Contemporary clinical trials最新文献

{"title":"The Mobile lifestyle intervention for food and exercise (mLife) study: Protocol of a remote behavioral weight loss randomized clinical trial for type 2 diabetes prevention.","authors":"K E DuBois, D C Delgado-Díaz, M McGrievy, H Valafar, C Monroe, S Wilcox, G Turner-McGrievy","doi":"10.1016/j.cct.2024.107735","DOIUrl":"https://doi.org/10.1016/j.cct.2024.107735","url":null,"abstract":"<p><strong>Background: </strong>Emerging research has examined electronic and mobile health (e/mHealth) technologies for weight loss and manage of type 2 diabetes mellitus (T2DM), but few studies have focused specifically on ways to target social support behaviors that have proven to be effective. While gamifying an mHealth behavioral weight loss intervention holds promise to promote and sustain social support, there has been very little research in this area. The mobile Lifestyle Intervention for Food and Exercise study (mLife) was designed to test if receiving points for social support is an effective way to promote sustained weight loss.</p><p><strong>Objective: </strong>To describe the design of the 12-month mLife study, a randomized clinical trial, which compares the differential long-term effect of a behavioral weight loss program with and without gamification among adults with overweight or obesity.</p><p><strong>Methods: </strong>Participants (target N = 240) in two consecutive cohorts were randomized to either the mLife+points or mLife group. The weight loss intervention for both groups included diet and physical activity (PA) recommendations, education, daily diet logging, visualization of PA and body weight readings captured with a wearable tracker and e-scale, and facilitation of social interaction among participants. The mLife+points group earned points for social support activities. Remote follow-up assessments of weight, anthropometric measures, diet (24 h dietary recalls), PA, social support provision, receipt and enjoyment, factors driving self-monitoring adherence and study compliance/responsiveness occurred at 6 and 12-months post-baseline.</p><p><strong>Conclusion: </strong>The mLife study informs the expansion of gamification within mHealth programs to enhance social support provision and receipt during weight loss.</p><p><strong>Trial registration: </strong>This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT05176847.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107735"},"PeriodicalIF":2.0,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616272","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}

{"title":"A parallel-group randomized controlled trial of blue light versus red light for improving sleep, fatigue, and cognition following stroke: Pilot results and recommendations for further study","authors":"Douglas L. Weeks ,&nbsp;Elena Crooks ,&nbsp;Katie E. O'Brien ,&nbsp;Gina Sprint ,&nbsp;Gregory T. Carter ,&nbsp;Kimberly A. Honn","doi":"10.1016/j.cct.2024.107736","DOIUrl":"10.1016/j.cct.2024.107736","url":null,"abstract":"<div><h3>Background</h3><div>Disordered sleep and fatigue are common in the acute phase of stroke and can impede recovery.</div></div><div><h3>Objective</h3><div>A randomized parallel group placebo-controlled pilot study compared daily morning exposure to blue light or red light (placebo) for improving daytime sleepiness, fatigue, nocturnal sleep, and cognition in patients receiving inpatient rehabilitation for acute stroke.</div></div><div><h3>Methods</h3><div>43 patients with disordered sleep secondary to first episode stroke (<em>n</em> = 34 ischemic, <em>n</em> = 9 hemorrhagic; aged 66.2 ± 14.1 years) were randomized to receive 25 min of blue or red light for 5 or more days depending on inpatient rehabilitation length of stay (blue-light <em>n</em> = 21, red-light <em>n</em> = 22). At baseline and study discharge, daytime sleepiness was measured with the Karolinska Sleepiness Scale and Wits Pictorial Sleepiness Scale, fatigue with a visual analogue scale, and cognitive function with the Rey Auditory Verbal Learning Test and Trail Making Test (TMT). Wrist actigraphs measured nocturnal sleep parameters. Effect sizes were used to estimate sample sizes for larger studies.</div></div><div><h3>Results</h3><div>Blue light exposure led to significant improvements in daytime sleepiness, fatigue, auditory verbal learning, and time to sleep onset (all <em>p</em> &lt; .05) relative to red light exposure (effect size range 0.75 to 1.83). Change in TMT, minutes of nocturnal sleep, and number of awakenings after sleep onset were not statistically significant (effect sizes range 0.38 to 0.57).</div></div><div><h3>Conclusion</h3><div>Morning blue light exposure for 5 or more days after acute stroke led to greater improvements than red light exposure. Effect sizes suggest a larger study is warranted to confirm generalizability of pilot findings.</div><div><strong>Trial Registration:</strong> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT03125967</span><svg><path></path></svg></span> (Registered 01/01/2017).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107736"},"PeriodicalIF":2.0,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603440","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}

