Contemporary Clinical Trials[JOURNAL]
Sun
200 papers
Mazdutide versus Semaglutide for the treatment of type 2 diabetes and obesity: Rationale, design and baseline data of DREAMS-3 phase 3 trial.
Luo Y, Jiang H, Shi B … +13 more , Cai H, Wang H, Li S, Qiu W, Li Y, Zhou R, Deng H, Guo Q, Li L, Pei L, Zhang HH, Qian L, Ji L
Contemp Clin Trials · 2026 Jan · PMID 41260459 · Publisher ↗
BACKGROUND: Effective weight management and glycemic control are both important in people with type 2 diabetes (T2D) and obesity. Despite the proven benefits of GLP-1 receptor agonists, there is a persistent need for mor...
BACKGROUND: Effective weight management and glycemic control are both important in people with type 2 diabetes (T2D) and obesity. Despite the proven benefits of GLP-1 receptor agonists, there is a persistent need for more effective weight management strategies in the treatment of T2D and obesity. Glucagon receptor-based co-agonists, such as mazdutide, represent a promising therapeutic class with the potential for enhanced weight loss compared to current standards of care. However, robust clinical evidence for these agents in populations with T2D and obesity is still lacking. The DREAMS-3 trial is designed to address this gap by directly comparing the efficacy and safety of mazdutide against semaglutide, a widely used GLP-1 receptor agonist, in Chinese adults with T2D and obesity. The results will provide crucial evidence to inform clinical decision-making for this large patient population. METHODS: DREAMS-3 is a randomized, open-label phase 3 trial. Obese Participants (BMI ≥ 28 kg/m) diagnosed with T2D (≤ 10 years) who had inadequate glycemic control after diet and exercise alone with/without metformin were randomized in a 1:1 ratio to receive mazdutide 6 mg or semaglutide 1 mg once weekly in the 32-week active-controlled treatment period, followed with a 24-week extension period. The primary endpoint is the proportion of participants achieving glycated hemoglobin <7.0 % and weight reduction of ≥10 % at week 32. RESULTS: A total of 349 participants were enrolled and randomized, the overall mean age was 42.4 years, 44.7 % of participants were male. The mean baseline duration of T2D was 1.8 years, and 39.5 % of participants were on metformin. The mean glycated hemoglobin was 8.0 %, body weight was 90.5 kg, BMI was 33.0 kg/m. Most participants had at least one comorbidity. The prevalence of some comorbidities (such as metabolic associated fatty liver disease, gout/hyperuricemia) showed strong association of BMI. CONCLUSION: DERAMS-3 is the first head-to-head trial to compare the efficacy and safety of mazdutide versus semaglutide in Chinese adults with T2D and obesity, with an expected completion date in early 2026.
A comparison of institutional review board models and study efficiency in the Environmental influences on Child Health Outcomes Cohort Consortium.
Kohlmann T, Chen A, Armsby P … +12 more , Copeland CAF, Gentry T, Jordan M, Morris M, Trampe A, Angal J, Taylor LS, Stroustrup A, Camargo CA, Yanez ND, Smith PB, ECHO Cohort Consortium
Contemp Clin Trials · 2026 Jan · PMID 41232754 · Full text
BACKGROUND: Institutional review board (IRB) approval is a key step in site activation and study initiation. Single IRBs aim to improve the timeliness of IRB review through centralization and standardization, whereas loc...
BACKGROUND: Institutional review board (IRB) approval is a key step in site activation and study initiation. Single IRBs aim to improve the timeliness of IRB review through centralization and standardization, whereas local IRBs conduct reviews only for specific sites. In Cycle 1 of the Environmental influences on Child Health Outcomes (ECHO) Cohort Consortium, 110 sites chose either single or local IRB review, providing the opportunity to compare the efficiency of single versus local IRBs within one multicenter observational study. OBJECTIVES: Data were collected from the ECHO Coordinating Center at the Duke Clinical Research Institute. Primary outcomes included: 1) time from IRB submission to approval and 2) time from regulatory pack receipt to first participant enrollment. Secondary outcomes included: 1) time from regulatory pack receipt to IRB submission, 2) time from IRB approval to site activation, and 3) time from site activation to first participant enrollment. We compared these outcomes between sites using local versus single IRBs. RESULTS: No significant differences were identified between the local and single IRB groups for the primary and secondary outcomes. The time from IRB submission to approval was similar for local and single IRBs (median [IQR]: 20 days [10-33]; 19 days [11-27]; p = 0.71, respectively). The time from regulatory pack receipt to first participant enrollment was similar for local and single IRBs (median [IQR]: 243 days [16-309]; 191 days [137-233]; p = 0.50, respectively). CONCLUSION: Multiple factors influence review timelines. Single IRBs do not guarantee faster review; additional work is needed to evaluate their impact on study timelines.
Strategies and challenges for the recruitment of young healthy participants in the dietary approaches to longevity and health (DiAL health) pilot trial.
