Contemporary clinical trials最新文献_第7页

Efficacy of a pain neuroscience educational program in improving executive function and pain intensity in fibromyalgia patients (Fibrobrain project): Study protocol for a randomized controlled clinical trial 疼痛神经科学教育项目在改善纤维肌痛患者执行功能和疼痛强度方面的效果（纤维脑项目）：随机对照临床试验研究方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-31 DOI: 10.1016/j.cct.2024.107731

Marco Antonio Morales-Osorio , Robinson Ramirez-Velez , Johana Mejía-Mejía , Laura Aline Martinez-Martinez , Fabian Román , Pedro Javier Lopez-Perez , Leidy Tatiana Ordoñez-Mora

Background

Fibromyalgia (FM) is a chronic musculoskeletal condition typically characterized by chronic pain, sleep disturbances, chronic fatigue, and cognitive problems. The present study aims to examine the efficacy of a pain neuroscience education program (PNE) in improving executive functions and pain intensity in patients with FM and compare them with those of standard treatment protocols.

Methods

This blinded, controlled clinical trial will compare changes in executive function and pain intensity between two groups. The first group will receive standard treatment supplemented with PNE, consisting of ten sessions spread over five weeks, with each session lasting 40–45 min. The main objective of this method is to remodel cognitive and emotional reactions to pain, challenging the idea that pain is directly related to injury and highlighting the influence of emotions, sleep, and physical activity on pain perception. The second group will receive only standard pharmacological treatment. The study sample will include 62 adults diagnosed with FM, according to initial sample size estimates based on previous evidence. A baseline assessment of baseline characteristics will be performed, after which patients will be randomly assigned to the PNE group or the control group. The results of the intervention will be evaluated and statistically compared after 5 weeks. This protocol complies with all relevant ethical guidelines. It has been approved by two institutional committees (Reference: NR2006; Conbioethics:21-CEI-004-20,170,829).

Conclusion

It is anticipated that this intervention will be a cost-effective and superior alternative to standard treatments.

Clinical trial registration: NCT05084300

背景纤维肌痛（FM）是一种慢性肌肉骨骼疾病，以慢性疼痛、睡眠障碍、慢性疲劳和认知问题为典型特征。本研究旨在探讨疼痛神经科学教育项目（PNE）在改善 FM 患者执行功能和疼痛强度方面的疗效，并将其与标准治疗方案进行比较。方法这项盲法对照临床试验将比较两组患者在执行功能和疼痛强度方面的变化。第一组将接受以 PNE 为辅的标准治疗，包括五个星期的十个疗程，每个疗程持续 40-45 分钟。这种方法的主要目的是重塑对疼痛的认知和情绪反应，挑战疼痛与受伤直接相关的观点，并强调情绪、睡眠和身体活动对疼痛感知的影响。第二组将只接受标准的药物治疗。根据以往证据对样本量的初步估计，研究样本将包括 62 名被诊断患有 FM 的成年人。在对基线特征进行基线评估后，患者将被随机分配到 PNE 组或对照组。5 周后将对干预结果进行评估和统计比较。本方案符合所有相关的伦理准则。该方案已获得两个机构委员会的批准（参考文献：NR2006；Conbioethics:21-CEI-004-20,170,829）：临床试验注册：NCT05084300

