Contemporary clinical trials最新文献_第5页

The influence of peer navigators on intervention adherence and retention among older adults: A study within a randomized trial - SWAT 同伴导航员对老年人干预依从性和保留性的影响：一项随机试验中的研究- SWAT。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2025-12-24 DOI: 10.1016/j.cct.2025.108206

Shannon K. Runge , Elizabeth M. Hudak , Jade A. Sutfin , Victor R. Dobrovolskiy , Jerri D. Edwards

Background/Purpose

Participant engagement such as intervention adherence and study retention are critical to evaluating treatment efficacy and clinical trial success. Investigations of navigators among patients with chronic illness report improved health-related outcomes; however, little is known about the effects of navigators in healthy populations or on participant engagement in clinical trials. The purpose of this study was to explore whether peer navigators – former study participants – enhanced intervention adherence or study retention in a clinical trial among healthy older adults.

Methods

We conducted a study within a randomized clinical trial (SWAT) among community-dwelling older adults (N = 268) by assigning a subsample of participants to peer navigators (n = 36). Six former trial participants served as peer navigators. Statistical analyses explored whether navigator assignment was associated with intervention adherence or study retention.

Results

Participants assigned to a navigator were not different from the overall trial sample and were, on average, 71 years of age (SD = 5) with 16 years of education (SD = 3); 56 % identified as female, 81 % as White, and 3 % as Hispanic. Navigator assignment was associated with better intervention adherence, t(134.2) = −6.0, p < .001; participants with a navigator completed an average of 5 more sessions (M = 20, SD = 3) compared to those without a navigator (M = 15, SD = 8). Retention was higher among navigator-assigned participants (100 % vs. 76 %), X² (1, N = 261) = 10.0, p = .002.

Conclusions

Peer navigators may improve intervention adherence and study retention among older adults in clinical trials. Results suggest that personalized support by a peer may enhance participant engagement in clinical trials, but replication is needed.

The data are from the registered clinical trial: Interventions to Attenuate Cognitive Decline, https://clinicaltrials.gov/study/NCT03528486

背景/目的：参与者参与，如干预依从性和研究保留是评估治疗效果和临床试验成功的关键。慢性病患者中导航者的调查报告改善了健康相关结果；然而，导航员对健康人群或临床试验参与者的影响知之甚少。本研究的目的是探讨同伴导航员（前研究参与者）是否在健康老年人的临床试验中增强了干预依从性或研究保留性。方法：我们在社区居住的老年人（N = 268）中进行了一项随机临床试验（SWAT），将参与者的子样本分配给同伴导航员（N = 36）。六名前试验参与者担任同伴导航员。统计分析探讨了导航员分配是否与干预依从性或研究保留有关。结果：分配到导航员的参与者与总体试验样本没有差异，平均年龄为71 岁（SD = 5），受教育年限为16 年（SD = 3）；56% %为女性，81% %为白人，3% %为西班牙裔。导航任务是与更好的干预的依从性相关,t(134.2) = -6.0,p 2 (1,N = 261) = 10.0,p = .002。结论：同伴导航员可以改善临床试验中老年人的干预依从性和研究保留性。结果表明，同伴的个性化支持可能会提高临床试验参与者的参与度，但需要复制。数据来自已注册的临床试验：干预以减轻认知衰退，https://clinicaltrials.gov/study/NCT03528486。

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引用次数: 0

Testing the effects of a text message intervention on depression and distress among Latino dementia caregivers: A randomized controlled trial protocol 测试短信干预对拉丁裔痴呆症护理人员抑郁和痛苦的影响：一项随机对照试验方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2026-01-02 DOI: 10.1016/j.cct.2025.108214

Jaime Perales-Puchalt , Mariana Ramírez-Mantilla , Henry P. Moore , Idaly Velez-Uribe , Vanessa Sepulveda-Rivera , Rachel Ruiz , Mónica Fracachán-Cabrera , Yesenia Herrera , Christina Baker , Antonio Miras-Neira , Becky Bothwell , Heidi Anderson , Tina Lewandowski , Francisco J. Diaz , K. Allen Greiner , Kristine Williams , Eric D. Vidoni , Edward Ellerbeck , Jeffrey M. Burns

Background

Latino caregivers have poor mental health and access to caregiver support services. Here, we describe the protocol for a randomized controlled trial (RCT) to evaluate the effect of a text message intervention on depression and distress among informal Latino dementia caregivers. We will also assess mechanisms of action.