Cabre HE, Peterson CM, Dutton GR … +9 more , Drews KL, Broyles ST, Dubin R, Rogers LQ, Champagne C, Villareal DT, Hsia DS, Redman LM, Martin CK
Contemp Clin Trials · 2026 Jan · PMID 41232753 · Full text
BACKGROUND: Understanding the impact of nutrition on human aging requires long-term trials in young, healthy, unmedicated adults. As part of the Dietary Approaches for Longevity and Health (DiAL Health) pilot project, we...
BACKGROUND: Understanding the impact of nutrition on human aging requires long-term trials in young, healthy, unmedicated adults. As part of the Dietary Approaches for Longevity and Health (DiAL Health) pilot project, we evaluated strategies for recruiting this population for aging-related dietary intervention studies. METHODS: We analyzed recruitment costs to enroll 70 participants (ages 25-49, BMI 22.0-29.9 kg/m) across two DiAL Health sites and used NHANES data (2017-March 2020) to estimate the proportion of U.S. adults meeting partial trial eligibility. Additionally, a formative study surveyed 492 U.S. adults (≥18 years) to assess interest in aging-focused dietary trials. RESULTS: Of 2049 applicants screened, 70 were enrolled (3.4 %), with recruitment costs of $1572 per participant at site 1 and $625 at site 2. NHANES data revealed only 3.6 % (555/15,560) of adults met partial eligibility criteria, while 2.2 % (11/492) of formative survey respondents met full eligibility. DiAL Health eligible participants were willing to participate in dietary interventions like time-restricted eating or caloric restriction, but willingness declined for longer or more burdensome trials. CONCLUSIONS: Recruiting young, healthy, unmedicated individuals for aging-focused dietary intervention trials is challenging due to low rates of eligibility and enrollment (∼3-4 % of initial applicants enrolled). Longer trials with stricter eligibility are likely to face greater recruitment barriers, highlighting the need for targeted strategies to engage, recruit, and retain this population effectively.
Enhanced trial efficiency of the novel "contemporaneous control recapture" parallel-cohort RCT design: Methods and application in the CRITICAL-Kids-TP trial.
Sochet AA, Amankwah EK, Andalib V … +5 more , Jaffray J, Male C, Faustino EV, Goldenberg NA, Pedi-ATLAS Group and the Antithrombotic Trials Working Party of the Pediatric Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis
Contemp Clin Trials · 2026 Jan · PMID 41223938 · Publisher ↗
The efficiency and generalizability of the traditional randomized clinical trial (RCT) design are reduced by the exclusion of otherwise eligible participants who decline randomization or undergo early withdrawal due to m...
The efficiency and generalizability of the traditional randomized clinical trial (RCT) design are reduced by the exclusion of otherwise eligible participants who decline randomization or undergo early withdrawal due to missed protocol-specified windows for randomization and/or first dose of the investigational drug. These limitations are particularly challenging for RCTs targeting rare diseases. In this report, we describe a novel adaptation to the previously-described "parallel-cohort RCT design", in which these up-front losses in an RCT are recaptured into a parallel, non-randomized, contemporaneous control cohort that augments the randomized controls. We also outline various statistical approaches employed to assure congruence of this non-randomized control group to the control arm of the randomized population, prior to analysis. Lastly, we describe the application of the "contemporaneous control recapture" parallel-cohort RCT design in the CRITICAL-Kids-TP trial (www.clinicaltrials.gov; NCT06628778), a proposed phase 3 trial of pharmacological thromboprophylaxis versus usual care (no pharmacological thromboprophylaxis) in critically ill adolescents.
Analytical treatment interruption as a tool in the evaluation of immune-mediated interventions for long-term antiretroviral-free control of HIV-1 among people with HIV.
Pires Dos Santos AG, Abunimeh M, Mothe B … +13 more , Routy JP, Lalezari JP, Sinclair GI, Sokhela SM, Diaz RS, Schwarze S, Berry J, Lewin SR, Dubé K, Krishnan P, Topp A, Gill S, Cohen D
Contemp Clin Trials · 2026 Jan · PMID 41218692 · Publisher ↗
BACKGROUND: Immune-mediated interventions have the potential to induce long-term antiretroviral treatment (ART)-free viral suppression in people with HIV. However, in the absence of biomarkers of viral control, studies l...
BACKGROUND: Immune-mediated interventions have the potential to induce long-term antiretroviral treatment (ART)-free viral suppression in people with HIV. However, in the absence of biomarkers of viral control, studies looking at immune interventions require a planned long-term analytical treatment interruption (ATI) that may bring risks to participants and challenges for data interpretation. Herein, we describe an ongoing, global, proof-of-concept, randomized, placebo-controlled, phase 2 clinical trial with a planned ATI and illustrate how those risks have been mitigated to safely evaluate the long-term durability of ART-free viral control. METHODS: The trial evaluates an immunologic combination of low-dose budigalimab and trosunilimab administered during ATI. Adults aged 18-70 with confirmed HIV-1 on stable ART with viremia below the limit of detection and CD4+ counts >500 cells/mL willing to undergo ATI are randomized to receive budigalimab, trosunilimab, both (at 2 different trosunilimab doses), or neither. The primary efficacy endpoint is the proportion of participants achieving viral control (HIV-1 RNA <1000 copies/mL) without restarting ART at week 24. The planned ATI duration (≤112 weeks) evaluates the durability of off-ART viral control, long-term safety, and biomarkers. Key ATI elements align with published consensus recommendations [1] while incorporating feedback from members of the global HIV community. CONCLUSIONS: By sharing this study design, we hope to inform on the lessons learned from operationalizing a global study evaluating durable ART-free viral control, including the critical role of engaging members of the HIV community during clinical trial design to ensure the success of an ATI-inclusive study.
