Contemporary clinical trials最新文献_第4页

Randomized controlled trial of a multiple technology-based physical activity intervention for Latina adolescents: Recruitment strategies and baseline data from the Chicas Fuertes trial 针对拉丁裔青少年的基于多种技术的体育活动干预随机对照试验：Chicas Fuertes 试验的招募策略和基线数据。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-15 DOI: 10.1016/j.cct.2024.107716

Jeanean B. Naqvi , Brittany Olesen , Emily Greenstadt , Jacob Carson , Bess Marcus , Job Godino , Michelle Zive , Dawn Meyer , Michael Higgins , Lilliana Osuna , Rubi Gomez , Shira Dunsiger , Britta Larsen

Background

Latina adolescents report low levels of physical activity (PA) and high lifetime risk of lifestyle-related diseases. They also have high rates of using technology, suggesting interventions delivered through mobile devices may be effective for this population. The current paper describes recruitment methods and baseline study characteristics for Chicas Fuertes, a fully powered randomized trial of a mobile technology PA intervention.

Methods

Underactive Latina adolescents (aged 13–18) were recruited using social media and presentations at local schools and community organizations in San Diego, California. Participants were randomly assigned 1:1 to either the intervention (Fitbit, tailored texting, social media, and website) or control group. Baseline measures included demographics, psychosocial variables, and PA measured by the 7-Day Physical Activity Recall (PAR), ActiGraph GT3X+ accelerometers, and Fitbits. Baseline data were collected from 2020 to 2023.

Results

Social media yielded the most contacts (465), but had the lowest chance of enrollment (14 %, vs. 52 % from school presentations). Participants (N = 160) were mostly second generation (68.8 %), and low income (61.8 %), but technology access was high (>99 %). Median self-reported moderate-to-vigorous PA (MVPA) using the 7-Day PAR was 120 min/week (range 0–720), and median daily steps were 5222 (IQR 359). Median MVPA measured by ActiGraphs, however, was 0 min per week. There was no correlation between the 7-day PAR and ActiGraphs (

ρ = .13, p = .12)

. However, ActiGraph MVPA was correlated with total steps recorded by the Fitbit (

ρ = .38, p < .001

).

Conclusions

Both remote and in-person approaches were successful in recruiting a sample that was underactive and low income, but had high technology use.

背景：拉丁裔青少年的体力活动（PA）水平较低，一生中患生活方式相关疾病的风险较高。他们使用技术的比例也很高，这表明通过移动设备进行干预可能对这一人群有效。本文介绍了 "Chicas Fuertes "项目的招募方法和基线研究特征：方法：通过社交媒体以及在加利福尼亚州圣迭戈市当地学校和社区组织的宣讲，招募缺乏运动的拉丁裔青少年（13-18 岁）。参与者按 1:1 随机分配到干预组（Fitbit、定制短信、社交媒体和网站）或对照组。基线测量包括人口统计学、社会心理变量以及通过 7 天体育活动回顾 (PAR)、ActiGraph GT3X+ 加速计和 Fitbits 测量的体育活动量。基线数据收集时间为 2020 年至 2023 年：结果：社交媒体获得的联系最多（465 人），但注册几率最低（14%，而学校宣讲会的注册几率为 52%）。参与者（N = 160）大多是第二代（68.8%）和低收入者（61.8%），但技术普及率很高（>99%）。使用 7 天 PAR 自我报告的中位数中强度运动量（MVPA）为每周 120 分钟（范围 0-720），中位数每日步数为 5222 步（IQR 359）。然而，ActiGraphs 测量的中位 MVPA 为每周 0 分钟。7 天 PAR 与 ActiGraphs 之间没有相关性（ρ=.13,p=.12）。然而，ActiGraph MVPA 与 Fitbit 记录的总步数存在相关性（ρ=.38,p 结论：远程和面对面两种方法都很有效：远程和面对面两种方法都成功地招募到了活动不足、收入低但技术使用率高的样本。

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引用次数: 0

Addressing rural health disparities by optimizing “high-touch” intervention components in digital obesity treatment: The iREACH Rural study 通过优化数字肥胖症治疗中的 "高接触 "干预内容，解决农村健康差距问题：iREACH 农村研究。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-11 DOI: 10.1016/j.cct.2024.107711

Rebecca A. Krukowski , Kelsey R. Day , Wen You , Christine A. Pellegrini , Delia S. West

Background

Rural residents are more impacted by obesity and related comorbidities than their urban counterparts. Digital weight management interventions may produce meaningful weight loss among rural residents.