{"title":"Efficacy of a pain neuroscience educational program in improving executive function and pain intensity in fibromyalgia patients (Fibrobrain project): Study protocol for a randomized controlled clinical trial","authors":"Marco Antonio Morales-Osorio , Robinson Ramirez-Velez , Johana Mejía-Mejía , Laura Aline Martinez-Martinez , Fabian Román , Pedro Javier Lopez-Perez , Leidy Tatiana Ordoñez-Mora","doi":"10.1016/j.cct.2024.107731","DOIUrl":"10.1016/j.cct.2024.107731","url":null,"abstract":"<div><h3>Background</h3><div>Fibromyalgia (FM) is a chronic musculoskeletal condition typically characterized by chronic pain, sleep disturbances, chronic fatigue, and cognitive problems. The present study aims to examine the efficacy of a pain neuroscience education program (PNE) in improving executive functions and pain intensity in patients with FM and compare them with those of standard treatment protocols.</div></div><div><h3>Methods</h3><div>This blinded, controlled clinical trial will compare changes in executive function and pain intensity between two groups. The first group will receive standard treatment supplemented with PNE, consisting of ten sessions spread over five weeks, with each session lasting 40–45 min. The main objective of this method is to remodel cognitive and emotional reactions to pain, challenging the idea that pain is directly related to injury and highlighting the influence of emotions, sleep, and physical activity on pain perception. The second group will receive only standard pharmacological treatment. The study sample will include 62 adults diagnosed with FM, according to initial sample size estimates based on previous evidence. A baseline assessment of baseline characteristics will be performed, after which patients will be randomly assigned to the PNE group or the control group. The results of the intervention will be evaluated and statistically compared after 5 weeks. This protocol complies with all relevant ethical guidelines. It has been approved by two institutional committees (Reference: NR2006; Conbioethics:21-CEI-004-20,170,829).</div></div><div><h3>Conclusion</h3><div>It is anticipated that this intervention will be a cost-effective and superior alternative to standard treatments.</div><div>Clinical trial registration: <span><span>NCT05084300</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107731"},"PeriodicalIF":2.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142560823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Study protocol for a sequential multiple assignment randomized trial to decrease alcohol use before and after surgery 减少手术前后饮酒的连续多重分配随机试验研究方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-28 DOI: 10.1016/j.cct.2024.107732

Xintong Ju , Jake Solka , Estevan Pena , Ashley Kocher , Richard Davies , Jennifer Waljee , Frederic C. Blow , Kelley M. Kidwell , Maureen A. Walton , Anne C. Fernandez

Background

High-risk alcohol consumption in the weeks before and after surgery poses significant risks for postoperative recovery. Despite this, elective surgical patients are rarely offered alcohol-focused education, interventions, or treatment. This paper describes the protocol of a research study designed to evaluate the effectiveness of brief, non-pharmacological, therapeutic approaches to reduce alcohol use before and after surgery.

Methods

The Alcohol Screening and Preoperative Intervention Research (ASPIRE-2) study trial includes 440 elective, non-cancer, surgery patients ages 21–75 years-old who report high-risk alcohol use. This trial uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to test the effectiveness of adaptive interventions that include preoperative Virtual Health Coaching (VHC) or Enhanced Usual Care (EUC) followed by postoperative intervention strategies tailored to participant response to the preoperative study condition. Intervention “response” is defined as achieving low-risk alcohol use following the preoperative intervention. The primary aims of this study are to: 1) examine the effectiveness of adaptive interventions that begin with preoperative VHC compared to EUC in reducing high-risk alcohol use among elective surgical patients; and 2) identify the most effective postoperative strategy for lasting alcohol use reduction over a period of 12 months. Secondary and exploratory aims will identify the best performing pre-specified adaptive interventions, identify baseline and time-varying moderators of intervention effectiveness, and evaluate surgical outcomes.

Conclusion

The ASPIRE-2 study is an innovative approach to develop adaptive interventions to reduce alcohol use proximal to elective surgery when alcohol use poses short- and long-term risks to surgery and health.

背景手术前后几周内的高风险饮酒会对术后恢复造成重大风险。尽管如此，择期手术患者很少接受以酒精为重点的教育、干预或治疗。本文介绍了一项研究的方案，该方案旨在评估简短、非药物治疗方法对减少手术前后饮酒的有效性。方法酒精筛查和术前干预研究（ASPIRE-2）研究试验包括 440 名年龄在 21-75 岁之间、报告有高饮酒风险的择期非癌症手术患者。该试验采用顺序、多重分配、随机试验（SMART）设计，以测试适应性干预措施的有效性，这些干预措施包括术前虚拟健康指导（VHC）或增强型常规护理（EUC），然后根据参与者对术前研究条件的反应制定术后干预策略。干预 "反应 "的定义是术前干预后达到低风险饮酒。本研究的主要目的是1）与 EUC 相比，检查术前 VHC 开始的适应性干预在减少择期手术患者高风险饮酒方面的有效性；以及 2）确定 12 个月内持续减少饮酒的最有效术后策略。ASPIRE-2研究是一种创新方法，旨在开发适应性干预措施，以减少择期手术前的饮酒，因为饮酒会给手术和健康带来短期和长期风险。