Trial of SiTes to IncreAse diversity in clinical TriaLs (TOTAL): A study protocol paper.
Wangdak Yuthok TY, Rodriguez AD, Ritter V … +10 more , Cruz ER, Okeke DA, Judge F, Vesom N, Shen S, Qin F, Brown-Johnson CG, Palaniappan L, Onwuanyi A, Lewis E
Contemp Clin Trials · 2026 Jan · PMID 41218691 · Publisher ↗
The Trial Of Sites to Increase Diversity in Clinical Trials (TOTAL) addresses the critical issue of underrepresentation in cardiometabolic clinical trials. Despite existing initiatives, disparities in trial participant r...
The Trial Of Sites to Increase Diversity in Clinical Trials (TOTAL) addresses the critical issue of underrepresentation in cardiometabolic clinical trials. Despite existing initiatives, disparities in trial participant racial and ethnic diversity persist, limiting the generalizability of findings and health equity. This study aims to evaluate the effectiveness of three diversity-enhancing recruitment strategies (DERS)-virtual community ambassadors, population-based research registries, and social media ads-compared to usual recruitment methods. A hybrid implementation-effectiveness cluster RCT design will randomize 36 cardiovascular clinical trial sites across the US to one of these 4 arms. The main outcome assessed is the proportion of underrepresented participants pre- and during the intervention. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, the study will assess recruitment effectiveness for historically underrepresented participants. Data collection includes de-identified demographic, screening, and enrollment information analyzed through robust statistical methods, including logistic regression and generalized estimating equations. Qualitative interviews with site teams will provide additional insights into implementation challenges and successes. The study aims to identify the most effective recruitment methods, refine these strategies, and disseminate findings to enhance future clinical trial diversity. The TOTAL study's findings will provide evidence-based recommendations for increasing representation in trials, addressing a long-standing barrier to equitable healthcare innovation. By improving diversity, TOTAL will contribute to the broader goal of ensuring that treatments are effective and safe for all populations, fostering inclusivity in scientific research, and advancing precision medicine. This research is supported by the American Heart Association, underscoring its importance in achieving health equity.
Protocol for the Kisoboka Mukwano pilot randomized controlled trial in Uganda: A couples-based intervention to reduce intimate partner violence and alcohol use among adolescent girls and young women living with HIV and their male partners.
Nwabuzor Ogbonnaya I, Nakigudde J, Naigino R … +9 more , Stockman JK, Chung Y, Nantongo M, Marsiglia FF, Hahn JA, Wechsberg WM, Mwebembezi A, Wanyenze RK, Kiene SM
Contemp Clin Trials · 2025 Dec · PMID 41207472 · Publisher ↗
BACKGROUND: Adolescent girls and young women living with HIV (AGYWLHIV) with intimate partner violence (IPV) have worse HIV care outcomes than those without IPV. The Kisoboka Mukwano intervention aims to improve AGYW's H...
BACKGROUND: Adolescent girls and young women living with HIV (AGYWLHIV) with intimate partner violence (IPV) have worse HIV care outcomes than those without IPV. The Kisoboka Mukwano intervention aims to improve AGYW's HIV care engagement through reducing IPV associated with male partner alcohol use. The primary objectives of this pilot randomized controlled trial (RCT) are to assess safety, acceptability, feasibility, and preliminary efficacy. METHODS: This 6-month parallel two-arm pilot RCT will occur in Wakiso District, Uganda. Participants are AGYWLHIV (aged 15-24) who are married/cohabiting with a male partner, non-engaged in HIV care, and report IPV. Male partners must report past 30-day hazardous alcohol use. Couples will be recruited through HIV clinics and nearby communities and randomized using a pre-programmed allocation sequence. The six-session intervention arm promotes strategies for reducing alcohol use, coping with relationship conflict and stress, changing norms that reduce IPV, and engaging in HIV care. The control arm involves brief counseling and referrals. The primary outcomes include safety, acceptability, feasibility, and the likelihood of changes in HIV care, alcohol use, and IPV. At 3-and-6-month follow-ups, we anticipate reduced IPV among couples, improved ART adherence in AGYW, and decreased hazardous alcohol use in male partners in the intervention arm compared to controls. Outcome assessors will be blind to the study arm. RESULTS: We screened 194 couples; 59 (30.4 %) were eligible, and 44 remain eligible. We aim to enroll 40 couples. CONCLUSIONS: If feasible, safe, and acceptable, Kisoboka Mukwano can improve HIV care engagement among Ugandan AGYWLHIV by reducing IPV. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05947539.
