025.108210","DOIUrl":"10.1016/j.cct.2025.108210","url":null,"abstract":"<div><div>Background: Adults with multiple chronic conditions (MCC, defined as two plus chronic conditions) account for one-third of the United States population but 71 % of healthcare expenditures. Many adults with MCC also manage social needs like food insecurity or housing instability, which are associated with worse disease outcomes and decreased life expectancy. Research on social needs interventions demonstrated that targeted interventions can significantly improve care utilization and patient well-being. However, many published trials evaluating social needs navigation or resource referrals have focused on a single social need, specific health conditions, or a single intervention strategy.</div><div>Methods: This trial (“Addressing Social Needs to Improve Health in Adults with Multiple Chronic Conditions”) is a comparative-effectiveness randomized control trial (CE-RCT) comparing the clinical impact of two commonly implemented social needs interventions (“higher intensity” social needs phone navigation versus “lower intensity” automated electronic resource outreach). It will enroll 12,000 adults with MCC, one or more evidence-based clinical care gaps, and one or more social needs within Kaiser Permanente, an integrated delivery system serving over 12.5 million members. Participants can be randomized to a higher or lower intensity intervention. The primary outcomes are 12-month clinical care gap closures measured via electronic health records, and 6-month receipt of social services and reductions in social needs, measured via patient surveys. Secondary outcomes include survey and interview assessments of stress and experiences of social care.</div><div>Conclusion: Results from this CE-RCT provide policy and practice-relevant evidence comparing the impacts of different approaches to addressing social needs in patients with MCC.</div><div>Trial registration: <span><span>clinicaltrials.gov/study/NCT06941519</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108210"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843569","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":"Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents","authors":"Andrea B. Goldschmidt ,&nbsp;Adrian Ortega ,&nbsp;Isabel R. Rooper ,&nbsp;Katrina T. Obleada ,&nbsp;Danielle A.N. Chapa ,&nbsp;Basia Silverberg ,&nbsp;Erin Stalvey ,&nbsp;Macarena Kruger Camino ,&nbsp;Michele D. Levine ,&nbsp;Lan Yu ,&nbsp;Dawn M. Eichen ,&nbsp;Andrea K. Graham","doi":"10.1016/j.cct.2025.108192","DOIUrl":"10.1016/j.cct.2025.108192","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric overweight and obesity continue to be major public health issues. Loss of control (LOC) eating and overeating are two obesity-related phenotypes affecting approximately 30 % of adolescents with overweight/obesity that may undermine weight control treatment outcome. Cognitive-behavioral therapy (CBT) has promising effects on dysregulated eating, but effects on weight are modest, access is limited, and developmental changes in self-regulation (which may limit implementation of treatment skills) are often ignored. <u>Methods</u>: In the current proposal, we will apply human-centered design methods to design and test a novel CBT-based digital intervention, augmented with content and features to improve self-regulation, for weight gain prevention and dysregulated eating in adolescents. The first phase will involve design activities with adolescents (<em>n</em> = 25–30) who have body mass index (BMI; kg/m²) ≥ 75th percentile for age and sex and report dysregulated eating, to understand desired presentation, features, and barriers/facilitators to engagement. Research activities will include a needs assessment and iterative prototyping, usability testing, and refinement of the digital intervention. The second phase will be a multisite single arm open trial involving 50 adolescents who have or are at risk for overweight/obesity and report LOC and/or overeating to investigate intervention feasibility and preliminary efficacy, as well as putative treatment mechanisms and targets. <u>Conclusions</u>: Results of the study will inform the design of an adequately powered randomized controlled trial. The project has clear potential to significantly impact public health via development of a relevant, accessible, and scalable intervention for adolescents at risk for adverse physical and mental health outcomes.