Contemporary clinical trials最新文献

{"title":"The Investigation of Vitamin D and Menstrual Cycles Trial (the inVitD Trial): A clinical trial of vitamin D supplementation on the hypothalamic-pituitary-ovarian axis","authors":"Michelle R. Klawans ,&nbsp;Olivia Kohrman ,&nbsp;W. Braxton Jackson II ,&nbsp;Chandra L. Jackson ,&nbsp;Christine N. Metz ,&nbsp;Ganesa Wegienka ,&nbsp;Alison Motsinger-Reif ,&nbsp;Anne Z. Steiner ,&nbsp;Donna D. Baird ,&nbsp;Dale P. Sandler ,&nbsp;Anne Marie Z. Jukic","doi":"10.1016/j.cct.2025.108176","DOIUrl":"10.1016/j.cct.2025.108176","url":null,"abstract":"<div><h3>Background</h3><div>While there is evidence that vitamin D deficiency is associated with long menstrual cycles, delayed ovulation, and reduced fertility, it is yet unknown if increasing vitamin D levels can regulate menstrual cycles, and thus possibly improve fertility. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that vitamin D supplementation influences the hypothalamic-pituitary-ovarian axis.</div></div><div><h3>Methods</h3><div>This two-site RCT (<span><span>NCT05050916</span><svg><path></path></svg></span>) required participants to be aged 19–40 years old, having spontaneous menstrual cycles, and without certain chronic diseases or contraindications for vitamin D supplementation. At baseline participants provided information on their demographics and health history. Blood was drawn at the first clinic visit after which participants collected daily urine samples for one menstrual cycle (phase 1). Those with a 25-hydroxyvitamin D level less than 20 ng/ml (“low”) received cholecalciferol supplementation (randomized to either 4200 IU/week or 50,000 IU/week). A random sample of those without low vitamin D received placebo. Supplement (or placebo) was taken for three menstrual cycles which included collection of daily urine samples and home ovulation testing (phase 2). Participants collected self-administered vaginal and oral swabs and a subset collected menstrual effluent samples. Finally, participants kept a daily menstrual diary and weekly behavior diaries. The primary endpoints were mid-luteal progesterone, rate of estrogen rise, and pre-ovulatory luteinizing hormone.</div></div><div><h3>Discussion</h3><div>Findings from this RCT will provide insight into the relationship between vitamin D supplementation and menstrual cycle hormones. Vitamin D shows promise as a low-cost, non-hormonal intervention to regulate menstrual cycles.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108176"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681682","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 PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial","authors":"Rebecca K. Sripada ,&nbsp;James Garlick ,&nbsp;Naomi Hemphill ,&nbsp;Heather M. Walters ,&nbsp;Dara Ganoczy ,&nbsp;H. Myra Kim ,&nbsp;Kara Zivin ,&nbsp;Andrea L. Nevedal ,&nbsp;Kimberly M. Avallone ,&nbsp;Jeffrey A. Cigrang ,&nbsp;Sheila A.M. Rauch","doi":"10.1016/j.cct.2025.108174","DOIUrl":"10.1016/j.cct.2025.108174","url":null,"abstract":"<div><h3>Background</h3><div>Healthcare workers and first responders are frequently exposed to traumatic events and subsequently are more susceptible to posttraumatic stress disorder (PTSD), but few receive treatment. Although Employee Assistance Programs (EAPs) are available at almost all large-sized companies, they lack the capacity to provide time-intensive first-line treatments for PTSD. To address this problem, our study team adapted a standard first-line PTSD treatment into a brief, 4–6 session format (Processing Emotions in Primary Care; PE-PC) and demonstrated its efficacy in military and veteran populations. This paper describes a study protocol to leverage the existing resource of the EAP to test intervention effectiveness among healthcare workers and first responders with treatment need.</div></div><div><h3>Method</h3><div>We are currently conducting a Hybrid Type 1 Effectiveness-Implementation trial to test the effectiveness of PE-PC, delivered by EAP counselors, versus EAP treatment as usual (TAU) in 360 healthcare workers and first responders with PTSD, and gather data regarding implementation. The specific aims are to compare the effectiveness of PE-PC versus EAP TAU in reducing PTSD symptoms at 6-week (post-treatment), 3-, and 6-month follow-ups, and prepare for future implementation through process evaluation and implementation mapping. We expect the study to yield an implementation strategy that is targeted to address EAP-specific implementation barriers.