Objectives

The iREACH Rural Study aims to identify “high-touch” component(s) that contribute to meaningful weight loss (≥1.5 kg) at 6-months, over and above what the 24-week core online program produces. Three treatment components are assessed: group video sessions (yes/no); self-monitoring feedback (counselor-crafted/pre-scripted, modular); and individual coaching calls (yes/no).

Design

The iREACH Rural Study is a factorial experiment (n = 616).

Methods

Participants receive up to 3 “high-touch” components (weekly synchronous facilitated group video sessions, weekly counselor-crafted self-monitoring feedback, and individual coaching calls) to determine which contribute meaningfully to 6-month weight loss. Participants complete assessments at baseline, 2 months, 6 months, and 12 months. Weight loss at 6 months (primary outcome) and 12 months (secondary outcome) is measured by Bluetooth-enabled scales. The study seeks to identify the weight loss approach for underserved rural residents which optimizes weight change outcomes and also examines costs associated with delivering different treatment constellations.

Summary

The iREACH Rural Study is the first of its kind to isolate digital weight loss intervention components to determine which meaningfully contribute to long-term weight loss among rural residing individuals. The results may be used to refine digital weight loss programs by enhancing their effectiveness to allow broad dissemination.

背景：与城市居民相比，农村居民受肥胖及相关并发症的影响更大。数字化体重管理干预措施可能会使农村居民的体重得到有效减轻：iREACH农村研究旨在确定 "高接触 "部分，这些部分有助于在6个月后实现有意义的体重减轻（≥1.5公斤），超过24周核心在线项目的效果。对三个治疗部分进行了评估：小组视频课程（是/否）；自我监测反馈（咨询师设计/预设，模块化）；个人辅导电话（是/否）：iREACH 农村研究是一项因子实验（n = 616）：方法：参与者最多可接受 3 个 "高接触 "部分（每周同步促进小组视频课程、每周咨询师自编自我监控反馈和个人辅导电话），以确定哪些部分对 6 个月的体重减轻有意义。参与者在基线、2 个月、6 个月和 12 个月时完成评估。6个月（主要结果）和12个月（次要结果）的体重减轻情况由蓝牙体重秤测量。摘要：iREACH 农村研究是同类研究中首次分离出数字减肥干预成分，以确定哪些成分对农村居民的长期减肥有意义。研究结果可用于完善数字减肥计划，提高其有效性，以便广泛推广。

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引用次数: 0

DiaBetter Together: Clinical trial protocol for a strengths-based Peer Mentor intervention for young adults with type 1 diabetes transitioning to adult care DiaBetter Together：针对向成人护理过渡的 1 型糖尿病年轻成人的基于优势的同伴指导干预临床试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-10 DOI: 10.1016/j.cct.2024.107713

Samantha A. Carreon , Charles G. Minard , Sarah K. Lyons , Wendy Levy , Stephanie Camey , Kishan Desai , Brenda Duran , Randi Streisand , Barbara J. Anderson , Siripoom V. McKay , Tricia S. Tang , Sridevi Devaraj , Ryan Ramphul , Marisa E. Hilliard

Background

Type 1 diabetes (T1D) management is challenging for young adults, who are expected to transfer from the pediatric to adult T1D healthcare system while also managing typical developmental demands (e.g., social, financial, work/school, residential). Many young adults have extended gaps in care before following up in adult care, increasing risk for poor health outcomes. There are few evidence-based programs to support young adults with T1D to promote a timelier transition during this period. This paper reports on the design of DiaBetter Together, a randomized controlled trial to evaluate a 12-month Peer Mentor-delivered intervention compared to usual care among young adults with T1D during the transfer from pediatric to adult care.

Methods

One-hundred young adults (age 17–25) with T1D and 29 Peer Mentors enrolled in this randomized clinical trial. Peer Mentors are experienced, older young adults with T1D, trained by the study team to share transition experiences and strategies to successfully navigate the adult healthcare system, help young adults prepare for the first adult care visit, and use strengths-based support strategies to teach and model skills for managing T1D-related challenges.

Results

The primary outcome of the trial is HbA1c, and secondary outcomes include time to adult care, engagement in diabetes self-management behaviors, and psychosocial well-being.

Conclusion

The goal of this research is to evaluate a developmentally appropriate, supportive intervention that can improve T1D self-management and successful transfer of care during the difficult young adult years and promote optimal T1D health outcomes.