</div><div><strong>Clinical trial registration number</strong>: <span><span>NCT06819813</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108192"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145789069","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 design and methodologies for the men moving forward lifestyle intervention trial with black prostate cancer survivors","authors":"Iwalola Awoyinka ,&nbsp;Patricia Sheean ,&nbsp;Paula Papanek ,&nbsp;Kathryn E. Flynn ,&nbsp;Kathryn Bylow ,&nbsp;Deepak Kilari ,&nbsp;Peter Gann ,&nbsp;Anjishnu Banerjee ,&nbsp;Melinda Stolley","doi":"10.1016/j.cct.2025.108205","DOIUrl":"10.1016/j.cct.2025.108205","url":null,"abstract":"<div><h3>Backgound</h3><div>Prostate cancer (PC) incidence and mortality rates are significantly higher among Black/African-American (Black) men compared to men of other race/ethnicities. Comorbidities and compromised quality of life are also greater challenges for this community of men. Many factors drive these differences among which body composition and health behaviors are important, yet modifiable contributors. Lifestyle interventions report beneficial results for PC survivors; however, the inclusion of Black men is critically limited. This paper describes Men Moving Forward (MMF) –a community-based lifestyle intervention for Black men with PC.</div></div><div><h3>Methods/Design</h3><div>This trial will randomize (1:1) 200 Black men with PC who completed treatment or are on active surveillance. The 16-week MMF intervention, conducted in partnership with the Milwaukee Recreation system, supports adoption of the American Cancer Society Nutrition and Physical Activity guidelines. Measures of body composition (primary), behavior (diet, physical activity), fitness, quality of life, and biomarkers of general health and PC recurrence risk are collected at baseline, post-intervention and at a 12-month follow-up. The primary hypothesis is that men receiving the MMF intervention will exhibit greater changes in body composition than those in the wait-list control group.</div></div><div><h3>Discussion</h3><div>The MMF trial addresses an important gap in the current literature, evaluating the potential efficacy of a lifestyle program developed with and for Black men with PC. Outcomes including body composition and biomarkers of general health and PC recurrence risk add to our knowledge and methodologies on health behaviors and PC survivorship. Study results will inform survivorship efforts for this high-risk, underrepresented population.</div><div>U.S. <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> number: <span><span>NCT03971591</span><svg><path></path></svg></span>, 06.01.2019.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108205"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843578","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":"Stand up for your health: Rationale and design for a randomized controlled trial","authors":"Muhammad Hammad ,&nbsp;Sindhu Shankar ,&nbsp;Yan Gao ,&nbsp;Jacquelyn Kulinski","doi":"10.1016/j.cct.2026.108216","DOIUrl":"10.1016/j.cct.2026.108216","url":null,"abstract":"<div><h3>Background</h3><div>Sedentary behavior is an independent risk factor for cardiometabolic disease. With the rise of desk-based occupations and work-from-home culture, the workplace offers a promising setting to employ interventions to reduce sedentary time.</div></div><div><h3>Objective</h3><div>The goal of this randomized controlled trial is to determine if reducing sedentary time with sit-stand desks improves cardiometabolic health outcomes in overweight and obese individuals with sedentary jobs who are at risk of developing diabetes.</div></div><div><h3>Methods</h3><div>Approximately 198 eligible participants (includes estimated 25% drop-out) with pre-diabetes or at-risk for type 2 diabetes will be randomized in a 1:1:1 ratio into three groups: a control group (no intervention), a 2-h group (instructed to stand at their sit-stand desks for at least 2 h daily), and a 3-h group (instructed to stand for at least 3 h daily). Each participant will complete three study visits over a 6-month period. The primary outcome is insulin resistance.</div></div><div><h3>Discussion</h3><div>The potential impact of this study is significant, given that over 70% of the U.S. population is overweight or obese, and more than 80% of jobs are sedentary. Affirmative findings from our study would advance the field by demonstrating that an easily adoptable intervention can reduce cardiometabolic risk, providing justification for widespread implementation of standing desks in the workplace.