</div></div><div><h3>Conclusions</h3><div>This project will contribute a point-of-care intervention for frontline healthcare workers and first responders with PTSD, thus improving clinical practice for populations vulnerable to PTSD and increasing preparedness for public health emergencies.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT05751473</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108174"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696068","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 the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial","authors":"Thrinisha Malpeddi ,&nbsp;Selvamuthu Poongulali ,&nbsp;Jonathan Shuter ,&nbsp;Nancy A. Rigotti ,&nbsp;Lawrence C. An ,&nbsp;Nagalingeswaran Kumarasamy ,&nbsp;Krishna P. Reddy ,&nbsp;Elena Shergina ,&nbsp;Kathryn Colborn ,&nbsp;Beulah Faith ,&nbsp;Yamila L. Sierra ,&nbsp;Gina R. Kruse","doi":"10.1016/j.cct.2025.108179","DOIUrl":"10.1016/j.cct.2025.108179","url":null,"abstract":"<div><h3>Introduction</h3><div>The use of tobacco remains a significant health concern among people with HIV (PWH) in India, exacerbating comorbidities, increasing the risk of HIV-related complications and reducing the effectiveness of antiretroviral therapy. This protocol outlines a randomized trial designed to evaluate the effectiveness, cost and implementation of a tobacco cessation intervention for PWH in India.</div></div><div><h3>Methods</h3><div>This is a type 1 hybrid implementation effectiveness study including a clinical trial (<em>n</em> = 400) randomizing adults who smoke 1:1 to varenicline and Positively Smoke Free Mobile (PSF-M), a theory-based, digital, behavioral intervention versus a standard care control of brief cessation advice and Quitline referral. The primary outcome is cotinine-validated 7-day point prevalence abstinence from tobacco at 24 weeks post-randomization. Implementation outcomes of acceptability, adoption, appropriateness, feasibility, fidelity, penetration, and sustainability will be measured by survey and interviews. Cost-effectiveness of the intervention will be calculated using a simulation model of tobacco and nicotine outcomes.</div></div><div><h3>Conclusion</h3><div>This study will test the effectiveness of a scalable and comprehensive tobacco use treatment approach with medication plus digital behavioral support in a low- and middle-income country setting, paired with examination of implementation and cost-effectiveness. This research has the potential to improve the health of PWH by demonstrating the health effects of a tobacco cessation treatment package that aims to reduce the morbidity and mortality associated with smoking.</div><div><strong>Trial Registration</strong></div><div><span><span>clinicaltrials.gov</span><svg><path></path></svg></span> #<span><span>NCT05786547</span><svg><path></path></svg></span>, Registered 27 March 2023.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108179"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of the stellate ganglion block for posttraumatic stress disorder in veterans: Rationale for and methods of a multisite trial","authors":"Michael Hollifield ,&nbsp;Charles Brock ,&nbsp;Kelvin Lim ,&nbsp;Paul Holtzheimer ,&nbsp;Michael Alkire ,&nbsp;Franz Macedo ,&nbsp;Michelle J. Bovin ,&nbsp;Tyler Smith ,&nbsp;Jennifer Romesser ,&nbsp;Michael Messina ,&nbsp;Tanja Jovanovic ,&nbsp;Seth Norrholm ,&nbsp;Anastasia Krajec","doi":"10.1016/j.cct.2025.108180","DOIUrl":"10.1016/j.cct.2025.108180","url":null,"abstract":"<div><div>Posttraumatic Stress Disorder (PTSD) is a debilitating disorder characterized by re-experiencing aspects of the original trauma, avoidance of trauma reminders, negative alterations in cognition and mood, and hyperarousal. Current evidence-based treatments for PTSD have both value and limitations, most notably slow response and high withdrawal rates. The field is searching for more rapid and highly effective interventions. The Stellate Ganglion Block (SGB), which has historically