Contemporary clinical trials最新文献

Screen-and-treat in trauma for opioid misuse prevention using an adaptive intervention (STOMP-AI): Protocol for a pilot sequential, multiple assignment, randomized trial 使用适应性干预预防阿片类药物滥用的创伤筛查和治疗（STOMP-AI）：一项先导顺序、多任务、随机试验方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-04-01 Epub Date: 2026-02-11 DOI: 10.1016/j.cct.2026.108255

M. Horton David , L. Leinweber David , Salihu Ejura , Sarwar Tehseen , Muller Hannah , Trevino Colleen , Zaborek Jen , Chen Guanhua , Quanbeck Andrew , Somers Tamara , Almirall Daniel , Zarzaur Ben , T. Brown Randall

Background

Approximately 75% of individuals hospitalized for traumatic injury receive prescription opioids and experience poorly controlled pain, psychological distress, and polysubstance use, placing these individuals at elevated risk for opioid misuse.

Risk factors for opioid misuse vary considerably, following traumatic injury, suggesting similarly variable responses to risk-mitigation attempts. Such heterogeneity necessitates the development of an adaptive intervention, yet no previous trials have evaluated the feasibility of researching nor delivering adaptive interventions to mitigate pain and misuse-related risk, in this population.

Methods

A pilot sequential, multiple-assignment randomized trial (SMART) will be conducted to determine the feasibility of delivering an adaptive intervention initiated within one week of hospital discharge, comprising opioid risk monitoring, trauma care coordination, and pain coping skills training for patients hospitalized for traumatic injury. 107 patients across two Level I trauma centers will be included in the study. Feasibility of conducting the proposed SMART will also be evaluated, including processes for recruitment, retention, randomization and re-randomization, data collection, and qualitative methods. Self-report research surveys, clinical and research visit tracking, fidelity, and qualitative data will be collected at multiple timepoints throughout the trial to inform feasibility and acceptability of the adaptive intervention's components.

Anticipated results

Pilot data will be used to ensure the feasibility and acceptability of the adaptive intervention components, as well as the SMART design.

Discussion

Pilot data will be used to develop and refine a manualized adaptive intervention, as well as a fully developed SMART protocol, for optimization-effectiveness testing in a future, full-scale trial.

Trial registration

Registered with clinicaltrials.gov (NCT06527599).

背景：大约75%因创伤性损伤住院的个体接受处方阿片类药物治疗，并经历控制不佳的疼痛、心理困扰和多种物质使用，使这些个体面临阿片类药物滥用的高风险。在创伤性损伤后，阿片类药物滥用的危险因素差异很大，这表明对减轻风险的尝试的反应也同样不同。这种异质性需要适应性干预的发展，但之前没有试验评估研究或提供适应性干预的可行性，以减轻这一人群的疼痛和滥用相关风险。方法进行一项先导顺序、多任务随机试验（SMART），以确定在出院一周内启动适应性干预的可行性，包括阿片类药物风险监测、创伤护理协调和创伤性损伤住院患者疼痛应对技能培训。来自两个一级创伤中心的107名患者将被纳入研究。还将评估实施拟议的SMART的可行性，包括招聘、保留、随机化和再随机化、数据收集和定性方法的过程。自我报告研究调查、临床和研究访问跟踪、保真度和定性数据将在整个试验期间的多个时间点收集，以告知适应性干预组成部分的可行性和可接受性。预期结果将使用ot数据来确保自适应干预组件以及SMART设计的可行性和可接受性。试点数据将用于开发和完善手动自适应干预措施，以及完全开发的SMART协议，以便在未来的全面试验中进行优化有效性测试。在clinicaltrials.gov注册（NCT06527599）。

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引用次数: 0

Trial design: Evaluating the safety, feasibility, and acceptability of time-restricted eating in pregnant women with obesity 试验设计：评估肥胖孕妇限时饮食的安全性、可行性和可接受性。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-04-01 Epub Date: 2026-02-10 DOI: 10.1016/j.cct.2026.108257

Brittany DiPiazza , Bhumi Patel , Yanqiao Li , Adrienne Tardif , Lacey Pezley , Anisa Fought-Boudaia , Alana Steffen , Irina Buhimschi , Tristesse Burton , Krista Varady , Mary Dawn Koenig , Lisa Tussing-Humphreys

Background

In the United States (U.S.), approximately 15% of women of reproductive age have a body mass index (BMI) of at least 35.0 kg/m², which is associated with increased risks of adverse maternal and fetal health outcomes. However, interventions targeting gestational weight gain have not improved perinatal health outcomes among this population, suggesting the need for innovation. Time-restricted eating (TRE) is an accessible eating pattern in which individuals consume food within a limited time frame each day. We hypothesize that TRE has the potential to optimize gestational weight gain and improve maternal cardiometabolic health and perinatal health outcomes among women with prenatal obesity.