</div></div><div><h3>Conclusion</h3><div>This randomized, control study will determine if reducing sedentary behavior at work, with an adjustable sit-stand desk, improves insulin resistance in individuals at risk for diabetes. This study may help inform public health guidelines benefitting a large population of sedentary workers.</div><div>Clinical trial registration identifier: <span><span>NCT05585190</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108216"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145922245","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":"Quantifying the role of communication in recruitment status outcomes for a clinical trial on genetic testing uptake","authors":"Arianna Morel ,&nbsp;Emerson Delacroix ,&nbsp;John D. Rice ,&nbsp;Sarah Austin ,&nbsp;Erika Koeppe ,&nbsp;Erika N. Hanson ,&nbsp;Jennifer J. Griggs ,&nbsp;Elena Martinez Stoffel ,&nbsp;Ken Resnicow","doi":"10.1016/j.cct.2026.108218","DOIUrl":"10.1016/j.cct.2026.108218","url":null,"abstract":"<div><h3>Background</h3><div>Participant recruitment remains a significant challenge in clinical trials, often resulting in delays, increased resource expenditures, and missed opportunities for advancing care. While previous research has largely focused on participants' perspectives regarding recruitment barriers, less is known about the influence of different outreach strategies (methods and frequency) from the viewpoint of research staff. This study evaluates the likelihood of reaching a definitive enrollment outcome to inform more effective and resource-efficient recruitment strategies.</div></div><div><h3>Methods</h3><div>Data were obtained from recruitment efforts for a two-phase clinical trial aimed at increasing hereditary cancer genetic testing uptake among eligible individuals. Participant recruitment utilized email invitations for patients in participating practices and multimedia campaigns for the public. Eligible participants received up to two email reminders and 5–8 recruitment calls, with a standardized call survey ensuring consistency.</div></div><div><h3>Results</h3><div>Of the invited, 2485 (82.8%) accessed the email link and completed the eligibility screening survey, of these 80.4% of invitees reached a definitive recruitment status outcome: ineligible (37.2%), refused (15.6%), consented (27.6%), while 19.5% were lost to enrollment. Analysis of call attempts revealed that call attempt one had the highest participant answer rate (∼45%), which declined with each additional attempt, reaching 13% at six or more attempts. Email outreach alone produced probability spikes in definitive outcomes following email reminders. Additional calls demonstrated sharply diminishing returns beyond the fourth to sixth attempts.</div></div><div><h3>Conclusion</h3><div>This study demonstrates that tracking and optimizing outreach frequency, timing, and mode can enhance clinical trial recruitment efficiency. Specifically, at least one email and one phone call significantly improve the likelihood of reaching a definitive recruitment outcome, while exceeding 4–6 call attempts yields minimal additional benefit. These findings provide a framework for recruitment strategies, enabling more effective allocation of resources and increasing the chances of meeting recruitment goals in future clinical trials.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108218"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145951532","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 missing outcome data methods for the analysis of the MEL-SELF trial of patient-led surveillance for early-stage melanoma: A simulation study","authors":"Ellie Medcalf ,&nbsp;Robin M. Turner ,&nbsp;David Espinoza ,&nbsp;Lin Zhu ,&nbsp;Katy J.L. Bell","doi":"10.1016/j.cct.2025.108186","DOIUrl":"10.1016/j.cct.2025.108186","url":null,"abstract":"<div><h3>Background</h3><div>Complete case analysis (CCA) is the most common method used to handle missing outcome data in trials but may often lead to biased estimates. Newer methods that address missing not at random data are infrequently used.</div></div><div><h3>Objective</h3><div>We evaluated six missing data methods in a simulation study based on a melanoma surveillance trial.