Methods

We are enrolling 288 Latino dementia informal caregivers 18 or older into a parallel group RCT. Participants randomized to the intervention group receive a remote, asynchronous, bilingual, bi-directional, 6-month texting program focused on dementia education, skill-building and community resources. The control group enters a 7-month waitlist after which they are offered the same intervention as the intervention group. Randomization is stratified by each of the four recruitment sites at a 1:1 ratio. Outcomes (e.g., caregiver depressive symptomatology, distress) are measured via surveys at baseline, 3, 6 and 7 months.

Conclusions

This RCT addresses two priority areas: eliminating dementia disparities and optimizing caregiver support. Findings have the potential to make clinical and policy-relevant contributions by providing appropriate caregiver support to Latinos in a highly scalable way.

Protocol version/date: 1/14/2025.

背景：拉丁裔护理人员心理健康状况较差，难以获得护理人员支持服务。在这里，我们描述了一项随机对照试验（RCT）的方案，以评估短信干预对非正式拉丁裔痴呆症照顾者的抑郁和痛苦的影响。我们还将评估行动机制。方法：我们将288名18岁或以上的拉丁裔痴呆症非正式护理人员纳入平行组随机对照试验。随机分配到干预组的参与者接受一个远程、异步、双语、双向、为期6个月的短信项目，重点是痴呆症教育、技能培养和社区资源。对照组进入一个为期7个月的等待名单，之后他们将接受与干预组相同的干预。四个招募地点按1:1的比例进行随机分层。通过基线、3、6和7 个月的调查来测量结果（例如，照顾者抑郁症状、痛苦）。结论：该随机对照试验解决了两个优先领域：消除痴呆差异和优化护理人员支持。通过以高度可扩展的方式为拉丁美洲人提供适当的护理人员支持，研究结果有可能做出临床和政策相关的贡献。协议版本/日期：2025年1月14日。

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引用次数: 0

Improving diagnostic safety through steatosis identification, risk stratification, and referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial 在ED （stir）中通过脂肪变性识别、风险分层和转诊途径提高诊断安全性：有效性实施试验方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2025-12-15 DOI: 10.1016/j.cct.2025.108187

Danielle M. McCarthy , Lisa B. VanWagner , Miriam R. Rafferty , Kenzie A. Cameron , Jungwha Lee , Siyuan Dong , Anuva Fellner , Amy V. Kontrick

Background

Up to a quarter of emergency department (ED) patients have incidental hepatic steatosis (fatty liver) noted on imaging studies; however, patients are infrequently notified about this new finding. This lack of communication may have consequences including delayed diagnosis of metabolic associated steatotic liver disease (MASLD) and disease progression.

Methods

This type-2 hybrid effectiveness-implementation study uses a Stepped Wedge-Cluster Randomized Trial design across 11 EDs to evaluate an electronic health record (EHR) delivered intervention. The STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED) clinical decision support system leverages the EHR to identify cases of hepatic steatosis and deliver risk-stratified communication to clinicians supporting patient notification about hepatic steatosis in the ED. The primary effectiveness outcome will be receipt of a new steatotic liver disease-related diagnosis among high-risk patients within 120 days post-ED discharge; the primary implementation outcome is fidelity, defined as the degree to which STIRRED was delivered as intended. Over the study period, ∼4700 patients with incidental hepatic steatosis will be analyzed, including 616 high-risk patients, providing 80 % power to detect a risk difference of 5.6 % (odds ratio of 3.5) between STIRRED and usual care in the receipt of a new steatotic liver disease-related diagnosis.