Methods

We describe a randomized controlled pilot study of TRE among pregnant women with a pre-pregnancy BMI between 35 and 60 kg/m². The study aims to enroll 60 participants. The study commences at 14 to ≤20 weeks gestational age and continues through labor and delivery. The TRE intervention includes an 8-h eating window (10 a.m. – 6 p.m. or 11 a.m. – 7 p.m.) during the 2nd trimester and a 10-h eating window (9 a.m. – 7 p.m. or 10 a.m. – 8 p.m.) during the 3rd trimester, for each day of the participants' enrollment in the study.

Results

The study will: 1) examine the safety, feasibility, and acceptability of TRE during pregnancy, 2) explore the impact of TRE on maternal body weight and cardiometabolic markers, and 3) explore the impact of TRE on perinatal health outcomes.

Conclusion

The primary outcomes of this study are focused on examining the safety, feasibility, and acceptability of TRE in pregnant women with class II and III obesity.

背景：在美国，大约15%的育龄妇女的身体质量指数（BMI）至少为35.0 kg/m2，这与母体和胎儿不良健康结局的风险增加有关。然而，针对妊娠期体重增加的干预措施并没有改善这一人群的围产期健康状况，这表明需要创新。限时饮食（TRE）是一种可接受的饮食模式，个人每天在有限的时间内进食。我们假设TRE有可能优化妊娠期体重增加，改善产前肥胖妇女的心脏代谢健康和围产期健康结果。方法：我们对孕前BMI在35 - 60 kg/m2之间的孕妇进行了一项随机对照的TRE试点研究。这项研究的目标是招募60名参与者。研究从14至≤20 周孕龄开始，并持续到分娩。TRE干预包括8小时进食窗口（上午10 ）。- 6 点。或11 点。-下午7点 )和10小时进食窗口（上午9点 ）。- 7 点。或10 点。- 8 p.m.)，在参与者参加研究的每一天。结果：本研究将：1)检验妊娠期人工流产的安全性、可行性和可接受性；2)探讨人工流产对孕产妇体重和心脏代谢指标的影响；3)探讨人工流产对围产期健康结局的影响。结论：本研究的主要结果集中在检查妊娠II类和III类肥胖妇女使用TRE的安全性、可行性和可接受性。

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引用次数: 0

Corrigendum to 'Optimization of a digital health intervention to enhance well-being among adolescent and young adult cancer survivors: Design and methods of the EMPOWER full factorial trial' [Contemporary Clinical Trials, Vol. 149 (2025) 107783]. “优化数字健康干预以提高青少年和年轻人癌症幸存者的福祉：EMPOWER全因子试验的设计和方法”的勘误表[当代临床试验，Vol. 149(2025) 107783]。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-24 DOI: 10.1016/j.cct.2026.108290

John M Salsman, Karly M Murphy, Elizabeth L Addington, Janet A Tooze, Laurie E McLouth, DerShung Yang, Stacy Sanford, Lynne Wagner, Stephanie C Bunch, Abby R Rosenberg, Carmina G Valle, Brad Zebrack, Dianna Howard, Michael Roth, Judith T Moskowitz

引用次数: 0

A novel clinical trials search tool with iterative and geospatial capabilities. 一种具有迭代和地理空间功能的新型临床试验搜索工具。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-19 DOI: 10.1016/j.cct.2026.108289

George Udeani, Joy Alonzo, Keith Biggers, Sergio Herrera, Chioma Ogbodo, Dorothy Farrell, Ladan Panahi, Miranda Steinkopf, Matthew Barry, Terri Moore, Marcia G Ory

Scope: ClinicalTrials.gov serves as a key resource for information on ongoing and completed clinical trials. To advance equitable promotion and broaden access, the Clinical Trials Search Tool (CTST) was developed to build on ClinicalTrials.gov data, offering a more comprehensive index with user-friendly geospatial, demographic, and socioeconomic features.