{"title":"Study protocol for a sequential multiple assignment randomized trial to decrease alcohol use before and after surgery","authors":"Xintong Ju , Jake Solka , Estevan Pena , Ashley Kocher , Richard Davies , Jennifer Waljee , Frederic C. Blow , Kelley M. Kidwell , Maureen A. Walton , Anne C. Fernandez","doi":"10.1016/j.cct.2024.107732","DOIUrl":"10.1016/j.cct.2024.107732","url":null,"abstract":"<div><h3>Background</h3><div>High-risk alcohol consumption in the weeks before and after surgery poses significant risks for postoperative recovery. Despite this, elective surgical patients are rarely offered alcohol-focused education, interventions, or treatment. This paper describes the protocol of a research study designed to evaluate the effectiveness of brief, non-pharmacological, therapeutic approaches to reduce alcohol use before and after surgery.</div></div><div><h3>Methods</h3><div>The Alcohol Screening and Preoperative Intervention Research (ASPIRE-2) study trial includes 440 elective, non-cancer, surgery patients ages 21–75 years-old who report high-risk alcohol use. This trial uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to test the effectiveness of adaptive interventions that include preoperative Virtual Health Coaching (VHC) or Enhanced Usual Care (EUC) followed by postoperative intervention strategies tailored to participant response to the preoperative study condition. Intervention “response” is defined as achieving low-risk alcohol use following the preoperative intervention. The primary aims of this study are to: 1) examine the effectiveness of adaptive interventions that begin with preoperative VHC compared to EUC in reducing high-risk alcohol use among elective surgical patients; and 2) identify the most effective postoperative strategy for lasting alcohol use reduction over a period of 12 months. Secondary and exploratory aims will identify the best performing pre-specified adaptive interventions, identify baseline and time-varying moderators of intervention effectiveness, and evaluate surgical outcomes.</div></div><div><h3>Conclusion</h3><div>The ASPIRE-2 study is an innovative approach to develop adaptive interventions to reduce alcohol use proximal to elective surgery when alcohol use poses short- and long-term risks to surgery and health.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107732"},"PeriodicalIF":2.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142560822","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

Efficacy of a conversational chatbot for cigarette smoking cessation: Protocol of the QuitBot full-scale randomized controlled trial 对话聊天机器人对戒烟的功效：QuitBot 全面随机对照试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-28 DOI: 10.1016/j.cct.2024.107727

Jonathan B. Bricker , Brianna M. Sullivan , Kristin E. Mull , Juan Lavista-Ferres , Margarita Santiago-Torres

Globally, cigarette smoking results in over 8 million premature annual deaths. Addressing this issue requires high-impact, cost-effective population-level interventions for smoking cessation. Conversational chatbots offer a potential solution given the recent advancements in machine learning and large language models. Chatbots can deliver supportive, empathetic behaviors, personalized responses, and timely advice tailored to users' needs that is engaging through therapeutic conversations aimed at creating lasting social-emotional connections. Despite their promise, little is known about the efficacy and underlying mechanisms of chatbots for cigarette smoking cessation. We developed QuitBot, a quit smoking program of two to three-minute conversations covering topics ranging from motivations to quit, setting a quit date, choosing cessation medications, coping with triggers, maintaining abstinence, and recovering from a relapse. QuitBot employs conversational interactions, powered by an expert-curated large language model, allowing users to ask questions and receive personalized guidance on quitting smoking. Here, we report the design and execution of a randomized clinical trial comparing QuitBot (n = 760) against Smokefree TXT (SFT) text messaging program (n = 760), with a 12-month follow-up period. Both interventions include 42-days of content on motivations to quit, skills to cope with triggers, and relapse prevention. The key distinction between QuitBot and SFT is that QuitBot has communication and engagement features. This study aims to determine: whether QuitBot yields higher quit rates than SFT; and whether therapeutic alliance processes and engagement are mechanisms underlying cessation outcomes. Additionally, we will explore whether baseline factors including trust, social support, and demographics, moderate the efficacy of QuitBot.

