Contemporary clinical trials最新文献

{"title":"Study design and protocol for cognitive anxiety sensitivity treatment for anxiety in adults with mild cognitive impairment or dementia","authors":"Abigail E. Markley ,&nbsp;Kayley M. Stratton ,&nbsp;Grace Y. Cho ,&nbsp;Norman B. Schmidt ,&nbsp;Julie Suhr ,&nbsp;Julia L. Sheffler ,&nbsp;Christopher Nguyen ,&nbsp;Frederick T. Schubert ,&nbsp;Jaime R.G. Quiles ,&nbsp;Miracle R. Potter ,&nbsp;Melissa A. Meynadasy ,&nbsp;Sarah Millisor Irvin ,&nbsp;Nicholas P. Allan","doi":"10.1016/j.cct.2025.108044","DOIUrl":"10.1016/j.cct.2025.108044","url":null,"abstract":"<div><h3>Background</h3><div>Anxiety is prevalent among older adults with mild cognitive impairment (MCI) and mild Alzheimer's disease and related disorders (ADRD) and may contribute to accelerated cognitive decline and increased care partner burden. Computerized Anxiety Sensitivity Treatment (CAST) is a novel, CBT-based intervention targeting anxiety sensitivity, which has not been widely tested in this population.</div></div><div><h3>Methods</h3><div>This randomized controlled trial (<span><span>NCT05748613</span><svg><path></path></svg></span>) will compare CAST to a health education control (HEC) in 194 dyads consisting of older adults with MCI/mild ADRD and their care partners. Primary outcomes include reductions in anxiety sensitivity and anxiety symptoms. Secondary outcomes include measures of mental health and well-being symptoms, improved cognitive performance, and decreased care partner burden. Participants will be assessed at baseline, during two intervention sessions, and follow-ups at 1-, 3-, and 6-months post-intervention.</div></div><div><h3>Expected outcomes</h3><div>CAST will significantly lower anxiety sensitivity (AS) post-intervention and reduce anxiety compared to HEC. Secondary hypotheses propose that CAST will reduce other mental symptoms and improve cognitive functioning more effectively than HEC. Additionally, CAST will alleviate care partner distress and improve their quality of life compared to HEC, with the secondary hypothesis suggesting that these effects will be mediated by reductions in AS in older adults. Furthermore, reductions in AS from pre- to post-intervention will account for the effect of CAST on anxiety, and the secondary hypothesis suggesting that reductions in interoceptive fear conditioning will also contribute to the observed anxiety reduction.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> registration: #NCT05748613.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108044"},"PeriodicalIF":1.9,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798424","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":"Study protocol for Log2Lose: A randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity","authors":"Corrine I. Voils ,&nbsp;Jennifer M. Gierisch ,&nbsp;Jane F. Pendergast ,&nbsp;Clemontina A. Davenport ,&nbsp;Maren K. Olsen ,&nbsp;Cherie Barnes ,&nbsp;Michelle Bean ,&nbsp;Lisa Cadmus-Bertram ,&nbsp;Jamie Colon ,&nbsp;Felix Elwert ,&nbsp;Katya Garza ,&nbsp;Kara L. Gavin ,&nbsp;Sarah Jackson ,&nbsp;Hailey Miller ,&nbsp;Sarah Morton-Oswald ,&nbsp;Samantha Pabich ,&nbsp;Shelby D. Reed ,&nbsp;William S. Yancy Jr. ,&nbsp;Ryan J. Shaw","doi":"10.1016/j.cct.2025.108042","DOIUrl":"10.1016/j.cct.2025.108042","url":null,"abstract":"<div><div>Although behavioral weight-loss programs are efficacious for achieving clinically significant weight loss, adherence to such programs is variable. Positive reinforcement through small financial incentives has shown promise for increasing adherence to behaviors and clinical outcomes in some domains. Yet, for weight management, it is unknown whether to incent the behavior (calorie logging), the outcome (weight loss), or both. We report the rationale and design for a two-site clinical trial employing a three-phase, 2 × 2 factorial design to evaluate the impact of financial incentives for calorie logging and/or weekly weight loss. Phase I involved a 26-week incentivized weight-loss period with virtual group sessions every two weeks; Phase II involved a 26-week incentivized weight-loss maintenance period with three monthly group sessions and five individual counseling telephone calls; and Phase III involved a 26-week weight-loss maintenance period without incentives with three bimonthly calls. Participants were asked to record their caloric intake on a smartphone application and to weigh themselves regularly on a cellular scale. These data were processed each week to determine if participants qualified for a financial incentive ranging from $0 to $10. The primary outcome was the proportion of participants achieving clinically significant weight loss of at least 5 % at 26 weeks. Secondary outcomes were the same proportions measured at 52 and 78 weeks, and blood pressure and cardiovascular medication use at 78 weeks. Motivation for weight loss will be examined as a potential mediator of the treatment effect. Intervention cost and cost-effectiveness will be calculated to inform implementation.