{"title":"The risk information and skin-cancer education for undergraduate prevention (RISE-UP) study: Protocol for a trial of personalized sun protection interventions for skin cancer prevention among undergraduate students","authors":"Yelena P. Wu ,&nbsp;Liberty A. Woodside ,&nbsp;Kimberly A. Kaphingst ,&nbsp;Jakob D. Jensen ,&nbsp;Jada G. Hamilton ,&nbsp;Wendy Kohlmann ,&nbsp;Ben Haaland ,&nbsp;Ben J. Brintz ,&nbsp;Siobhan M. Phillips ,&nbsp;Jennifer L. Hay","doi":"10.1016/j.cct.2024.107728","DOIUrl":"10.1016/j.cct.2024.107728","url":null,"abstract":"<div><h3>Background</h3><div>Addressing the increasing incidence of skin cancer among young adults is a priority. The objective of the Risk Information and Skin-cancer Education for Undergraduate Prevention (RISE-UP) study is to identify personalized intervention components to prevent sunburn, a clinically significant outcome highly associated with skin cancer, in college students.</div></div><div><h3>Methods</h3><div>Guided by the Elaboration Likelihood Model, the study will use Multiphase Optimization Strategy (MOST) methodology to test three intervention components (ultraviolet photography, <em>MC1R</em> genetic testing, and action planning) each with two levels (yes v. no) in a full-factorial experiment to evaluate unique and combined effects of these components to improve outcomes over the longer-term, with seasonally timed follow-up. At-risk University of Utah students (<em>N</em> = 528) will be recruited. Eligibility criteria include self-reported sunburn or tanning in the past year, or not utilizing recommended sun protection. After baseline assessment, participants will be randomized to intervention group, stratified by sex. Assessments will be completed at (1) Baseline; (2) Intervention; (3) 1 month after intervention; (4) 4 months after intervention (the end of the first summer); and (5) 15 months after intervention (the end of the second summer). The primary outcome will be participants' self-reported number of sunburns. Secondary outcomes will include self-reported sun protection and tanning behaviors and, in a randomly selected subgroup, an objective measure of ultraviolet radiation (UVR) exposure.</div></div><div><h3>Conclusion</h3><div>The RISE-UP study will determine the efficacy of different combinations of personalized skin cancer preventative interventions for young adults and determine the optimal combination of intervention components to prevent skin cancer.</div><div><strong>Clinical Trial Registration:</strong> <span><span>NCT05634252</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107728"},"PeriodicalIF":2.0,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567845","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}

{"title":"Lifestyle empowerment for Alzheimer's prevention prescribed by physicians: Methods and adaptations to COVID-19","authors":"Amanda N. Szabo-Reed ,&nbsp;Amber Watts ,&nbsp;Eric D. Vidoni ,&nbsp;Jonathan Mahnken ,&nbsp;Angela Van Sciver ,&nbsp;Katrina Finley ,&nbsp;Jonathan Clutton ,&nbsp;Rachel Holden ,&nbsp;Mickeal N. Key ,&nbsp;Jeffery M. Burns","doi":"10.1016/j.cct.2024.107729","DOIUrl":"10.1016/j.cct.2024.107729","url":null,"abstract":"<div><div>The health care system is insufficiently capitalizing on the benefits of physical exercise in America's aging population. Few tools exist to help clinicians incorporate physical activity into their clinical care, and barriers limit older adults from initiating and maintaining exercise programs. The Lifestyle Empowerment for Alzheimer's Prevention (LEAP! Rx) Program has been designed to support providers and participants in lifestyle change. LEAP! Rx uses two forms of participant enrollment: physician referrals through electronic health records and self-referrals to test the efficacy of delivering a community-based exercise and healthy lifestyle program to older adults. After referral into the program, participants are randomized to receive the LEAP! Rx Program or are placed in a standard-of-care group to receive the program later. The LEAP! Rx program consists of a personalized and structured exercise program, lifestyle education, and mobile health monitoring. This includes a 12-week Empowerment phase with coaching and supervised exercise training, followed by a 40-week Lifestyle phase with intermittent supervised exercise and coaching. Lifestyle education includes monthly, evidence-based classes on optimal aging. The evaluation of LEAP! Rx focuses on 1) the assessment of implementation and scalability of the LEAP!Rx Program for clinicians and patients 2) the effect of the LEAP! Rx Program on cardiorespiratory fitness, 3) the impact of the LEAP! Rx Program on secondary intervention outcome measures of chronic disease risk factors, including insulin resistance, body composition, and lipids. If successful, this study's findings could advance future healthcare practices, providing a new and practical approach to aging and chronic disease prevention.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107729"},"PeriodicalIF":2.0,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567843","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}

