Contemporary clinical trials最新文献

{"title":"Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol","authors":"Samantha G. Farris ,&nbsp;Mindy M. Kibbey ,&nbsp;Brittany Keller ,&nbsp;Lilly Derby ,&nbsp;Teresa M. Leyro ,&nbsp;Brandon L. Alderman ,&nbsp;Angelo M. DiBello ,&nbsp;Michael B. Steinberg ,&nbsp;Ana M. Abrantes","doi":"10.1016/j.cct.2024.107706","DOIUrl":"10.1016/j.cct.2024.107706","url":null,"abstract":"<div><h3>Background</h3><div>Exercise anxiety is a novel mechanism related to non-adherence to exercise and lifestyle physical activity. We developed a cognitive-behavioral treatment, Behavioral Exposure For Interoceptive Tolerance (BE-FIT), which is a manualized, values-based exposure intervention designed to target exercise anxiety that is delivered as a supplement to outpatient cardiac rehabilitation (CR).</div></div><div><h3>Method</h3><div>We describe a Stage II randomized controlled trial (RCT) to test BE-FIT, compared to a Health Education Control (HEC) intervention on exercise and physical activity outcomes at end-of-treatment (EOT) and follow-ups (Weeks 12, 18, and 24), and evaluate mechanisms of change (i.e., reductions in exercise anxiety). Adults (<em>N</em> = 146) who are ≥40 years of age, cleared for outpatient exercise-based CR, low active, and have elevated exercise anxiety will be recruited. The primary study hypothesis is that BE-FIT compared to HEC will result in higher levels of overall exercise and lifestyle physical activity at EOT and follow-ups. The second hypothesis is that BE-FIT vs HEC will produce greater reductions in exercise anxiety at EOT and Week 12. The third hypothesis is that reductions in exercise anxiety at EOT and Weeks 12 will mediate the effect of BE-FIT on activity outcomes at Weeks 18 and 24.</div></div><div><h3>Discussion</h3><div>We expect the results of this study will produce knowledge regarding BE-FIT's efficacy and mechanisms of action. Our goal is to better understand “how and why” the intervention is (or is not) effective and for whom, and increase collective knowledge and reproducibility of behavior change research.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107706"},"PeriodicalIF":2.0,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142399647","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":"A randomized trial of aerobic exercise in colorectal cancer: Rationale, design, recruitment, and exercise adherence results","authors":"Stephanie L.E. Compton ,&nbsp;Shengping Yang ,&nbsp;Lauren S. Maniscalco ,&nbsp;Reem A. Muhsen ,&nbsp;Pratibha Shrestha ,&nbsp;Xiaocheng Wu ,&nbsp;Kaylee T. Woodard ,&nbsp;Elizabeth R.M. Zunica ,&nbsp;Eunhan Cho ,&nbsp;Rachel L. Wall ,&nbsp;John Brown ,&nbsp;Anjana Jayaraman ,&nbsp;Brian J. Kirby ,&nbsp;L. Anne Gilmore ,&nbsp;Frank L. Greenway ,&nbsp;Guillaume Spielmann ,&nbsp;Justin C. Brown","doi":"10.1016/j.cct.2024.107702","DOIUrl":"10.1016/j.cct.2024.107702","url":null,"abstract":"<div><h3>Background</h3><div>Physical activity is associated with improved disease-free survival in colorectal cancer survivors. This report describes the purpose, design, recruitment, and exercise adherence results of the National Cancer Institute (NCI)-sponsored Exercise and Colorectal Cancer Treatment (EXACT) trial.</div></div><div><h3>Methods</h3><div>The primary objective of the EXACT trial is to determine if randomization to 150 min per week of moderate-intensity aerobic exercise reduces systemic inflammation among stage I-III colorectal cancer survivors compared with a waitlist control group over 12 weeks. Participants were provided with an in-home treadmill and heart rate monitor. Characteristics associated with randomization were identified using χ² or Fisher's exact test for categorical variables and <em>t</em>-tests or analysis of covariance (ANCOVA). Exercise adherence was calculated as the total minutes exercised by total minutes prescribed.