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> registration: <span><span>NCT04770909</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108042"},"PeriodicalIF":1.9,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798425","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":"Corrigendum to “The short- and long-term effects of a fall prevention program on the frequency of falls following total knee replacement: A pragmatic single-blinded randomized controlled trial protocol” [Contemporary Clinical Trials 150 (2025) 107837]","authors":"Hadeel Al-Saleh ,&nbsp;Eman Merza ,&nbsp;Bader Al-Adwanie ,&nbsp;Stephen Pearson ,&nbsp;Peter Malliaras","doi":"10.1016/j.cct.2025.108034","DOIUrl":"10.1016/j.cct.2025.108034","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108034"},"PeriodicalIF":1.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144749754","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":"Optimizing a mHealth physical activity intervention with mindful awareness lessons in breast cancer survivors: Fit2ThriveMIND protocol","authors":"Melanie Wolter ,&nbsp;Jean M. Reading ,&nbsp;Payton Solk ,&nbsp;Julia Starikovsky ,&nbsp;Kristina Hasanaj ,&nbsp;Shirlene D. Wang ,&nbsp;Juned Siddique ,&nbsp;Bruriah Horowitz ,&nbsp;Bonnie Spring ,&nbsp;Lillian B. Carden ,&nbsp;Rina Fox ,&nbsp;Christina Sauer ,&nbsp;Hannah Freeman ,&nbsp;Julia Frey ,&nbsp;David Victorson ,&nbsp;Siobhan M. Phillips","doi":"10.1016/j.cct.2025.108038","DOIUrl":"10.1016/j.cct.2025.108038","url":null,"abstract":"<div><div>Fit2ThriveMIND is a theory-guided moderate to vigorous physical activity (MVPA) promotion trial guided by the Multiphase Optimization Strategy (MOST) framework to evaluate the efficacy of four intervention components for increasing MVPA among inactive, post-treatment breast cancer survivors (BCS; <em>n</em> = 304). All participants receive a core mHealth intervention, including a Fitbit and custom-built self-monitoring Fit2ThriveMIND smartphone application. Participants are randomized to one of 16 intervention conditions, reflecting every possible combination of the four intervention components, each of which has two levels (Yes v. No): 1) Buddy, 2) <em>E</em>-Coach, 3) General Mindfulness (MIND), 4) MVPA-guided mindfulness (PAMIND). The primary aim is to determine the individual and combined effects of the intervention components on accelerometer-assessed MVPA at 24-weeks (post-intervention) and 48-weeks follow-up. The secondary aim is to examine how changes in MVPA influence patient-reported outcomes, other intensity activities (light and sedentary), and sleep duration and quality. All components have a 24-week duration, except <em>E</em>-coaching, which includes “boosters” personalized to an individual's MVPA goal attainment during weeks 25–48. Fit2ThriveMIND represents the first systematic effort to use MOST to design an optimized mHealth MVPA intervention for BCS that incorporates mindfulness and tests a maintenance strategy. This trial will improve understanding of how to effectively and efficiently change and maintain MVPA among BCS to inform more effective and scalable interventions to improve health and disease outcomes. Clinical Trials Registration #<span><span>NCT05931874</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108038"},"PeriodicalIF":1.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768439","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 Chrono-Vax trial protocol: The effect of the time of day of influenza vaccination on immune responses in adults aged 60–85 years","authors":"Koen Vink ,&nbsp;Tamara M.J. Brouwers ,&nbsp;Lisa Beckers ,&nbsp;Debbie Smit ,&nbsp;Martijn Vos ,&nbsp;Teun Guichelaar ,&nbsp;Tobias N. Bonten ,&nbsp;Laura Kervezee ,&nbsp;Debbie van Baarle ,&nbsp;Jacco Wallinga","doi":"10.1016/j.cct.2025.108040","DOIUrl":"10.1016/j.cct.2025.108040","url":null,"abstract":"<div><div>Increasing evidence suggests that timing of vaccine administration affects immune responses, with some studies indicating that morning administration of the influenza vaccine elicits a stronger antibody response than afternoon vaccination in older adults. Existing trials focused on antibody responses, contrasting two time groups (morning versus afternoon), without