been used to treat regional pain syndromes, causalgia (nerve injury), and intractable angina, has support for being a rapid and highly effective intervention from multiple case series. However, one of two published RCTs was negative and the other had limitations. A larger more definitive study is necessary to provide the evidence needed to determine if SGB is an effective intervention. This paper describes the background, theory and methods of a multi-site triple-blind placebo-controlled trial about the efficacy and safety of the SGB for PTSD. Elements that make this a more definitive study include using and describing a reliably conducted sham, using a standard dose of anesthetic, including an untreated group, rigorously assessing side-effects and safety, and evaluating durability, enhanced dosing, and an objective physiological outcome measure (fear-potentiated startle) to evaluate treatment response in addition to the clinical effect. The strengths and limitations of this research are also presented.</div></div><div><h3>Clinical trial registration</h3><div>This study is registered on <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID <span><span>NCT05169190</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108180"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681683","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 a randomized controlled trial of the Let's Connect® intervention: A trauma-responsive, emotion-focused parenting skills program","authors":"Marcela Torres Pauletic,&nbsp;Kimberly Shipman,&nbsp;Christine M. Steeger,&nbsp;Megan Holton,&nbsp;Jill Trammell","doi":"10.1016/j.cct.2025.108177","DOIUrl":"10.1016/j.cct.2025.108177","url":null,"abstract":"<div><h3>Background</h3><div>This paper outlines the study protocol for an evaluation of the Let's Connect® (LC) parenting program. LC is a trauma-responsive, emotion-focused parenting program that teaches parents/caregivers to identify and respond to children's emotional needs and behaviors in a way that builds connection and warmth and promotes children's emotional competence, mental and behavioral health, and overall well-being. In a randomized controlled trial (RCT), this project will evaluate the efficacy of LC in a virtual delivery format with families who are at-risk for or have experienced trauma, violence, and/or other adverse life events.</div></div><div><h3>Methods</h3><div>We will recruit up to 200 parent-child dyads (children ages 4–14 years) and randomize them to the 14-week LC intervention condition or waitlist control condition. Primary outcomes include parent well-being, parenting practices, child well-being, and child social-emotional competencies. Outcomes will be assessed using parent and child report questionnaires, parent interview, and observational data at three time points: baseline (T1), posttest (T2; ∼14 weeks after baseline), and follow-up (T3; 6-months after posttest). Intent-to-treat analyses will be used to estimate intervention effects across the three assessment points.</div></div><div><h3>Conclusion</h3><div>This study is the first RCT of the LC parenting intervention that will evaluate its efficacy and will contribute to evidence of innovative and culturally responsive, emotion-focused parenting interventions in a sustainable delivery format. This trial is preregistered on the Open Science Framework (<span><span>https://osf.io/xd5he/</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108177"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696078","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":"Personalising the management of obesity-related asthma using medical nutrition therapy and physical activity prescription: The IDEAL study protocol","authors":"Tamara Blickisdorf ,&nbsp;Lisa G. Wood ,&nbsp;Sarah R. Valkenborghs ,&nbsp;Anne E. Dixon ,&nbsp;Jay C. Horvat ,&nbsp;Natasha A. Weaver ,&nbsp;Serene Yoong ,&nbsp;Bronwyn S. Berthon ,&nbsp;Evan J. Williams ,&nbsp;Alexandra C. Brown ,&nbsp;Christine R. Jenkins ,&nbsp;Meagan L. Morrissey ,&nbsp;Peter A. Wark ,&nbsp;Katie Wynne ,&nbsp;Christopher L. Grainge ,&nbsp;Emad M. El-Omar ,&nbsp;Lily M. Williams ,&nbsp;John D. Brannan ,&nbsp;Liang De Wang ,&nbsp;Siu Ling Wong ,&nbsp;Hayley