Aim: To create a web-based Clinical Trials Search Tool (CTST) that builds on ClinicalTrials.gov data, offering custom querying, reporting functions, and interactive geospatial mapping capabilities.

Methods: The CTST was built using a rapid, iterative, feedback-driven Agile approach. Its front-end client, developed in Svelte and TypeScript with the SvelteKit framework and Tailwind CSS UI library, supports detailed search specifications and result rendering. Iterative means user-driven refinement of queries, adjusting keywords, filters, and geography based on results. This workflow enables dynamic exploration and optimization of feasibility queries. The back-end server, implemented in Java with Spring Boot framework, processes searches and delivers ranked results, storing application data in a PostgreSQL database. Communication occurs through the server's REST API via asynchronous HTTP requests with JSON-serialized data.

Results: The CTST, equipped with a Toggle Advanced Search button, provides an easy-to-use interface for specifying input search criteria, allowing users to customize their selection. An interactive geospatial map renders the returned results as listings that summarize clinical trials in a tabular form, several layers that integrate population density, racial and ethnic demographics, and socioeconomic details.

Conclusion: The CTST builds on the ClinicalTrials.gov database, integrating geospatial, demographic, and socioeconomic dimensions to support advanced research and maximize its value for clinicians and investigators.

网站范围：ClinicalTrials.gov是正在进行和已完成临床试验信息的关键资源。为了促进公平推广和扩大获取，临床试验搜索工具（CTST）是在ClinicalTrials.gov数据的基础上开发的，提供了一个更全面的索引，具有用户友好的地理空间、人口和社会经济特征。目的：创建基于ClinicalTrials.gov数据的基于web的临床试验搜索工具（CTST），提供自定义查询、报告功能和交互式地理空间映射功能。方法：CTST采用快速、迭代、反馈驱动的敏捷方法构建。它的前端客户端使用SvelteKit框架和顺风CSS UI库，使用SvelteKit和TypeScript开发，支持详细的搜索规范和结果渲染。迭代意味着用户驱动的查询细化，基于结果调整关键字、过滤器和地理位置。该工作流支持动态探索和优化可行性查询。后端服务器使用Java和Spring Boot框架实现，处理搜索并提供排序结果，将应用程序数据存储在PostgreSQL数据库中。通信通过服务器的REST API通过带有json序列化数据的异步HTTP请求进行。结果：CTST配备了Toggle高级搜索按钮，提供了一个易于使用的界面来指定输入搜索条件，允许用户自定义他们的选择。交互式地理空间地图将返回的结果呈现为列表，这些列表以表格的形式总结了临床试验，其中有几个层次集成了人口密度、种族和民族人口统计以及社会经济细节。结论：CTST建立在ClinicalTrials.gov数据库的基础上，整合了地理空间、人口统计和社会经济维度，以支持先进的研究，并最大化其对临床医生和研究人员的价值。

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引用次数: 0

Randomized controlled pilot trial of extended-release buprenorphine vs. sublingual buprenorphine-naloxone in rural settings (RXR): Study rationale and design. 丁丙诺啡与舌下丁丙诺啡-纳洛酮在农村地区的随机对照试验（RXR）：研究原理和设计。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-16 DOI: 10.1016/j.cct.2026.108288

Larissa J Mooney, Andrew J Saxon, Megan Black, Allison J Ober, Mitra Lewis, Robrina Walker, Jennifer McCormack, Christina Scheele, Yih-Ing Hser

Background: Rural communities continue to experience high overdose mortality rates and challenges retaining individuals with opioid use disorder (OUD) on medications for opioid use disorder (MOUD). The most recent formulation of injectable extended-release buprenorphine (XR-BUP) may improve treatment engagement and outcomes for people with OUD.

Objectives: The RXR study (CTN-0102XR) aims to evaluate the feasibility of implementing XR-BUP in rural settings, acceptability of XR-BUP to clinic staff and patients, and effectiveness of XR-BUP compared with sublingual buprenorphine-naloxone (SL-BUP).

