Contemporary clinical trials最新文献

{"title":"Design and methods of a multi-level intervention to improve adherence to childhood cancer survivorship care by partnering with primary care providers: The BRIDGES randomized controlled trial","authors":"Wilhelmenia L. Ross ,&nbsp;Yaiomy Santiago-Rivera ,&nbsp;Ming T. Tan ,&nbsp;Megan M. Roy ,&nbsp;Stacy Bryant ,&nbsp;Burton E. Appel ,&nbsp;Jacqueline Casillas ,&nbsp;Jenna Demedis ,&nbsp;Andrew B. Smitherman ,&nbsp;Leora I. Horwitz ,&nbsp;Alejandra Hurtado-de-Mendoza ,&nbsp;Jason A. Mendoza ,&nbsp;Sheila J. Santacroce ,&nbsp;Nina S. Kadan-Lottick","doi":"10.1016/j.cct.2025.107859","DOIUrl":"10.1016/j.cct.2025.107859","url":null,"abstract":"<div><h3>Background</h3><div>Despite heightened risk of chronic health conditions, &lt;20 % of childhood cancer survivors (CCS) receive guideline-recommended surveillance for late effects. Barriers include avoidance of reminders, lack of knowledge, and costs. The goal of the BRIDGES Study is to evaluate the effects of a multi-level, remote intervention on adherence to guideline-recommended surveillance among CCS by partnering with primary care providers (PCPs).</div></div><div><h3>Methods</h3><div>This ongoing study is a multi-site, two-arm, prospective, parallel design, 1:1 randomized controlled non-inferiority trial (<em>N</em> = 240; <em>n</em> = 120/group). Eligibility criteria are: cancer diagnosis at age &lt; 21 years, 2.0–4.0 years post-cancer therapy, and no previous specialty survivorship clinic care. The intervention includes: 1) patient survivorship education via telehealth with a cancer center nurse, including discussion of patient's individualized survivorship care plan (SCP), 2) ongoing patient-tailored health education within the electronic health record's patient portal, 3) a structured interactive phone call between the cancer center nurse and PCP, including discussion of patient's SCP, and 4) an in-person PCP visit for survivorship care. Patients randomized to the comparison group are contacted to schedule an in-person visit at their cancer center-based survivorship clinic. Adherence to guideline-recommended surveillance tests (primary outcome) is assessed at 1-year post-randomization (primary follow-up time point) and 2-years post-randomization (for durability). Patient knowledge, self-efficacy, and activation; PCP knowledge and self-efficacy; and process outcomes are also assessed.</div></div><div><h3>Conclusion</h3><div>Models of survivorship care that overcome existing barriers are needed. If efficacious, this scalable, remote intervention would be a valuable strategy to address barriers and bridge gaps in care to reach more CCS.</div><div><strong>Clinical Trial Registration:</strong> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT05448560</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107859"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482459","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":"Cognitive remediation in breast cancer survivors: A study protocol","authors":"Pedro Alejandro Rodriguez Nunez ,&nbsp;Véronique Gérat-Muller ,&nbsp;Carine Bellera ,&nbsp;Caroline Lalet ,&nbsp;Bruno Quintard ,&nbsp;Camille Chakiba ,&nbsp;Virginie Postal","doi":"10.1016/j.cct.2025.107858","DOIUrl":"10.1016/j.cct.2025.107858","url":null,"abstract":"<div><div>Cancer treatment-related cognitive impairment, also known as “Chemobrain,” is frequently reported among cancer survivors. This condition can persist for months after the end of cancer treatment and can affect various aspects of a patients' quality of life. Despite growing evidence, research into effective treatments remains an emerging field. This project aims to assess the effectiveness of a cognitive remediation protocol called Oncogite in reducing cancer treatment-related cognitive impairment. The primary outcomes are self-reported functional and emotional well-being. The secondary outcomes include measures of executive function (working memory, inhibition, shifting), episodic memory, perceived cognitive function and perceived quality of life. One hundred sixty-four breast cancer survivors will be recruited from an existing cohort. Patients will be randomized to either a cognitive remediation group or a no intervention group. Participation in the workshops will be via videoconferencing, led by a neuropsychologist. Patients in the experimental group will also have access to an internet platform with the exercises practiced between the group workshops. The intervention will last four months at a rate of one workshop per week. The following data will be collected: emotional and functional well-being, neurocognitive performance, switching, inhibition, cognitive complaints, episodic memory, fatigue and depression. We will conclude that the intervention is effective if there is 4-month improvement in both emotional and functional well-being to find in the experimental group in their cognitive functioning. This research will contribute to the development of new clinical tools for cancer treatment-related cognitive impairment and facilitate the return to work in cancer survivors.