</div></div><div><h3>Methods</h3><div>We used the MEL-SELF pilot of patient-led surveillance for patients with early-stage melanoma as the empirical basis of our simulated study. We evaluated three commonly used methods (CCA, mixed models for repeated measurements (MMRM), multiple imputation (MI)), and three recently developed methods (retrieved dropout (RD) imputation, jump to reference (J2R) imputation and trimmed means (TM)), under 48 scenarios where treatment effect size, missingness percentage and missingness assumptions were varied.</div></div><div><h3>Results</h3><div>Under scenarios with small or small-moderate treatment effects and missing not at random outcome data, all methods produced some bias, with TM and CCA the most biased towards and away from the null, respectively. Both also had low precision and power. J2R performed best of methods that were biased towards the null (JR, TM), with small bias for small and small-moderate treatment effects, high precision and high coverage. RD performed best of methods that were biased away from the null (RD, CCA, MMRM, MI) with small bias, good precision and good coverage.</div></div><div><h3>Conclusion</h3><div>In this simulation of a melanoma surveillance trial with non-random missing outcomes, RD produced the least bias away from the null and J2R produced the least bias towards the null.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108186"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773939","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 cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol","authors":"Nickola D. Pallin ,&nbsp;Naomi Algeo ,&nbsp;Mary Eileen O'Connor ,&nbsp;Hayley Connolly ,&nbsp;Michelle Lowry ,&nbsp;Kathleen Bennett ,&nbsp;Patrick Gillespie ,&nbsp;Anna Hobbins ,&nbsp;Pamela Gallagher ,&nbsp;Louise Mullen ,&nbsp;Kathleen D. Lyons ,&nbsp;Sheena M. McHugh ,&nbsp;Deirdre Connolly","doi":"10.1016/j.cct.2025.108185","DOIUrl":"10.1016/j.cct.2025.108185","url":null,"abstract":"<div><h3>Introduction</h3><div>Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for those LWBBC are a recommended component of cancer survivorship care. CanWork is a six-week, self-management support programme designed to facilitate women LWBBC in developing knowledge and skills to manage cancer-related symptoms that interfere with RTW. This paper presents the protocol for a cluster randomised controlled trial that will test the effectiveness and cost effectiveness of CanWork in supporting women LWBBC in RTW following completion of cancer treatment.</div></div><div><h3>Methods</h3><div>A cluster-randomised controlled trial will be conducted through community cancer support centres in the Republic of Ireland. Centres will be assigned to the control or intervention arms by randomisation and the aim is to recruit 248 women. The two primary outcomes are changes in RTW (yes: returned to work; no: not returned to work) and self-efficacy to manage physical, psychological and emotional demands of work at 12 months follow up post-intervention. Secondary outcomes are readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, health related quality of life and absence from work for cancer-related reasons at 12 months follow up post-intervention. Cost effectiveness will also be measured. Follow-up will occur up to 12-months post-intervention using self-reported questionnaires.</div></div><div><h3>Discussion</h3><div>Findings will determine whether CanWork is an effective and cost-effective intervention in supporting women with breast cancer to return to work.</div><div><strong>Trial registration number:</strong> <span><span>NCT06723899</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108185"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773816","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":"Remotely-delivered exercise training program among older adults with multiple sclerosis: Feasibility results of a randomized controlled trial","authors":"Peixuan Zheng ,&nbsp;Sydney R. DeJonge ,&nbsp;Noah G. DuBose ,&nbsp;Ariel Kidwell-Chandler ,&nbsp;Trevor B. Martin ,&nbsp;Trinh L.T. Huynh ,&nbsp;Shane A. Phillips ,&nbsp;Jennifer Duffecy ,&nbsp;Robert W. Motl","doi":"10.1016/j.cct.2025.108190","DOIUrl":"10.1016/j.cct.2025.108190","url":null,"abstract":"<div><h3>Background</h3><div>Older adults with multiple sclerosis (MS) are often physically inactive and present with walking and cognitive impairments that may be remediated through rehabilitation approaches such as exercise training.</div></div><div><h3>Objectives</h3><div>We conducted a phase-Ib, randomized controlled trial (RCT) that examined the feasibility and initial efficacy of a 16-week remotely-delivered, home-based exercise training program in older adults with MS who had moderate mobility disability.