Contemporary clinical trials最新文献

{"title":"Qualitative understanding of experiences of people with cystic fibrosis in a treatment discontinuation trial: The QUEST study","authors":"Jill Maggs ,&nbsp;Gregory S. Sawicki ,&nbsp;Callie Bacon ,&nbsp;Emma McWilliams ,&nbsp;Dana Yablon ,&nbsp;Benjamin Ertman ,&nbsp;Liam Sweeney ,&nbsp;Jennifer L. Butcher ,&nbsp;Robin S. Everhart ,&nbsp;Michelle Prickett ,&nbsp;Christopher Siracusa ,&nbsp;Alex H. Gifford ,&nbsp;Nicole Mayer-Hamblett ,&nbsp;David P. Nichols ,&nbsp;Andrea Goodman ,&nbsp;Tia Woo ,&nbsp;Kristin A. Riekert","doi":"10.1016/j.cct.2024.107752","DOIUrl":"10.1016/j.cct.2024.107752","url":null,"abstract":"<div><h3>Background</h3><div>As people with cystic fibrosis (PWCF) live longer due to the breakthrough drug elexacaftor-tezacaftor-ivacaftor (ETI), they have questioned whether other CF therapies could be safely discontinued. SIMPLIFY was the first prospective, randomized trial to evaluate non-inferiority of discontinuing versus continuing two therapies. The QUEST (Qualitative Understanding of Experiences in the SIMPLIFY Trial) study was conducted to understand experiences of PWCF enrolled in SIMPLIFY, including why they joined, perceptions of randomization, decision-making around study withdrawal, and considerations for future discontinuation studies.</div></div><div><h3>Methods</h3><div>QUEST enrolled SIMPLIFY participants 14 years or older stable on ETI and caregivers of the 14–17 year-olds. Interviews were audio-recorded, transcribed, and coded. A phenomenological approach was used to inductively develop codes with no a priori hypotheses; identified themes were then organized around current research and recruitment literature.</div></div><div><h3>Results</h3><div>114 interviews were completed (68 adults, 23 teenagers, and 23 caregivers). Among PWCF, median age was 27.8 years, 49 % were female and 80 % had participated in research before SIMPLIFY. Five themes were identified: (1) Experience with SIMPLIFY randomization, [2] Trust, [3] Altruism, [4] Perceived personal benefits, and [5]) Perceived risks and protocol burden.</div></div><div><h3>Conclusion</h3><div>QUEST findings highlight how a long-standing culture of research and thoughtful protocol design contributed to SIMPLIFY's successful recruitment and retention. This included understanding the importance of remaining in the trial despite not being randomized to their preferred treatment assignment. Using patient-centered approaches to select research questions, design a protocol to minimize participant barriers, and frame recruitment materials messaging contribute to successful research participation.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"148 ","pages":"Article 107752"},"PeriodicalIF":2.0,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142667153","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":"INteractive survivorship program to improve health care REsources [INSPIRE]: A study protocol testing a digital intervention with stepped care telehealth to improve outcomes for adolescent and young adult survivors","authors":"Jean C. Yi ,&nbsp;Sheri Ballard ,&nbsp;Casey Walsh ,&nbsp;Danielle N. Friedman ,&nbsp;Patricia A. Ganz ,&nbsp;Linda A. Jacobs ,&nbsp;Ann H. Partridge ,&nbsp;Sandra A. Mitchell ,&nbsp;Wendy M. Leisenring ,&nbsp;Karen L. Syrjala ,&nbsp;K. Scott Baker","doi":"10.1016/j.cct.2024.107745","DOIUrl":"10.1016/j.cct.2024.107745","url":null,"abstract":"<div><h3>Background</h3><div>Adolescents and young adults with cancer (AYAs, ages 15–39 at the time of diagnosis) experience significant adverse health and psychosocial outcomes. AYAs live with emotional distress and health care demands that exceed those of their healthy peers but can have difficulty accessing care. Digitally delivered interventions are an attractive option for AYA survivors, a population that routinely utilizes online resources when seeking health information and support.</div></div><div><h3>Aim</h3><div>By improving access to survivorship resources and support and strengthening health literacy and self-management skills, the INteractive Survivorship Program to Improve Health care REsources [INSPIRE] is designed to improve adherence to AYA health care guidelines and reduce cancer-related distress. We describe the protocol for a two-arm randomized controlled trial (RCT) testing the AYA-adapted INSPIRE program.