Contemporary clinical trials最新文献_第3页

A multilevel clinic- and community-based intervention to increase COVID-19 vaccination among Latinos in San Diego County: Protocol description of the vaccine promotion program 在圣地亚哥县开展多层次诊所和社区干预，以增加拉丁裔人的COVID-19疫苗接种：疫苗推广计划的方案描述。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-19 DOI: 10.1016/j.cct.2026.108227

Noe C. Crespo , John Elder , Eyal Oren , Elva Arredondo , Chii-Dean Joey Lin , Job Godino , Hala Madanat , Griselda Cervantes , Amanda Patron , Kiria Fraga , Bianca Vargas-Tequida , Christian B. Ramers

Background

COVID-19 has disproportionately affected minority groups, including Latinos. Since the development of COVID-19 vaccines, effective implementation faced challenges due to multiple factors, necessitating multi-level and multi-sector approaches. This study describes the Vaccine Promotion Program (VPP), a multi-level intervention to increase COVID-19 vaccine uptake among Latinos in clinical and community settings.

Methods

VPP is a double-blind, pragmatic, 12-month cluster-randomized trial in collaboration with a large Federally Qualified Health Center (FQHC) in San Diego, CA. Ten clinics will be randomized to a Multilevel Intervention involving activities at the interpersonal, clinic, and community levels (VPP) or Standard Clinical Practice (SCP) (n = 5 clinics, respectively). Patients in VPP clinics will receive tailored clinic-originated messages about COVID-19 vaccination and motivational interviews (MI) (15–30-min telephone/telehealth encounters) from Health Educators (HE) to encourage COVID-19 vaccination. HEs will send emails and/or text message-based information to encourage vaccination. The community-level intervention involves targeted and tailored activities to promote COVID-19 vaccine uptake in neighborhoods surrounding the five VPP clinics. A cohort of 200 patients will be enrolled to participate in comprehensive surveys and follow-up for 24 months to assess longer-term outcomes. The primary outcome (COVID-19 aggregated vaccination rates) will be compared at baseline, 6, and 12 months between VPP and SCP clinics and neighborhoods, respectively.

Discussion

VPP directly addresses the most prominent COVID-19 vaccination barriers, including health literacy, community trust, and vaccine access, through a multi-level approach in collaboration with an FQHC. This approach has the potential to be an effective and scalable public health approach to vaccination among underserved communities.

背景：2019冠状病毒病对包括拉丁美洲人在内的少数群体的影响尤为严重。自COVID-19疫苗开发以来，实施工作面临多种因素的挑战，需要采取多层次、多部门的方法。本研究描述了疫苗推广计划（VPP），这是一项旨在提高临床和社区环境中拉丁裔人COVID-19疫苗接种率的多层次干预措施。方法：VPP是一项双盲、实用的、为期12个月的集群随机试验，与加利福尼亚州圣地亚哥的一家大型联邦合格健康中心（FQHC）合作。10家诊所将被随机分配到涉及人际、诊所和社区层面活动的多层次干预（VPP）或标准临床实践（SCP）（n = ，各5家诊所）。VPP诊所的患者将收到量身定制的诊所发起的关于COVID-19疫苗接种的信息和健康教育者的动机性访谈（15-30分钟的电话/远程医疗接触），以鼓励接种COVID-19疫苗。卫生主任将发送电子邮件和/或短信信息，鼓励接种疫苗。社区层面的干预包括有针对性和量身定制的活动，以促进五个VPP诊所周围社区的COVID-19疫苗接种。将招募200名患者参加综合调查和随访24 个月，以评估长期结果。将分别在基线、6和12 个月比较VPP和SCP诊所和社区的主要结局（COVID-19总疫苗接种率）。讨论：VPP通过与FQHC合作的多层次方法，直接解决最突出的COVID-19疫苗接种障碍，包括卫生素养、社区信任和疫苗获取。这种方法有可能成为在服务不足的社区进行疫苗接种的有效和可扩展的公共卫生方法。

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引用次数: 0

Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension 心脏井的设计：一项社区卫生工作者为低收入高血压成年人提供营养干预的随机试点研究

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-28 DOI: 10.1016/j.cct.2026.108244

Kristine D. Gu , Jessica Cheng , Oldy Bejarano , Emily Gelsomin , Ashlie Malone , Katherine C. Faulkner , Anne N. Thorndike

Background

Suboptimal diet and food insecurity contribute to hypertension disparities experienced by individuals with low-income. Clinic-based nutrition counseling is limited by time constraints and low access to dietitians. Integrating community health workers (CHWs) with basic nutrition training into care teams may be an effective strategy to promote sustainable dietary modifications.