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107858"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The modified combo i3 + 3 design for novel-novel combination dose-finding trials in oncology","authors":"Jiaxin Liu ,&nbsp;Shijie Yuan ,&nbsp;Qiqi Deng ,&nbsp;Yuan Ji","doi":"10.1016/j.cct.2025.107857","DOIUrl":"10.1016/j.cct.2025.107857","url":null,"abstract":"<div><div>We consider a modified Ci3 + 3 (MCi3 + 3) design for dual-agent dose-finding trials in which both agents are tested on multiple doses. This usually happens when the agents are novel therapies. The MCi3 + 3 design offers a two-stage or three-stage version, depending on the practical need. The first stage begins with single-agent dose escalation, the second stage launches a model-free combination dose finding for both agents, and optionally, the third stage follows with a model-based design. MCi3 + 3 aims to maintain a relatively simple framework to facilitate practical application, while also address challenges that are unique to novel-novel combination dose finding. Through simulations, we demonstrate that the MCi3 + 3 design adeptly manages various toxicity scenarios. It exhibits operational characteristics on par with other combination designs, while offering an enhanced safety profile. The design is motivated and tested for a real-life clinical trial.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107857"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143481773","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":"MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people","authors":"Stephanie L. Fitzpatrick ,&nbsp;Jennifer Polo ,&nbsp;Patti Ephraim ,&nbsp;Elizabeth Vrany ,&nbsp;Codruta Chiuzan ,&nbsp;Melissa Basile ,&nbsp;Ciaran P. Friel ,&nbsp;Khatiya Chelidze Moon ,&nbsp;Emily Silvia ,&nbsp;Hallie Bleau ,&nbsp;Wanda Nicholson ,&nbsp;Dawnette Lewis","doi":"10.1016/j.cct.2025.107850","DOIUrl":"10.1016/j.cct.2025.107850","url":null,"abstract":"<div><h3>Background</h3><div>Black birthing people are disproportionately affected by severe maternal morbidity (SMM). The MOMs Chat &amp; Care Study (R01NR021134) is a pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model to facilitate timely, appropriate care for high-risk Black birthing people and reduce the risk for SMM.</div></div><div><h3>Methods</h3><div>We will recruit 674 adult, English and Spanish-speaking Black birthing people who are less than 17 weeks gestational age, considered high risk based on the Obstetrics-Comorbidity Index and/or history of preeclampsia, and receive care at a Northwell Health obstetric practice. Participants will be randomized to either MOMs High Touch or Low Touch. In both intervention arms participants will receive close monitoring via chatbot technology and navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods, Fitbit to track physical activity, and bi-weekly postpartum telehealth visits up to 6-weeks postpartum. MOMs High Touch will also receive 12 bi-weekly self-management support telehealth visits during pregnancy and a home blood pressure monitor. The two arms will be compared on incidence of SMM at labor and delivery (Aim 1), SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and treatment (Aim 2), perceived social support (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will be used to examine facilitators and barriers to intervention implementation (Aim 5).</div></div><div><h3>Conclusion</h3><div>Findings from this study will inform how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities.</div><div><strong>Registration of Clinical Trials</strong>: This trial is registered on <span><span>www.ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06335381</span><svg><path></path></svg></span>).</div><div><strong>Protocol version</strong>: 07/22/2024, 24–0131-NH.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107850"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143481831","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":"Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals","authors":"Kristin Klemmetsby Solli ,&nbsp;Jūratė Šaltytė Benth ,&nbsp;Linn Camilla Wergeland Digranes ,&nbsp;Line Holtan ,&nbsp;Nikolaj Kunoe ,&nbsp;Lars Tanum","doi":"10.1016/j.cct.2025.107861","DOIUrl":"10.1016/j.cct.2025.107861","url":null,"abstract":"<div><h3>Background</h3><div>Mental health status may be improved in patients receiving treatment with the opioid antagonist extended-release naltrexone (XR-NTX), but longer-term outcomes remain unexamined.