Discussion

This trial uses the electronic health record to deliver an evidence-based risk stratification score and referral recommendation to the bedside clinician in patients with incidentally noted hepatic steatosis. Rigorous implementation science methodology used in both the intervention development and assessment will increase the usability of the intervention and future scalability.

Trial Registration: This trial was prospectively registered on 10/9/2024 with ClinicalTrials.gov (# NCT06944353).

背景：高达四分之一的急诊科（ED）患者在影像学检查中发现有偶发性肝脂肪变性（脂肪肝）；然而，患者很少被告知这一新发现。缺乏沟通可能会导致代谢性脂肪变性肝病（MASLD）的诊断延迟和疾病进展。方法：这项2型混合有效性实施研究采用阶梯楔形聚类随机试验设计，横跨11个急诊室，评估电子健康记录（EHR）提供的干预措施。急诊科的脂肪变性识别、风险分层和转诊途径（简称“烦扰”）临床决策支持系统利用电子病历识别肝脂肪变性病例，并向临床医生提供风险分层沟通，以支持急诊科的肝脂肪变性患者通知。主要有效结果将是在急诊科出院后120 天内接受高风险患者的新的脂肪变性肝病相关诊断；主要的实现结果是保真度，定义为按照预期交付的程度。在研究期间，将分析约4700例偶发性肝脂肪变性患者，其中包括616例高危患者，在接受新的脂肪变性肝病相关诊断时，在stir和常规治疗之间检测到5.6% %（优势比为3.5）的风险差异的能力为80% %。讨论：本试验使用电子健康记录为偶然发现肝脂肪变性的患者提供循证风险分层评分，并向床边临床医生推荐转诊。在干预开发和评估中采用严格的实施科学方法将增加干预的可用性和未来的可扩展性。试验注册：该试验于2024年10月9日在ClinicalTrials.gov （# NCT06944353）前瞻性注册。

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引用次数: 0

The pharmaceutically enhanced reinforcement for reduced alcohol and smoking (PERRAS) study: Protocol for a randomized clinical trial 减少酒精和吸烟的药物增强强化（PERRAS）研究：一项随机临床试验方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2025-12-19 DOI: 10.1016/j.cct.2025.108189

Paola Palombo , Nicole Akana , Abigail Bowen , Alex Schmidt , Rachel Ryan , Sean Hovland , B. Connor Stark , Nicole Rodin , Naomi Chaytor , Michael G. McDonell , Ekaterina Burduli , Matthew Layton , John M. Roll , Crystal L. Smith , André Q. Miguel , Sterling M. McPherson

Background

Alcohol and tobacco are often used together, and their co-use is directly associated with a high incidence of morbidity and mortality. While there are currently no guidelines for treating co-addiction to alcohol and tobacco, studies suggest that integrated approaches may effectively reduce the use of both substances. Grounded in the Addiction Neuroclinical Assessment (ANA) framework, this study aims to evaluate the effectiveness of combining Contingency Management (CM) for Alcohol Use Disorder (AUD) with Varenicline for smoking cessation to significantly reduce alcohol and tobacco use among individuals with an AUD who smoke and are seeking treatment. In addition, the study will evaluate the mediator effect of the ANA domains, systematically measured and evaluated to determine their role in treatment outcomes.

Methods

Study will take place in Spokane-WA. After a two-week induction period, a total of 205 eligible participants will be randomized into one of two 12-week treatment conditions in equal proportions: CM + varenicline (experimental condition) and Non-Contingent (NC) + varenicline (control condition). Participants in the CM + varenicline group will receive rewards contingent on the submission of negative alcohol samples, while the NC + varenicline group will receive rewards for submitting urine samples, independent of alcohol positivity. Primary outcomes include objective verification of abstinence during the 12-week intervention phase (measured thrice-weekly). Follow-up evaluations will be conducted during the first, third, and sixth months.

