Trials最新文献

{"title":"REVERSE model: a novel approach in medical research.","authors":"Luca Saba, Gianluca De Rubeis, Francesco Pisu","doi":"10.1186/s13063-025-08974-9","DOIUrl":"10.1186/s13063-025-08974-9","url":null,"abstract":"<p><strong>Background: </strong>Randomized controlled trials are considered the gold standard but they are limited by high costs and external validity. The REVERSE model is introduced to address these challenges.</p><p><strong>Methods: </strong>The REVERSE model encompasses two sequential phases. First, in the data mining phase, compatible datasets are identified and merged by using matching or stricter inclusion/exclusion criteria, thereby reducing selection bias. Second, a randomization phase addresses the inherent biases of the selected datasets. For a dichotomous scenario, the data are organized into four sub-cohorts according to the concordance with the original and new assignments: two concordant and two non-concordant. New decision factors are tested in concordant groups. Patients in non-concordant cohorts were excluded. ROMICAT-II was used to reproduce the findings from both the ROMICAT-II and ROMICAT-I trials, with results reported as the median of 10,000 applications.</p><p><strong>Findings: </strong>The REVERSE model successfully replicated the results of ROMICAT-II and ROMICAT-I using only ROMICAT-II data. For ROMICAT-II, the median (interquartile range) of all median differences between length of hospitalization stay with cardiac computed tomography angiography (CCTA) and standard diagnostic strategy after 10,000 applications matched the trial's findings 100% of the time (18.06 h [17.76-18.32] vs. 18.1 h; p < 0.05). For ROMICAT-I, median of all REVERSE plaque prevalence (PP) at CCTA matched the observed PP at CCTA from ROMICAT-I (49.63% [48.2-51.2] vs. 49.7%). The REVERSE PP fell within 49.63% ± 5% in 9733 (97.33%) applications.</p><p><strong>Conclusion: </strong>The REVERSE model allows repurposing existing datasets to explore novel research questions while mitigating inherent biases through stringent inclusion criteria matching and randomization.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"248"},"PeriodicalIF":2.0,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12275234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144668605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of SGLT2 inhibitors on cardiac autonomic activity and ventricular remodeling in patients with acute myocardial infarction: study protocol for a clinical trial.","authors":"Jun Wan, Qinglong Zhang, Feng Xu, Xin Jiang, Cai Chen, Xiaodong Pan, Jinglin Cheng, He Li","doi":"10.1186/s13063-025-08956-x","DOIUrl":"10.1186/s13063-025-08956-x","url":null,"abstract":"<p><strong>Background: </strong>Sodium-glucose co-transporter 2 inhibitors (SGLT2-I) exhibit significant cardiovascular protective effects in patients with acute myocardial infarction (AMI) complicated with type 2 diabetes mellitus (T2DM), mainly through enhancing cardiac function and reducing malignant arrhythmias. However, limited evidence exists regarding their efficacy in non-diabetic AMI patients. Moreover, the relationship between these benefits and improvements in cardiac autonomic function and left ventricular remodeling remains contentious, hindering a comprehensive understanding of their mechanisms of action. This study aims to fill this knowledge gap regarding dapagliflozin's effects on cardiac autonomic activity and ventricular remodeling in AMI patients.</p><p><strong>Methods: </strong>This study is a prospective, randomized, open-label, assessor-blinded, single-center trial in AMI patients in China. A total of 110 participants will be randomly allocated in a 1:1 ratio to either receive standardized treatment alone or receive standardized treatment along with 10 mg of dapagliflozin taken once daily. The primary endpoint is the change from the baseline to 24 weeks in heart rate variability (HRV) and deceleration capacity (DC) measured by 24-h ambulatory Holter monitoring. Secondary endpoints include changes in the left ventricular remodeling index (a relative change of LV end-diastolic volume, LVRI) as measured from baseline, along with the incidence of major adverse cardiovascular events throughout the follow-up period. Changes in various variables from the baseline will also be analyzed, encompassing glucose and lipid levels, blood pressure, body weight, and biomarkers linked to diagnostic and functional parameters of AMI, such as creatine kinase, troponin I (TnI) level, and N terminal pro B type natriuretic peptide (NT-proBNP) level.</p><p><strong>Discussion: </strong>This will be the first trial to evaluate the effects of dapagliflozin on cardiac autonomic function and ventricular remodeling in AMI patients. This study seeks to elucidate the mechanisms underlying dapagliflozin's cardioprotective effects, potentially informing future therapeutic strategies for improving outcomes in this population.</p><p><strong>Trial registration: </strong>Clinical trial ID: ChiCTR2400084050. Registration date: May 9, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"246"},"PeriodicalIF":2.