Study design and methods: This is an open-label randomized controlled trial (RCT) using intention-to-treat (ITT) analysis. Approximately 144 participants recruited from seven rural clinic sites will be randomized to receive XR-BUP or SL-BUP in a ratio of 2:1, and will receive study medication for 14 weeks. Participants in the XR-BUP condition will receive two weekly initiation dosages, followed by the target monthly dosage (128 mg) at Weeks 2, 6, and 10. Participants in the SL-BUP condition will receive medication on a similar schedule, with a target dose range of 16-24 mg/day. The main comparative effectiveness outcome measure is the number of monthly opioid negative urine drug screens (UDS) for non-prescribed opioids from Weeks 2-14. Feasibility and acceptability will be evaluated using mixed methods, combining participant survey and interview data from clinic administrators, providers, and patients.

Conclusions: If demonstrated to be feasible and acceptable to participants and staff and there is evidence of effectiveness for people with OUD in reducing opioid use, XR-BUP may be considered an important option for addressing OUD in rural settings.

Clinicaltrials: gov Identifier: NCT06023459.

背景：农村社区继续经历高过量死亡率，并挑战留住阿片类药物使用障碍（OUD）患者的药物治疗阿片类药物使用障碍（mod）。注射用缓释丁丙诺啡（XR-BUP）的最新配方可能改善OUD患者的治疗参与和结果。目的：RXR研究（CTN-0102XR）旨在评估在农村地区实施XR-BUP的可行性，临床工作人员和患者对XR-BUP的接受程度，以及XR-BUP与舌下丁丙诺啡-纳洛酮（SL-BUP）的有效性。研究设计和方法：这是一项开放标签随机对照试验（RCT），采用意向治疗（ITT）分析。从7个农村诊所招募的约144名参与者将以2:1的比例随机接受XR-BUP或SL-BUP，并将接受14 周的研究药物治疗。XR-BUP患者将接受两周起始剂量，随后在第2周、第6周和第10周接受目标月剂量（128 mg）。SL-BUP患者将按照类似的时间表接受药物治疗，目标剂量范围为16-24 mg/天。主要的比较疗效指标是2-14周每月阿片类药物阴性尿液药物筛查（UDS）非处方阿片类药物的数量。可行性和可接受性将采用混合方法进行评估，结合参与者调查和来自诊所管理人员、提供者和患者的访谈数据。结论：如果被证明对参与者和工作人员是可行和可接受的，并且有证据表明对OUD患者减少阿片类药物使用的有效性，XR-BUP可能被认为是解决农村地区OUD的重要选择。临床试验：gov标识符：NCT06023459。

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引用次数: 0

An adapted brief negotiation interview for alcohol and cannabis use among assault-injured emerging adults: A randomized pilot trial protocol. 一个改编的简短谈判访谈酒精和大麻的使用在攻击受伤的新成人：一个随机试点试验协议。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-14 DOI: 10.1016/j.cct.2026.108287

Edouard Coupet, James Dodington, Gail D'Onofrio, Carla S Stover, James Dziura, Cecilio Pepe Vega, Elaine Couvertier, Erin Latham, Marcie Gawel, David A Fiellin, Samantha Lew Fretz, Federico E Vaca

Emerging adults are disproportionately at risk for substance misuse and assault injury. Assault-injured emerging adults with substance misuse have increased risk of morbidity and mortality compared to those without and often receive care in the Emergency Department (ED). This manuscript describes the development of a protocol for a pilot randomized trial of an adapted brief behavioral intervention, the Brief Negotiation Interview (BNI), for use among assault-injured emerging adults with alcohol and/or cannabis misuse presenting to the ED. First, we will perform a mixed methods study of assault-injured emerging adults with alcohol and/or cannabis misuse to elicit the shared psychosocial risk factors that contribute to both alcohol and/or cannabis misuse in the context of assault injury. We will then use these data to adapt the BNI for use among assault-injured emerging adults with alcohol and/or cannabis misuse. We will evaluate the feasibility and acceptability of the adapted BNI in a randomized trial in the ED setting (N = 50). This pilot study is a critical initial step in developing an effective brief behavioral intervention for reducing alcohol and cannabis use among assault-injured emerging adults. Trial Registration Number NCT07070414.