</div></div><div><h3>Methods/Design</h3><div>The intervention includes an interactive mobile app, study website, and social media platforms, adding telehealth for those with continued distress, lower survivorship health care literacy, or poor engagement with the digital program at 6 weeks. Participants are randomized to INSPIRE or an active control. In the active control arm, survivors receive access to a study website with links to existing AYA survivor resources followed by delayed access to the INSPIRE program. Participants are not blinded; study staff not providing telehealth are blinded. The primary outcomes are cancer-related distress and health care adherence specific to second cancer and cardiometabolic screenings.</div></div><div><h3>Discussion</h3><div>If effective, the program is positioned for accelerated implementation to improve care for AYA survivors by using a scalable informatics-based administration and largely digital intervention program.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"148 ","pages":"Article 107745"},"PeriodicalIF":2.0,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674994","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":"Keep it Movin’: Design and methods of a church-based physical activity program to improve physical function among midlife and older black adults","authors":"Brittney S. Lange-Maia ,&nbsp;Amber Deckard ,&nbsp;Sheila A. Dugan ,&nbsp;Yolanda Cartwright ,&nbsp;Steve M. Epting ,&nbsp;LaDawne Jenkins ,&nbsp;Sumihiro Suzuki ,&nbsp;Valerie G. Press ,&nbsp;Steven K. Rothschild ,&nbsp;Elizabeth B. Lynch","doi":"10.1016/j.cct.2024.107742","DOIUrl":"10.1016/j.cct.2024.107742","url":null,"abstract":"<div><h3>Background</h3><div>Older Black adults have high rates of physical function (PF) limitations. Physical activity (PA) is effective for improving PF and reducing mobility disability risk; however, community-based PA interventions focused on improving PF for older Black adults are lacking. Given the importance of churches as trusted institutions in Black communities, church-based interventions developed through community collaborations may help increase access to PA interventions.</div></div><div><h3>Methods</h3><div>Keep it Movin’ is a church-based cluster randomized controlled trial testing the effectiveness of a 24-week group-based (intervention arm) versus a self-guided (comparator arm) program in improving PF among Black adults aged ≥ 40 years with PF limitations (short physical performance battery [SPPB] score ≤ 9). A church-wide virtual walking program is available to congregants in both arms. The intervention arm receives weekly group-based classes held at the church that include education, goal setting, and structured PA (walking, lower-extremity strength, balance, and stretching). The comparator arm receives educational materials about PA appropriate for people with PF limitations. Outcomes are assessed at 6 (program completion) and 12 months (maintenance). The primary outcome is PF change as measured by the SPPB at 6 months. Secondary outcomes include change in moderate-to-vigorous PA, social support and self-efficacy for PA, quality of life, and self-reported PF. Factors related to successful adoption, implementation, and maintenance are assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.</div></div><div><h3>Conclusion</h3><div>This is the first study to evaluate the effectiveness of a group-based PA program delivered in Black churches to improve PF.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107742"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616253","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":"Challenges and prospects of clinical trials in Nigeria - Lessons from the WHO COVID-19 solidarity plus trial","authors":"Adefolarin Opawoye ,&nbsp;Vivian Kwaghe ,&nbsp;Zaiyad G. Habib ,&nbsp;Yusuf Jibrin ,&nbsp;Ibrahim Maigari ,&nbsp;Bashir Hussaini ,&nbsp;Olukemi Adekanmbi ,&nbsp;Uche Unigwe ,&nbsp;Olusola Ayoola ,&nbsp;Akin Osibogun ,&nbsp;Kolawole Salami ,&nbsp;Marie-Pierre Preziosi ,&nbsp;Abdulrazaq G. Habib","doi":"10.1016/j.cct.2024.107743","DOIUrl":"10.1016/j.cct.2024.107743","url":null,"abstract":"<div><div>Conducting randomized clinical trials (RCTs) during a pandemic is essential for