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12257681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144638172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of generative artificial intelligence on cognitive effort and task performance: study protocol for a randomized controlled experiment among college students.","authors":"Youjie Chen, Yingying Wang, Torsten Wüstenberg, Rene F Kizilcec, Yiwen Fan, Yanfei Li, Bin Lu, Meng Yuan, Junlai Zhang, Ziyue Zhang, Pascal Geldsetzer, Simiao Chen, Till Bärnighausen","doi":"10.1186/s13063-025-08950-3","DOIUrl":"10.1186/s13063-025-08950-3","url":null,"abstract":"<p><strong>Background: </strong>The advancement of generative artificial intelligence (AI) has shown great potential to enhance productivity in many cognitive tasks. However, concerns are raised that the use of generative AI may erode human cognition due to over-reliance. Conversely, others argue that generative AI holds the promise to augment human cognition by automating menial tasks and offering insights that extend one's cognitive abilities. To better understand the role of generative AI in human cognition, we study how college students use a generative AI tool to support their analytical writing in an educational context. We will examine the effect of using generative AI on cognitive effort, a major aspect of human cognition that reflects the extent of mental resources an individual allocates during the cognitive process. We will also examine the effect on writing performance achieved through the human-generative AI collaboration.</p><p><strong>Methods: </strong>This study is a randomized controlled lab experiment that compares the effects of using generative AI (intervention group) versus not using it (control group) on cognitive effort and writing performance in an analytical writing task designed as a hypothetical writing class assignment for college students. During the experiment, eye-tracking technology will monitor eye movements and pupil dilation. Functional near-infrared spectroscopy (fNIRS) will collect brain hemodynamic responses. A survey will measure individuals' perceptions of the writing task and their attitudes on generative AI. We will recruit 160 participants (aged 18-35 years) from a German university where the research will be conducted.</p><p><strong>Discussion: </strong>This trial aims to establish the causal effects of generative AI on cognitive effort and task performance through a randomized controlled experiment. The findings aim to offer insights for policymakers in regulating generative AI and inform the responsible design and use of generative AI tools.</p><p><strong>Trial registration: </strong></p><p><strong>Clinicaltrials: </strong>gov NCT06511102. Registered on July 15, 2024. https://clinicaltrials.gov/study/NCT06511102.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"244"},"PeriodicalIF":2.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12255134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144620667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Realizing the benefits of the estimand framework when reporting and communicating clinical trial results-some recommendations.","authors":"Vivian Lanius, Barbara Glocker, Christian Lösch, Daniel J Bratton, Francesca Callegari, Melanie Wright, Suvi Rajamäki","doi":"10.1186/s13063-025-08915-6","DOIUrl":"10.1186/s13063-025-08915-6","url":null,"abstract":"<p><p>Reports of the results of clinical studies are integral to regulatory decision making. They are used to support marketing authorization, to substantiate labeling information, and to inform academic publications, trial postings, and promotional messages intended to communicate study results to doctors and patients. Therefore, beyond summarizing the study design, methods, and data, study reports should provide clear descriptions of the benefits and risks of an intervention for a given medical condition. The ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials provides a framework aiming for more clarity about the reported \"treatment effects.\" In practice, stakeholders are still learning how to embrace the estimand framework and how it impacts the reporting of study results in the most value-adding manner. This paper provides recommendations and considerations for implementing the estimand framework in the reporting of results to realize its full potential of increased transparency for interpretation and decision-making. These recommendations are based on practical experiences of working with clinical trial teams through the reporting process following implementation of the estimand framework in the protocol. As illustrated by two case studies, the primary application is in reporting studies for the scientific evaluation of medicines by regulatory agencies, directly impacting clinical study reports and submission documents, and will also extend to publications in scientific journals.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"241"},"PeriodicalIF":2.