Objective

Describe the design of Heart Well, a study to determine whether adding nutrition counseling to a primary care-based CHW hypertension program is feasible and acceptable and improves diet and blood pressure (BP).

Methods

Heart Well is a 4-month randomized controlled study of low-income adults (N = 60) who have uncontrolled hypertension and are enrolled in a CHW hypertension coaching program. The control group receives usual care in the existing hypertension program. The intervention group additionally receives nutrition counseling on label reading, healthy eating on a budget, and simplified nutrition education (e.g., traffic light categories, green = healthy). Intervention CHWs are trained by a registered dietitian, who also provides ongoing CHW support. Primary outcomes are feasibility (i.e., proportion of participants enrolled, percent completion of nutrition modules) and acceptability (i.e., participant ratings of nutrition components). Secondary outcomes are changes over 4 months in Healthy Eating Index-2020 scores (calculated from dietary recalls) and in BP.

Conclusions

Heart Well tests a novel strategy integrating nutrition counseling tailored to low-income adults into an existing CHW hypertension program. Results will inform a larger trial to evaluate the intervention's impact on cardiovascular health and may have implications for CHW interventions for other diet-sensitive chronic diseases. Trial Registration: ClinicalTrials.gov NCT06358417

背景：次优饮食和粮食不安全导致了低收入人群的高血压差异。以诊所为基础的营养咨询受到时间限制和难以接触到营养师的限制。将接受过基本营养培训的社区卫生工作者（CHWs）纳入护理团队可能是促进可持续饮食改变的有效策略。目的描述Heart Well的设计，这是一项研究，旨在确定在以初级保健为基础的CHW高血压项目中加入营养咨询是否可行和可接受，并能改善饮食和血压（BP）。方法：heart Well是一项为期4个月的随机对照研究，研究对象为低收入成年人（N = 60），他们患有未控制的高血压，并参加了CHW高血压指导计划。对照组在现有高血压方案中接受常规护理。干预组还接受有关标签阅读、预算内健康饮食和简化营养教育（例如，交通信号灯类别，绿色=健康）的营养咨询。干预护理生由注册营养师培训，并提供持续的护理生支援。主要结果是可行性（即参与者注册的比例，营养模块完成的百分比）和可接受性（即参与者对营养成分的评分）。次要结果是4个月内健康饮食指数-2020评分（根据饮食召回计算）和血压的变化。heart Well测试了一种将针对低收入成年人的营养咨询整合到现有CHW高血压项目中的新策略。结果将为更大规模的试验提供信息，以评估干预措施对心血管健康的影响，并可能对其他饮食敏感型慢性病的CHW干预措施产生影响。试验注册：ClinicalTrials.gov NCT06358417

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引用次数: 0

Reaching rural veterans: Applying mind-body skills for pain using a whole health telehealth intervention: The RAMP pilot study 接触农村退伍军人：使用整个健康远程医疗干预应用身心技能治疗疼痛：RAMP试点研究。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-02-08 DOI: 10.1016/j.cct.2026.108254

Katherine Hadlandsmyth , Roni Evans , Brent D. Leininger , Brent C. Taylor , Lee J.S. Cross , Ann Bangerter , Emily M. Hagel Campbell , Alexander C. Haley , Mallory Mahaffey , Marianne S. Matthias , J. Stephanie L. Taylor , Diana J. Burgess

Purpose

The current study piloted a telehealth, multicomponent intervention for rural Veterans, to increase access to non-pharmacological approaches to managing chronic pain.