assessing other immunological parameters, such as T-cell responses, which also play a crucial role in immunity to respiratory viruses and may contribute to the time-of-day dependent response to vaccination. Therefore, the Chrono-Vax trial aims to determine the effect of influenza vaccination timing on antibody and T-cell responses across a continuous time window from 09:00–17:00 to gain novel insights into an optimal administration time. Additionally, this study will investigate how chronotype influences the relationship between vaccination timing and vaccine-induced immune responses and examine the impact of vaccination timing on the incidence of influenza-like illness (ILI) and influenza infection up to six months post-vaccination. A total of 440 adults aged 60–85 years will be included in the trial and receive the seasonal influenza vaccine at a random time between 09:00 and 17:00. Blood samples will be collected at baseline and 28 days post-vaccination to determine vaccine-induced immune responses. ILI symptoms and influenza infection will be monitored by participants up to six months after vaccination using a diary and rapid diagnostic self-tests, respectively. As such, the Chrono-Vax trial aims to determine the optimal time of day for influenza vaccination, thereby contributing to more effective vaccination strategies and increased protection against severe disease in older adults.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108040"},"PeriodicalIF":1.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144763660","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":"Theory-based physical activity behavior change intervention in people newly diagnosed with multiple sclerosis: Study protocol for a pilot randomized controlled trial","authors":"Trinh L.T. Huynh ,&nbsp;Robert W. Motl","doi":"10.1016/j.cct.2025.108035","DOIUrl":"10.1016/j.cct.2025.108035","url":null,"abstract":"<div><h3>Background</h3><div>Physical activity (PA) is strongly recommended for people newly diagnosed with multiple sclerosis (MS). Nevertheless, this MS sub-population is physically inactive, and this disease stage might require unique interventions for promoting PA.</div></div><div><h3>Purpose</h3><div>This proposed pilot randomized controlled trial (RCT) examines the effects of a remote-delivered, theory-based behavior change intervention for promoting PA in people newly diagnosed with MS.</div></div><div><h3>Methods/design</h3><div>The intervention was developed using a comprehensive approach guided by the Capability-Opportunity-Motivation-Behavior (COM<img>B) Model and the Behavior Change Wheel (BCW). This two-armed RCT (<span><span>NCT06355804</span><svg><path></path></svg></span>) will enroll 50 people diagnosed with MS within the past two years. Participants will then be randomly assigned, using computer-generated random numbers with allocation concealment, into either the PA intervention or waitlist control (WLC) conditions. Participants randomized into the PA intervention condition will receive the intervention following the baseline assessment, whereas participants in WLC condition will receive the intervention after the follow-up assessment (i.e., after 16 weeks). The primary outcomes of interest include device-measured (light PA [LPA], moderate-to-vigorous PA [MVPA], step counts) and self-reported (i.e., Godin Leisure-Time Exercise Questionnaire and International Physical Activity Questionnaire) PA. Secondary outcomes include fatigue, depression, anxiety, and health-related quality of life (HRQOL). Data will be analyzed with an intent-to-treat approach, using 2 (condition) by 2 (time) mixed-effects ANOVA with effect size estimates of eta-squared (η²) and Cohen's <em>d</em>.</div></div><div><h3>Discussion</h3><div>The findings will inform a full-powered RCT of the intervention for promoting immediate and sustained changes in lifestyle, PA, health outcomes, and HRQOL in people newly diagnosed with MS.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108035"},"PeriodicalIF":1.