A. Scott","doi":"10.1016/j.cct.2025.108178","DOIUrl":"10.1016/j.cct.2025.108178","url":null,"abstract":"<div><h3>Background</h3><div>Obesity is associated with more severe asthma symptoms, more frequent exacerbations, and more frequent asthma-related hospitalisations compared to adults without obesity. Because the origins and expression of obesity varies between individuals, a one-size-fits-all approach to obesity management will not address the underlying cause(s), increasing the risk of treatment failure. We hypothesise that obesity-related asthma is driven by excess adiposity, poor diet quality, physical inactivity, and poor metabolic health, while an individualised obesity management intervention, utilising medical nutrition therapy and personalised physical activity prescription, will result in better asthma control.</div></div><div><h3>Methods</h3><div>The Individualised Diet and Exercise Intervention for Optimising Asthma Control and Lung Function (IDEAL) Study will test the first individualised obesity management approach for people with asthma. In this 16-week randomised controlled trial with 12-month follow-up, 102 adults with obesity and uncontrolled asthma will be randomised to either the IDEAL program or control group. Participants will be assessed for outcomes at baseline, 16 and 52 weeks. Participants randomised to the IDEAL Program will attend five sessions with a dietitian and physiotherapist/exercise physiologist during the 16-week intervention period. We will test the intervention effect on asthma (asthma control, lung function), inflammatory (e.g. sputum cell counts, plasma IL-6) and non-asthma outcomes (e.g. diet quality, physical activity levels, metabolic health), as well as the acceptability and cost of the intervention.</div></div><div><h3>Conclusion</h3><div>This trial aims to provide people living with asthma and obesity an effective and sustainable way to help control their asthma symptoms and will assess mechanisms responsible for any improvements observed.</div></div><div><h3>Ethics/Registrations</h3><div><strong>NSW REGIS ETHICS Reference:</strong> 2023/ETH00833.</div><div><strong>UoN IBC Reference No:</strong> SP-23-92.</div><div><strong>ANZCTR Reference No:</strong> ACTRN12623000979651.</div><div><strong>Universal Trial Number</strong>: U1111–1291–8501.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108178"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696106","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":"Assessing the feasibility, acceptability, and efficacy of a pragmatic pilot and full-scale trial to improve care for older adults with complex care needs: The SPIRE study","authors":"Thomas G. Travison ,&nbsp;Edward Pham ,&nbsp;Karen Donelan ,&nbsp;Stephen J. Bartels ,&nbsp;Jocelyn A. Carter ,&nbsp;Kathryn Corelli ,&nbsp;Steven R. Counsell ,&nbsp;Maggie Crean ,&nbsp;Ellen Flaherty ,&nbsp;Carie Michael ,&nbsp;Daniel S. Moran ,&nbsp;Harvey J. Murff ,&nbsp;Jennifer Perloff ,&nbsp;Christine S. Ritchie","doi":"10.1016/j.cct.2025.108072","DOIUrl":"10.1016/j.cct.2025.108072","url":null,"abstract":"<div><div>Older adults with complex health and social care needs comprise some 5% of the United States population but contribute roughly half of healthcare costs. Patient and caregiver perspectives in qualitative studies emphasize care fragmentation in traditional care delivery models. The need for more streamlined and personalized care for these older adults is acute, particularly in value-based care systems such as Accountable Care Organizations (ACOs). Prior studies suggest that older adults with complex health needs are best cared for through person-centered care plans conducted by interdisciplinary teams of healthcare professionals, but adoption remains suboptimal. In this study, we compare two different geriatric-focused approaches to care for older adults: Annual Wellness Visits (AWV) and/or AWV augmented with GRACE (Geriatric Resources for Assessment and Care of Elders). AWVs are a Medicare benefit with a brief geriatric assessment; GRACE is a geriatric model of care that uses a home-based geriatric assessment, structured protocols, team-based care planning and primary care co-management to support older adults with complex care needs. The two-phase study includes a Phase 1 feasibility pilot, conducted in two primary care practices in one health system; and a Phase 2 cluster-randomized trial conducted in 32 primary care practices in four ACOs. Phase 2 assesses the comparative effectiveness of AWVs vs. AWV with GRACE, with primary outcomes of hospitalizations and patient experience, and secondary outcomes of caregiver strain and clinician professional fulfillment. Results will help inform personalized care among older adults with complex health needs.