</div></div><div><h3>Results</h3><div>Between August 2019 and February 2023, 3082 colorectal cancer survivors were invited to participate, 89 were screened, and 60 were randomized to the study protocol. Younger age (<em>P</em> = 0.02), female sex (<em>P</em> = 0.002), white race (<em>P</em> = 0.01), proximal time since tumor resection (<em>P</em> = 0.02), and regional tumor stage (<em>P</em> &lt; 0.001) were associated with study participation. Average exercise adherence was 92.2 % (95 % CI: 85.5, 98.8) and all study participants achieved ≥80 % exercise adherence. Endpoint data collection was completed for all participants in May 2023.</div></div><div><h3>Conclusion</h3><div>The results from the EXACT trial will characterize the changes that occur from exercise to advance our understanding of the biological mechanisms by which exercise may prevent tumor recurrence and death in colorectal cancer survivors.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107702"},"PeriodicalIF":2.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371213","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":"Family model diabetes self-management education and support in faith-based organizations in the Republic of the Marshall Islands: A study protocol","authors":"Pearl A. McElfish ,&nbsp;Sheldon Riklon ,&nbsp;Jennifer A. Andersen ,&nbsp;James P. Selig ,&nbsp;Jonell Hudson ,&nbsp;Williamina Ioanna Bing ,&nbsp;Francyne Wase-Jacklick ,&nbsp;Jack Niedenthal ,&nbsp;Kyle Lemari ,&nbsp;Henry Otuafi ,&nbsp;Philmar Mendoza-Kabua ,&nbsp;Joseph A. Henske ,&nbsp;Dinesh Edem ,&nbsp;Brett Rowland ,&nbsp;Janine Boyers Schuh ,&nbsp;Gail O'Connor ,&nbsp;Mohammed Ason ,&nbsp;Andy Bauleni ,&nbsp;Britni L. Ayers","doi":"10.1016/j.cct.2024.107705","DOIUrl":"10.1016/j.cct.2024.107705","url":null,"abstract":"<div><h3>Introduction</h3><div>The Republic of the Marshall Islands (RMI) is an independent nation and a member of the United States (US) Affiliated Pacific Islands through a Compact of Free Association. Health disparities in the RMI are striking, with high rates of type 2 diabetes mellitus (T2DM). The International Diabetes Federation has documented age-adjusted prevalence of T2DM at 23.0 %, compared to the US (13.2 %) and globally (9.8 %). T2DM has a devastating impact on patients and their families.</div></div><div><h3>Methods</h3><div>The purpose of this article is to present the study protocol for the fully powered two-arm cluster randomized controlled trial using a wait-list control to evaluate the effectiveness of a Family Diabetes Self-Management Education and Support (Family DSMES) program when delivered in a group setting by community health workers (CHWs) in faith-based organizations (FBOs) in the RMI. The study used a community engaged approach, and the study protocol includes adaptations based on the results of our one-arm pilot study.</div></div><div><h3>Summary</h3><div>This study will provide new and innovative information on the effectiveness of Family DSMES delivered in a group setting by CHWs in FBOs in the RMI. The knowledge gained from this research will inform DSMES interventions conducted with Marshallese and other Pacific Islander communities, as well as DSMES interventions conducted in other low-resource countries.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107705"},"PeriodicalIF":2.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364652","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 of a randomized controlled trial into guided internet-delivered cognitive behavioral therapy for insomnia in autistic adults (i-Sleep Autism)","authors":"Kirsten L. Spaargaren ,&nbsp;Sander M. Begeer ,&nbsp;Kirstin Greaves-Lord ,&nbsp;Heleen Riper ,&nbsp;Annemieke van Straten","doi":"10.1016/j.cct.2024.107704","DOIUrl":"10.1016/j.cct.2024.107704","url":null,"abstract":"<div><h3>Background</h3><div>Sleep problems, especially insomnia, are prevalent among autistic adults, affecting about 60 %, and significantly impact their quality of life. Internet-based cognitive behavioral therapy for insomnia (iCBT-I) could provide accessible and scalable treatment. Given the unique sensory- and information processing, and social challenges at play in autism, a tailored treatment approach may be essential to tackle sleep problems. Yet, interventions developed and tested specifically for autistic adults were scarce. Addressing this gap is crucial to meet the urgent need for effective insomnia treatments in this population.