Trial Registration number ClinicalTrials.gov NCT04308759

在全球范围内，吸烟每年导致 800 多万人过早死亡。要解决这一问题，就必须采取影响大、成本效益高的人群戒烟干预措施。鉴于机器学习和大型语言模型的最新进展，对话聊天机器人提供了一种潜在的解决方案。聊天机器人可以根据用户的需求，通过旨在建立持久社会情感联系的治疗性对话，提供支持性、移情行为、个性化回复和及时建议。尽管聊天机器人大有可为，但人们对其戒烟功效和内在机制知之甚少。我们开发了戒烟机器人 QuitBot，这是一个由两到三分钟对话组成的戒烟程序，对话主题包括戒烟动机、设定戒烟日期、选择戒烟药物、应对诱因、维持戒烟以及从复吸中恢复。QuitBot 采用对话互动的方式，由专家编辑的大型语言模型提供支持，允许用户提出问题并获得个性化的戒烟指导。在此，我们报告了一项随机临床试验的设计和执行情况，该试验比较了QuitBot（n = 760）和Smokefree TXT（SFT）短信项目（n = 760），并进行了为期12个月的随访。两种干预都包括42天的内容，涉及戒烟动机、应对诱因的技巧和预防复吸。QuitBot 和 SFT 的主要区别在于 QuitBot 的沟通和参与功能。本研究旨在确定：QuitBot 的戒烟率是否高于 SFT；治疗联盟过程和参与是否是戒烟结果的基础机制。此外，我们还将探讨包括信任、社会支持和人口统计学在内的基线因素是否会影响 QuitBot 的疗效。试验注册号ClinicalTrials.govNCT04308759。

{"title":"Efficacy of a conversational chatbot for cigarette smoking cessation: Protocol of the QuitBot full-scale randomized controlled trial","authors":"Jonathan B. Bricker , Brianna M. Sullivan , Kristin E. Mull , Juan Lavista-Ferres , Margarita Santiago-Torres","doi":"10.1016/j.cct.2024.107727","DOIUrl":"10.1016/j.cct.2024.107727","url":null,"abstract":"<div><div>Globally, cigarette smoking results in over 8 million premature annual deaths. Addressing this issue requires high-impact, cost-effective population-level interventions for smoking cessation. Conversational chatbots offer a potential solution given the recent advancements in machine learning and large language models. Chatbots can deliver supportive, empathetic behaviors, personalized responses, and timely advice tailored to users' needs that is engaging through therapeutic conversations aimed at creating lasting social-emotional connections. Despite their promise, little is known about the efficacy and underlying mechanisms of chatbots for cigarette smoking cessation. We developed QuitBot, a quit smoking program of two to three-minute conversations covering topics ranging from motivations to quit, setting a quit date, choosing cessation medications, coping with triggers, maintaining abstinence, and recovering from a relapse. QuitBot employs conversational interactions, powered by an expert-curated large language model, allowing users to ask questions and receive personalized guidance on quitting smoking. Here, we report the design and execution of a randomized clinical trial comparing QuitBot (<em>n</em> = 760) against Smokefree TXT (SFT) text messaging program (n = 760), with a 12-month follow-up period. Both interventions include 42-days of content on motivations to quit, skills to cope with triggers, and relapse prevention. The key distinction between QuitBot and SFT is that QuitBot has communication and engagement features. This study aims to determine: whether QuitBot yields higher quit rates than SFT; and whether therapeutic alliance processes and engagement are mechanisms underlying cessation outcomes. Additionally, we will explore whether baseline factors including trust, social support, and demographics, moderate the efficacy of QuitBot.</div><div><strong>Trial Registration number</strong> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04308759</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107727"},"PeriodicalIF":2.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567839","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

A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study 治疗开角型青光眼或眼压过高的一氧化氮供体比马前列素 NCX 470 的 3 期适应性剂量选择试验：MONT BLANC研究。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-28 DOI: 10.1016/j.cct.2024.107730

Steven L. Mansberger , Robert Fechtner , Krisi Lopez , Doug Hubatsch

Purpose

To identify the optimal dose of NCX 470, a nitric oxide (NO)-donating bimatoprost, for comparison to latanoprost in a phase 3 trial for open-angle glaucoma (OAG) or ocular hypertension (OHTN) using an adaptive dose selection design.