</div><div><span><span>NCT06287801</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108072"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999810","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":"Assessment of a novel functional food modulating the microbiota-inflammation-brain axis in patients with heart failure and/or /atrial fibrillation patients (the AMBROSIA study): Protocol for a randomized controlled trial","authors":"Simone Baldi ,&nbsp;Francesca Cuffaro ,&nbsp;Edda Russo ,&nbsp;Kate Porter ,&nbsp;William Cheung ,&nbsp;Maria Magdalena Coman ,&nbsp;Marco Garcia Vaquero ,&nbsp;Thomas Lingner ,&nbsp;Maria Cristina Verdenelli ,&nbsp;Gwendolyn Barceló-Coblijn ,&nbsp;Iain Brownlee ,&nbsp;Stefano Fumagalli ,&nbsp;Amedeo Amedei","doi":"10.1016/j.cct.2025.108170","DOIUrl":"10.1016/j.cct.2025.108170","url":null,"abstract":"<div><h3>Background and aims</h3><div>Atrial fibrillation (AF), heart failure (HF), and undernutrition represent a complex triad with major clinical and socioeconomic consequences in older adults, often predisposing to frailty. Undernutrition often remains underdiagnosed due to a reliance on weight-based measures and limited awareness of inflammation-related cachexia. The AMBROSIA study aims to fill these gaps by exploring the response of the microbiota–inflammation–brain axis to a targeted, fortified food product-based intervention, with comprehensive outcome assessments, alongside mechanistic/exploratory -omics analyses and gut microbiota (GM) functional profiling.</div></div><div><h3>Methods and results</h3><div>This single-center, prospective, parallel-group randomized controlled trial aims to enroll 120 older adults with confirmed AF and/or HF. Participants will be randomized 1:1 into an intervention group (<em>n</em> = 60) or control group (n = 60). All participants receive individualized dietary counseling; the intervention group additionally consumes one AMBROSIA nutritional bar daily for six months. The bar contains hydrolyzed proteins, inulin, CoQ₁₀, and probiotics (<em>L. rhamnosus</em> IMC 501® and L. <em>paracasei</em> IMC 502®) in a flavonoid-rich chocolate matrix. Clinical, cognitive, and nutritional data, along with blood, saliva, urine, and stool samples, will be collected at baseline, 3, and 6 months. The primary endpoint is the change in skeletal muscle mass, physical function and frailty, while secondary endpoints include changes in nutritional status, inflammation, GM, metabolomics, and quality of life.</div></div><div><h3>Conclusion</h3><div>By integrating cutting-edge omics tools and a multidimensional nutritional strategy, AMBROSIA aims to uncover mechanisms driving undernutrition and identify biomarkers to support personalized interventions for older patients with AF and HF.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108170"},"PeriodicalIF":1.9,"publicationDate":"2025-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145654007","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":"Pilot randomized trial of cash transfer interventions to improve health outcomes in low income adults with poorly controlled type 2 diabetes: Study protocol and baseline characteristics","authors":"Jennifer A. Campbell,&nbsp;Rebekah J. Walker,&nbsp;Leonard E. Egede","doi":"10.1016/j.cct.2025.108171","DOIUrl":"10.1016/j.cct.2025.108171","url":null,"abstract":"<div><h3>Background</h3><div>Monetary interventions, such as cash transfers, have emerged as important intervention approaches to address the complex determinants at the structural and individual level impacting diabetes outcomes.