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144764694","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":"Description of a cruciferous vegetable intervention trial to test the efficacy of a maintenance component to reduce bladder cancer recurrence and progression","authors":"Karen H. Kim Yeary ,&nbsp;Margaret Gates Kuliszewski ,&nbsp;Han Yu ,&nbsp;Qiang Li ,&nbsp;Elizabeth DiCarlo ,&nbsp;Li Tang","doi":"10.1016/j.cct.2025.108036","DOIUrl":"10.1016/j.cct.2025.108036","url":null,"abstract":"<div><h3>Background</h3><div>Bladder cancer is primarily (70–80 %) diagnosed at non-muscle invasive stages (NMIBC), which can be removed but typically recurs (up to 75 %) and progresses, necessitating active surveillance and high cost of care. Treatment options are limited. Built on our preclinical findings on the role of isothiocyanates (ITCs) from cruciferous vegetables (cruciferae) in bladder cancer, we developed and tested an intervention (POW-R Health) that increased cruciferae intake and urinary ITC from 6 to 24 months to the levels hypothesized to inhibit cancer growth. To ensure the intervention's impact on NMIBC prognosis, our goal is to sustain urinary ITC levels from baseline to 24 months, the time window when the majority of NMIBCs recur.</div></div><div><h3>Objectives</h3><div>To develop a maintenance component to our dietary intervention and test its sustained impact on cruciferae intake and urinary ITC levels through 24 months in NMIBC survivors.</div></div><div><h3>Methods</h3><div>After developing the maintenance component, we will conduct a randomized controlled trial with 344 NMIBC survivors to compare our intervention with a maintenance component (POW-R Health + Maintenance) vs. POW-R Health alone (POW-R Health Core). All participants will receive a 6-month dietary intervention, with half randomized to receive an additional 18-month maintenance component. Assessments will occur at baseline, 6, 12, 18, and 24 months.</div></div><div><h3>Discussion</h3><div>POW-R Health is a scalable intervention that could meaningfully impact bladder cancer survivorship. If shown to impact outcomes, POW-R Health would be the first non-pharmacological dietary preventative strategy for cancer recurrence and progression, providing a cost-effective and easily accessible intervention to improve NMIBC survivorship.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108036"},"PeriodicalIF":1.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144763661","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":"Virtually-delivered prenatal yoga to prevent postpartum depression (PRYD) in women with a history of depression: Protocol for an exploratory pilot randomized controlled trial","authors":"Amy M. Loree ,&nbsp;Sara Santarossa ,&nbsp;Paige Coyne ,&nbsp;Erin N. Haley ,&nbsp;Mia Boulay ,&nbsp;Celeste Pappas ,&nbsp;Jordan M. Braciszewski ,&nbsp;Lisa R. Miller-Matero ,&nbsp;Laurel M. Hicks","doi":"10.1016/j.cct.2025.108032","DOIUrl":"10.1016/j.cct.2025.108032","url":null,"abstract":"<div><div>Postpartum depression affects approximately 13 % of women in the United States and contributes to adverse maternal and infant health outcomes. While a range of effective treatment approaches are available, there are substantial barriers to receiving care for postpartum depression. Preventive interventions during pregnancy to reduce the risk of postpartum depression may mitigate some of the barriers experienced in the postpartum period, and approaches that help manage stress and improve wellness are needed. Prenatal yoga, which has a range of physical and mental health benefits and has been shown to improve depressive symptoms in pregnancy, may be a feasible and acceptable alternative to traditional mental health treatment. However, additional research is needed to increase the accessibility of prenatal yoga for high-risk populations and determine whether it can be effectively implemented in healthcare settings to reduce postpartum depression risk. The PRY-D Study is an exploratory pilot randomized controlled trial that optimizes a mindful prenatal yoga intervention to prevent postpartum depression for pregnant patients at high risk of postpartum depression and examines feasibility, acceptability, satisfaction and preliminary effectiveness of the intervention. Results from this pilot randomized controlled trial enrolling a total of 48 pregnant patients at a large healthcare system will inform the development of a future fully powered hybrid type 2 effectiveness-implementation trial.</div><div><strong>Clinical Trial Registration Number:</strong> NCT06004232.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108032"},"PeriodicalIF":1.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144738425","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":"Research recruitment strategies in the digital era: Opportunities and challenges of social media","authors":"Lauren Uy ,&nbsp;Nancy Safwan ,&nbsp;Ridwan Ahmad ,&nbsp;Erin R. Uddenberg ,&nbsp;Jana Karam ,&nbsp;Maria D. Hurtado Andrade ,&nbsp;Nicola J. Sykes ,&nbsp;Stephanie S. Faubion ,&nbsp;Chrisandra L. Shufelt","doi":"10.1016/j.cct.2025.108033","DOIUrl":"10.1016/j.cct.2025.108033","url":null,"abstract":"<div><h3>Background</h3><div>Effective recruitment is crucial for clinical research, yet traditional methods can be costly and time-consuming. Digital platforms offer a promising opportunity for reaching broader populations. This paper aims to provide a descriptive analysis of digital and traditional recruitment strategies used to engage women with functional hypothalamic amenorrhea (FHA) and identify the most effective methods.