</div></div><div><h3>Objectives</h3><div>This study aims to assess changes in symptoms of anxiety, depression, and insomnia among opioid-dependent individuals in long-term treatment with XR-NTX and to explore possible associations between such symptoms and the use of illicit opioids. Methods: After completing an initial 3-month randomized clinical trial and an extended 9-month follow-up study, 50 opioid-dependent individuals (9 women) chose to continue treatment with XR-NTX at their own discretion for a prolonged period of up to 2 years. Symptoms of anxiety, depression, and insomnia were assessed every 4th week. In addition, the participants reported use of illicit opioids.</div></div><div><h3>Results</h3><div>The participants reported improved mental health status during up to 3 years treatment with XR-NTX. Symptoms of anxiety and depression were reduced from mean 18.0 (SD:6.1) to 12.3 (SD:4.4) (<em>p</em> &lt; 0.001), and from 30.5 (SD:9.1) to 17.8 (SD:5.4) (<em>p</em> &lt; 0.01), respectively, whereas symptoms of insomnia were reduced from 14.2 (SD:7.9) to 3.6 (SD:3.6), (p &lt; 0.001). The reduction in these symptoms was more pronounced in participants who did not relapse to opioid use (<em>n</em> = 35) during the study.</div></div><div><h3>Conclusion</h3><div>Long-term treatment with XR-NTX may promote a reduction in symptoms of anxiety, depression, and insomnia in opioid-dependent individuals. Those who managed to stay abstinent from opioids were likelier to experience a greater reduction in symptoms compared to those who relapsed to opioid use during the 3-year treatment period.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> no. <span><span>NCT01717963</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107861"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482455","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":"Design of a randomized controlled trial to test the efficacy of interrupting sitting on type 2 diabetes risk factors in children with overweight/obesity: The sedentary behavior study 3 protocol","authors":"B.R. Belcher Ph.D., M.P.H. ,&nbsp;K.L. McAlister Ph.D., M.S. ,&nbsp;J. Zink Ph.D. ,&nbsp;T.M. Chapman M.P.H. ,&nbsp;K.N. Moore ,&nbsp;S. Castillo ,&nbsp;M. Hewus M.P.H. ,&nbsp;J.N. Kaslander ,&nbsp;C.M. Dieli-Conwright Ph.D., M.P.H. ,&nbsp;J. Huh Ph.D. ,&nbsp;K.A. Page M.D., M.S.","doi":"10.1016/j.cct.2025.107862","DOIUrl":"10.1016/j.cct.2025.107862","url":null,"abstract":"<div><h3>Background</h3><div>Sedentary behaviors are pervasive in children. We found acute 3-h improvements in metabolic and affective outcomes by interrupting sitting. It is unknown whether acute responses translate to sustained or improved responses over multiple days. This paper describes the rationale, study design, recruitment, data collection, and data analytic protocols for the Sedentary Behavior Study 3 (SBS3).</div></div><div><h3>Methods</h3><div>This is a 3-arm parallel-group randomized controlled trial of <em>N</em> = 150 (50 per group) 8–11-year-old children with overweight/obesity. Following screening and 7–10 day baseline free-living assessment, children are randomly assigned to complete one of three in-lab conditions for 3 h/day for 7 consecutive days: (1) continuous sitting (SIT); (2) sitting interrupted by 3-min bouts of moderate-intensity walking every 30 min (SIT+WALK); or (3) a single 18-min bout of moderate-intensity walking followed by continuous sitting (EX). Three-hour oral glucose tolerance tests are conducted on Days 1 and 7. Participants also wear continuous glucose monitors and accelerometers for the duration of the study, and complete daily 24-h dietary recalls and affective assessments.</div></div><div><h3>Conclusions</h3><div>The overall aim of this study is to evaluate the effectiveness of interrupting sitting over one week on glucose homeostasis (primary outcome) and secondary (cognitive and affective) outcomes in children. If successful, it will provide novel intervention strategies that can be translated to other settings, and age and weight groups, thereby contributing to efforts at reducing type 2 diabetes risk in U.S. youth.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04469790</span><svg><path></path></svg></span>, registered July 14, 2020.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107862"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482461","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":"Intervention to reduce barriers to type 1 diabetes self-management: Diabetes Journey study design and participant characteristics","authors":"Kimberly A. Driscoll ,&nbsp;Paige J. Trojanowski ,&nbsp;Desireé N. Williford ,&nbsp;Holly K. O'Donnell ,&nbsp;Erin Flynn ,&nbsp;Constance A. Mara ,&nbsp;Sara E. Wetter ,&nbsp;Alexandra C. Himelhoch ,&nbsp;Hannah Manis ,&nbsp;Alicia Pardon ,&nbsp;Cheyenne M. Reynolds ,&nbsp;Emily R. Shaffer ,&nbsp;Bailey Tanner ,&nbsp;Jessica Kichler ,&nbsp;Laura Smith ,&nbsp;Sarah Westen ,&nbsp;Anastasia Albanese-O'Neill ,&nbsp;Sarah D. Corathers ,&nbsp;Laura M. Jacobsen ,&nbsp;Amy Poetker ,&nbsp;Avani C. Modi","doi":"10.1016/j.cct.2025.107849","DOIUrl":"10.1016/j.cct.2025.107849","url":null,"abstract":"<div><div>Most adolescents with type 1 diabetes (T1D) encounter barriers to achieving optimal glycemia, including effective planning and monitoring their T1D and problem-solving, and following through with T1D treatment decisions. Thus, the overall aim of Diabetes Journey, a randomized controlled clinical trial, was to assess the feasibility, acceptability, and preliminary efficacy of a novel, amusement park-themed, web-based mobile health (mHealth) intervention tailored for adolescents who experienced barriers to T1D self-management. Secondary aims included examining post-intervention changes in T1D health-related quality of life, T1D self-management behaviors, and hemoglobin A1c (HbA1c). This article describes the study rationale, recruitment, design, and baseline characteristics of the adolescents (aged 12–17 years) who were randomized to one of two groups: Diabetes Journey or Enhanced Standard of Care. Diabetes Journey focused on reducing challenges related to stress, burnout, time pressure, and planning through the delivery of 5–8 intervention sessions using a problem-solving framework. Enhanced Standard of Care participants attended 4 education sessions focused on similar topics through the T1D Toolkit© website (educational content and brief videos about T1D). Adolescents (<em>N</em> = 195) were recruited with <em>n</em> = 162 randomized (M_age = 14.8 ± 1.6 years; 50 % female, 88 % White; HbA1c% = 8.2 ± 1.8; 86 % on insulin pumps). Diabetes Journey was impacted by COVID-19 and modifications to the study design were warranted. Future directions include examining the impact of Diabetes Journey on primary and secondary outcomes, while accounting for the impact of COVID-19.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107849"},"PeriodicalIF":2.0,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476419","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":"Boost your health (Refuerza tu Salud): Design of a randomized controlled trial of a community health worker intervention to reduce inequities in COVID-19 and influenza vaccinations","authors":"Lisa S. Meredith ,&nbsp;Jonathan N. Tobin ,&nbsp;Andrea Cassells ,&nbsp;Khadesia Howell ,&nbsp;Helin G. Hernandez ,&nbsp;Courtney Gidengil ,&nbsp;Stephanie Williamson ,&nbsp;Lu Dong ,&nbsp;George Timmins ,&nbsp;Gabriela Alvarado ,&nbsp;Tameir Holder ,&nbsp;Jacqueline Cortez Lainez ,&nbsp;T.J. Lin ,&nbsp;Marielena Lara","doi":"10.1016/j.cct.2025.107848","DOIUrl":"10.1016/j.cct.2025.107848","url":null,"abstract":"<div><h3>Introduction</h3><div>Low-income and underserved populations, especially racial and ethnic minorities, experience health disparities linked to social determinants. The COVID-19 pandemic amplified these disparities, necessitating effective strategies to address structural racism and related factors. Vaccination, crucial for mitigating infectious diseases, including COVID-19 and influenza, remains challenging among underserved populations. Community health worker (CHW) interventions show promise in addressing these disparities but have not undergone rigorous evaluation with a randomized controlled trial to increase vaccination uptake among underserved populations. This study develops and evaluates a CHW vaccination behavior (CHW-VB) intervention to increase COVID-19 and influenza vaccination among adult patients in primary care settings.</div></div><div><h3>Methods</h3><div>Tailoring of the Boost Your Health <em>(Refuerza tu Salud)</em> intervention is grounded in behavior change theory and integrates input from a Community Advisory Board. The study employs a patient randomized controlled trial design to test the effectiveness the CHW-VB intervention compared with usual care across six Federally Qualified Health Centers (FQHCs) in New York. Patients are being screened for eligibility (vaccinated but not up to date with the COVID-19 vaccine and have at least one of seven common chronic illnesses) and 800 are assessed at baseline and three months. Outcomes include COVID-19 vaccine (primary) and influenza vaccine (secondary) uptake. The study also evaluates intervention implementation using the RE-AIM model.</div></div><div><h3>Conclusion</h3><div>Boost Your Health aims to increase COVID-19 and influenza vaccination among racially/ethnically diverse, underserved populations with chronic illness through the CHW-VB intervention, targeting critical gaps in vaccination uptake to reduce health disparities and increase health equity.