obtaining timely evidence on safe and effective treatments, but it presents numerous obstacles. During the COVID-19 pandemic, the World Health Organization (WHO) sponsored multinational RCTs investigating repurposed drugs among hospitalized COVID-19 patients across countries with varying clinical research capacities. In Nigeria, several challenges hindered our progress, including inadequate infrastructure, initial insufficient investigator certification and expertise, and delays in securing regulatory approvals due to bureaucratic hurdles. Despite these challenges, the WHO-sponsored Solidarity Plus Trial (SPT) offered valuable opportunities to enhance research capacity, streamline participant enrolment through electronic randomization, and bolster infection prevention and control measures for healthcare workers. Moreover, the trial enabled us to upgrade infrastructure at multiple sites, facilitating improved case detection through more testing and data collection. A crucial lesson learned was the importance of expediting trial initiation to capitalize on the limited window for data collection during an outbreak. To optimize RCTs during pandemics, we advocate for enhanced community engagement, collaborative efforts across sectors, strengthened research capacity, flexible regulatory frameworks, and the establishment of adaptive clinical trial units. By addressing these challenges and leveraging opportunities, we can significantly enhance the efficiency and impact of RCTs during public health emergencies.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107743"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616252","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":"Protocol for a randomized controlled trial to evaluate the effectiveness of a telehealth group intervention to reduce perinatal depressive symptoms","authors":"Eli Iacob ,&nbsp;Ryoko Kausler ,&nbsp;Marcia Williams ,&nbsp;Sara Simonsen ,&nbsp;Marcela Smid ,&nbsp;Kristen Weissinger ,&nbsp;Gwen Latendresse","doi":"10.1016/j.cct.2024.107738","DOIUrl":"10.1016/j.cct.2024.107738","url":null,"abstract":"<div><h3>Background</h3><div>Perinatal depression and anxiety (PDA) affect approximately 20 % of individuals and are associated with adverse outcomes, including preterm birth, low birth weight, and impaired cognitive development of the child. Telehealth may reduce access barriers to needed mental health services. However, lack of disseminated, standardized study protocols aimed at investigating the role of telehealth in reducing PDA symptoms limits the ability to compare findings across studies. The purpose of this paper is to provide a conceptual framework and a randomized controlled trial protocol (RCT) for use in future studies.</div></div><div><h3>Methods and analysis</h3><div>An RCT was designed to evaluate the effectiveness of a group videoconference intervention (VCI) to reduce PDA symptoms across pregnancy and postpartum period. Participants are randomly assigned to study groups: VCI + standard of care, or attention control (AC) + standard of care. Both groups have weekly one-hour group videoconference sessions for 9 weeks. The VCI groups are facilitated by a mental health professional using a manualized program based on mindfulness-based practices and cognitive behavioral therapy (MBCT). The AC groups are facilitated by a registered nurse using a manualized program for childbirth and parenting education. The primary outcomes are depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7).</div></div><div><h3>Conclusion</h3><div>This RCT study protocol can be used as a standard approach to improve the ability to compare findings across studies, applied in any setting (e.g., rural or urban), and adapted to diverse communities.