The telehealth vs. web-based delivered home-based walking for veterans with peripheral artery disease (TREK-PAD) trial.
Jackson EA, Aldama G, Spangler E … +6 more , Richman J, Henderson K, Dutton G, Dempsey D, Guzman A, Myers J
Contemp Clin Trials · 2026 Jan · PMID 41205861 · Publisher ↗
BACKGROUND: Facility-based exercise such as walking is recommended for adults with peripheral artery disease (PAD). PAD is prevalent among US Veterans; thus, understanding effective methods for delivering home-based PAD...
BACKGROUND: Facility-based exercise such as walking is recommended for adults with peripheral artery disease (PAD). PAD is prevalent among US Veterans; thus, understanding effective methods for delivering home-based PAD exercise programs to Veterans is clinically important. METHODS: Veterans with documented PAD will be recruited from three sites (Birmingham, AL, Aurora, CO, and Palo Alto, CA) for a sequential multiple assignment randomized trial (SMART) comparing a web-based delivered walking program to a telehealth delivered walking program or usual care. After 12-weeks of the walking program, participants assigned to one of the walking program intervention arms who do not increase their maximal walking distance will be re-randomized to either receive both web-based and telehealth programs or continue their original assignment till week 24. Follow-up will continue for a third 12-weeks for a total duration of 36-weeks. A total of 225 Veterans will be recruited. The primary outcome of maximal walking distance will be assessed at baseline, 12, 24, and 36-weeks with a standardized treadmill protocol. Additional outcomes include pain-free walking distance and changes in health-related quality of life, measured at the same time points. CONCLUSION: Determining the efficacy of delivering a home-based walking program can address barriers to facility-based programs which are often not available and create participant burden, particularly to those residing in rural areas distant from healthcare facilities. Veterans are both vulnerable to such barriers and overburdened by PAD. This study will contribute to current evidence related to home-based exercise interventions for Veterans with PAD.
Rationale and design of the Adipose Dysfunction, Imaging, Physiology, and Outcomes with sodium-glucose cotransporter - 2 inhibitors for Sleep Apnea (ADIPOSA) study.
Aneni E, Karim I, Rutter J … +7 more , Olaseni O, Kreinin I, Tsang S, Wang Z, Strohl KP, Yaggi HK, Neeland IJ
Contemp Clin Trials · 2025 Dec · PMID 41202973 · Full text
BACKGROUND: Obstructive sleep apnea (OSA) is a chronic condition that is associated with significant morbidity and mortality. Positive airway pressure (PAP) therapy is the gold-standard treatment for OSA but has low adhe...
BACKGROUND: Obstructive sleep apnea (OSA) is a chronic condition that is associated with significant morbidity and mortality. Positive airway pressure (PAP) therapy is the gold-standard treatment for OSA but has low adherence rates. Observational studies, including post-hoc analyses of clinical trials, suggest an association between treatment with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and reduction in incident or diminished severity of prevalent OSA. However, the effects of SGLT2i therapy on the clinical severity of OSA and its mechanistic relation to underlying OSA pathophysiology have not been tested in a randomized clinical trial. METHODS AND RESULTS: The Adipose Dysfunction, Imaging, Physiology, and Outcomes with SGLT2i's for Sleep Apnea (ADIPOSA) study is a double-blind, randomized, placebo-controlled clinical trial that will enroll 164 patients with overweight/obesity and moderate to severe OSA across two sites (Cleveland, OH and New Haven, CT). All participants will complete medical history and sleep questionnaires and undergo ambulatory polysomnography, neck and body fat imaging, 7-day actigraphy, 24-h ambulatory blood pressure monitoring, and a blood draw at baseline and 6-month follow-up. Patients will be randomized 1:1 to receive either bexagliflozin 20 mg once daily or a matching placebo. The primary outcome is a reduction in the apnea-hypopnea index, and secondary outcomes include changes in sleep health, body fat distribution, blood pressure, activity, and biomarkers of inflammation and metabolism. CONCLUSIONS: The ADIPOSA study will identify the mechanisms underlying the effects of SGLT2i on OSA while providing evidence for future investigation to test the efficacy of pharmacologic SGLT2i on OSA prevention and treatment.
Rationale and design of the Response to Behavioral Obesity Treatment (REBOOT) study.
Crane MM, Li M, Suzuki S … +3 more , Bleil ME, Sliwinski MJ, Appelhans BM
Contemp Clin Trials · 2025 Dec · PMID 41202972 · Full text
BACKGROUND: For poorly understood reasons, individuals of lower socioeconomic status (SES) lose half as much weight in behavioral weight loss interventions as individuals of higher SES. Potential explanations for this di...