</div></div><div><h3>Methods</h3><div>With this two-arm, parallel, superiority randomized controlled trial, we will assess the effectiveness of a guided iCBT-I intervention for adults (<em>N</em> = 160) with autism and insomnia (i-Sleep Autism). In co-creation, i-Sleep Autism has been adjusted from an existing intervention (i-Sleep). Inclusion criteria are: age ≥ 18, an ASD diagnosis, and at least sub-threshold insomnia (Insomnia Severity Index ≥10). Participants are randomly assigned to either i-Sleep Autism or an information only waitlist control condition (online psychoeducation and sleep hygiene). After 6 weeks, the control group receives the intervention. Insomnia severity is the primary outcome. Secondary outcomes include pre-sleep arousal, general mental health, depression, anxiety, daily functioning, and quality of life. Assessments will occur at baseline, mid-intervention (3 weeks), post-intervention (6 weeks), and at 6-month follow-up (the intervention group). Linear mixed-effect regression models are employed to evaluate the effectiveness of i-Sleep Autism, alongside exploration of potential moderators and mediators.</div></div><div><h3>Conclusion</h3><div>This trial can reveal whether autistic adults with insomnia benefit from a guided e-health intervention.</div><div>Trial registration: NL-OMON56692.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107704"},"PeriodicalIF":2.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364653","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":"Racial and ethnic representation of youth in type 1 diabetes interventional trials","authors":"Emilie S. Zoltick,&nbsp;Ann Chen Wu,&nbsp;Mei-Sing Ong","doi":"10.1016/j.cct.2024.107703","DOIUrl":"10.1016/j.cct.2024.107703","url":null,"abstract":"<div><h3>Background</h3><div>Underrepresentation of racial and ethnic groups in clinical trials can limit generalizability of research findings and equitable access to treatment. This study evaluates racial and ethnic representation of youth in US-based interventional trials on childhood type 1 diabetes (T1D).</div></div><div><h3>Methods</h3><div>This cross-sectional study examined interventional trials of T1D conducted in the US and registered on ClinicalTrials.gov. Trials were included if completed as of June 6, 2023, began between years 2010 and 2022, and exclusively enrolled youth ≤19 years old. We assessed representation of racial and ethnic groups in T1D trials, estimated using the enrollment-prevalence difference (EPD).</div></div><div><h3>Results</h3><div>A total of 106 trials were eligible for inclusion. Of those eligible, 62 (58 %) trials reported participant race or ethnicity and were included in the analyses. Significant disparities in enrollment were observed for American Indian/Alaska Native, Asian/Pacific Islander, Black, and Hispanic youth compared to their respective contribution to disease burden among youth in the US. Disparities in trial enrollment were greatest for Black (EPD, −10.2; 95 % confidence interval [CI], −14.4 to −7.9) and Hispanic (EPD, −7.7; 95 % CI, −12.6 to −4.8) youth. EPDs of trials conducted prior to year 2017 did not differ significantly from those conducted as of year 2017.</div></div><div><h3>Conclusions</h3><div>Historically marginalized racial and ethnic youth were underrepresented in T1D trials. Strategies to improve recruitment of these populations are needed to reduce inequities in diabetes treatment and outcomes.