Patients and methods

In this prospective, multicenter trial, subjects were randomized 1:1:1 to NCX 470 0.065 %, NCX 470 0.1 %, or latanoprost 0.005 % dosed topically to both eyes once daily. After at least 30 subjects were assigned to each group, interim analysis was undertaken at 2 weeks and an independent committee selected the final NCX 470 dose for the full 12-week trial.

Results

The interim analysis included 103 subjects. The least-squares mean (95 % confidence interval [CI]) difference in diurnal intraocular pressure (IOP) was −1.51 mmHg (−2.88, −0.14) in the NCX 470 0.065 % group (p = 0.0308) and − 1.71 mmHg (−3.04, −0.38) in the NCX 470 0.1 % group (p = 0.0123), both favoring NCX 470 over latanoprost. The most common side effect was conjunctival/ocular hyperemia, the frequency and severity of which were similar in both NCX 470 dosing groups (p > 0.05). NCX 470 0.1 % was selected as the final dose and the NCX 470 0.065 % dose arm was terminated with subsequent subjects randomized 1:1 to NCX 470 0.1 % or latanoprost.

Conclusion

Both concentrations of the NO-donating bimatoprost NCX 470 lower IOP more than latanoprost following 2 weeks of daily therapy. This adaptive dose selection design allowed identification of the optimal dose of NCX 470 with reduced trial costs, recruitment time, and the number of patients exposed to study medication.

目的：在一项治疗开角型青光眼（OAG）或眼压过高（OHTN）的3期试验中，采用自适应剂量选择设计，确定一氧化氮（NO）捐献型比马前列素NCX 470的最佳剂量，并与拉坦前列素进行比较：在这项前瞻性多中心试验中，受试者按1:1:1的比例随机分配到NCX 470 0.065 %、NCX 470 0.1 %或拉坦前列素0.005 %，每天一次，双眼局部用药。在每组至少分配了30名受试者后，在2周时进行了中期分析，并由一个独立委员会选定了整个12周试验的最终NCX 470剂量：结果：中期分析包括103名受试者。NCX 470 0.065%组的昼间眼压（IOP）最小二乘平均值（95%置信区间[CI]）为-1.51 mmHg (-2.88, -0.14)（p = 0.0308），NCX 470 0.1%组为-1.71 mmHg (-3.04, -0.38)（p = 0.0123），NCX 470均优于拉坦前列素。最常见的副作用是结膜/眼球充血，两个NCX 470剂量组出现这种副作用的频率和严重程度相似（p > 0.05）。NCX 470 0.1%被选为最终剂量，NCX 470 0.065%剂量组被终止，随后受试者按1:1随机分配到NCX 470 0.1%或拉坦前列素：结论：两种浓度的NO-供体比马前列素NCX在每日治疗2周后降低眼压的效果均优于拉坦前列素。这种自适应剂量选择设计可以确定NCX 470的最佳剂量，同时减少试验成本、招募时间和接触研究药物的患者人数。