</div><div><strong>Trial Registration:</strong> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT03932760</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107738"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616256","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":"Design and methodology of a randomized clinical trial of quetiapine to reduce central nervous system polypharmacy in veterans with postconcussive syndrome symptoms","authors":"Muhammad R. Baig ,&nbsp;Gerardo Villarreal ,&nbsp;Lizette Aviles ,&nbsp;Adeel Meraj ,&nbsp;Betsy Davis ,&nbsp;Eric C. Meyer ,&nbsp;Casey Straud ,&nbsp;Stacey Young-McCaughan ,&nbsp;Alan L. Peterson ,&nbsp;John D. Roache","doi":"10.1016/j.cct.2024.107741","DOIUrl":"10.1016/j.cct.2024.107741","url":null,"abstract":"<div><div>Lack of evidence to guide medication treatments for mild traumatic brain injury (mTBI) in veterans too often results in polypharmacy practices attempting to provide symptomatic relief from multiple postconcussive syndrome symptoms. Therefore, the field needs to find an effective medication that reduces the burden of postconcussive symptoms without complicating the treatment burden of veterans. This clinical trial seeks to determine whether switching veterans to quetiapine monotherapy (intervention) is superior to continuing to receive treatment as usual (TAU, control) polypharmacy for veterans with symptoms of postconcussive syndrome and posttraumatic stress disorder who are receiving rehabilitation treatment for mTBI. This study will test the conceptual mediation model hypothesis that quetiapine monotherapy may enhance recovery from mTBI by (1) increasing engagement in rehabilitation services, and/or (2) reducing the adverse effects of TAU polypharmacy. This study will enroll 146 patients from two Veterans Administration Medical Centers into a 12- week phase III, randomized, pragmatic clinical trial comparing outcomes from treatment with quetiapine monotherapy and TAU. Quetiapine will be cross tapered up to a maximum dose of 200 mg (as tolerated) as other medications are discontinued. The primary outcome measures are postconcussive syndrome symptoms (Neurobehavioral Symptom Inventory), functional disability (World Health Organization Disability Assessment), and quality of life (World Health Organization Quality of Life Assessment). Overall, this study aims to determine whether quetiapine monotherapy is superior to TAU polypharmacy and improves the quality of life for veterans with comorbid postconcussive syndrome and posttraumatic stress disorder symptoms who are receiving rehabilitation treatment for mTBI.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107741"},"PeriodicalIF":2.0,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616276","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 eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy","authors":"Janelle L. Wagner ,&nbsp;Anup D. Patel ,&nbsp;Heather Huszti ,&nbsp;Matthew Schmidt ,&nbsp;Gigi Smith ,&nbsp;Sonal Bhatia ,&nbsp;Shanna M. Guilfoyle ,&nbsp;Amy Lang ,&nbsp;Stacy Buschhaus ,&nbsp;Shannon Williams ,&nbsp;Jessica Ardo ,&nbsp;Marie Davidian ,&nbsp;Avani C. Modi","doi":"10.1016/j.cct.2024.107739","DOIUrl":"10.1016/j.cct.2024.107739","url":null,"abstract":"<div><h3>Background</h3><div>Epilepsy is a common, chronic pediatric neurological condition predominately treated with anti-seizure medications (ASMs) to control or reduce seizures. Approximately 60 % of youth with epilepsy demonstrate suboptimal adherence to their ASM. This paper describes the methodology, recruitment, design, and baseline participant characteristics of a sequential, multiple assignment, randomized trial (SMART) designed to test the effectiveness of a behavioral health intervention to improve adherence in families of young children with epilepsy.</div></div><div><h3>Methods</h3><div>Using a two-stage SMART, youth ages 2–12 years old with newly diagnosed epilepsy and their families were enrolled. Following an 8-week run-in phase, families with ≤95 % adherence were randomized to control (education + automated digital reminders) or intervention (education + automated digital reminders + individualized feedback) arms. After three months, families in the intervention group who remained non-adherent (i.e., ≤ 95 %) were re-randomized to 1) continue with same intervention or 2) receive two telehealth problem-solving sessions with an interventionist over the next two months. Study measures were completed at baseline, 8-, 14-, and 20-months post-baseline.</div></div><div><h3>Results</h3><div>Of the <em>n</em> = 466 ethnically and racially diverse study participants, <em>n</em> = 268 participants were non-adherent and were randomized. The primary outcome was electronically monitored ASM adherence at post-intervention, while secondary outcomes included seizure freedom, health care utilization, and epilepsy-specific health-related quality of life.