背景：1 型糖尿病（T1D）的管理对年轻成人来说具有挑战性，他们需要从儿科医疗系统转到成人 T1D 医疗系统，同时还要处理典型的发展需求（如社交、财务、工作/学校、居住）。许多青壮年在接受成人后续治疗之前，会有较长的治疗间隔，从而增加了不良健康后果的风险。目前很少有循证计划来支持患有 T1D 的年轻人，以促进他们在此期间更及时地过渡。本文报告了 "DiaBetter Together "项目的设计情况，该项目是一项随机对照试验，旨在评估在 T1D 青少年患者从儿科转入成人护理期间，同伴导师提供的为期 12 个月的干预措施与常规护理措施的比较：100名患有T1D的青少年（17-25岁）和29名同伴导师参加了这项随机临床试验。同伴指导员是经验丰富的年长 T1D 患者，接受过研究小组的培训，他们将分享成功驾驭成人医疗系统的过渡经验和策略，帮助青少年为首次成人护理就诊做好准备，并使用基于优势的支持策略教授和示范应对 T1D 相关挑战的技能：试验的主要结果是 HbA1c，次要结果包括接受成人护理的时间、参与糖尿病自我管理行为和社会心理健康：本研究的目标是评估一种适合发展的支持性干预措施，该措施可以改善 T1D 自我管理和在困难的青年时期成功转移护理，并促进最佳的 T1D 健康结果。

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引用次数: 0

Family history and cancer risk study (FOREST): A clinical trial assessing electronic patient-directed family history input for identifying patients at risk of hereditary cancer. 家族史与癌症风险研究（FOREST）：一项临床试验，评估患者在电子指导下输入家族病史以识别有遗传性癌症风险的患者。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-10 DOI: 10.1016/j.cct.2024.107714

Kathleen F Mittendorf, Harris T Bland, Justin Andujar, Natasha Celaya-Cobbs, Clasherrol Edwards, Meredith Gerhart, Gillian Hooker, Mryia Hubert, Sarah H Jones, Dana R Marshall, Rachel A Myers, Siddharth Pratap, S Trent Rosenbloom, Azita Sadeghpour, R Ryanne Wu, Lori A Orlando, Georgia L Wiesner

Background: Hereditary cancer syndromes cause a high lifetime risk of early, aggressive cancers. Early recognition of individuals at risk can allow risk-reducing interventions that improve morbidity and mortality. Family health history applications that gather data directly from patients could alleviate barriers to risk assessment in the clinical appointment, such as lack of provider knowledge of genetics guidelines and limited time in the clinical appointment. New approaches allow linking these applications to patient health portals and their electronic health records (EHRs), offering an end-to-end solution for patient-input family history information and risk result clinical decision support for their provider.

Methods: We describe the design of the first large-scale evaluation of an EHR-integrable, patient-facing family history software platform based on the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) standard. In our study, we leverage an established implementation science framework to evaluate the success of our model to facilitate scalable, systematic risk assessment for hereditary cancers in diverse clinical environments in a large pragmatic study at two sites. We will also evaluate the success of the approach to improve the efficiency of downstream genetic counseling resulting from pre-counseling pedigree generation.

Conclusions: Our research study will provide evidence regarding a new care delivery model that is scalable and sustainable for a variety of medical centers and clinics.

Trial registration: This study was registered on ClinicalTrials.gov under NCT05079334 on 15 October 2021.

背景：遗传性癌症综合征导致终生罹患早期侵袭性癌症的风险很高。及早识别高危人群可以采取降低风险的干预措施，从而提高发病率和死亡率。直接从患者处收集数据的家庭健康史应用程序可减轻临床预约中的风险评估障碍，如医疗服务提供者对遗传学指南缺乏了解以及临床预约时间有限等。新方法可将这些应用程序与患者健康门户网站及其电子健康记录（EHR）连接起来，为患者输入家族病史信息提供端到端解决方案，并为医疗服务提供者提供风险结果临床决策支持：方法：我们描述了对可整合电子病历、面向患者的家族史软件平台的首次大规模评估设计，该平台基于快速医疗保健互操作性资源上的可替代医疗应用和可重复使用技术（SMART on FHIR）标准。在我们的研究中，我们将利用已建立的实施科学框架来评估我们的模型是否成功，以促进在两个地点进行的大型实用研究中，在不同的临床环境中对遗传性癌症进行可扩展的系统性风险评估。我们还将评估该方法在提高咨询前血统生成所产生的下游遗传咨询效率方面是否成功：我们的研究将为各种医疗中心和诊所提供可扩展、可持续的新医疗服务模式：本研究于 2021 年 10 月 15 日在 ClinicalTrials.gov 上注册，注册号为 NCT05079334。