Methods

This single arm pilot study examined the feasibility of trialing the Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP). RAMP consisted of an individual session followed by 11 facilitated group sessions (90-min each), that included expert-led educational and experiential physical exercise and mind-body skill-building videos. Feasibility was assessed using pre-specified milestones.

for recruitment and enrollment (N = 40), satisfaction (75%), fidelity (90%), intervention engagement (75%), and data collection (surveys of pain and health outcomes at 14 weeks, 80%).

Findings

The following milestones were met: 1) 40 rural VA patients with moderate to severe chronic pain were enrolled, 2) 90% of participants were satisfied with the intervention, and 3) facilitators delivered 100% of session activities 100% of the time. The following milestones were nearly met: 4) intervention engagement: 68% of Veterans engaged in at least 7 of 12 sessions, and 5) data collection: 75% survey completion at 14 weeks. Participants reported that the intervention supported their pain self-management capabilities, provided useful self-management opportunities and resources, and enhanced their motivation to self-manage their pain. Participant and other key stakeholders identified important areas for improvement.

Conclusions

Pilot results demonstrated that RAMP is feasible and acceptable to rural Veterans with chronic pain and helped identify optimization strategies to enhance future program engagement.

目的：目前的研究试点远程医疗，多成分干预农村退伍军人，以增加获得非药物方法来管理慢性疼痛。方法：本研究采用单臂先导试验的方法，考察了“接触农村退伍军人：运用身心技能治疗疼痛的全健康远程医疗干预”（RAMP）的可行性。RAMP包括一个单独的会议，然后是11个促进小组会议（每次90分钟），其中包括专家指导的教育和体验性体育锻炼以及身心技能建设视频。可行性评估使用预先指定的里程碑。招募和入组（N = 40）、满意度（75%）、保真度（90%）、干预参与度（75%）和数据收集（14 周疼痛和健康结果调查，80%）。研究结果：达到了以下里程碑：1)40名患有中度至重度慢性疼痛的农村VA患者入组，2)90%的参与者对干预感到满意，3)辅导员在100%的时间内提供了100%的会话活动。我们几乎达到了以下里程碑：4)参与干预：68%的退伍军人参与了12个疗程中的至少7个；5)数据收集：75%的调查在14 周内完成。参与者报告说，干预支持了他们的疼痛自我管理能力，提供了有用的自我管理机会和资源，并增强了他们自我管理疼痛的动机。参与者和其他关键利益相关者确定了需要改进的重要领域。结论：试点结果表明，RAMP对于患有慢性疼痛的农村退伍军人是可行和可接受的，并有助于确定优化策略，以提高未来项目的参与度。

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引用次数: 0

Study protocol for a patient-centered hybrid type 1 effectiveness-implementation randomized controlled trial evaluating caregiver involvement in primary care-based brief interventions for adolescents with mild alcohol use disorder 一项以患者为中心的混合1型有效性-实施随机对照试验的研究方案，评估照顾者参与以初级保健为基础的青少年轻度酒精使用障碍简短干预。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-20 DOI: 10.1016/j.cct.2026.108241

Zachary W. Adams , Brigid R. Marriott , Ashlyn Burns , Jon Agley , Wei Wu , Matthew C. Aalsma , Leslie A. Hulvershorn , Tamika C. Zapolski

Introduction

Primary care is a useful setting for identifying and delivering brief interventions to adolescents with mild alcohol use disorders (AUD). High-quality evidence suggests brief interventions that incorporate motivational interviewing (MI) and basic cognitive behavioral therapy (CBT) skills help adolescents reduce substance use. Caregiver involvement in interventions for mild AUD may improve outcomes. However, when and how to involve caregivers in primary care-based interventions for adolescents with mild AUD remains unclear.

Methods

In this patient-centered hybrid type 1 effectiveness-implementation randomized controlled trial, adolescents with mild AUD receiving an individual skill-building intervention (Teen Intervene, TI) in primary care will be randomized to one of three conditions: 1) no caregiver involvement; 2) a single, live caregiver session; and 3) an online, self-paced caregiver program. The primary aim is to compare the effectiveness of TI conditions (i.e., no caregiver involvement vs. caregiver session vs. online caregiver component) in reducing alcohol use in adolescents. The second study aim is to identify youth and family factors associated with intervention response vs. non-response in each treatment condition, such as baseline substance use intensity, youth and caregiver perceptions of alcohol/substance use risk, youth personality factors, and caregiving practices.