{"title":"Healthy Drinks, Healthy Teeth – Ciunerkaq Tanqigtuq (The Future is Bright): A study protocol for a community-based, non-randomized sociobehavioral trial to reduce added sugar intake in Alaska Native Yup'ik children in the Yukon-Kuskokwim Delta","authors":"Donald L. Chi ,&nbsp;Frances Marcus Lewis ,&nbsp;Philip Weinstein ,&nbsp;Lloyd Mancl ,&nbsp;Peter Milgrom ,&nbsp;Todd Edwards ,&nbsp;Susan Coldwell ,&nbsp;Diane O'Brien ,&nbsp;Andrea Bersamin ,&nbsp;Scarlett Hopkins ,&nbsp;Eliza Orr ,&nbsp;Patricia Rivera ,&nbsp;Dane Lenaker ,&nbsp;Allison Sylvetsky ,&nbsp;Joel Gittelsohn ,&nbsp;Peter Walter ,&nbsp;Cameron L. Randall ,&nbsp;Deanna Wiseman ,&nbsp;Andrea Dock ,&nbsp;Alice Ko ,&nbsp;Ellen MacLachlan","doi":"10.1016/j.cct.2024.107734","DOIUrl":"10.1016/j.cct.2024.107734","url":null,"abstract":"<div><h3>Background</h3><div>This study protocol describes a community-based intervention that will seek to reduce added sugar intake in Yup'ik Alaska Native children by targeting reductions in sugar-sweetened fruit drinks.</div></div><div><h3>Methods</h3><div>A two-group non-randomized design will be used to evaluate the intervention in three Yup'ik communities in Alaska focusing on children age 1 to less than age 12 years with a minimum enrollment target of 192 children. Families in the intervention arm will participate in a program consisting of five sessions plus four brief check-ins, all delivered by a Yup'ik Community Health Worker. Modifications to the local store environment will be made to give families a place to purchase sugar-free water enhancers. Families in the delayed treatment control arm will receive no intervention during the main study period. There will be five data collection visits (baseline, 1-month, 3-months, 6-months, and 12-months) that will include collection of survey and dietary data, and a hair and plaque sample from each participating child. The outcomes will be change, from baseline to 6 months, in added sugar intake based on a validated hair biomarker (grams of added sugar/day). We hypothesize children in the intervention arm will have greater reductions in added sugar intake compared to children in the control arm as measured by the hair biomarker.</div></div><div><h3>Discussion</h3><div>This is one of the first known community-based sociobehavioral interventions aimed specifically at reducing added sugar intake in Alaska Native communities by targeting sugar-sweetened fruit drinks.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT05219448</span><svg><path></path></svg></span> (first posted on February 2, 2022).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107734"},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567841","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}

{"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 ,&nbsp;Robinson Ramirez-Velez ,&nbsp;Johana Mejía-Mejía ,&nbsp;Laura Aline Martinez-Martinez ,&nbsp;Fabian Román ,&nbsp;Pedro Javier Lopez-Perez ,&nbsp;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}

{"title":"Study protocol for a sequential multiple assignment randomized trial to decrease alcohol use before and after surgery","authors":"Xintong Ju ,&nbsp;Jake Solka ,&nbsp;Estevan Pena ,&nbsp;Ashley Kocher ,&nbsp;Richard Davies ,&nbsp;Jennifer Waljee ,&nbsp;Frederic C. Blow ,&nbsp;Kelley M. Kidwell ,&nbsp;Maureen A. Walton ,&nbsp;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}

{"title":"Efficacy of a conversational chatbot for cigarette smoking cessation: Protocol of the QuitBot full-scale randomized controlled trial","authors":"Jonathan B. Bricker ,&nbsp;Brianna M. Sullivan ,&nbsp;Kristin E. Mull ,&nbsp;Juan Lavista-Ferres ,&nbsp;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}

{"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 ,&nbsp;Robert Fechtner ,&nbsp;Krisi Lopez ,&nbsp;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> &gt; 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}

{"title":"Neural and metabolic factors in carbohydrate reward: Rationale, design, and methods for a flavor-nutrient learning paradigm in humans","authors":"Amber L. Kelly ,&nbsp;Mary Elizabeth Baugh ,&nbsp;Monica L. Ahrens ,&nbsp;Abigail N. Valle ,&nbsp;Rhianna M. Sullivan ,&nbsp;Mary E. Oster ,&nbsp;Mary E. Fowler ,&nbsp;Bridget E. Carter ,&nbsp;Brenda M. Davy ,&nbsp;Alexandra L. Hanlon ,&nbsp;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}