Conclusions

If demonstrated to be efficacious, this treatment approach has the potential to produce important health benefits for a highly prevalent population in desperate need for an integrated treatment. It may also assist in identifying how different ANA-based responses impact treatment outcomes.

背景：酒精和烟草经常一起使用，它们的共同使用与高发病率和高死亡率直接相关。虽然目前没有治疗酒精和烟草双重成瘾的指导方针，但研究表明，综合方法可以有效地减少这两种物质的使用。在成瘾神经临床评估（ANA）框架的基础上，本研究旨在评估将酒精使用障碍（AUD）的应急管理（CM）与伐尼克兰戒烟相结合的有效性，以显着减少吸烟并正在寻求治疗的AUD患者的酒精和烟草使用。此外，该研究将评估ANA结构域的中介作用，系统地测量和评估以确定其在治疗结果中的作用。方法：研究将在华盛顿州斯波坎市进行。在两周的诱导期后，共有205名符合条件的参与者将被随机分配到两种为期12周的治疗条件之一：CM + 伐尼克兰（实验条件）和非偶然（NC） + 伐尼克兰（对照条件）。CM + varenicline组的参与者将根据提交的阴性酒精样本获得奖励，而NC + varenicline组的参与者将根据提交的尿液样本获得奖励，与酒精阳性无关。主要结果包括在12周的干预阶段（每周测量三次）对戒断的客观验证。后续评估将在第一个月、第三个月和第六个月进行。结论：如果证明有效，这种治疗方法有可能为迫切需要综合治疗的高度流行人群带来重要的健康益处。它还可以帮助确定不同的基于ana的反应如何影响治疗结果。

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引用次数: 0

Rationale and design of the FREEDOM study: A hybrid type 1 optimization-implementation trial to improve type 2 diabetes management in primary care FREEDOM试验的基本原理和设计：一项改善初级保健中2型糖尿病管理的1型优化-实施混合试验。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2025-12-05 DOI: 10.1016/j.cct.2025.108173

Aseel El Zein , Vishnu Garla , Michael E. Hall , Tanjila Nawshin , Druss Hays , Tejossy John , Erin Delaney , Eric Wallace , Larry Hearld , Andrea L. Cherrington , Tapan Mehta

Background

In the U.S. Deep South, Black adults experience disproportionate rates of type 2 diabetes (T2D) and associated complications, driven in part by adverse social determinants of health (SDoH). Addressing these disparities requires multilevel interventions that can be optimized for both effectiveness and cost. The Food Delivery, Remote Monitoring, & Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM) trial aims to identify an optimized, scalable intervention package that improves glycemic control among Black adults with T2D.

Methods

FREEDOM is a multicenter, hybrid type 1 optimization-implementation trial uses a 2 × 2 × 2 factorial design to test three intervention components—digital health coaching, food box delivery, and remote patient monitoring (RPM)—among 304 adults recruited from three health systems in Alabama and Mississippi. Interventions are delivered over six months with follow-up assessments through 12 months. The primary clinical outcome is change in HbA1c at 12 months. Secondary outcomes include within-trial cost-utility using net monetary benefit, RE-AIM outcomes, and CFIR-guided qualitative assessment of contextual determinants. Mixed methods will evaluate fidelity and context. Optimization will be determined using the net monetary benefit framework based on quality-adjusted life years (QALYs).

Discussion

This protocol describes the design and methods of the FREEDOM trial, which seeks to address key gaps in optimizing multilevel interventions for adults with T2D in underserved regions of the Deep South. Findings will guide the selection of scalable, cost-effective intervention strategies to improve glycemic control among adults with T2D.

Registration

ClinicalTrials.gov identifier: NCT05288452; first posted December 29, 2022.