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引用次数: 0

Active symptom monitoring for premenopausal women with breast cancer initiating adjuvant endocrine therapy: Protocol for the SWOG S2010 randomized controlled efficacy trial 对开始接受辅助内分泌治疗的绝经前乳腺癌妇女进行主动症状监测：SWOG S2010 随机对照疗效试验方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-10 DOI: 10.1016/j.cct.2024.107712

N.L. Henry , J.M. Unger , R. Vaidya , A.K. Darke , T.C. Skaar , M.J. Fisch , D.L. Hershman

Background

Premenopausal women with early stage, high risk hormone receptor positive breast cancer are at risk of early discontinuation of adjuvant endocrine therapy (ET), primarily because of toxicity, which can increase the risk of disease recurrence and death. We hypothesize that identification of bothersome symptoms between clinic visits, and automated notification of clinicians about symptoms, will result in improved persistence with ET.

Methods

Pre- and perimenopausal women planning to receive adjuvant treatment with tamoxifen or an aromatase inhibitor plus ovarian function suppression or ablation for treatment of breast cancer are eligible. A total of 540 participants will be enrolled and randomized 1:1 to patient education with or without Active Symptom Monitoring (ASM). The ASM intervention includes 6 symptom questions (hot flashes, sadness, anxiety, insomnia, vaginal dryness, joint pain) that will be completed via text, email, or telephone weekly for 24 weeks, then every 4 weeks for 48 weeks. All participants will complete a battery of questionnaires every 12 weeks to examine symptoms, beliefs about medicine, self-efficacy, and ET adherence. Optional blood draws will be collected at baseline and after 12, 48, and 72 weeks of therapy to examine estradiol and ET concentrations. The primary endpoint is time to nonpersistence with initially prescribed ET within the first 72 weeks, evaluated using Kaplan-Meier plots and multivariable Cox regression.

Conclusion

We expect early identification and management of ET-related toxicities to improve persistence with breast cancer therapy, breast cancer outcomes, and quality of life for premenopausal women at high risk of breast cancer recurrence.

Clinicaltrials.gov NCT05568472

背景患有早期、高风险激素受体阳性乳腺癌的绝经妇女面临着过早中断辅助内分泌治疗（ET）的风险，这主要是因为毒性会增加疾病复发和死亡的风险。我们假设，在就诊间隙发现令人烦恼的症状，并将症状自动通知临床医生，将提高 ET 的坚持率。方法计划接受他莫昔芬或芳香化酶抑制剂加卵巢功能抑制或消融辅助治疗乳腺癌的绝经前和绝经期妇女均符合条件。共有 540 名参与者将被登记，并按 1:1 随机分配接受患者教育，同时接受或不接受主动症状监测 (ASM)。ASM 干预包括 6 个症状问题（潮热、悲伤、焦虑、失眠、阴道干涩、关节疼痛），这些问题将在 24 周内每周通过短信、电子邮件或电话完成，然后在 48 周内每 4 周完成一次。所有参与者将每 12 周完成一次问卷调查，以了解症状、对药物的看法、自我效能和坚持服药的情况。在基线期以及治疗 12、48 和 72 周后，将选择性地抽血检查雌二醇和 ET 浓度。主要终点是在最初开具的 72 周内不坚持使用 ET 的时间，使用 Kaplan-Meier 图和多变量 Cox 回归进行评估。结论：我们希望及早识别和处理 ET 相关毒性，以提高乳腺癌复发风险高的绝经前妇女的乳腺癌治疗坚持率、乳腺癌预后和生活质量。

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引用次数: 0

Intensive postpartum antihypertensive treatment (IPAT) and healthy lifestyle education: Study protocol for a pilot randomized controlled trial for patients with hypertensive disorders of pregnancy 产后高血压强化治疗（IPAT）和健康生活方式教育：针对妊娠期高血压疾病患者的随机对照试验研究方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-10 DOI: 10.1016/j.cct.2024.107710

Anna Palatnik , Nadine Sunji , Zaira Peterson , Jennifer Ohlendorf , Amy Y. Pan , Jacquelyn Kulinski

Background

Hypertensive disorders of pregnancy (HDP) complicate about 10 % of pregnancies and lead to postpartum hospital readmissions and cardiovascular complications. Following HDP, vascular dysfunction could persist and accelerate the trajectory of cardiovascular disease risk. The benefits of intensive blood pressure (BP) control following HDP have not been adequately investigated. Therefore, no standard guidelines exist to guide the management of mild-to-moderate hypertension in the postpartum period, leading to a wide variation in clinical practice. The present study will investigate the effect of intensive BP control and healthy lifestyle education on maternal cardiovascular health (CVH) and vascular function following HDP.