Conclusion

Findings from this study will help support decisions and eventual cost-benefit analyses about which programs to offer to different patients. When interventions are matched appropriately to patient needs at scale, possible long-term benefits include improved outcomes among the approximately 750,000 U.S. adolescents with mild AUD.

初级保健是一个有用的环境，用于识别和提供简短的干预青少年轻度酒精使用障碍（AUD）。高质量的证据表明，结合动机访谈（MI）和基本认知行为疗法（CBT）技能的简短干预有助于青少年减少物质使用。护理人员参与轻度AUD的干预可能会改善结果。然而，何时以及如何让照顾者参与到对轻度AUD青少年的初级保健干预中仍不清楚。方法：在这项以患者为中心的混合型1型有效性实施随机对照试验中，患有轻度AUD的青少年在初级保健中接受个人技能建设干预（Teen intervention， TI），将被随机分为三种情况之一：1)没有照顾者参与；2)单次现场护理人员会议；3)在线自学看护课程。主要目的是比较TI条件（即无照顾者参与、照顾者会话、在线照顾者组成部分）在减少青少年酒精使用方面的有效性。第二个研究目的是确定在每种治疗条件下与干预反应和无反应相关的青少年和家庭因素，如基线物质使用强度、青少年和照顾者对酒精/物质使用风险的看法、青少年人格因素和照顾实践。结论：这项研究的发现将有助于支持决策和最终的成本效益分析，以确定为不同的患者提供哪些方案。当干预措施与患者需求适当匹配时，可能的长期效益包括改善大约75万 美国患者的预后轻度AUD青少年。

{"title":"Study protocol for a patient-centered hybrid type 1 effectiveness-implementation randomized controlled trial evaluating caregiver involvement in primary care-based brief interventions for adolescents with mild alcohol use disorder","authors":"Zachary W. Adams , Brigid R. Marriott , Ashlyn Burns , Jon Agley , Wei Wu , Matthew C. Aalsma , Leslie A. Hulvershorn , Tamika C. Zapolski","doi":"10.1016/j.cct.2026.108241","DOIUrl":"10.1016/j.cct.2026.108241","url":null,"abstract":"<div><h3>Introduction</h3><div>Primary care is a useful setting for identifying and delivering brief interventions to adolescents with mild alcohol use disorders (AUD). High-quality evidence suggests brief interventions that incorporate motivational interviewing (MI) and basic cognitive behavioral therapy (CBT) skills help adolescents reduce substance use. Caregiver involvement in interventions for mild AUD may improve outcomes. However, when and how to involve caregivers in primary care-based interventions for adolescents with mild AUD remains unclear.</div></div><div><h3>Methods</h3><div>In this patient-centered hybrid type 1 effectiveness-implementation randomized controlled trial, adolescents with mild AUD receiving an individual skill-building intervention (Teen Intervene, TI) in primary care will be randomized to one of three conditions: 1) no caregiver involvement; 2) a single, live caregiver session; and 3) an online, self-paced caregiver program. The primary aim is to compare the effectiveness of TI conditions (i.e., no caregiver involvement vs. caregiver session vs. online caregiver component) in reducing alcohol use in adolescents. The second study aim is to identify youth and family factors associated with intervention response vs. non-response in each treatment condition, such as baseline substance use intensity, youth and caregiver perceptions of alcohol/substance use risk, youth personality factors, and caregiving practices.</div></div><div><h3>Conclusion</h3><div>Findings from this study will help support decisions and eventual cost-benefit analyses about which programs to offer to different patients. When interventions are matched appropriately to patient needs at scale, possible long-term benefits include improved outcomes among the approximately 750,000 U.S. adolescents with mild AUD.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108241"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146028592","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}