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12247363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144609703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Repetitive transcranial magnetic stimulation in children and adolescents with autism spectrum disorder: study protocol for a double-blind, sham-controlled, randomized clinical trial.","authors":"Rosa Savino, Sergio Davinelli, Anna Nunzia Polito, Giovanni Scapagnini, Aldo Scirano, Anna Valenzano, Giuseppe Cibelli","doi":"10.1186/s13063-025-08946-z","DOIUrl":"10.1186/s13063-025-08946-z","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of autism spectrum disorder (ASD) has significantly increased over recent decades, representing a serious public health issue. Neurobiological characteristics of ASD include imbalances in cortical excitation and inhibition, along with disruptions in neural network connectivity. Repetitive transcranial magnetic stimulation (rTMS) may provide a therapeutic option when cognitive-behavioral therapy alone is insufficient to alleviate core symptoms. This article outlines the protocol for a double-blind, sham-controlled, randomized study assessing low-frequency rTMS targeting the bilateral dorsolateral prefrontal cortex (DLPFC) in children and adolescents with ASD. The objective is to evaluate the efficacy of rTMS compared to sham stimulation.</p><p><strong>Methods: </strong>Forty patients with ASD, aged 7-18 years and with different levels of clinical severity, will be randomized into an active treatment group (n = 20) and a sham control group (n = 20). Each participant will receive 18 low-frequency (2 Hz) rTMS sessions over 9 weeks, administered at 90% of the motor threshold with 180 pulses per session. Treatment will target the left DLPFC (six sessions), the right DLPFC (six sessions), and both hemispheres (six sessions). Clinical, cognitive, and neurophysiological assessments will be conducted at baseline, post-treatment, and 1-month follow-up. Biological samples (blood, urine) will be collected at each time point to evaluate changes in various biomarkers, including tryptophan metabolites, neurotrophic factors, neurotransmitters, and inflammatory mediators. Safety will be monitored through semi-structured interviews and adverse event reporting.</p><p><strong>Discussion: </strong>This study aims to identify a safe rTMS protocol for ASD that could complement existing therapies. By assessing the cognitive domains and the clinical and biochemical profiles most responsive to rTMS, this study may contribute to optimize ASD treatments and enhance therapeutic outcomes in pediatric populations.</p><p><strong>Trial registration: </strong>The study protocol is registered at \"ClinicalTrials.gov\" with the following ID: NCT06069323.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"240"},"PeriodicalIF":2.0,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12232753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144576349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of device-assisted practice of activities of daily living in a close-to-normal pattern on upper extremity motor recovery in individuals with moderate to severe stroke: study protocol of a randomized control trial.","authors":"Justin M Drogos, Carolina Carmona, Riegele Arceo, Jun Yao","doi":"10.1186/s13063-025-08930-7","DOIUrl":"10.1186/s13063-025-08930-7","url":null,"abstract":"<p><strong>Background: </strong>The majority of individuals with chronic stroke have residual upper extremity (UE) disability which they cite as their greatest barrier to recovery. Using orthoses, robotic devices, and functional electrical stimulation (FES) represent rehabilitation techniques that have demonstrated the ability to improve arm and hand function in the chronic stroke population, but individuals with more severe impairments are typically not eligible for these studies. The very few studies incorporating these techniques with the severely impaired population do not utilize volitional FES control or modulated loading, which has been shown to promote greater motor recovery and functional improvement. An UE intervention utilizing an advanced orthosis incorporating volitionally controlled FES and robotically modulated shoulder abduction (SABD) loading may provide a pathway to improved coordinated use of the arm and hand for the more severely impaired chronic stroke population.</p><p><strong>Methods: </strong>In a double-blinded, two-baseline, randomized control trial individuals with chronic moderate to severe stroke resulting in UE hemiparesis will participate in a task-based reaching-grasping-retrieving-releasing (GR3) intervention three times a week for 8 weeks. An anticipated 60 individuals will perform a repeated GR3 task with the ReIn-Hand device (ReIn-Hand), a customized forearm/hand orthosis integrating volitionally controlled FES, to assist with paretic hand-opening. Participants will be randomly assigned to a control group (ReIn-Hand only) or experimental group which will also receive modulated SABD loading via the PACT3D robot. Groups will be compared by (1) their change in function primarily measured by the Box and Blocks Test; (2) change in performance measured by kinematic analysis of reaching and hand-opening and (3) changes in neural motor recovery measured using electroencephalography (EEG) and magnetic resonance imaging (MRI).