背景：美国南部黑人2型糖尿病（T2DM）及相关并发症的发病率不成比例，部分原因是不利的健康社会决定因素（SDoH）。解决这些差异需要创新的多层次干预措施。食品配送、远程监测和指导——优化糖尿病管理的强化教育研究（FREEDOM）旨在确定一种优化的、具有成本效益的干预方案，以改善黑人成年2型糖尿病患者的血糖控制。方法：这项多中心、混合型1型优化实施试验采用2 × 2 × 2因子设计，对来自阿拉巴马州和密西西比州三个卫生系统的304名成年人进行了三个组成部分——数字健康指导、健康食品盒递送和远程患者监测（RPM）。干预措施为期6个月，随访评估期为12个 月。主要临床结果是12 个月时HbA1c的变化。次要结局包括试验内成本效用（净货币效益）、RE-AIM结局和cfr指导的实施决定因素。混合方法将评估保真度和上下文。优化将使用包含质量调整生命年（QALYs）的净货币效益框架来确定。讨论：本方案描述了FREEDOM试验的设计和方法，该试验解决了优化多层次干预以改善血糖控制和减少糖尿病差异的关键空白。研究结果将为初级保健和服务不足地区的糖尿病管理提供可扩展的、具有成本效益的战略。注册：ClinicalTrials.gov标识符：NCT05288452；首次发布于2022年12月29日。

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引用次数: 0

The long-term effectiveness of the anti-obesity medication phentermine (LEAP) trial: Rationale, design, and baseline characteristics 抗肥胖药物芬特明（LEAP）试验的长期有效性：基本原理、设计和基线特征。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2026-01-08 DOI: 10.1016/j.cct.2026.108219

Caroline Blackwell Young , Emily Rives , Kimberly A. Gudzune , Byron C. Jaeger , Courtney G. Simmons , Brian N. White , Stephanie A. Hooker , Deborah B. Horn , Deborah R. Young , Jennifer Vesely , Amanda Velazquez , Catherine Price , Shelly D. Cook , Katy Martin-Fernandez , Galina Inzhakova , Nicholas M. Pajewski , Jamy D. Ard , Kristina H. Lewis

Background

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.

Methods

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.

Conclusions

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.

Trial Registration: Clinicaltrials.gov, NCT05176626.

背景：目前的临床实践指南支持长期使用药物治疗肥胖。从历史上看，芬特明一直是处方最多的减肥药（OMs）之一，然而，其长期疗效和安全性从未在随机试验中进行评估，因为其市场批准早于此类要求。在此，我们描述了一项为期24个月、双盲、随机对照试验的设计、基本原理和基线特征，该试验评估了芬特明对超重或肥胖成人的疗效、心血管风险和安全性。方法：这项多中心试验将比较随机分配给芬特明24 mg /天和安慰剂24 个月的参与者的结果。所有参与者还接受了在线生活方式干预。共有870名体重指数为27-44.9 kg/m2的参与者被随机分配到北卡罗来纳州(2)、明尼苏达州、德克萨斯州和加利福尼亚州(2)的六个地点。主要结局是24个月平均体重减轻百分比（有效性），24个月平均收缩压变化（心脏代谢风险），以及不良事件和严重不良事件的总体发生率（安全性）。次要结局包括静息能量消耗/静息代谢率的变化，使用心率变异性和心电图测量的心脏自主功能，以及自我报告的芬特明依赖性测量。结论：长期芬特明的安全性和有效性仍然是一个紧迫的、悬而未决的问题，特别是考虑到它的低成本和高可用性，与较新的OMs相比，后者非常有效，但往往伴随着高昂的成本。无论结果如何，这项研究都将影响临床实践——要么提供证据支持使用现有的低成本选择，要么优先使用其他OMs。试验注册：Clinicaltrials.gov, NCT05176626。

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引用次数: 0

Addressing social needs to improve health in adults with multiple chronic conditions: A comparative effectiveness trial of two real-world social needs interventions 解决社会需求以改善患有多种慢性疾病的成年人的健康：两种现实世界社会需求干预措施的比较有效性试验。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2025-12-24 DOI: 10.1016/j.cct.2025.108210

Emma L. Tucher , Allison L. Steele , Connie S. Uratsu , Leah K. Hamilton , Meagan C. Brown , Joshua R. Nugent , Danielle Hessler Jones , Laura M. Gottlieb , Richard W. Grant

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.