引用次数: 0

Trials augmented by external control data using balancing weights: A comparison of estimands and estimators 使用平衡权值的外部控制数据增强的试验：估计值和估计值的比较

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-13 DOI: 10.1016/j.cct.2026.108220

Peijin Wang , Hwanhee Hong , Kyungeun Jeon , Laine Elliott Thomas

As the availability of real-world data has expanded in recent years, studies leveraging external controls (ECs) have emerged as potential alternatives to conventional randomized controlled trials (RCTs). While RCTs remain the gold standard for estimating treatment effects, in some contexts, such as rare diseases, it is infeasible or unethical to enroll and randomize a sufficient number of patients. In such cases, it may be justified to conduct a hybrid or single-arm trial that incorporates EC data. This integration first depends on the harmonization of inclusion criteria, covariates, and outcomes, and then requires appropriate statistical methods that account for differences between the trial and EC patients. The propensity score (PS) has emerged as a valuable tool to summarize such differences in patient characteristics. The PS may contribute to a range of estimation methods, including balancing weights, augmented estimators, and Bayesian methods for dynamic borrowing. However, in the context of trials with ECs, the interpretation of the PS and associated causal estimands is often unclear. Motivated by the LIMIT-JIA trial of juvenile idiopathic arthritis, we elucidate potential estimands and evaluate the performance of PS-weighted estimators. We show that some estimands are easier to estimate than others, with potentially greater feasibility for small studies like LIMIT-JIA.

近年来，随着真实世界数据的可用性不断扩大，利用外部对照（ECs）的研究已成为传统随机对照试验（rct）的潜在替代方案。虽然随机对照试验仍然是估计治疗效果的金标准，但在某些情况下，如罕见疾病，招募和随机分配足够数量的患者是不可行或不道德的。在这种情况下，进行合并EC数据的混合或单组试验可能是合理的。这种整合首先取决于纳入标准、协变量和结果的统一，然后需要适当的统计方法来解释试验和EC患者之间的差异。倾向评分（PS）已成为一个有价值的工具，以总结这些差异的患者特征。PS可能有助于一系列估计方法，包括平衡权值、增广估计器和动态借用的贝叶斯方法。然而，在ECs试验的背景下，对PS和相关因果估计的解释往往不明确。在青少年特发性关节炎的LIMIT-JIA试验的激励下，我们阐明了潜在的估计并评估了ps加权估计器的性能。我们表明，一些估计比其他估计更容易估计，对于像LIMIT-JIA这样的小型研究来说，潜在的可行性更大。

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引用次数: 0

Prehabilitation in oncological patients undergoing major gastrointestinal surgery: rationale and design of the PROGRESS trial 接受胃肠大手术的肿瘤患者的康复：进展试验的基本原理和设计。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-31 DOI: 10.1016/j.cct.2026.108249

Federico Mattia Oliva , Stefano Turi , Marta Veneziano , Filippo D'Amico , Nicola Passuello , Lisa Notarianni , Camilla Fiorindi , Noemi De Piccoli , Lorenzo Ripamonti , Laura Fossati , Monica Gualtierotti , Matteo Ghezzi , Massimo Vecchiato , Domenico Pontillo , Simone Priolo , Cristiano Marchetti , Daniele Sandonà , Perla Cicero , Vincenzo Nicastro , Arianna Fumagalli , Chong Lei

Background

Preliminary evidence suggests that multimodal prehabilitation may reduce postoperative complications in patients undergoing cancer surgery. However, its true effectiveness has yet to be fully demonstrated, and there are still significant gaps in knowledge that need to be addressed.

Methods

This is a two-arm, multicenter, randomized controlled trial including 400 adult oncological patients undergoing major gastrointestinal surgery. Patients are randomized with a 1:1 allocation ratio either to receive a multimodal prehabilitation program in addition to standard care or standard care alone. The prehabilitation program consists of four weeks of intervention including exercise training, nutritional support, and psychological counseling. The standard of care is delivered in accordance with the Enhanced Recovery After Surgery (ERAS) pathways.