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107703"},"PeriodicalIF":2.0,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342978","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":"Significant delays exist in industry-sponsored pediatric clinical drug trial start-up and enrollment processes","authors":"Angie Price ,&nbsp;Hannah Simmons ,&nbsp;Emily Gehring ,&nbsp;Lauren Davis ,&nbsp;Gwyneth Fischer ,&nbsp;Ann R. Klipsch ,&nbsp;Erin Richmond ,&nbsp;Janice E. Sullivan ,&nbsp;Steven J. Steiner","doi":"10.1016/j.cct.2024.107701","DOIUrl":"10.1016/j.cct.2024.107701","url":null,"abstract":"<div><h3>Background</h3><div>Significant barriers to advancing pediatric drug development continue despite federal incentives to expedite pediatric drug development. There is an urgent need to improve how clinical trials are designed, implemented, and conducted to increase the number of approved therapeutic interventions for children.</div></div><div><h3>Methods</h3><div>The Pediatric Improvement Collaborative for Clinical Trials &amp; Research was created to measure timelines and address delays in the pediatric clinical trials process. This multi-site collaborative prospectively monitored sixteen time points in industry-sponsored pediatric clinical drug trials, including times to budget approval, contract execution, ancillary protocol review, Institutional Review Board approval, Site Initiation Visit, and first patient consented.</div></div><div><h3>Results</h3><div>Twenty-four sites contributed data on 330 industry-sponsored pediatric drug studies. The average duration to final study budget approval was 121 (range 3–585) days, to final study Institutional Review Board (IRB) approval was 51 (range 1–205) days, to Site Initiation Visit was 204 (range 23–600) days, and to first patient consented was 239 (range 30–534) days.</div></div><div><h3>Conclusion</h3><div>Significant study start-up delays were noted in industry-sponsored clinical drug trials among a large group of pediatric sites. Delays and wide variation in all steps of the study process indicate multiple opportunities for improvement.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107701"},"PeriodicalIF":2.0,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142326780","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":"Collaborating to heal addiction and mental health in primary care (CHAMP): A protocol for a hybrid type 2a trial","authors":"John C. Fortney ,&nbsp;Anna D. Ratzliff ,&nbsp;Brittany E. Blanchard ,&nbsp;Lori Ferro ,&nbsp;Julien Rouvere ,&nbsp;Erin Chase ,&nbsp;Mark H. Duncan ,&nbsp;Joseph O. Merrill ,&nbsp;Tracy Simpson ,&nbsp;Emily C. Williams ,&nbsp;Elizabeth J. Austin ,&nbsp;Geoffrey M. Curran ,&nbsp;Michael Schoenbaum ,&nbsp;Patrick J. Heagerty ,&nbsp;Andrew J. Saxon","doi":"10.1016/j.cct.2024.107700","DOIUrl":"10.1016/j.cct.2024.107700","url":null,"abstract":"<div><h3>Background</h3><div>The gold-standard treatment for opioid use disorder (OUD) is medication for OUD (MOUD). However, less than a quarter of people with OUD initiate MOUD. Expanding the Collaborative Care Model (CoCM) to include primary care patients with OUD could improve access to and initiation of MOUD. This paper presents the methods and baseline sample characteristics of a Hybrid Type 2a trial comparing the effectiveness of CoCM for OUD and co-occurring mental health symptoms (MHS) to CoCM for MHS only.</div></div><div><h3>Method</h3><div>42 primary care clinics were cluster randomized and 254 primary care patients with OUD and elevated MHS were enrolled. Recruitment was terminated early by the Data and Safety Monitoring Board for futility. Participants completed research assessments at baseline, 3 months, and 6 months. The multiple primary outcomes were past-month number of days of nonmedical opioid use and SF12 Mental Health Component Summary (MCS) scores.</div></div><div><h3>Results</h3><div>MCS scores were over a standard deviation below the national mean (M = 34.5). Nearly half (47.6 %) of participants had previously overdosed in their lifetimes. Three quarters (76.0 %) were already being prescribed MOUD at baseline, only 30.4 % reported non-medical use of opioids, and only 33.9 % reported being bothered by opioid cravings.