</p><p><strong>Discussion: </strong>The present study will evaluate the effectiveness of a novel interventional device, with and without shoulder abduction assistance, as part of a task-specific training protocol with the moderate to severe chronic stroke population. The focus on the more impaired chronic stroke population provides the opportunity to improve the rehabilitation of this overlooked population. Functional and structural measures using advanced imaging techniques offer the possibility to further delineate recovery and compensation at the neuronal level.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID NCT04077073. Registration date: September 04, 2019.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"238"},"PeriodicalIF":2.0,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12231668/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144565270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Do pregnant people have opportunities to participate in clinical trials? an exploratory survey of NIHR HTA-funded trialists.","authors":"Rebekah Burrow, Lisa Hinton, Mike Clarke","doi":"10.1186/s13063-025-08949-w","DOIUrl":"10.1186/s13063-025-08949-w","url":null,"abstract":"<p><strong>Background: </strong>Pregnant people are often excluded from clinical trials, primarily due to safety concerns. However, exclusion causes population-level harms as well as sometimes providing individual protection. Harms caused to pregnant people by exclusion from clinical trials have been clearly evidenced and highlighted during the COVID pandemic. The National Institute for Health and Care Research (NIHR) has since provided guidance on improving inclusion of under-served groups, which includes pregnant people, in clinical research. Appropriate inclusion and active facilitation to participate are required to provide equitable evidence-based healthcare during pregnancy and to comply with ethical principles for research.</p><p><strong>Methods: </strong>We carried out an exploratory, online, cross-sectional survey of trialists to assess whether, why, and how pregnant people are included or excluded from clinical trials funded by the NIHR Health Technology Assessment (HTA) Programme, with awards starting in 2022-2023. Trialists were the respondents, with trials the primary focus of this survey. Invitations were sent to trialists between October 2023 and March 2024. Summary statistics were calculated to describe the characteristics of the trials and respondents, to describe eligibility of pregnant people, reasons for this, and how this eligibility is documented and implemented.</p><p><strong>Results: </strong>We identified 120 trials of which 88 were eligible for this survey. Responses were received for 81 trials. Pregnant people are excluded from 34 of these 81 trials. Pregnant people are eligible for inclusion in 40 of the 81 trials, including four which partially exclude people during pregnancy. Eligibility is unclear for seven trials. Exclusions are mostly for safety reasons. Sponsors and regulatory authorities are unnecessary barriers to inclusion in some trials. Eight trials of 40 trials make explicit or deliberate attempts to include people during pregnancy.</p><p><strong>Conclusions: </strong>A minority of the 120 trials include people during pregnancy. Most trials for which pregnant people are eligible do not report explicitly including people during pregnancy or facilitating their inclusion. A small number of trials, different in setting, clinical area, and intervention type, are intentionally designed and conducted in a way that include people during pregnancy. There are clear opportunities to improve the inclusion of pregnant people in clinical trials in the NIHR HTA Programme.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"239"},"PeriodicalIF":2.0,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12232068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144565269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan.","authors":"Emily J J Horn-Oudshoorn, Marijn J Vermeulen, Ronny Knol, Rebekka Bout-Rebel, Arjan B Te Pas, Stuart B Hooper, Suzan C M Cochius-den Otter, Rene M H Wijnen, Kelly J Crossley, Neysan Rafat, Thomas Schaible, Willem P de Boode, Anne Debeer, Berndt Urlesberger, Calum T Roberts, Florian Kipfmueller, Irma Capolupo, Carmen M Burgos, Bettina E Hansen, Irwin K M Reiss, Philip L J DeKoninck","doi":"10.1186/s13063-025-08939-y","DOIUrl":"10.1186/s13063-025-08939-y","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"235"},"PeriodicalIF":2.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12224492/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating a brief imagery-based intervention for adolescent depression: study protocol for a Phase IIB randomised control trial (INDIGO) in secondary schools.","authors":"Victoria Pile, Rose Tinch-Taylor, Ben Carter, Jessica Richardson, Lisa De Rijk, Mary Leamy, Simon E Blackwell, Richard Meiser-Stedman, Barnaby D Dunn, Sarah Byford, Emily A Holmes, Cathy Creswell, Patrick Smith","doi":"10.1186/s13063-025-08920-9","DOIUrl":"10.1186/s13063-025-08920-9","url":null,"abstract":"<p><strong>Background: </strong>There is an urgent need for psychological interventions that can target depression in late adolescence and prevent it from having lifelong implications. Schools have been identified as a promising setting to enhance access to interventions and offer support earlier. We have co-developed a novel intervention, IMAGINE, that targets key cognitive mechanisms implicated in depression across the lifespan. Depression has been associated with distressing negative mental images, a deficit in positive future images and overgeneral autobiographical memories. Interventions targeting these factors have shown clinical promise in adults. Here, we combine techniques targeting these cognitive processes into a novel, brief psychological intervention for adolescent depression. This Phase IIb randomised controlled trial will evaluate IMAGINE compared to an active psychological intervention.