Results

The trial is ongoing and currently recruiting. The primary outcome is the rate of patients experiencing major postoperative complications within 30 days after surgery. We hypothesize that prehabilitation will reduce this rate from 40% to 25%. Secondary outcomes include the time of functional recovery, length of hospital stay, and complication severity.

Conclusion

The PROGRESS trial will provide data to assess whether a prehabilitation program can reduce major postoperative complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery.

Trial registration: This trial was registered on ClinicalTrials.gov with the trial identification NCT06404489.

背景：初步证据表明，多模式康复可以减少癌症手术患者的术后并发症。然而，它的真正效力尚未得到充分证明，在知识方面仍有重大差距需要解决。方法：这是一项两组、多中心、随机对照试验，包括400名接受大胃肠手术的成年肿瘤患者。患者按1:1的比例随机分配，接受除标准治疗外的多模式康复计划或单独接受标准治疗。康复计划包括为期四周的干预，包括运动训练、营养支持和心理咨询。护理标准是根据术后增强恢复（ERAS）途径提供的。结果：该试验正在进行中，目前正在招募。主要结果是术后30 天内出现主要术后并发症的患者比例。我们假设康复会将这一比率从40%降低到25%。次要结局包括功能恢复时间、住院时间和并发症严重程度。结论：PROGRESS试验将提供数据来评估康复计划是否可以减少主要的术后并发症并促进接受重大胃肠道肿瘤手术的患者的康复。试验注册：该试验在ClinicalTrials.gov上注册，试验标识为NCT06404489。

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引用次数: 0

Time-restricted eating in patients with metabolic syndrome: A protocol paper for a feasibility clinical trial 代谢综合征患者的限时饮食：一项可行性临床试验的协议文件。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-17 DOI: 10.1016/j.cct.2026.108223

Bárbara Piñeiro , Jennifer Kue , Jennifer Costa , Ashley Santiago , John Msaddi , Kalie Nuss , Hariom Yadav , Laura Szalacha , Usha Menon

Recent studies have evaluated Time-Restricted Eating (TRE) as a promising dietary behavioral intervention for weight loss and cardiometabolic risk factor improvement. Yet the results are mixed. We describe a TRE protocol, a behavioral dietary intervention where all calorie intake is limited to 10-h eating window followed by a 14-h fasting period, without altering diet quality and quantity. This study aims to determine the feasibility and acceptability of a 12-week TRE intervention among patients with metabolic syndrome. Dietary lifestyle changes can decrease risk in metabolic syndrome, but such changes are difficult to implement and sustain. This is a pilot feasibility study with a single-arm group. A total of 40 adult patients with metabolic syndrome are being enrolled. Participants document their daily eating patterns through MyCap app. The primary outcome is to assess the feasibility and acceptability of the intervention, including recruitment, program delivery, adherence and patient satisfaction. Secondary outcome measures include changes in weight, blood pressure, sleep, quality of life, and biological measures including gut microbiome, HbA1c, lipids, and thyroid function. Findings of this pilot study will provide novel insights into improving information health markers in individuals with metabolic syndrome, as well as inform the feasibility and sustainability of this dietary intervention.

最近的研究已经评估了限时饮食（TRE）作为一种有希望的饮食行为干预减肥和心脏代谢危险因素的改善。然而，结果喜忧参半。我们描述了一个TRE方案，这是一种行为饮食干预，在不改变饮食质量和数量的情况下，将所有卡路里摄入量限制在10小时的进食窗口，然后是14小时的禁食期。本研究旨在确定代谢综合征患者进行为期12周的TRE干预的可行性和可接受性。饮食生活方式的改变可以降低代谢综合征的风险，但这种改变很难实施和维持。这是一个单臂组的试点可行性研究。共有40名患有代谢综合征的成年患者被纳入研究。参与者通过MyCap应用程序记录他们的日常饮食模式。主要结果是评估干预的可行性和可接受性，包括招募、项目交付、依从性和患者满意度。次要结局指标包括体重、血压、睡眠、生活质量的变化，以及包括肠道微生物组、糖化血红蛋白、血脂和甲状腺功能在内的生物学指标。这项初步研究的结果将为改善代谢综合征患者的健康指标信息提供新的见解，并为这种饮食干预的可行性和可持续性提供信息。