</div><div><em>Trial registration:</em> (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT06156254</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107848"},"PeriodicalIF":2.0,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448079","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":"Is exergaming a viable exercise option for obese black women?","authors":"Jennifer Hicks ,&nbsp;Chiranjeev Dash ,&nbsp;Danyel Smith ,&nbsp;James Hagberg ,&nbsp;Kepher Makambi ,&nbsp;Lucile Adams-Campbell","doi":"10.1016/j.cct.2025.107846","DOIUrl":"10.1016/j.cct.2025.107846","url":null,"abstract":"<div><h3>Background</h3><div>Physical inactivity and obesity, which are disproportionately higher in Black women, are known risk factors of breast cancer. Novel methods to address this public health concern involve leveraging screen-viewing activities to reduce sedentary behavior and increase energy expenditure levels. Exergaming has demonstrated efficacy in increasing physical activity levels, yet no studies have examined exergaming in overweight/obese Black women. The primary objective of this study was to examine the effect of exergaming on anthropometric markers among overweight/obese Black women.</div></div><div><h3>Methods</h3><div>This study was a 2-arm, 6-month randomized controlled trial examining the efficacy of exergaming in improving obesity-related anthropometric markers among overweight and obese Black women (n = 100). Participants randomized to the exergaming condition (<em>n</em> = 50) engaged in supervised exergaming activities (i.e., Nintendo Wii Fit/X-box Kinect for 3 days/week; 60-min), while the control group (<em>n</em> = 50) maintained current physical activity levels. Assessments on anthropometric variables, physical activity, medical history and sociodemographic variables were completed at baseline, 3-, and 6-months. Two-sample <em>t-</em>tests were used to examine group differences in outcome variables at 6 months.</div></div><div><h3>Results</h3><div>There were no significant between-group differences observed in waist circumference (108.7(14.6) cm vs 107.2(14.8) cm), fat mass (44.3(12.8) kg vs 46.1(12.5) kg) or lean mass (47.0(6.9) kg vs 48.2(4.7) kg) at 6-months.</div></div><div><h3>Conclusions</h3><div>Exergaming did not demonstrate efficacy in improving obesity-related anthropometric markers in overweight/obese Black women. Exergaming is not a viable exercise for obese women. Future studies should consider pairing exergaming with traditional exercises (i.e., variety support) and exploring other factors related to energy expenditure (e.g., motivation, enjoyment).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107846"},"PeriodicalIF":2.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425038","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 randomised controlled trial of a multidisciplinary TEAM-based approach to guide secondary cardiovascular risk reduction for patients with Peripheral Artery Disease (TEAM-PAD) study protocol","authors":"Ritesh Chimoriya ,&nbsp;Sophie James ,&nbsp;Leonard Kritharides ,&nbsp;Janani Thillainadesan ,&nbsp;Samim Behdasht ,&nbsp;Shaundeep Sen ,&nbsp;Avinash Suryawanshi ,&nbsp;Huw Davie ,&nbsp;Amy Kitajima ,&nbsp;Sarah Joy Aitken","doi":"10.1016/j.cct.2025.107844","DOIUrl":"10.1016/j.cct.2025.107844","url":null,"abstract":"<div><h3>Background</h3><div>Peripheral arterial disease (1) is a vascular condition associated with significant cardiovascular morbidity and mortality. Effective secondary prevention strategies are essential to improve cardiovascular outcomes in patients with PAD. The TEAM-PAD study aims to determine if a centralised virtual multidisciplinary team (MDT) model of care is effective in improving guideline-recommended secondary cardiovascular risk reduction for outpatients with PAD.</div></div><div><h3>Methods</h3><div>TEAM-PAD is a multicentre, randomised controlled trial involving patients with PAD. Participants will be randomised into two groups: the intervention group, who will receive care supported by cardiovascular risk reduction recommendations from a centralised MDT; and the control group, who will receive usual care by their vascular surgeon. The MDT will consist of the following clinicians: vascular surgeon, cardiologist, endocrinologist, nephrologist, geriatrician, drug health physician and clinical pharmacist. The primary outcome is the change in a composite measure of an individual's 10-year cardiovascular risk between baseline to 9-months follow-up. Secondary outcomes include control of modifiable cardiovascular risk factors and medication optimisation, cardiovascular and limb outcomes, PAD symptom control, quality of life outcomes, and health-service use outcomes.</div></div><div><h3>Conclusion</h3><div>This article details the TEAM-PAD trial protocol, which will provide robust evidence on the benefits of an MDT-based approach to cardiovascular risk reduction in PAD patients. TEAM-PAD has the potential to inform clinical practice by demonstrating whether coordinated, personalised care recommendations can improve cardiovascular risk and potentially reduce cardiovascular events in this high-risk population.</div><div><strong>Trial Registration:</strong> This study has been registered at the Australia New Zealand Clinical Trial Registry (Registration number: ACTRN12623000995673).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107844"},"PeriodicalIF":2.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}