{"title":"A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study","authors":"Steven L. Mansberger , Robert Fechtner , Krisi Lopez , Doug Hubatsch","doi":"10.1016/j.cct.2024.107730","DOIUrl":"10.1016/j.cct.2024.107730","url":null,"abstract":"<div><h3>Purpose</h3><div>To identify the optimal dose of NCX 470, a nitric oxide (NO)-donating bimatoprost, for comparison to latanoprost in a phase 3 trial for open-angle glaucoma (OAG) or ocular hypertension (OHTN) using an adaptive dose selection design.</div></div><div><h3>Patients and methods</h3><div>In this prospective, multicenter trial, subjects were randomized 1:1:1 to NCX 470 0.065 %, NCX 470 0.1 %, or latanoprost 0.005 % dosed topically to both eyes once daily. After at least 30 subjects were assigned to each group, interim analysis was undertaken at 2 weeks and an independent committee selected the final NCX 470 dose for the full 12-week trial.</div></div><div><h3>Results</h3><div>The interim analysis included 103 subjects. The least-squares mean (95 % confidence interval [CI]) difference in diurnal intraocular pressure (IOP) was −1.51 mmHg (−2.88, −0.14) in the NCX 470 0.065 % group (<em>p</em> = 0.0308) and − 1.71 mmHg (−3.04, −0.38) in the NCX 470 0.1 % group (<em>p</em> = 0.0123), both favoring NCX 470 over latanoprost. The most common side effect was conjunctival/ocular hyperemia, the frequency and severity of which were similar in both NCX 470 dosing groups (<em>p</em> > 0.05). NCX 470 0.1 % was selected as the final dose and the NCX 470 0.065 % dose arm was terminated with subsequent subjects randomized 1:1 to NCX 470 0.1 % or latanoprost.</div></div><div><h3>Conclusion</h3><div>Both concentrations of the NO-donating bimatoprost NCX 470 lower IOP more than latanoprost following 2 weeks of daily therapy. This adaptive dose selection design allowed identification of the optimal dose of NCX 470 with reduced trial costs, recruitment time, and the number of patients exposed to study medication.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107730"},"PeriodicalIF":2.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544197","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

Neural and metabolic factors in carbohydrate reward: Rationale, design, and methods for a flavor-nutrient learning paradigm in humans 碳水化合物奖赏的神经和代谢因素：人类口味-营养素学习范例的原理、设计和方法。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-15 DOI: 10.1016/j.cct.2024.107717

Amber L. Kelly , Mary Elizabeth Baugh , Monica L. Ahrens , Abigail N. Valle , Rhianna M. Sullivan , Mary E. Oster , Mary E. Fowler , Bridget E. Carter , Brenda M. Davy , Alexandra L. Hanlon , Alexandra G. DiFeliceantonio

Overconsumption of ultra-processed foods (UPFs), which are linked with adverse health outcomes, is a growing public health concern. UPFs deliver highly bioavailable calories rapidly, which may contribute to their reinforcing potential and drive overconsumption. Our primary aim is to test the role of speed of nutrient availability on reward learning. We hypothesize that brain activity in reward related areas and behavioral preferences will be greater to a flavored drink predicting rapidly available calories (CS + Fast) compared with a flavored drink predicting more slowly available (CS + Slow) or no (CS-) calories. Participants (n = 64, aged 18–45 years, will consume 3 novel flavored, isosweet beverages containing 110 kcal of sucrose (CS + Fast), 110 kcal of maltodextrin (CS + Slow), or 0-kcal sucralose (CS-) 6 times in randomized, crossover order. Blood metabolites and indirect calorimetry measures, including metabolic rate and carbohydrate oxidation, will be assessed before and for 1 h after beverage consumption. Behavioral preference for beverages will be assessed in a pre- and post-test. Brain response to each flavor without calories will be assessed via functional magnetic resonance imaging in a post-test. Findings from this study will contribute to the understanding of basic mechanisms that may drive overconsumption of UPFs.

Trial registration: clinicaltrials.gov registration #NCT06053294

过度消费超加工食品（UPFs）与不良健康后果有关，是一个日益严重的公共健康问题。超加工食品能迅速提供高生物利用率的卡路里，这可能有助于其强化潜能并推动过度消费。我们的主要目的是测试营养素供应速度对奖赏学习的作用。我们假设，与预测热量供应速度较慢（CS + 慢）或无热量（CS-）的风味饮料相比，预测热量供应速度较快的风味饮料（CS + 快）的奖励相关区域的大脑活动和行为偏好会更大。参与者（n = 64，18-45 岁）将以随机、交叉的顺序饮用 3 种新颖的等甜味饮料，分别含有 110 千卡的蔗糖（CS + 快）、110 千卡的麦芽糊精（CS + 慢）或 0 千卡的蔗糖素蔗糖（CS-），共饮用 6 次。血液代谢物和间接热量测量（包括代谢率和碳水化合物氧化）将在饮用饮料前和饮用饮料后 1 小时内进行评估。对饮料的行为偏好将在前后测试中进行评估。在后测试中，将通过功能磁共振成像评估大脑对每种不含卡路里的口味的反应。这项研究的结果将有助于了解可能导致过度摄入 UPFs 的基本机制。试验注册：clinicaltrials.gov 注册号：NCT06053294。