初出期的成年人在药物滥用和人身伤害方面的风险不成比例。与那些没有药物滥用并且经常在急诊室接受治疗的人相比，滥用药物伤害的新兴成年人的发病率和死亡率风险增加。本文描述了一项随机试验方案的发展，该方案是一种适应性的简短行为干预，即简短谈判访谈（BNI），用于向急诊科提出的滥用酒精和/或大麻的殴打受伤的新成年患者。我们将对因酒精和/或大麻滥用而遭受袭击伤害的新生成人进行一项混合方法研究，以找出在袭击伤害背景下导致酒精和/或大麻滥用的共同心理社会风险因素。然后，我们将使用这些数据来调整BNI，以便在滥用酒精和/或大麻的攻击受伤的新成年人群中使用。我们将在一项ED随机试验中评估改编BNI的可行性和可接受性（N = 50）。这项初步研究是制定一项有效的短期行为干预措施，以减少受袭击伤害的新生成人中酒精和大麻的使用的关键的第一步。试验注册号NCT07070414。

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引用次数: 0

A study within a trial evaluating supplemental, reinforced risk-based training to reduce implementation barriers in a pediatric multicenter randomized controlled trial. 在一项儿科多中心随机对照试验中，一项试验中的研究评估了补充的、强化的基于风险的培训以减少实施障碍。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-13 DOI: 10.1016/j.cct.2026.108284

Danielle J Green, Valeriya Vasenina, Kelsee Meyerhoffer, Russell K Banks, Mark W Hall, Athena F Zuppa, Kevin M Watt, Natalie Dilts, John M VanBuren

Background: High-quality conduct of clinical trials depends on strict adherence to both regulatory protocols and trial-specific procedures to ensure data integrity and participant safety. Standard methods utilized to train research staff have limitations, including lack of specificity and declining impact over time. We developed a Supplemental, Reinforced, Risk-Based Training (SRRBT) program, designed to target study-specific challenges and provide ongoing reinforcement. Our objective was to evaluate whether SRRBT improves protocol adherence.

Methods: SRRBT was executed as a cluster-randomized, educational implementation study embedded in a multicenter clinical trial. We compared standard training with and without the addition of SRRBT across 23 clinical sites. SRRBT consisted of five interactive electronic vignettes focusing on trial-specific competencies. The primary outcome was the proportion of eligible participants approached for study participation. Secondary outcomes included consent and enrollment rates, protocol deviations, and completeness of study documentation.

Results: Approach rates immediately following training trended higher at SRRBT sites compared to those receiving standard training alone (OR = 3.98, 95% CI [0.87, 18.17], p = 0.074); however, this difference was not statistically significant and attenuated over time, with odds ratios of 2.24 (95% CI [0.78, 6.49], p = 0.14) at six months and 1.38 (95% CI [0.53, 3.59], p = 0.51) at 12 months post-training.

Conclusions: SRRBT shows potential in enhancing early site-level protocol adherence but may require ongoing reinforcement to sustain benefits over time. This study highlights the need for continuous, adaptive training approaches in complex clinical trials to maintain high standards of protocol adherence.

背景：临床试验的高质量进行取决于严格遵守监管方案和试验特定程序，以确保数据完整性和参与者安全。用于培训研究人员的标准方法有局限性，包括缺乏特异性和随着时间的推移而下降的影响。我们制定了一项补充、强化、基于风险的培训（SRRBT）计划，旨在针对特定的研究挑战并提供持续的强化。我们的目的是评估SRRBT是否提高了协议的依从性。方法：SRRBT是一项多中心临床试验中嵌入的集群随机、教育实施研究。我们比较了在23个临床站点添加SRRBT和不添加SRRBT的标准训练。SRRBT由五个互动电子小片段组成，重点关注特定于试验的能力。主要结果是符合条件的参与者的比例。次要结局包括同意率和入组率、方案偏差和研究文件的完整性。结果：与仅接受标准培训的患者相比，SRRBT站点培训后立即接近率更高（OR = 3.98,95% CI [0.87, 18.17], p = 0.074）；然而，这种差异在统计学上不显著，并且随着时间的推移逐渐减弱，在训练后6个月时的比值比为2.24 (95% CI [0.78, 6.49], p = 0.14)，在训练后12 个月时的比值比为1.38 （95% CI [0.53, 3.59], p = 0.51）。结论：SRRBT显示了增强早期站点级协议依从性的潜力，但可能需要持续加强以保持效益。这项研究强调了在复杂的临床试验中需要持续的、适应性的训练方法，以保持高标准的协议依从性。