</div></div><div><h3>Methods</h3><div>This NIH funded (K01DK131319), pilot randomized controlled trial (RCT) is an ongoing 5 year study to evaluate the efficacy of two diabetes-tailored cash transfer interventions in low-income adults in which 1) cash transfers are conditional on participating in nurse-led, telephone-delivered diabetes education/skills training and stress/coping intervention delivered every 2 weeks for 6 months (DM-CCT); or 2) cash transfers are unconditional (DM-UCT), on clinical outcomes (HbA1c and blood pressure), and quality of life among 100 African Americans aged 18+ years with T2DM and HbA1c ≥8 %. Assessments will be conducted at baseline, 3-, and 6-months with primary outcome at 6 months post-randomization.</div></div><div><h3>Discussion</h3><div>Recruitment began in March 2023 and was completed in February 2024. Average age was 51 years. Most participants were women (71.0 %). Mean HbA1c was 10.1±1.8 for DM-CCT group and 10.2±1.8 for DM-UCT group. Mean systolic and diastolic blood pressure was 128.0±22.7 mmHg and 80.2±13.7 mmHg for DM-CCT group and 133.5±22.2 mmHg and 83.7±13.7 mmHg for DM-UCT group. Mean BMI was 36.2±10.3 kg/m² for DM-CCT and 35.7±9.2 kg/m² for DM-UCT. This pilot RCT represents a promising intervention to address the underlying poverty driven social risk factors while simultaneously addressing diabetes specific behaviors to improve outcomes. Findings from this study will provide preliminary evidence on efficacy of cash transfer interventions to improve clinical outcomes in low-income adults with poorly controlled T2DM.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108171"},"PeriodicalIF":1.9,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630892","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":"Effects of daily low oxygen exposure on weight status, body composition, and metabolic health in adults with obesity: protocol for a randomized, double-blind, controlled-feeding study","authors":"Terrence M. Riley ,&nbsp;Camila Weschenfelder ,&nbsp;Eric Ravussin ,&nbsp;Jennifer C. Rood ,&nbsp;Frank Greenway ,&nbsp;Sarah Taff ,&nbsp;Robert C. Hickner ,&nbsp;Hongyuan Cao ,&nbsp;Angelina R. Sutin ,&nbsp;Gregory Todd ,&nbsp;Stephen R. Hennigar ,&nbsp;Claire E. Berryman","doi":"10.1016/j.cct.2025.108167","DOIUrl":"10.1016/j.cct.2025.108167","url":null,"abstract":"<div><h3>Background</h3><div>Diet and exercise are the cornerstone of obesity prevention and treatment. However, a substantial number of individuals are non-responsive to existing weight-loss interventions and obesity rates continue to rise. Daily exposure to low-oxygen conditions may aid in current weight-loss strategies by increasing resting metabolic rate and decreasing appetite. Whether in-home, overnight, normobaric hypoxic exposure promotes body weight loss in adults with obesity remains unknown.</div></div><div><h3>Methods</h3><div>Fifty adults with obesity (BMI: 30–39.9 kg/m²) will complete this double-blind, parallel-arm, randomized, controlled-feeding clinical trial. Participants will be provided with a weight maintenance diet for 2 weeks while undergoing baseline measurements. Following the weight maintenance phase, an energy restricted diet (500 kcal/day below weight maintenance needs) will be provided in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% oxygen, elevation ∼2,640 m) or normoxia (8 h/night, 21% oxygen, elevation ∼60 m), using a commercially available, in-home tent system, for 8 weeks. The primary outcome is the difference in body weight change between interventions. Secondary outcomes include measures of body composition, total and resting energy expenditure, energy intake from an ad libitum meal, insulin sensitivity and glycemic control, sympathetic tone, iron absorption and indicators of iron status, stool microbial diversity and composition, appetite, psychosocial factors, and sleep quantity and quality.</div></div><div><h3>Discussion</h3><div>Chronic, overnight, low oxygen exposure may provide a novel intervention to supplement current weight-loss strategies, inform new strategies to accelerate weight loss, and aid long-term weight management efforts in adults with obesity.</div></div><div><h3>Clinical trial registration</h3><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT05289310</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108167"},"PeriodicalIF":1.9,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615978","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}