Methods

The Intensive Postpartum Antihypertensive Treatment (IPAT) study is a randomized controlled, two-arm, single-site, pilot trial where 60 postpartum HDP patients will be randomized 1:1 to one of two groups: 1) Intensive postpartum BP control – nifedipine initiation at BP ≥140/90 mmHg to maintain BP <140/90 mmHg; or 2) Less intensive postpartum BP control – nifedipine initiation at BP ≥150/100 mmHg to maintain BP <150/100 mmHg. All participants will also undergo vascular function assessments and receive healthy lifestyle education. The study will primarily test feasibility of all study procedures. It will secondarily examine changes in BP and CVH scores from baseline to 12 months postpartum.

Conclusion

This pilot trial will study whether the BP threshold of 140/90 is superior to 150/100 for initiation of pharmacotherapy and evaluate feasibility to ultimately conduct a trial capable of generating robust evidence to standardize clinical practice and guidelines in postpartum HDP management.

Trial registration number: NCT05687344

背景妊娠高血压疾病（HDP）约占妊娠并发症的 10%，并导致产后再次入院和心血管并发症。HDP 发生后，血管功能障碍可能会持续存在，并加速心血管疾病的风险轨迹。目前尚未充分研究 HDP 后加强血压（BP）控制的益处。因此，目前还没有标准指南来指导产后轻度至中度高血压的管理，导致临床实践中的差异很大。本研究将探讨产后强化血压控制和健康生活方式教育对产妇心血管健康（CVH）和血管功能的影响。方法产后强化降压治疗（IPAT）研究是一项随机对照、双臂、单站点的试点试验，60 名产后 HDP 患者将按 1:1 的比例随机分配到两组中的一组：1）强化产后血压控制--在血压≥140/90 mmHg时开始使用硝苯地平，以维持血压140/90 mmHg；或2）较低强化产后血压控制--在血压≥150/100 mmHg时开始使用硝苯地平，以维持血压150/100 mmHg。所有参与者还将接受血管功能评估和健康生活方式教育。该研究将主要测试所有研究程序的可行性。结论这项试点试验将研究血压阈值为 140/90 是否优于 150/100 以启动药物治疗，并评估可行性，以便最终开展一项试验，为规范产后 HDP 管理的临床实践和指南提供有力证据：NCT05687344

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引用次数: 0

Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis 设计一项为期 48 周的 3 期随机、双盲、安慰剂对照研究，以评估仙达单抗对成人和青少年嗜酸性粒细胞食管炎患者的疗效和安全性。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-09 DOI: 10.1016/j.cct.2024.107708

Christina M. Charriez , Sandra Zhang , Claudia H.M.C. de Oliveira , Vrunda Patel , Young S. Oh , Ikuo Hirano , Alain Schoepfer , Evan S. Dellon

Background

Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory condition that interferes with normal food ingestion, negatively impacting quality of life (QoL). Treatment options include proton pump inhibitors, corticosteroids, biologics, or dietary elimination; however, ∼1/3 of patients remain insufficiently controlled. The pathogenesis of EoE involves interleukin-13 (IL-13); therefore, targeted IL-13 inhibition may be beneficial. In a phase 2 study, cendakimab, a recombinant, humanized anti–IL-13 monoclonal antibody, significantly reduced mean esophageal eosinophil counts and improved other inflammatory parameters in patients with EoE. These findings prompted further investigation of the efficacy and safety of cendakimab in adults and adolescents with EoE in a phase 3 registrational study (NCT04753697), the design of which is presented here.

Methods

This multicenter, multinational, randomized, double-blind, placebo-controlled, 48-week, treat-through study plans to enroll 399 adults and adolescents. Randomized patients (1:1:1) will receive subcutaneous administration of 1) cendakimab 360 mg once weekly (QW) for 48 weeks, 2) cendakimab 360 mg QW for 24 weeks followed by cendakimab 360 mg every other week (with matching placebo on alternative weeks to maintain the blind) for 24 weeks, or 3) placebo QW for 48 weeks. Co-primary endpoints are mean change from baseline in dysphagia days and proportion of patients with eosinophil histologic response, defined as peak esophageal eosinophil count ≤6 per high-power field, at 24 weeks. Secondary and exploratory endpoints will address endoscopic and histologic features, QoL, safety, and pharmacokinetic assessments.

Conclusion

This phase 3 pivotal study will determine whether cendakimab provides an effective, safe, targeted treatment for patients with EoE.