</div></div><div><h3>Methods</h3><div>From January 2023 to November 2024, women aged 18–40 were recruited through traditional methods (flyers, referrals, word-of-mouth, health fairs) and digital platforms (Instagram, X, Facebook, Reddit, podcasts, electronic boards, clinical trial websites, data exploration tool). Respondents were categorized into “All”, “Consented,” and “Completed,” then stratified by generation and geographic location. Enrollment and completion rates were calculated.</div></div><div><h3>Results</h3><div>Among 220 respondents (mean age 28.0 ± 5.9 years), 74 (34 %) consented, and 47 (21 %) completed participation. Of all responses, Instagram provided the highest recruitment (37 %, <em>n</em> = 82), but had the lowest enrollment rate (17 %). Podcasts and word-of-mouth were also effective, with physician referrals yielding the highest enrollment (80 %) and completion (100 %) rates yet representing one of the lowest recruitment counts (<em>n</em> = 5). While digital strategies had three times more outreach, enrollment and completion rates remained similar to those of traditional methods. Millennials (<em>n</em> = 117) relied more on Facebook and Podcasts, while Gen Z (<em>n</em> = 102) engaged more via electronic boards and Reddit.</div></div><div><h3>Conclusions</h3><div>Digital platforms, particularly social media and podcasts showed significant potential to enhance recruitment efficiency and outreach. However, varying completion rates across methods underscore the importance of a multifaceted approach to ensure participant diversity and study generalizability.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108033"},"PeriodicalIF":1.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752559","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":"Preference for behavior change strategies in randomized controlled trials: Evidence from weight management","authors":"Michael Sobolev ,&nbsp;Julissa Ruiz ,&nbsp;Márcio A. Diniz ,&nbsp;Hollie Raynor ,&nbsp;Gary D. Foster ,&nbsp;Aaron R. Seitz ,&nbsp;Sarah-Jeanne Salvy","doi":"10.1016/j.cct.2025.108031","DOIUrl":"10.1016/j.cct.2025.108031","url":null,"abstract":"<div><h3>Background</h3><div>Randomized controlled trial participants are expected to embrace assignment to any of the study arms, yet individuals' relative preference for the study arms invariably affects <em>who</em> participates in trials and for <em>how long</em>.</div></div><div><h3>Methods</h3><div>Our ongoing Avoid/Resist trial (1R01DK130851) tests two strategies to bridge the intention-behavior gap in a weight management intervention. <em>Avoid</em> combines pantry makeover and online grocery shopping. <em>Resist</em> involves gamified, inhibitory control training. During screening, individuals rate Avoid and Resist on affective valence (<em>I don't like this</em> – <em>I like this</em>) and instrumental utility (<em>This will not benefit me</em> – <em>This will benefit me</em>) using a 0–100 analogue scale. K-means clustering was used to identify clusters of individuals based on their liking and perceived benefits of the tested strategies before randomization.</div></div><div><h3>Results</h3><div>Among respondents who completed the screener between January 2024 and January 2025 (<em>n</em> = 306; 64 % Female; 40 % Hispanic/Latino), the correlations between liking and perceived benefit ratings were high (&gt;0.70). Median scores of liking and perceived benefits were 90 and 88 for Resist, and 91.5 and 90 for Avoid. K-means clustering revealed 3 groups: (1) highly favorable to Avoid and Resist (all ratings &gt;90; 61 %); (2) relative preference for Resist (22 %); (3) relative preference for Avoid (17 %).</div></div><div><h3>Conclusions</h3><div>Even among individuals willing to be randomized, nearly 40 % had a relative preference for one of the study arms. Additional work is needed to understand the role of relative preference on retention, adherence, and outcomes in weight management trials.</div><div>Trial registration: The study is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05143931</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108031"},"PeriodicalIF":1.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144738424","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}