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引用次数: 0

Comparative study for managing OCD and anxiety symptoms (COSMOS) study: Rationale, design, and methods. 强迫症和焦虑症状管理的比较研究（COSMOS）研究：基本原理、设计和方法。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-12 DOI: 10.1016/j.cct.2026.108286

Joanna X Zhou, Ogechi C Onyeka, Jeffrey A Carter, Annika Myers, Adam Garcia, Janie Contreras-Muñoz, Marianna C Messerli, Brian Dang, Alyssa Vieira, Annisa Ahmed, Daphne M Ayton, Peter Boedeker, Andrew G Guzick, Ticiane Silva, Hannah C Moore, Erika S Trent, Abigail E Candelari, Amanda D Palo, Eric A Storch

Anxiety and obsessive-compulsive disorders are common among children and adolescents and, if left untreated, can lead to further psychiatric morbidity and impairment. Practical barriers, such as financial constraints, limited availability of therapists, and time limitations of families, may impede access to evidence-based treatments. Low-intensity treatments show promise in addressing these barriers while conserving resources for those who require additional support. However, further empirical evidence is needed regarding the comparative efficacy of different interventions. To address this gap, we detail the protocol for a randomized controlled trial that compares the effectiveness of three different low-intensity therapy interventions - internet guided cognitive-behavioral therapy, parent-led treatment, and relaxation therapy - and explores the underlying mechanisms of each.

焦虑和强迫症在儿童和青少年中很常见，如果不及时治疗，可能会导致进一步的精神疾病和损害。实际障碍，如财政限制、治疗师有限的可用性和家庭的时间限制，可能阻碍获得循证治疗。低强度治疗有望解决这些障碍，同时为那些需要额外支持的人节省资源。然而，关于不同干预措施的比较效果，还需要进一步的经验证据。为了解决这一差距，我们详细介绍了一项随机对照试验的方案，该试验比较了三种不同的低强度治疗干预措施的有效性——互联网引导的认知行为治疗、父母主导的治疗和放松治疗——并探讨了每种治疗的潜在机制。

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引用次数: 0

Promoting sustained behavior change and nutrition security in medicaid-enrolled individuals with stage 2 cardiovascular kidney metabolic syndrome (CKMS): Protocol of the SUSTAIN study. 促进医疗保险登记的2期心血管肾脏代谢综合征（CKMS）患者持续的行为改变和营养安全：SUSTAIN研究方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2026-03-10 DOI: 10.1016/j.cct.2026.108285

Daniel M Walker, Colleen Spees, Guy Brock, Amaris Williams, Jade Smith, Jenny Shrodes, Daniel Gilmore, Amy Headings, Carrie Baker, Tanikka Price, Mysheika W Roberts, Erin Frey, Jillian Tatro, Lauren McGlade, Harlan Derry, Kemba Johnson, Joshua J Joseph

Background: Medicaid-enrolled populations are disproportionately impacted by suboptimal dietary intake leading to a high prevalence of Stage 2 cardiovascular-kidney-metabolic syndrome (CKMS), and lower Life's Essential 8 (LE8) cardiovascular health (CVH) measures.

Methods: A pilot randomized controlled trial to test the feasibility, engagement, and preliminary efficacy of a novel Food-is-Medicine (FIM) intervention in Medicaid-enrolled adults with Stage 2 CKMS.

Setting: Participants were recruited from an academic medical center in an urban environment in the Midwest.

Design: Parallel group design.

Interventions: SUSTAIN tests a phased-approach over 24 weeks: Weeks 1-8: Instacart food vouchers (known as Fresh Funds) and home delivery, behavioral nutrition counseling and culinary education, community health worker (CHW)-led social needs coordination, and produce prescription via Mid-Ohio Farmacy (MOF) access; Weeks 9-16: study supported Instacart platform access without the vouchers (Fresh Funds), while other components remain the same; Weeks 17-24: option to continue Instacart without study support, counseling and culinary education cease, and MOF and CHW continue. Control participants receive the same intervention without counseling and culinary education or the CHW.

Outcomes: Primary and secondary outcomes include study enrollment, adherence to intervention components (i.e., total Instacart spending, counseling sessions, number of food pantry visits, linkage with CHW), retention across study visits, acceptability (i.e, satisfaction), practicality (i.e., participant costs), adaptations to the intervention, and efficacy (i.e., dietary patterns, nutrition security, American Heart Association's Life's Essential 8).