BACKGROUND: For poorly understood reasons, individuals of lower socioeconomic status (SES) lose half as much weight in behavioral weight loss interventions as individuals of higher SES. Potential explanations for this disparity involve environmental constraints on healthy eating and physical activity, decision-making tendencies, and exposure to stress and cognitively demanding tasks. The Response to Behavioral Obesity Treatment (REBOOT) study aims to identify mechanisms that account for SES-related disparities in behavioral weight loss outcomes. METHODS: Equal numbers of lower and higher SES adults with obesity are allocated to a six-month standard-of-care weight loss intervention. The primary and secondary clinical outcomes are weight change and three key weight control behaviors (dietary lapses, adherence to dietary self-monitoring, and physical activity) across six months. Ecological momentary assessments (EMA) feature embedded cognitive assessments of working memory, present-biased decision making, and processing speed to capture fluctuations in cognitive performance following exposure to adverse experiences in daily life (e.g., stress, resource scarcity). Neighborhood-level data focused on the food retail environment, walkability, and safety obtained from existing databases and self-report. Planned analyses will test whether the expected socioeconomic disparity in weight change is attributable to differential exposure to adverse experiences in daily life, decision-making tendencies, and their joint impact on adherence to weight control behaviors. DISCUSSION: Support for study hypotheses would represent a significant advance in the conceptualization of disparities in behavioral obesity treatment outcomes and suggest the need to mitigate the adverse impact of certain daily experiences on the cognitive processes that support adherence to weight management behaviors.
Rationale, design, and methodology of a randomized controlled trial evaluating the impact of peer-enhanced care coordination on linkage to HCV care among formerly incarcerated individuals.
Riback LR, Davis M, King A … +7 more , Boswell K, Moore C, Dendy B, Hoeflich C, Heo M, Litwin AH, Akiyama MJ
Contemp Clin Trials · 2025 Dec · PMID 41192754 · Full text
BACKGROUND: Hepatitis C Virus (HCV) disproportionately affects criminal legal-involved individuals (CLI), yet low treatment availability and high turnover in U.S. jails limits the number of individuals treated while inca...
BACKGROUND: Hepatitis C Virus (HCV) disproportionately affects criminal legal-involved individuals (CLI), yet low treatment availability and high turnover in U.S. jails limits the number of individuals treated while incarcerated. HCV care coordination upon release is also an unmet need requiring improved models of care. This study will assess the feasibility and preliminary effectiveness of a peer-enhanced HCV care coordination intervention among individuals leaving jail. METHODS/DESIGN: We aim to enroll 80 current or formerly incarcerated CLI with current HCV infection. Participants will be 1:1 randomized to the enhanced linkage and retention intervention (HCV-ACCELERATE) intervention or advanced standard of care (SOC) coordination. HCV-ACCELERATE participants will receive peer mentorship to support community reentry, HCV treatment and other ancillary needs such as mental health or substance use disorder treatment, as well as scheduling and accompaniment to their first community-based HCV appointment. SOC participants will receive a community resource flyer to schedule their first community-based HCV appointment. Participants will complete five research visits over six months and medical records will be reviewed. The primary outcome will be linkage to HCV care after release. Secondary outcomes include HCV treatment initiation and completion, sustained virologic response, and HCV re-infection. DISCUSSION: The evaluation of this intervention will be critical in understanding the feasibility of a peer-enhanced care coordination intervention among CLI to promote linkage to and retention in the HCV care continuum. Moreover, the methodology discussed here can serve as a template for future programs and studies regarding treatment provision and outcomes among CLI with HCV. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT04701437). Trial registration was obtained prospectively February 19, 2021.
Rationale and design of the A-STAC study: A multi-stage, hybrid effectiveness-implementation trial to prevent and reduce racial disparities in postpartum hypertension.
Bowen AE, Garbacz SA, Alaniz KM … +7 more , Berry-Smith M, Bolt D, Denson JS, Kliems H, Sinaise MK, Resnik F, Hoppe K
Contemp Clin Trials · 2025 Dec · PMID 41176219 · Full text
BACKGROUND: Hypertensive disorders of pregnancy are a leading cause of maternal and neonatal morbidity and mortality and are 60 % more common among Black birthing people than non-Black birthing people. Staying Healthy Af...
BACKGROUND: Hypertensive disorders of pregnancy are a leading cause of maternal and neonatal morbidity and mortality and are 60 % more common among Black birthing people than non-Black birthing people. Staying Healthy After Childbirth (STAC) is an evidence-based healthcare program that increases healthcare access by providing postpartum patients with a home blood pressure monitor and a healthcare team that remotely monitors and treats hypertension. This study adapts STAC to expand program reach for Black birthing people via implementation in community-based organizations. METHOD: The study team is partnering with community-based organizations led by and/or serving Black birthing people and Black individuals with lived experiences of hypertension during pregnancy to inform care model adaptation. Guided by the Replicating Effective Programs Framework, the study will be conducted over three stages. The pre-implementation stage will consist of identifying adaptations to STAC to align with community values and priorities. We will apply these adaptations in rapid Plan-Do-Study-Act implementation cycles to create a finalized adapted STAC (A-STAC) program. The implementation stage will consist of delivering A-STAC through community-based organizations and evaluating A-STAC effectiveness, reach, and adoption. The maintenance and evolution stage will consist of identifying strategies for sustainment of A-STAC. CONCLUSION: This adapted intervention has the potential to decrease disparities in postpartum morbidity and mortality for Black birthing people and enhance generational health equity.