</div></div><div><h3>Conclusion</h3><div>The unexpectedly high proportion of enrollees already prescribed MOUD at baseline indicates that most patients were in the maintenance rather than acute phase of treatment. Challenges identifying and enrolling patients in the acute phase of OUD treatment implies that intervention effectiveness will depend on its success preventing the discontinuation of MOUD rather than initiating MOUD.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107700"},"PeriodicalIF":2.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342977","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":"Addressing diabetes by elevating access to nutrition (ADELANTE) - A multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes: A randomized controlled trial","authors":"Marcela D. Radtke ,&nbsp;Wei-Ting Chen ,&nbsp;Lan Xiao ,&nbsp;Patricia Rodriguez Espinosa ,&nbsp;Marcela Orizaga ,&nbsp;Tainayah Thomas ,&nbsp;Elizabeth Venditti ,&nbsp;Amy L. Yaroch ,&nbsp;Kenia Zepada ,&nbsp;Lisa G. Rosas ,&nbsp;June Tester","doi":"10.1016/j.cct.2024.107699","DOIUrl":"10.1016/j.cct.2024.107699","url":null,"abstract":"<div><h3>Background</h3><div>Latinx adults are disproportionately impacted by the interrelated challenges of food insecurity and nutrition sensitive chronic diseases. Food and nutrition insecurity can exacerbate the development and progression of chronic diseases, such as diabetes. Sustainable, effective interventions aimed at improving food insecurity and diabetes management for Latinx populations are needed.</div></div><div><h3>Methods</h3><div>This hybrid type 1 trial evaluates the effectiveness of a multi-level intervention that includes a medically supportive food and behavioral lifestyle program on the primary outcome of Hemoglobin A1c (HbA1c) at 6 months. Latinx adults (<em>n</em> = 355) with type 2 diabetes (HbA1c of 6.0–12.0 %), overweight/obesity (BMI &gt; 25 kg/m²), and self-reported risk of food insecurity will be randomized 1:1 to intervention (12 weekly deliveries of vegetables, fruits, and whole-grain foods + culturally-modified behavioral lifestyle program) versus control (food deliveries after a 6-month delay). Outcome asessments will occur at 0, 6 and 12 months, and include HbA1c, dietary intake, psychosocial health outcomes, and diabetes-related stressors. In addition, food insecurity and the impact of the intervention on up to two household members will be measured. Qualitative interviews with patients, healthcare providers, and community partners will be conducted in accordance with Reach, Effectivenes, Adoption, Implementation, and Maintenence (RE-AIM) framework to identify barriers and best practices for future dissemination.</div></div><div><h3>Conclusions</h3><div>The ADELANTE trial will provide novel insight to the effectiveness of a multi-level intervention on diabetes-related outcomes in Latinx adults. The mixed-method approach will also identity the reach of this ‘Food is Medicine’ intervention on additional household members to inform diabetes prevention efforts.</div><div>Clinical Trial Registration: <span><span>NCT05228860</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107699"},"PeriodicalIF":2.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342976","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":"Does cancer clinical trial enrollment for sexual and gender minority people differ from heterosexual, cisgender people?","authors":"Ash B. Alpert ,&nbsp;Juno Obedin-Maliver ,&nbsp;Annie Gjelsvik ,&nbsp;Siraj Amanullah ,&nbsp;Theresa I. Shireman ,&nbsp;John R. Blosnich","doi":"10.1016/j.cct.2024.107695","DOIUrl":"10.1016/j.cct.2024.107695","url":null,"abstract":"<div><h3>Background</h3><div>Sexual and gender minority (SGM) people experience cancer disparities compared to heterosexual and cisgender (non-SGM) people and likely have barriers to cancer clinical trial enrollment. Data are sparse, however, regarding cancer clinical trial enrollment for SGM versus non-SGM people.