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.

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.

Trial registration: clinicaltrials.gov/study/NCT06941519

背景：患有多种慢性疾病（MCC，定义为两种以上慢性疾病）的成年人占美国人口的三分之一，但占医疗保健支出的71% %。许多患有MCC的成年人还需要应对诸如粮食不安全或住房不稳定等社会需求，这些需求与疾病结果恶化和预期寿命缩短有关。社会需求干预的研究表明，有针对性的干预可以显著提高护理利用率和患者幸福感。然而，许多已发表的评估社会需求导航或资源转介的试验都侧重于单一的社会需求、特定的健康状况或单一的干预策略。方法：本试验（“解决社会需求以改善患有多种慢性疾病的成年人的健康状况”）是一项比较有效性的随机对照试验（CE-RCT），比较两种常用的社会需求干预措施（“高强度”社会需求电话导航与“低强度”自动电子资源外展）的临床影响。它将招募12,000名患有MCC的成年人，一个或多个基于证据的临床护理差距，以及Kaiser Permanente（一个为超过1250万会员提供服务的综合服务系统）内的一个或多个社会需求。参与者可以随机分配到较高或较低强度的干预。主要结果是通过电子健康记录测量12个月的临床护理差距，以及通过患者调查测量6个月的社会服务接收和社会需求减少。次要结果包括对压力和社会关怀经历的调查和访谈评估。结论：本CE-RCT的结果提供了政策和实践相关的证据，比较了不同方法对解决MCC患者社会需求的影响。试验注册：clinicaltrials.gov/study/NCT06941519。

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引用次数: 0

Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents 暴饮暴食的虚拟干预（VIBE）：针对青少年饮食失调和体重增加预防的用户知情移动干预研究方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2025-12-18 DOI: 10.1016/j.cct.2025.108192

Andrea B. Goldschmidt , Adrian Ortega , Isabel R. Rooper , Katrina T. Obleada , Danielle A.N. Chapa , Basia Silverberg , Erin Stalvey , Macarena Kruger Camino , Michele D. Levine , Lan Yu , Dawn M. Eichen , Andrea K. Graham

Background

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. Methods: 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 (n = 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. Conclusions: 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.

Clinical trial registration number: NCT06819813

儿童超重和肥胖仍然是主要的公共卫生问题。饮食失控（LOC）和暴饮暴食是两种与肥胖相关的表型，影响了大约30%的超重/肥胖青少年，这可能会破坏体重控制治疗结果。认知行为疗法（CBT）对饮食失调有很好的效果，但对体重的影响不大，获取途径有限，而且自我调节的发育变化（这可能限制治疗技巧的实施）经常被忽视。方法：在当前的提案中，我们将应用以人为本的设计方法来设计和测试一种新的基于cbt的数字干预，增强内容和功能，以提高自我调节，预防青少年体重增加和饮食失调。第一阶段将涉及青少年（n = 25-30）的设计活动，他们的身体质量指数(BMI; kg/m2)≥年龄和性别的第75个百分位数，并报告饮食失调，以了解期望的表现、特征和参与的障碍/促进因素。研究活动将包括需求评估和迭代原型、可用性测试以及数字干预的细化。第二阶段将是一项多地点单臂开放试验，涉及50名患有或有超重/肥胖风险并报告LOC和/或暴饮暴食的青少年，以调查干预的可行性和初步疗效，以及假定的治疗机制和目标。结论：研究结果将为设计一项足够有力的随机对照试验提供信息。该项目显然有可能通过为面临不利身心健康结果风险的青少年制定相关、可获得和可扩展的干预措施，对公共卫生产生重大影响。临床试验注册号：NCT06819813

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引用次数: 0

Study design and methodologies for the men moving forward lifestyle intervention trial with black prostate cancer survivors 黑人前列腺癌幸存者男性生活方式干预试验的研究设计和方法。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-02-01 Epub Date: 2025-12-24 DOI: 10.1016/j.cct.2025.108205

Iwalola Awoyinka , Patricia Sheean , Paula Papanek , Kathryn E. Flynn , Kathryn Bylow , Deepak Kilari , Peter Gann , Anjishnu Banerjee , Melinda Stolley

Backgound

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.