</p><p><strong>Methods/design: </strong>One hundred sixty adolescents (aged 16-18) with high levels of depressive symptoms will be recruited from schools. Participants will be randomly allocated to IMAGINE or the active psychological control intervention, non-directive support (NDS). Assessment will take place at baseline, 8-, 16- and 24-week post randomisation. The primary objective is to establish whether IMAGINE reduces symptoms of depression, relative to NDS, at 8 weeks following randomisation. Secondary objectives include whether changes in depression are maintained at 16- and 24-week follow-up, the efficacy of IMAGINE on secondary clinical outcomes and key cognitive mechanisms and, finally, to assess outcomes around acceptability, safety and adherence.</p><p><strong>Discussion: </strong>If IMAGINE is shown to be safe and clinically effective, an effectiveness-implementation hybrid RCT will be indicated. If rolled out as an intervention, IMAGINE would significantly extend the range of effective therapies available for adolescent depression.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN14015295. Registered 11 September 2023, https://doi.org/10.1186/ISRCTN14015295 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"236"},"PeriodicalIF":2.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12225131/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"MoveMentor-examining the effectiveness of a machine learning and app-based digital assistant to increase physical activity in adults: protocol for a randomised controlled trial.","authors":"Corneel Vandelanotte, Stewart Trost, Danya Hodgetts, Tasadduq Imam, M D Mamunur Rashid, Quyen G To, Carol Maher","doi":"10.1186/s13063-025-08926-3","DOIUrl":"10.1186/s13063-025-08926-3","url":null,"abstract":"<p><strong>Background: </strong>Physical inactivity is prevalent, leading to a high burden of disease and large healthcare costs. Thus, there is a need for affordable, effective and scalable interventions. However, interventions that are affordable and scalable are beset with modest effects and engagement. Interventions that integrate machine learning with real-time data to offer unprecedented levels of personalisation and customisation might offer solutions. The aim of this study is to conduct a randomised controlled trial to evaluate the effectiveness of a machine learning and app-based digital assistant to increase physical activity.</p><p><strong>Methods: </strong>One hundred and ninety-eight participants will be recruited through Facebook advertisements and randomly allocated to an intervention or control group. Intervention participants will gain access to an app-based physical activity digital assistant that can learn and adapt in real-time to achieve high levels of personalisation and user engagement by virtue of applying a range of machine learning techniques (i.e. reinforcement learning, natural language processing and large language models). The digital assistant will interact with participants in 3 main ways: (1) educational conversations about physical activity; (2) just-in-time personalised in-app notifications ('nudges'), cues to action encouraging physical activity and (3) chat-based questions and answers about physical activity. Additionally, the app includes adaptive goal setting and an action planning tool. The control group will gain access to the intervention after the last assessment. Outcomes will be measured at baseline, 3 and 6 months. The primary outcome is device-measured (Axivity AX3) moderate-to-vigorous physical activity. Secondary outcomes include app engagement and retention, quality of life, depression, anxiety, stress, sitting time, sleep, workplace productivity, absenteeism, presenteeism and habit strength.</p><p><strong>Discussion: </strong>The trial presents a unique opportunity to study the effectiveness of a new generation of digital interventions that use advanced machine learning methods to improve physical activity behaviour. By addressing the limitations of existing conversational agents, we aim to pave the way for more effective and adaptable interventions.</p><p><strong>Trial registration: </strong>Australian New Zealand Clinical Trial Registry ACTRN12624000255583p. Registered on 14 March 2024. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=387332 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"233"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12220097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}