背景：嗜酸性粒细胞食管炎（EoE）是一种免疫介导的慢性炎症，会影响正常进食，对生活质量（QoL）造成负面影响。治疗方法包括质子泵抑制剂、皮质类固醇、生物制剂或饮食疗法；然而，约有三分之一的患者病情仍未得到充分控制。肠易激综合征的发病机制涉及白细胞介素-13（IL-13）；因此，靶向抑制 IL-13 可能是有益的。在一项二期研究中，重组的人源化抗 IL-13 单克隆抗体仙达昔单抗显著降低了食管嗜酸性粒细胞的平均数量，并改善了食管水肿患者的其他炎症指标。这些发现促使我们在一项三期注册研究（NCT04753697）中进一步研究仙达昔单抗对成人和青少年咽喉炎患者的疗效和安全性，本文介绍了该研究的设计：这项多中心、跨国、随机、双盲、安慰剂对照、为期 48 周、治疗全程的研究计划招募 399 名成人和青少年患者。随机患者（1:1:1）将接受皮下注射：1）仙达单抗 360 毫克，每周一次（QW），共 48 周；2）仙达单抗 360 毫克，QW，共 24 周，然后每隔一周注射仙达单抗 360 毫克（另一周注射匹配的安慰剂以维持盲法），共 24 周；或 3）安慰剂，QW，共 48 周。共同主要终点是吞咽困难天数与基线相比的平均变化和24周时嗜酸性粒细胞组织学反应（定义为每高倍视野食管嗜酸性粒细胞计数峰值≤6）患者的比例。次要和探索性终点将涉及内镜和组织学特征、QoL、安全性和药代动力学评估：这项三期关键性研究将确定仙达单抗是否能为咽喉炎患者提供有效、安全的靶向治疗。

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引用次数: 0

Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance STAR 项目的设计：随机对照试验，评估适应性干预对长期保持减肥效果的影响。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-09 DOI: 10.1016/j.cct.2024.107707

Kathryn M. Ross , Meena N. Shankar , Peihua Qiu , Zibo Tian , Taylor N. Swanson , Armaan Shetty , Jaime Ruiz , Lisa Anthony , Michael G. Perri

Background

Without provision of additional intervention, most individuals regain weight after the end of weight-loss programs. Extended-care programs have been demonstrated to improve long-term weight-loss maintenance, but effects are modest.

Methods

We proposed to evaluate whether delivering extended-care telephone sessions on an ADAPTIVE (provided when individuals are deemed to be at high-risk for weight regain) versus STATIC (the once-per-month schedule typically used in extended-care programs) schedule improves weight regain after initial weight loss. Adults with obesity were initially recruited for a 16-week lifestyle weight-loss program, and those who lost ≥5 % of their initial weight were eligible for enrollment in the Project STAR maintenance trial.

Results

A total of 449 individuals (mean ± SD age = 49.5 ± 11.4 years, BMI = 35.7 ± 4.0 kg/m², 83.5 % female, 23.4 % Black or African American, 9.8 % Hispanic) were recruited for the initial weight-loss program and lost an average of 6.4 ± 4.9 % of their initial body weight; 255 were randomized to the maintenance trial. There were no significant differences between participants randomized to the trial versus those who were not in terms of baseline weight, gender, race/ethnicity, education, or marital status, all ps > 0.05; however, participants who were randomized to the trial were older, p = .014, and reported higher incomes, p < .001.

Conclusion

Results from Project STAR will demonstrate whether providing extended-care intervention on an individually adaptable schedule improves long-term weight-loss maintenance. Moreover, the rich longitudinal dataset collected during the trial will serve as a foundation for building future predictive algorithms of weight regain and novel weight-maintenance interventions.

背景：如果不采取额外的干预措施，大多数人在减肥计划结束后体重会反弹。延长护理计划已被证明可改善长期减肥效果，但效果并不明显：方法：我们建议评估电话延长护理课程的适应性（在个人被认为有体重反弹高风险时提供）与稳定性（延长护理项目通常采用的每月一次的计划）是否能改善初始减肥后的体重反弹。最初招募肥胖症成人参加为期 16 周的生活方式减肥计划，体重减轻≥5% 的人有资格参加 STAR 项目维持试验：共有 449 人（平均 ± SD 年龄 = 49.5 ± 11.4 岁，BMI = 35.7 ± 4.0 kg/m2，83.5% 为女性，23.4% 为黑人或非裔美国人，9.8% 为西班牙裔美国人）被招募参加初始减肥计划，平均减掉了初始体重的 6.4 ± 4.9%；255 人被随机分配到维持试验中。在基线体重、性别、种族/民族、教育程度或婚姻状况方面，被随机选入试验的参与者与未被随机选入试验的参与者之间没有明显差异（Ps 均大于 0.05）；但是，被随机选入试验的参与者年龄更大（P = 0.014），收入更高（P 结论）：STAR 项目的结果将证明，按照个人适应性时间表提供延伸护理干预是否能改善长期减肥效果。此外，试验期间收集的丰富纵向数据集将为未来建立体重反弹预测算法和新型体重维持干预措施奠定基础。