Methods/Design

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.

Discussion

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.

U.S. Clinicaltrials.gov number: NCT03971591, 06.01.2019.

背景：与其他种族/族裔的男性相比，黑人/非裔美国人（黑人）男性的前列腺癌（PC）发病率和死亡率明显更高。合并症和生活质量下降也是这一群体面临的更大挑战。许多因素导致了这些差异，其中身体组成和健康行为是重要的，但可以改变的因素。生活方式干预报告对PC幸存者有益；然而，黑人男性的参与非常有限。本文描述了男性前进(MMF) -一个以社区为基础的生活方式干预黑人男性PC。方法/设计：本试验将随机抽取（1:1）200名已完成治疗或正在积极监测的黑人男性PC患者。与密尔沃基娱乐系统合作进行的为期16周的MMF干预，支持采用美国癌症协会营养和体育活动指南。在基线、干预后和12个月随访时收集身体组成（主要）、行为（饮食、身体活动）、健康、生活质量和一般健康和PC复发风险的生物标志物。主要的假设是，接受MMF干预的男性在身体成分上的变化比那些等候名单对照组的男性更大。讨论：MMF试验解决了当前文献中的一个重要空白，评估了为患有PC的黑人男性开发的生活方式计划的潜在功效。结果包括身体组成和一般健康的生物标志物以及前列腺癌复发风险，增加了我们对健康行为和前列腺癌生存率的认识和方法。研究结果将为这一高风险、未被充分代表的人群的生存努力提供信息。美国临床试验：gov编号：NCT03971591, 06.01.2019。

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引用次数: 0

Stand up for your health: Rationale and design for a randomized controlled trial 维护你的健康：随机对照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 : 2026-02-01 Epub Date: 2026-01-06 DOI: 10.1016/j.cct.2026.108216

Muhammad Hammad , Sindhu Shankar , Yan Gao , Jacquelyn Kulinski

Background

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.

Objective

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.

Methods

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.

Discussion

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.

Conclusion

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.

Clinical trial registration identifier: NCT05585190

背景久坐行为是心脏代谢疾病的独立危险因素。随着办公桌型职业和在家工作文化的兴起，工作场所为采取干预措施减少久坐时间提供了一个很有前景的环境。这项随机对照试验的目的是确定减少坐立两用办公桌的久坐时间是否能改善有患糖尿病风险的久坐工作的超重和肥胖人群的心脏代谢健康状况。方法大约198名符合条件的糖尿病前期或2型糖尿病风险参与者（包括估计25%的退出者）将按1:1:1的比例随机分为三组：对照组（不干预），2小时组（指示每天站在坐立办公桌前至少2小时）和3小时组（指示每天至少站3小时）。每位参与者将在6个月的时间内完成三次研究访问。主要结果是胰岛素抵抗。这项研究的潜在影响是重大的，因为超过70%的美国人超重或肥胖，超过80%的工作是久坐不动的。我们的研究结果表明，一种易于采用的干预措施可以降低心脏代谢风险，这将推动这一领域的发展，为在工作场所广泛实施站立式办公桌提供了理由。结论：这项随机对照研究将确定在工作中减少久坐行为，使用可调节的坐立两用办公桌，是否能改善糖尿病高危人群的胰岛素抵抗。这项研究可能有助于制定有益于大量久坐工作者的公共卫生指南。临床试验注册标识：NCT05585190

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引用次数: 0