AI-powered hybrid self-management coaching for adults with early-onset Type 2 diabetes in Korea: A randomized clinical trial protocol.
Cha E, Son NH, Huh YE … +9 more , Jang H, Park H, Sung G, Kim G, Baek G, Kim J, Shin YA, Jeon MS, Joung KH
Contemp Clin Trials · 2025 Dec · PMID 41173185 · Publisher ↗
BACKGROUND: Existing diabetes self-management education and support (DSME/S) programs have predominantly focused on middle-aged and older adult populations with type 2 diabetes (T2D), leaving unclear whether these approa...
BACKGROUND: Existing diabetes self-management education and support (DSME/S) programs have predominantly focused on middle-aged and older adult populations with type 2 diabetes (T2D), leaving unclear whether these approaches adequately address individuals with early-onset T2D (diagnosed before age 40). While AI-powered applications show promise for digital-native populations, research indicates systematic resistance to medical AI due to uniqueness neglect-The perception that algorithms cannot account for individual circumstances. The 3IM intervention (3I: Interest, intimacy, interactions; 3 M: Monitoring, measurement, maximization) examines whether augmenting AI-driven coaching with human support enhances outcomes for adults with early-onset T2D. METHOD/DESIGN: A randomized controlled trial employing a two-arm parallel-group design will be conducted with eighty-two Korean adults of childbearing age (20-44 years) diagnosed with type 2 diabetes before the age of 40. After a 2-week run-in period for baseline data collection, participants will be randomly assigned to either a comparison group receiving a 12-week coaching program via an AI-powered mobile application only, or an intervention group receiving the same AI coaching supplemented with virtual human support. All statistical analyses will be performed using SPSS (version 26.0+) and/or SAS (version 9.4+). Statistical significance will be defined as a two-sided p-value <0.05. Primary analysis will follow the intention-to-treat (ITT) principle, with a per-protocol (PP) analysis additionally conducted to assess efficacy among study completers. Qualitative data will be analyzed using a triangulation method. DISCUSSION: Findings will facilitate the translation of an evidence-based, clinically relevant DSME/S intervention tailored specifically for adults with early-onset T2D. TRIAL REGISTRATION: KCT0010509, Korea Diabetes Control and Prevention agency.
Addressing sleep apnea post-stroke and transient ischemic attack (ASAP) clinical trial design features: Inclusion of usual care control sites and electronic health record data validation.
Bravata DM, Myers LJ, Perkins AJ … +11 more , Sexson AE, Daggy JK, Taylor SE, Burrone L, Koo BB, Miech EJ, Rattray NA, Story KM, Waddell K, Ding Q, Sico JJ
Contemp Clin Trials · 2025 Dec · PMID 41173184 · Publisher ↗
BACKGROUND: Addressing Sleep Apnea Post-Stroke and TIA (ASAP) evaluated a quality improvement (QI) intervention to increase sleep apnea testing among patients with ischemic stroke or transient ischemic attack (TIA). We d...
BACKGROUND: Addressing Sleep Apnea Post-Stroke and TIA (ASAP) evaluated a quality improvement (QI) intervention to increase sleep apnea testing among patients with ischemic stroke or transient ischemic attack (TIA). We describe ASAP methods highlighting two features: inclusion of usual care control sites and validation of electronic health record (EHR) data. METHODS: ASAP was a stepped-wedge cluster-randomized clinical trial at N = 6 intervention sites augmented with N = 30 control sites to evaluate the effectiveness, implementation, sustainability, and business case of a quality improvement intervention to increase sleep apnea testing among stroke/TIA patients. The study period included the COVID-19 pandemic and an international device recall. EHR data were compared with chart review for cerebrovascular diagnosis, sleep study eligibility, sleep study receipt, and patient characteristics. EHR data accuracy (ACC) was assessed as: (true positives + true negatives)/(true positives + false positives + true negatives + false negatives). RESULTS: During the baseline period (May 2019-February 2021), the average 30-day diagnostic rate was 2.0 % (implementation sites) and 1.3 % (control sites). Among N = 1658 implementation site patients, the index event was stroke in 78.7 %. EHR data accuracy was high for cerebrovascular diagnoses (ACC 0.918-0.953), sleep study receipt (ACC 0.949), and patient characteristics (0.898-0.996). EHR data accuracy was lower for sleep study eligibility (ACC 0.850). CONCLUSIONS: The addition of control sites to stepped-wedge trials allows for intervention evaluation within the context of potential temporal trends influencing outcomes. EHR data can be used to evaluate sleep apnea diagnostic testing after ischemic stroke or TIA. Trial registration ClinicalTrials.govNCT04322162 Date of trial registration: 04/02/2020.
Patient-directed data capture for clinical research: A pilot study testing two platforms.