</div></div><div><h3>Conclusions</h3><div>Novel aspects of the trial design (e.g., sequential, recruitment of racial and ethnic diverse youth), modifications to the protocol related to the COVID-19 pandemic and evolving socio-political and medical climate, as well as recruitment and retention challenges are discussed.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Number: <span><span>NCT03817229</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107739"},"PeriodicalIF":2.0,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616259","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 pilot randomized clinical trial of a smartphone-based application to support at-home PSA screening and culturally tailored prostate cancer education for African American men: A study protocol","authors":"Jordan Neil ,&nbsp;Bingjing Mao ,&nbsp;Ruosi Shao ,&nbsp;Motolani E. Ogunsanya ,&nbsp;Summer Frank-Pearce ,&nbsp;Michael Businelle ,&nbsp;Michael Cookson ,&nbsp;Kelly Stratton ,&nbsp;Mark Doescher ,&nbsp;Stephanie Pharr ,&nbsp;Valerie Moise ,&nbsp;Brianna Fleshman ,&nbsp;Jack Fronheiser ,&nbsp;Kimberly Estrada ,&nbsp;Iván Flores ,&nbsp;David Bradley ,&nbsp;Ashley Kendrick ,&nbsp;Adam C. Alexander","doi":"10.1016/j.cct.2024.107737","DOIUrl":"10.1016/j.cct.2024.107737","url":null,"abstract":"<div><h3>Background</h3><div>Prostate cancer is the most diagnosed cancer in Black/African American men (AA) and the second‑leading cause of cancer-related deaths. A prostate-specific antigen (PSA) blood test is an early detection screening tool for prostate cancer, but uptake of PSA screening remains low among AA men. Greater PSA screening rates among AA men, coupled with earlier treatment, may reduce disparities in prostate cancer outcomes, including mortality. The current pilot study will test the first-of-its-kind mobile health (mHealth) app to improve prostate cancer knowledge and increase PSA screening uptake among AA men using home-based screening methods.</div></div><div><h3>Methods</h3><div>AA men aged 55 to 69 and are not up to date with PSA screening will be randomly assigned 1:1 to receive a prostate cancer screening app: Prevention Taskforce App (Taskforce App; control condition) or the Prostate Cancer Genius App (Genius App; intervention condition), which was developed specifically for AA men.</div></div><div><h3>Results</h3><div>We will evaluate the preliminary efficacy of the apps via post-intervention group differences on the validated 18-item Prostate Cancer Knowledge Scale (primary outcome). We will also explore post-intervention group differences in perceived engagement, accessibility, and acceptability between the apps. Finally, we will derive preliminary estimates of PSA screening rates between study conditions and identify mechanisms of screening adherence.</div></div><div><h3>Discussion</h3><div>mHealth apps offer promise to improve prostate cancer knowledge and screening rates among AA men. Demonstrating the preliminary efficacy of the Genius App will support future fully-powered mHealth interventions to address health disparities.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107737"},"PeriodicalIF":2.0,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616250","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":"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 ,&nbsp;D.C. Delgado-Díaz ,&nbsp;M. McGrievy ,&nbsp;H. Valafar ,&nbsp;C. Monroe ,&nbsp;S. Wilcox ,&nbsp;G. Turner-McGrievy","doi":"10.1016/j.cct.2024.107735","DOIUrl":"10.1016/j.cct.2024.107735","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>Participants (target <em>N</em> = 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.</div></div><div><h3>Conclusion</h3><div>The mLife study informs the expansion of gamification within mHealth programs to enhance social support provision and receipt during weight loss.</div></div><div><h3>Trial registration</h3><div>This study was registered on <span><span>clintrials.gov</span><svg><path></path></svg></span> on the 30th of October 2017, under the trial registration number: <span><span>NCT05176847</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"148 ","pages":"Article 107735"},"PeriodicalIF":2.0,"publicationDate":"2024-11-09","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}