Discussion: Scalable FIM approaches to improve CVH in individuals with Stage 2 CKMS are needed to inform inclusive and impactful interventions to address nutrition security.

Clinicaltrials: gov: NCT06589336.

背景：参加医疗补助的人群不成比例地受到次优饮食摄入的影响，导致2期心血管-肾-代谢综合征（CKMS）的高患病率，以及生命基本8 （LE8）心血管健康（CVH）指标的降低。方法：一项随机对照试验，以测试一种新的食物即药物（FIM）干预在医疗补助登记的2期CKMS成人患者中的可行性、参与性和初步疗效。环境：参与者从中西部城市环境中的学术医疗中心招募。设计：平行组设计。干预措施：SUSTAIN在24 周内测试了一种分阶段的方法：第1-8周：Instacart食品券（称为Fresh Funds）和送货上门、行为营养咨询和烹饪教育、社区卫生工作者（CHW）领导的社会需求协调，并通过俄亥俄州中部农场（MOF）获取处方；第9-16周：研究支持无代金券（Fresh Funds）的Instacart平台访问，而其他组件保持不变；第17-24周：选择继续Instacart，但没有学习支持、咨询和烹饪教育，MOF和CHW继续。对照组接受同样的干预，没有咨询和烹饪教育，也没有CHW。结果：主要和次要结果包括研究入组、对干预成分的依从性（即Instacart总支出、咨询会议、食品储藏室访问次数、与CHW的联系）、研究访问期间的保留率、可接受性（即满意度）、实用性（即参与者成本）、对干预的适应性和有效性（即饮食模式、营养安全、美国心脏协会的生活必需品8）。讨论：需要可扩展的FIM方法来改善2期CKMS患者的CVH，以提供包容性和有效的干预措施，以解决营养安全问题。Clinicaltrials: gov: NCT06589336。

{"title":"Promoting sustained behavior change and nutrition security in medicaid-enrolled individuals with stage 2 cardiovascular kidney metabolic syndrome (CKMS): Protocol of the SUSTAIN study.","authors":"Daniel M Walker, Colleen Spees, Guy Brock, Amaris Williams, Jade Smith, Jenny Shrodes, Daniel Gilmore, Amy Headings, Carrie Baker, Tanikka Price, Mysheika W Roberts, Erin Frey, Jillian Tatro, Lauren McGlade, Harlan Derry, Kemba Johnson, Joshua J Joseph","doi":"10.1016/j.cct.2026.108285","DOIUrl":"10.1016/j.cct.2026.108285","url":null,"abstract":"<p><strong>Background: </strong>Medicaid-enrolled populations are disproportionately impacted by suboptimal dietary intake leading to a high prevalence of Stage 2 cardiovascular-kidney-metabolic syndrome (CKMS), and lower Life's Essential 8 (LE8) cardiovascular health (CVH) measures.</p><p><strong>Methods: </strong>A pilot randomized controlled trial to test the feasibility, engagement, and preliminary efficacy of a novel Food-is-Medicine (FIM) intervention in Medicaid-enrolled adults with Stage 2 CKMS.</p><p><strong>Setting: </strong>Participants were recruited from an academic medical center in an urban environment in the Midwest.</p><p><strong>Design: </strong>Parallel group design.</p><p><strong>Interventions: </strong>SUSTAIN tests a phased-approach over 24 weeks: Weeks 1-8: Instacart food vouchers (known as Fresh Funds) and home delivery, behavioral nutrition counseling and culinary education, community health worker (CHW)-led social needs coordination, and produce prescription via Mid-Ohio Farmacy (MOF) access; Weeks 9-16: study supported Instacart platform access without the vouchers (Fresh Funds), while other components remain the same; Weeks 17-24: option to continue Instacart without study support, counseling and culinary education cease, and MOF and CHW continue. Control participants receive the same intervention without counseling and culinary education or the CHW.</p><p><strong>Outcomes: </strong>Primary and secondary outcomes include study enrollment, adherence to intervention components (i.e., total Instacart spending, counseling sessions, number of food pantry visits, linkage with CHW), retention across study visits, acceptability (i.e, satisfaction), practicality (i.e., participant costs), adaptations to the intervention, and efficacy (i.e., dietary patterns, nutrition security, American Heart Association's Life's Essential 8).</p><p><strong>Discussion: </strong>Scalable FIM approaches to improve CVH in individuals with Stage 2 CKMS are needed to inform inclusive and impactful interventions to address nutrition security.</p><p><strong>Clinicaltrials: </strong>gov: NCT06589336.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108285"},"PeriodicalIF":1.9,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147442905","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