{"title":"Neural and metabolic factors in carbohydrate reward: Rationale, design, and methods for a flavor-nutrient learning paradigm in humans","authors":"Amber L. Kelly , Mary Elizabeth Baugh , Monica L. Ahrens , Abigail N. Valle , Rhianna M. Sullivan , Mary E. Oster , Mary E. Fowler , Bridget E. Carter , Brenda M. Davy , Alexandra L. Hanlon , Alexandra G. DiFeliceantonio","doi":"10.1016/j.cct.2024.107717","DOIUrl":"10.1016/j.cct.2024.107717","url":null,"abstract":"<div><div>Overconsumption of ultra-processed foods (UPFs), which are linked with adverse health outcomes, is a growing public health concern. UPFs deliver highly bioavailable calories rapidly, which may contribute to their reinforcing potential and drive overconsumption. Our primary aim is to test the role of speed of nutrient availability on reward learning. We hypothesize that brain activity in reward related areas and behavioral preferences will be greater to a flavored drink predicting rapidly available calories (CS + Fast) compared with a flavored drink predicting more slowly available (CS + Slow) or no (CS-) calories. Participants (<em>n</em> = 64, aged 18–45 years, will consume 3 novel flavored, isosweet beverages containing 110 kcal of sucrose (CS + Fast), 110 kcal of maltodextrin (CS + Slow), or 0-kcal sucralose (CS-) 6 times in randomized, crossover order. Blood metabolites and indirect calorimetry measures, including metabolic rate and carbohydrate oxidation, will be assessed before and for 1 h after beverage consumption. Behavioral preference for beverages will be assessed in a pre- and post-test. Brain response to each flavor without calories will be assessed via functional magnetic resonance imaging in a post-test. Findings from this study will contribute to the understanding of basic mechanisms that may drive overconsumption of UPFs.</div><div><strong>Trial registration:</strong> <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> registration #<span><span>NCT06053294</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107717"},"PeriodicalIF":2.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459892","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

Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children MetA-Bone试验中采用的招募策略的效果和成本，该试验是一项随机临床试验，旨在测试在儿童中补充为期一年的可溶性玉米纤维的效果

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-10-15 DOI: 10.1016/j.cct.2024.107715

Cristina Palacios, Julia Leone, Priscilla Clayton, Jacqueline Hernandez, María Angélica Trak-Fellermeier, Alison Macchi, Daniela Ramirez-Roggio, Yivani Cobo, Shanelle Bautista, Jeneene Connelly, Malik Elington, Jorge Romero, Rodolfo Galvan

Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.

ClinicalTrials.gov registry number: NCT02916862

背景：招募儿童参与临床试验非常具有挑战性。我们设计了一项招募计划，招募健康儿童（9-14 岁）参加一项试验，测试补充玉米可溶性纤维对骨质的 1 年影响。我们评估了该试验所采用的招募策略的有效性和成本。方法：招募计划包括 "传统"（邮寄、传单、海报、访问、滚雪球等）或 "在线"（电子邮件宣传、社交媒体、网站等）策略。所有策略都指向预选在线表格，其中询问他们是如何了解到这项研究的。本分析包括预选和注册（签署同意书）人数、不合格人数、社会人口统计以及每种策略的成本。差异分析采用方差分析或卡方检验。结果649 人完成了预筛选；37.1% 来自 "传统 "策略，46.7% 来自 "在线 "策略，2.6% 来自 "其他 "策略，13.6% 来自 "未知 "策略。最成功的策略与佛罗里达国际大学有关（在校园内张贴传单和电子邮件宣传）。不符合条件的主要原因是肥胖（38.9%）或超出年龄范围（22.7%）。共有 48.4% 的儿童通过 "传统"、50.2% 通过 "在线 "和 1.4% 通过 "其他 "策略报名。传统 "策略和 "在线 "策略每筛选一名参与者的成本分别为 1112 美元和 512 美元，"传统 "策略和 "在线 "策略每招收一名参与者的成本分别为 2704 美元和 1454 美元。成本最高的是员工工资。结论与 "传统 "策略相比，"在线 "策略更有效，实施成本更低，尽管这些策略对于实现招募目标也很重要。未来的儿科试验应考虑这些策略及其成本：NCT02916862