Shoji S, Cohen LW, Marsolo KA … +5 more , Lydon EJ, Patel MR, Sanders G, Wruck LM, DeVore AD
Contemp Clin Trials · 2025 Dec · PMID 41161381 · Publisher ↗
BACKGROUND: Patient-directed data capture enables individuals to access and share their electronic health record (EHR) data, potentially supporting patient engagement while also reducing data fragmentation. Although many...
BACKGROUND: Patient-directed data capture enables individuals to access and share their electronic health record (EHR) data, potentially supporting patient engagement while also reducing data fragmentation. Although many vendors offer patient-directed data capture, little is known about how feasible or reliable these approaches are in practice. METHODS: We conducted a single-site pilot study to evaluate the feasibility of different patient-directed data capture platforms. Thirty-four participants hospitalized for heart failure at Duke Health participated; 26 engaged with Hugo Health, which used application programming interfaces (APIs) to retrieve data, and 17 with Datavant, which relied on records requests. Nine participants used both platforms. RESULTS: Data retrieval success varied by method: the API approach retrieved 88 % of requested records, while the records request approach retrieved 20 %. Concordance analysis showed the API approach captured additional terms from external systems (e.g., sacubitril/valsartan, 75.0 %) but missed some local EHR diagnoses (e.g., coronary heart disease, 50.0 %). The records-request method captured less external data and had higher rates of data omission. Only 22 % of participants reported willingness to reuse their assigned vendor, and 33 % required onboarding support. Technical challenges included the need to process JavaScript Object Notation (JSON) files (API approach) and to manually abstract documents from PDF files (records request approach). CONCLUSIONS: This pilot study demonstrates that patient-directed data capture is technically possible but shows substantial variability by method. While API-based retrieval achieved high success rates, records request achieved limited success, underscoring the need for improved workflows and user support to make this approach broadly feasible.
Effects of soy foods on urinary sex steroid excretion and metabolic and cognitive health: The plants optimizing development study (PODS) protocol.
Bristina A, Manavbasi IE, Donovan SM … +1 more , Khan NA
Contemp Clin Trials · 2025 Dec · PMID 41139062 · Publisher ↗
Soy foods are a dietary source of high-quality protein, essential micronutrients, and isoflavones with the potential to contribute to numerous health benefits. Previous research has examined the effects of soy isoflavone...
Soy foods are a dietary source of high-quality protein, essential micronutrients, and isoflavones with the potential to contribute to numerous health benefits. Previous research has examined the effects of soy isoflavones on health in adults, but comparatively little is known regarding the health effects of isoflavones in childhood. The Plants Optimizing Development Study (PODS) seeks to address this significant research gap. Children (N = 96) between the ages of 8-11 years will be recruited to participate in a 3-month randomized-controlled clinical trial. Treatment group participants will receive daily, a mix of soy foods with the target total isoflavone (i.e., daidzein, genistein, and glycitein) intake of 50 mg/d. The control group will consume isocaloric soy-free alternatives. The primary outcomes are sex steroids excreted in urine. Secondary outcomes include Android:Gynoid fat ratio, bone mineral density (BMD), blood lipids and fasting glucose, fecal microbial α-diversity, β-diversity, microbial taxa relative abundance, and cognition. Dual-energy X-ray absorptiometry will assess BMD and Android:Gynoid fat ratio. Urine samples will be analyzed for sex steroids using Liquid chromatography-mass spectrometry and adjusted for urinary creatinine. Stool and venous blood samples will assess gut microbiota and metabolic marker analyses, respectively. Cognitive assessments will include the Woodcock-Johnson Tests of Cognitive Abilities and Academic Achievement IV, a spatial memory task, and a modified Eriksen flanker task. The central hypothesis is that greater soy isoflavone consumption will not alter sex steroid levels but will be associated with beneficial outcomes on body composition, metabolic health, and the gut-brain axis in pre- and early adolescents.
Protocol for a type 1 hybrid effectiveness implementation trial to evaluate whether a technology-based collaborative care model is non-inferior to remote blood pressure monitoring on persistent hypertension and preventive care attendance among postpartum people with hypertension.
Nuñez SD, Spratt LM, Ware CF … +20 more , Machado S, Rousseau J, Jackson TL, Buckley J, Magee S, Wohler D, Blosser E, Sales S, Simmons D, Ramos VN, Castillo MM, Murray C, Bailey K, Gutman R, Richardson CR, Grobman WA, Hauspurg A, Miller ES, Tuuli MG, Lewkowitz AK
Contemp Clin Trials · 2025 Dec · PMID 41139061 · Full text
BACKGROUND: Because persistent hypertensive disorders of pregnancy (HDP) are major sources of short- and long-term maternal morbidity, national guidelines recommend blood pressure (BP) measurement 3-10 days after childbi...