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引用次数: 0

The impact of prescribed versus achieved resistance training intensity on strength, body composition, and psychological health in women survivors of breast cancer: Protocol for the EFICAN 2.0 randomized trial 处方抗阻训练强度与实际抗阻训练强度对乳腺癌女性幸存者力量、身体成分和心理健康的影响：EFICAN 2.0随机试验方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-17 DOI: 10.1016/j.cct.2026.108225

Alba Esteban-Simón , David M. Díez-Fernández , Andrés Baena-Raya , Alejandro Pérez-Castilla , Andrea Rodriguez-Solana , Máriam Ramos-Teodoro , Antonio Pérez-Romero , Manuel A. Rodríguez-Pérez , Alberto Soriano-Maldonado

Background

Strength training (ST) is recommended for survivors of breast cancer due to its health-related benefits. However, the optimal method for prescribing ST intensity in this population remains unexplored.

Objective

To compare the effects of three intensity prescription methods on muscular strength, body composition, physical function and psychological health in survivors of breast cancer; and to examine how the training intensity progresses over time according to each method.

Methods

A three-arm randomized trial will be conducted with 60 women survivors of breast cancer randomly allocated to: (1) daily estimated one-repetition maximum (1RM) using individual load-velocity relationship; (2) initial 1RM estimation via load-velocity relationship, without daily updates; or (3) initial 1RM estimation via a 10RM test, without daily updates. The intervention includes a 2-week familiarization phase and an 8-week intervention phase. Training intensity will be prescribed between 60 and 75% 1RM, following the American College of Sports Medicine guidelines. Primary outcomes include muscle strength, physical function, cardiorespiratory fitness, fatigue, pain, quality of life, anxiety, and depressive symptoms. The secondary outcome is the difference between prescribed and achieved training intensity, which will be continuously monitored in all groups using a linear velocity transducer, and analyzed over time. Adherence, adverse events, and deviations from the protocol will be recorded.

Conclusion

This trial will provide novel insights into the effects of different ST intensity prescription methods on physical and psychological outcomes in survivors of breast cancer. It will also determine whether traditional approaches achieve intended training intensities, thereby advancing knowledge on exercise prescription in oncology.

背景：力量训练（ST）被推荐用于乳腺癌幸存者，因为它对健康有益。然而，在这一人群中处方ST强度的最佳方法仍未探索。目的：比较三种强度处方方法对乳腺癌幸存者肌力、体成分、生理功能和心理健康的影响；并根据每种方法检查训练强度随时间的变化情况。方法：一项三组随机试验将对60名乳腺癌女性幸存者进行随机分配：(1)使用个体负荷-速度关系每日估计单次重复最大值（1RM）；(2)基于荷载-速度关系的初始1RM估计，不需要每日更新；或(3)通过10RM测试进行初始1RM估计，不进行每日更新。干预包括2周的熟悉期和8周的干预期。按照美国运动医学学院的指导方针，训练强度将在60 - 75% 1RM之间。主要结局包括肌肉力量、身体功能、心肺健康、疲劳、疼痛、生活质量、焦虑和抑郁症状。次要结果是规定的训练强度和达到的训练强度之间的差异，这将在所有组中使用线速度传感器持续监测，并随时间分析。记录依从性、不良事件和偏离方案的情况。结论：该试验将为不同ST强度处方方法对乳腺癌幸存者生理和心理结局的影响提供新的见解。它还将决定传统方法是否达到预期的训练强度，从而提高肿瘤运动处方的知识。

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引用次数: 0

Handling missing data in longitudinal randomized clinical trials within the framework of targeted learning under MAR and MNAR 在MAR和MNAR的目标学习框架下处理纵向随机临床试验中的缺失数据。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-29 DOI: 10.1016/j.cct.2026.108245

Man Jin

Missing data is a common issue in longitudinal randomized clinical trials (RCTs), where the effect of treatment is estimated by a pre-specified statistical model. The targeted learning approach, through targeted maximum likelihood estimation (TMLE), has been suggested and evaluated in both clinical trials and observational studies to deal with missing data under the assumption of missing at random (MAR).