{"title":"Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children","authors":"Cristina Palacios, Julia Leone, Priscilla Clayton, Jacqueline Hernandez, María Angélica Trak-Fellermeier, Alison Macchi, Daniela Ramirez-Roggio, Yivani Cobo, Shanelle Bautista, Jeneene Connelly, Malik Elington, Jorge Romero, Rodolfo Galvan","doi":"10.1016/j.cct.2024.107715","DOIUrl":"10.1016/j.cct.2024.107715","url":null,"abstract":"<div><div>Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> registry number: <span><span>NCT02916862</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107715"},"PeriodicalIF":2.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142444903","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

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。

{"title":"Randomized controlled trial of a multiple technology-based physical activity intervention for Latina adolescents: Recruitment strategies and baseline data from the Chicas Fuertes trial","authors":"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","doi":"10.1016/j.cct.2024.107716","DOIUrl":"10.1016/j.cct.2024.107716","url":null,"abstract":"<div><h3>Background</h3><div>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 <em>Chicas Fuertes</em>, a fully powered randomized trial of a mobile technology PA intervention.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>Social media yielded the most contacts (465), but had the lowest chance of enrollment (14 %, vs. 52 % from school presentations). Participants (<em>N</em> = 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<strong>.</strong> There was no correlation between the 7-day PAR and ActiGraphs (<span><math><mi>ρ</mi><mo>=</mo><mn>.13</mn><mo>,</mo><mi>p</mi><mo>=</mo><mn>.12</mn><mo>)</mo></math></span>. However, ActiGraph MVPA was correlated with total steps recorded by the Fitbit (<span><math><mi>ρ</mi><mo>=</mo><mn>.38</mn><mo>,</mo><mi>p</mi><mo><</mo><mn>.001</mn></math></span>).</div></div><div><h3>Conclusions</h3><div>Both remote and in-person approaches were successful in recruiting a sample that was underactive and low income, but had high technology use.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107716"},"PeriodicalIF":2.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459893","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

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。

{"title":"Addressing rural health disparities by optimizing “high-touch” intervention components in digital obesity treatment: The iREACH Rural study","authors":"Rebecca A. Krukowski , Kelsey R. Day , Wen You , Christine A. Pellegrini , Delia S. West","doi":"10.1016/j.cct.2024.107711","DOIUrl":"10.1016/j.cct.2024.107711","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Objectives</h3><div>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).</div></div><div><h3>Design</h3><div>The iREACH Rural Study is a factorial experiment (<em>n</em> = 616).</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Summary</h3><div>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.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107711"},"PeriodicalIF":2.0,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459889","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

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。

{"title":"DiaBetter Together: Clinical trial protocol for a strengths-based Peer Mentor intervention for young adults with type 1 diabetes transitioning to adult care","authors":"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","doi":"10.1016/j.cct.2024.107713","DOIUrl":"10.1016/j.cct.2024.107713","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107713"},"PeriodicalIF":2.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459891","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

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。

{"title":"Active symptom monitoring for premenopausal women with breast cancer initiating adjuvant endocrine therapy: Protocol for the SWOG S2010 randomized controlled efficacy trial","authors":"N.L. Henry , J.M. Unger , R. Vaidya , A.K. Darke , T.C. Skaar , M.J. Fisch , D.L. Hershman","doi":"10.1016/j.cct.2024.107712","DOIUrl":"10.1016/j.cct.2024.107712","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT05568472</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107712"},"PeriodicalIF":2.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142444902","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