The impact of a potassium-enriched salt substitute on blood pressure control in patients with resistant arterial hypertension: A randomized pilot trial 一种富钾盐替代品对顽固性动脉高血压患者血压控制的影响：一项随机先导试验

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.2026.108230

Enilson Carmo Barbosa dos Santos , Yasmin de Souza Lima Bitar , Jorge Luís Motta dos Anjos , Cristiano Ricardo Bastos de Macedo , Apoenna Marina Noronha Brito , Marina Pereira Ferreira , Tomaz Mattedi Carvalho , Gabriele Eliza Assis , Jackson Pedro Barros Pereira , Ana Beatriz Cazé Ceron , Victoria Bastos Rodrigues , Leonardo Roever , André Rodrigues Durães

Background

Dietary sodium reduction and potassium enrichment are recommended non-pharmacological strategies for blood pressure (BP) control; however, randomized evidence evaluating potassium-enriched salt substitutes specifically in patients with resistant arterial hypertension (RAH) remains limited.

Methods

We conducted a randomized, double-blind, controlled pilot trial including adults with RAH. Participants were assigned to receive either a potassium-enriched salt substitute (approximately 50% sodium chloride and 50% potassium chloride) or regular salt for 24 weeks. The primary outcome was the between-group difference in change in 24-h systolic BP assessed by ambulatory blood pressure monitoring (ABPM). The primary analyses used an available-case approach (completers) to prioritize analytical rigor, with intention-to-treat and sensitivity analyses assessing robustness. Between-group comparisons were utilized to control for regression to the mean and white-coat variability.

Results

Among 60 randomized participants, 49 completed valid baseline and follow-up ABPM assessments (23 intervention, 26 control). At 24 weeks, patients assigned to potassium-enriched salt exhibited a directionally greater reduction in 24-h systolic blood pressure compared with the control group, resulting in a between-group difference of −2.47 mmHg (95% CI −4.93 to 0.00; P = 0.05). A similar directional pattern was observed for diastolic blood pressure. Office blood pressure measurements showed greater variability and less consistent between-group differences over time. Urinary potassium excretion increased in the intervention group, whereas changes in urinary sodium excretion were modest. No cases of clinically relevant hyperkalemia or serious adverse events were observed.

Conclusions

In this randomized pilot trial, the use of a potassium-enriched salt substitute was safe and associated with modest, directionally greater reductions in ambulatory BP compared with regular salt in patients with RAH. These findings support the feasibility and safety of potassium-enriched salt substitution as a pragmatic adjunctive strategy for blood pressure management in patients with resistant hypertension.

背景：饮食减钠和富钾是控制血压的推荐非药物策略；然而，评估富钾盐替代品对顽固性动脉高血压（RAH）患者的疗效的随机证据仍然有限。方法：我们进行了一项随机、双盲、对照的先导试验，包括患有RAH的成年人。参与者被分配接受富钾盐替代品（大约50%氯化钠和50%氯化钾）或常规盐24 周。主要终点是通过动态血压监测（ABPM）评估的24小时收缩压变化的组间差异。主要分析在具有有效基线和24周ABPM数据的参与者（完成者）中进行，并进行意向治疗分析作为敏感性分析。结果：在60名随机受试者中，49名完成了有效的基线和随访ABPM评估（干预23名，对照组26名）。在第24 周，与对照组相比，富钾盐组患者的24小时收缩压有更大的方向性降低，组间差异为-2.47 mmHg （95% CI -4.93至0.00;P = 0.05）。舒张压也有类似的方向模式。随着时间的推移，办公室的血压测量结果显示出更大的变异性，而组间的差异则不那么一致。干预组尿钾排泄量增加，而尿钠排泄量变化不大。未观察到临床相关的高钾血症或严重不良事件。结论：在这项随机试验中，与常规盐相比，在RAH患者中使用富钾盐替代品是安全的，并且与适度的、方向性更大的动态血压降低相关。这些研究结果支持了富钾盐替代作为顽固性高血压患者血压管理的实用辅助策略的可行性和安全性。

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引用次数: 0