In this research project, we propose methods for handling missing data in longitudinal RCTs Within the framework of targeted learning through longitudinal maximum likelihood estimation (LTMLE), with missing data mechanisms MAR and missing not at random (MNAR). The methods are applied to a real public RCT dataset.

缺失数据是纵向随机临床试验（rct）中常见的问题，其中治疗效果是通过预先指定的统计模型估计的。通过目标最大似然估计（TMLE）的目标学习方法已在临床试验和观察性研究中得到建议和评估，以处理随机缺失（MAR）假设下的缺失数据。在本研究项目中，我们提出了通过纵向最大似然估计（LTMLE）在目标学习框架内处理纵向随机对照试验中缺失数据的方法，其中缺失数据机制为MAR和非随机缺失（MNAR）。该方法应用于一个真实的公共RCT数据集。

引用次数: 0

Protocol for a single-arm, multi-component behavior change technique (BCT) intervention to develop a walking habit among caregivers for persons with Alzheimer disease and related dementias (ADRD) 单臂、多组分行为改变技术（BCT）干预在阿尔茨海默病及相关痴呆（ADRD）患者护理人员中培养行走习惯的方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-01 Epub Date: 2026-01-30 DOI: 10.1016/j.cct.2026.108248

Danielle Miller , Luis Jordan , Sherene Lambert , Ashley M. Goodwin , Liron Sinvani , Alexandra Perrin , Ying Kuen Cheung , Karina W. Davidson , Mark J. Butler

Even low to moderate physical activity is critical in improving and maintaining physical health and well-being. Caregivers of people living with Alzheimer disease and related dementias (ADRD) are a burdened population and, as such, can experience challenges with managing even modest increases in physical activity while caring for others. While some interventions have been proposed to increase physical activity, many fail to consider the unique needs of caregivers of people with ADRD.

The purpose of this 12-week decentralized behavioral trial is to test the efficacy of a multi-component, personalized text-message delivered BCT intervention to encourage the formation of a daily walking habit among caregivers of persons with ADRD assessed by Fitbit activity trackers via the key mechanism of behavior change (MoBC) of behavioral automaticity. Formation of a daily walking habit will be defined as attainment of walking 1000 or more additional steps during the same one-hour period on 7 consecutive days as set up in a personalized walking plan. We will also evaluate the association of habit formation attainment with changes in behavioral automaticity, association between longitudinal behavioral automaticity and habit formation attainment over time, and the heterogeneity of treatment effects between participants.

Results will advance science about behavioral habit formation among caregivers for persons with ADRD and determine whether behavioral automaticity acts as the primary MoBC for the effect on this BCT intervention on daily habitual walking.

This trial is registered on www.ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT06803797); NCT #: NCT06803797.

即使是低至中度的身体活动，对于改善和维持身体健康和幸福也是至关重要的。阿尔茨海默病和相关痴呆症（ADRD）患者的护理人员负担沉重，因此，在照顾他人的同时，即使是适度增加身体活动，也可能面临挑战。虽然已经提出了一些增加身体活动的干预措施，但许多干预措施未能考虑到ADRD患者护理人员的独特需求。这项为期12周的分散行为试验的目的是测试多组件、个性化短信传递的BCT干预的效果，以鼓励ADRD患者护理人员形成日常行走习惯，该干预由Fitbit活动追踪器通过行为自动性的行为改变关键机制（MoBC）进行评估。每日步行习惯的形成将被定义为在一个个性化的步行计划中，连续7天在相同的一小时内达到1000步或更多的额外步行。我们还将评估习惯形成与行为自动性变化的关系，纵向行为自动性与习惯形成随时间的关系，以及参与者之间治疗效果的异质性。研究结果将进一步推动有关ADRD照料者行为习惯形成的科学研究，并确定行为自动性是否作为BCT干预对日常习惯性行走影响的主要MoBC。该试验已在www.ClinicalTrials.gov （https://clinicaltrials.gov/study/NCT06803797）上注册；nct06803797。

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