</div></div><div><h3>Methods</h3><div>This study utilized a parallel-group RCT design. Participants (<em>n</em> = 51; mean age = 60.5 years, 78 % females) were randomized into exercise training (aerobic and resistance) or active control (stretching) conditions. Both conditions were undertaken within a participant's home/community and remotely supported by a behavioral coach. Participants received training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and social cognitive theory-based newsletters. Feasibility was assessed across process, resource, management, and scientific domains. Scientific outcomes focused on physical function, cognition, and physical activity, with data collected by treatment-blinded assessors.</div></div><div><h3>Results</h3><div>The intervention was cost-effective, accessible, well-received, and safe based on formative evaluation. Forty-one (80.4 %) participants completed the conditions, with adherence and compliance rates across conditions exceeding 80 %. There were moderate-to-large improvements in walking speed, functional mobility, lower-extremity function, and verbal learning and memory (<em>p</em> &lt; 0.05, <em>|d|</em> = 0.58–0.80) in the exercise condition, but not in control (<em>p</em> &gt; 0.05).</div></div><div><h3>Conclusions</h3><div>This study established the feasibility and initial efficacy of a theory-based, remotely-delivered exercise training intervention for older adults with MS. The promising results support the design and implementation of a subsequent, phase-II RCT for improving physical and cognitive functions in the older MS population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108190"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145789180","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":"Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease: A pilot randomized clinical trial protocol","authors":"Mukoso N. Ozieh ,&nbsp;Charity G. Patterson ,&nbsp;Joni S. Williams ,&nbsp;Rebekah J. Walker ,&nbsp;Leonard E. Egede","doi":"10.1016/j.cct.2025.108183","DOIUrl":"10.1016/j.cct.2025.108183","url":null,"abstract":"<div><h3>Background</h3><div>Diabetic kidney disease (DKD) is the leading cause of end stage kidney disease (ESKD) in the United States. African Americans have a risk of developing chronic kidney disease and are almost four times more likely to progress to ESKD compared to non-Hispanic whites. The presence of social adversities impacts the complex self-management of DKD and negatively impacts health outcomes. Patient navigation interventions offer a promising strategy to improve health outcomes in individuals with chronic disease. However, it is not known whether a basic needs navigation intervention that addresses social adversities in combination with patient education and lifestyle coaching leads to improved clinical and patient-centered outcomes.</div></div><div><h3>Methods and analysis</h3><div>This ongoing 3-year two-arm pilot randomized clinical trial will test the feasibility of a basic needs navigation intervention in African American adults with DKD experiencing multidimensional adversity (having one or more social adversity). Fifty African American adults with DKD experiencing one or more social adversity and who have uncontrolled diabetes (HbA1c 8 % or more) will be randomized into one of two arms: 1) basic needs navigation intervention arm or 2) enhanced usual care arm. The primary clinical outcome is feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention.</div></div><div><h3>Discussion</h3><div>The results of this study will serve as a first step in addressing current gaps in knowledge and will provide feasibility data for a large-scale appropriately powered, randomized clinical trial focused on addressing social adversity in African American adults with DKD.</div></div><div><h3>Ethics and dissemination</h3><div>This trial was approved by Medical College of Wisconsin IRB Protocol # PRO00041675.</div></div><div><h3>Trial registration number</h3><div>Registration for this trial can be found under ID: <span><span>NCT05357742</span><svg><path></path></svg></span> and online (<span><span>https://clinicaltrials.gov/ct2/show/NCT05357742?id=NCT05357742&amp;draw=2&amp;rank=1</span><svg><path></path></svg></span>) on the NIH U.S. National Library of Medicine Clinical Trials Database.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108183"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145793408","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}