{"title":"Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance","authors":"Kathryn M. Ross , Meena N. Shankar , Peihua Qiu , Zibo Tian , Taylor N. Swanson , Armaan Shetty , Jaime Ruiz , Lisa Anthony , Michael G. Perri","doi":"10.1016/j.cct.2024.107707","DOIUrl":"10.1016/j.cct.2024.107707","url":null,"abstract":"<div><h3>Background</h3><div>Without provision of additional intervention, most individuals regain weight after the end of weight-loss programs. Extended-care programs have been demonstrated to improve long-term weight-loss maintenance, but effects are modest.</div></div><div><h3>Methods</h3><div>We proposed to evaluate whether delivering extended-care telephone sessions on an <em>ADAPTIVE</em> (provided when individuals are deemed to be at high-risk for weight regain) versus <em>STATIC</em> (the once-per-month schedule typically used in extended-care programs) schedule improves weight regain after initial weight loss. Adults with obesity were initially recruited for a 16-week lifestyle weight-loss program, and those who lost ≥5 % of their initial weight were eligible for enrollment in the Project STAR maintenance trial.</div></div><div><h3>Results</h3><div>A total of 449 individuals (<em>mean</em> ± <em>SD</em> age = 49.5 ± 11.4 years, BMI = 35.7 ± 4.0 kg/m<sup>2</sup>, 83.5 % female, 23.4 % Black or African American, 9.8 % Hispanic) were recruited for the initial weight-loss program and lost an average of 6.4 ± 4.9 % of their initial body weight; 255 were randomized to the maintenance trial. There were no significant differences between participants randomized to the trial versus those who were not in terms of baseline weight, gender, race/ethnicity, education, or marital status, all <em>p</em>s > 0.05; however, participants who were randomized to the trial were older, <em>p</em> = .014, and reported higher incomes, <em>p</em> < .001.</div></div><div><h3>Conclusion</h3><div>Results from Project STAR will demonstrate whether providing extended-care intervention on an individually adaptable schedule improves long-term weight-loss maintenance. Moreover, the rich longitudinal dataset collected during the trial will serve as a foundation for building future predictive algorithms of weight regain and novel weight-maintenance interventions.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107707"},"PeriodicalIF":2.0,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388711","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

Testing Interventions for Mobility through Exercise (TIME): Study protocol for a randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for older adults with mobility disability 测试通过运动提高行动能力的干预措施（TIME）：针对行动不便的老年人，比较新颖、简短的家庭锻炼计划和标准的家庭集体锻炼的随机试验研究方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-09 DOI: 10.1016/j.cct.2024.107709

Christopher N. Sciamanna , Jordan D. Kurth , William Luzier , David E. Conroy , Willam A. Calo , Kathryn Schmitz , Matthew L. Silvis , Noel H. Ballentine , Shouhao Zhou , Margaret Danilovich , Liza S. Rovniak , Matthew Moeller , Natalia Pierwola-Gawin , Jennifer L. Kraschnewski , Jennifer Poger , Cheyenne Herrell

One in four older adults report difficulty walking, greatly increasing the risk of future disability and death. Though exercise improves mobility, too few older adults do it. While studies show that brief exercise sessions provide most of the benefit of longer sessions and that older adults note that “time” is a critical barrier to being active, what remains unknown is whether briefer RT sessions can improve mobility as well as, or better than, longer traditional sessions, possibly due to greater adherence. We present the design of a 12-month randomized controlled trial of 700 older adults with self-reported walking difficulty. Participants will be randomly assigned, in a 2 × 2 factorial design, to one of two home-based exercise programs: 1) Standard of Care: 45-min, three-times weekly sessions or 2) Experimental: 5-min daily sessions and to one of two doses of behavior change techniques (Standard or Enhanced) as part of their exercise program. The primary outcome measure is self-reported physical function. Secondary outcome measures include objectively measured lower extremity physical performance, walking endurance, balance, walking speed, strength and physical activity as well as self-reported falls, pain, fatigue and balance. This is one of the first studies to examine the clinical outcomes of brief exercise sessions, which may lead to a new generation of exercise programs that are optimized not only for impact, but for adherence as well.