</div></div><div><h3>Methods</h3><div>Using data from the 2020 Behavioral Risk Factor Surveillance Survey (BRFSS), we applied a logistic regression to assess associations between SGM status and clinical trial enrollment for 346 SGM and 9441 non-SGM people diagnosed with cancer. The model was adjusted for age at diagnosis, race/ethnicity, partnership status, education, employment, and sex assigned at birth.</div></div><div><h3>Results</h3><div>SGM individuals had 94 % greater odds than non-SGM individuals to report participation in a clinical trial (aOR 1.94; 95 % CI 1.02–3.68) after adjusting for other factors.</div></div><div><h3>Conclusions</h3><div>Data from the BRFSS suggest that SGM people with cancer have higher odds of clinical trial enrollment compared to non-SGM people with cancer. Future work is needed to prospectively track oncology treatment, including clinical trial participation, and outcomes of SGM people versus non-SGM people with cancer. Other studies will be needed to develop and implement systematic, consistent, and non-stigmatizing sexual orientation and gender identity data collection methods.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107695"},"PeriodicalIF":2.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281566","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":"Effect of time restricted eating versus current practice in dietetics on glycaemic control and cardio-metabolic outcomes in individuals at risk of developing type 2 diabetes: Protocol for a multi-centre, parallel group, non-inferiority, randomised controlled trial","authors":"Rasha Charrouf ,&nbsp;Evelyn B. Parr ,&nbsp;Amy T. Hutchison ,&nbsp;Steve A. Flint ,&nbsp;Xiao Tong Teong ,&nbsp;Gary Wittert ,&nbsp;Andrew D. Vincent ,&nbsp;Leah Brennan ,&nbsp;Brooke L. Devlin ,&nbsp;John A. Hawley ,&nbsp;Leonie K. Heilbronn","doi":"10.1016/j.cct.2024.107696","DOIUrl":"10.1016/j.cct.2024.107696","url":null,"abstract":"<div><h3>Background</h3><p>Time restricted eating (TRE) is a dietary strategy that may improve metabolic health. However, no studies have compared TRE with current practice (CP) in dietetics.</p></div><div><h3>Hypothesis</h3><p>TRE will not be inferior to CP to improve glycaemic control in individuals at risk of type 2 diabetes (T2D).</p></div><div><h3>Methods</h3><p>This parallel group, randomised, non-inferiority, controlled trial randomised 247 participants by site and glycated haemoglobin (HbA1c) into TRE or CP (1:1) for 12 months. Participants were aged 35–70 years, with a body mass index (BMI) &gt;25 but &lt;45 kg/m², and score ≥15 on the Australian type 2 diabetes risk (AUSDRISK) assessment, without a diagnosis of T2D. Study visits were balanced between groups and all participants received five consultations at 0, 0.5, 1, 2 and 3 months. TRE followed a self-selected 9 h eating window (≥0600 and ≤1900), whereas CP followed Australian dietary guidelines.</p></div><div><h3>Outcomes</h3><p>The primary endpoint is the estimate of group mean difference (TRE vs CP) of HbA1c at 4 months in a covariate linear regression adjusting for stratification factors and sex. Secondary efficacy outcomes at 4 and 12 months are changes in fasting glucose, fasting insulin, HOMA-IR and nocturnal glucose by continuous glucose monitor incremental area under the curve and change in HbA1c at 12 months. Other endpoints are exploratory and will not be adjusted for multiplicity.</p></div><div><h3>Conclusions</h3><p>We will determine whether TRE is an alternate strategy to current practice in dietetics to improve glucose control.</p><p><strong>Trial registration:</strong> <span><span>NCT04762251</span><svg><path></path></svg></span>; 21 Feb 2021.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107696"},"PeriodicalIF":2.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002799/pdfft?md5=acd72838f482adbb9b38430b3eb361a6&pid=1-s2.0-S1551714424002799-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142274850","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}