每四位老年人中就有一位表示行走困难，这大大增加了未来残疾和死亡的风险。虽然运动能提高行动能力，但做运动的老年人太少了。虽然研究表明，简短的运动疗程能提供较长时间疗程的大部分益处，而且老年人也指出 "时间 "是阻碍他们积极锻炼的关键因素，但仍不清楚的是，较简短的 RT 疗程是否能像传统的较长时间疗程一样改善行动能力，甚至比后者更好，这可能是由于坚持的程度更高。我们介绍了一项为期 12 个月的随机对照试验的设计方案，试验对象是 700 名自称行走困难的老年人。参与者将以 2 × 2 的因子设计被随机分配到两种家庭锻炼计划中的一种：1）标准护理计划：每周三次，每次 45 分钟；或 2）实验计划：每天一次，每次 5 分钟。主要结果指标是自我报告的身体功能。次要结果指标包括客观测量的下肢体能、行走耐力、平衡能力、行走速度、力量和体力活动，以及自我报告的跌倒、疼痛、疲劳和平衡能力。这是首批研究简短锻炼课程临床效果的研究之一，它可能会催生新一代的锻炼计划，这些计划不仅要优化效果，还要优化坚持性。

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引用次数: 0

Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol 行为暴露促进感知间耐受（BE-FIT）：第二阶段随机临床试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-09 DOI: 10.1016/j.cct.2024.107706

Samantha G. Farris , Mindy M. Kibbey , Brittany Keller , Lilly Derby , Teresa M. Leyro , Brandon L. Alderman , Angelo M. DiBello , Michael B. Steinberg , Ana M. Abrantes

Background

Exercise anxiety is a novel mechanism related to non-adherence to exercise and lifestyle physical activity. We developed a cognitive-behavioral treatment, Behavioral Exposure For Interoceptive Tolerance (BE-FIT), which is a manualized, values-based exposure intervention designed to target exercise anxiety that is delivered as a supplement to outpatient cardiac rehabilitation (CR).

Method

We describe a Stage II randomized controlled trial (RCT) to test BE-FIT, compared to a Health Education Control (HEC) intervention on exercise and physical activity outcomes at end-of-treatment (EOT) and follow-ups (Weeks 12, 18, and 24), and evaluate mechanisms of change (i.e., reductions in exercise anxiety). Adults (N = 146) who are ≥40 years of age, cleared for outpatient exercise-based CR, low active, and have elevated exercise anxiety will be recruited. The primary study hypothesis is that BE-FIT compared to HEC will result in higher levels of overall exercise and lifestyle physical activity at EOT and follow-ups. The second hypothesis is that BE-FIT vs HEC will produce greater reductions in exercise anxiety at EOT and Week 12. The third hypothesis is that reductions in exercise anxiety at EOT and Weeks 12 will mediate the effect of BE-FIT on activity outcomes at Weeks 18 and 24.

Discussion

We expect the results of this study will produce knowledge regarding BE-FIT's efficacy and mechanisms of action. Our goal is to better understand “how and why” the intervention is (or is not) effective and for whom, and increase collective knowledge and reproducibility of behavior change research.

背景：运动焦虑是一种与不坚持运动和生活方式体育锻炼有关的新机制。我们开发了一种认知行为疗法--行为暴露促进互感耐受（BE-FIT），这是一种针对运动焦虑开发的手动化、基于价值观的暴露干预，作为门诊心脏康复（CR）的补充疗法：我们介绍了一项第二阶段随机对照试验（RCT），该试验旨在测试 BE-FIT 与健康教育对照（HEC）干预相比，在治疗结束（EOT）和随访（第 12、18 和 24 周）时对运动和体育锻炼结果的影响，并评估变化机制（即运动焦虑的减轻）。将招募年龄≥40 岁、已获准接受门诊以运动为基础的 CR 治疗、运动量低且运动焦虑升高的成年人（N = 146）。主要研究假设是，与 HEC 相比，BE-FIT 将提高 EOT 和随访时的总体运动和生活方式体育锻炼水平。第二个假设是，BE-FIT 与 HEC 相比，将在 EOT 和第 12 周时更大程度地降低运动焦虑。第三个假设是，在 EOT 和第 12 周时，运动焦虑的减轻将调节 BE-FIT 对第 18 周和第 24 周活动结果的影响：我们希望这项研究的结果能让我们了解 BE-FIT 的疗效和作用机制。我们的目标是更好地了解干预 "如何以及为何 "有效（或无效），以及对谁有效，并增加行为改变研究的集体知识和可重复性。

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引用次数: 0