BACKGROUND: Because persistent hypertensive disorders of pregnancy (HDP) are major sources of short- and long-term maternal morbidity, national guidelines recommend blood pressure (BP) measurement 3-10 days after childbirth and preventive care visits within one year of delivery. Programs in which patients self-measure BP (SMBP) at home improve BP ascertainment but have unclear effects on preventive care receipt or maternal morbidity. We aim to examine a novel SMBP program's effect on HDP-related morbidity and to develop a toolkit to support wide dissemination of our program. METHODS: In this type 1 hybrid effectiveness implementation trial, 1536 postpartum patients with HDP will be randomized 1:1 to a routine SMBP program or a novel SMBP program, RI-SPHERES. In routine care, participants enter SMBP into the electronic medical record for provider response. In RI-SPHERES, a 4G Long Term Evolution (LTE)-enabled BP cuff automatically sends all SMBP to an artificial-intelligence-based platform, which provides participants with text-message feedback and notifies providers of abnormal SMBP. A multidisciplinary collaborative care group meets weekly to review RI-SPHERES's participant registry. The primary outcome of this non-inferiority trial is stage II hypertension (≥140/90 mmHg) at six weeks postpartum, with a non-inferiority margin of 6 %. The main secondary outcome is preventive care receipt (non-urgent well visit appointment from six weeks to one year postpartum). Mixed methods research will identify facilitators and barriers to RI-SPHERES that will promote its widespread implementation. ETHICS AND DISSEMINATION: Women & Infants Hospital of Rhode Island's IRB approved this study. CLINICAL TRIALS REGISTRATION: NCT06842875.
Rationale and study protocol for a pilot study to determine the feasibility and acceptability of a tailored stress management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity.
Carson TL, Llanos AAM, Fleming K … +8 more , Pittman S, Peña A, Henderson J, Doerr V, Cooper AJ, Mallory M, Sutton S, Jim HSL
Contemp Clin Trials · 2025 Dec · PMID 41135815 · Publisher ↗
BACKGROUND: Despite similar incidence, age-adjusted breast cancer mortality remains higher among Black women compared to White women in the U.S. Racial disparities are also noted in survivorship-associated indicators (e....
BACKGROUND: Despite similar incidence, age-adjusted breast cancer mortality remains higher among Black women compared to White women in the U.S. Racial disparities are also noted in survivorship-associated indicators (e.g., fatigue, cognition, quality of life). Black women also have a higher prevalence of obesity compared to White women, which may contribute to a higher incidence of obesity-associated cancers and poorer survivorship. Because current behavioral weight loss (BWL) interventions have been less effective for Black women, we built upon an existing culturally tailored BWL intervention to develop Survivors RESET, a program designed to promote weight loss among Black female breast cancer survivors with obesity and elevated stress. This pilot study will assess the feasibility and acceptability of Survivors RESET and measure changes in weight, allostatic load score, and patient reported outcomes. METHODS: For this single-arm study, Black women with obesity (n = 30) will be enrolled in a 16-session, culturally targeted, stress management-enhanced BWL intervention adapted to increase cancer-relevancy. Primary outcomes are feasibility and acceptability. We will also assess pre- to post-intervention changes in weight, allostatic load score, and patient reported outcomes (e.g., perceived stress, fatigue, cognition, quality of life). DISCUSSION: Our focus on culturally targeted, breast cancer specific stress management in a BWL trial offers a new approach to lifestyle interventions for breast cancer survivors which may lead to improved outcomes for Black women. If feasible and acceptable, this pilot study will support a future fully powered trial to test the efficacy of this novel intervention.
Rationale and protocol for a randomized parallel intervention trial of two intermittent fasting approaches in patients with type 2 diabetes.
Steger FL, Donnelly JE, Montgomery RN … +6 more , Clark L, Martin CK, Miles JM, Grdinovac K, Henderson AE, Thyfault JP
Contemp Clin Trials · 2025 Dec · PMID 41135814 · Full text
BACKGROUND: Type 2 diabetes (T2D) is a progressive disease driven by insulin resistance and β-cell dysfunction, often exacerbated by excess body weight. Intermittent fasting (IF) approaches, including intermittent energy...
BACKGROUND: Type 2 diabetes (T2D) is a progressive disease driven by insulin resistance and β-cell dysfunction, often exacerbated by excess body weight. Intermittent fasting (IF) approaches, including intermittent energy restriction (IER) and time-restricted eating (TRE), have shown promise for improving glycemic control and facilitating diabetes remission. However, the feasibility and effectiveness of these IF approaches in individuals with T2D remain underexplored. OBJECTIVE: This study aims to compare the feasibility, acceptability, and metabolic effects of IER and TRE in a randomized parallel trial in adults with T2D. METHODS: Adults with T2D (N = 56) and overweight/obesity will be randomized to one of two interventions: IER (550-800 kcal/day on 2-3 days/week) or TRE (caloric intake within an 8-h daily window). Both groups will receive a comprehensive, remotely delivered diabetes education and behavioral support program over 6 months, followed by a 6-month low-contact follow-up during which participants continued the intervention on their own. Primary outcomes include feasibility (recruitment, retention, adherence) and acceptability. Secondary outcomes include changes in HbA1c, insulin sensitivity, insulin response to a mixed-meal tolerance test, body composition, and diabetes remission. Continuous glucose monitoring, metabolic and behavioral phenotyping will inform predictors of response. CONCLUSION: This study is the first parallel trial to compare IER and TRE in patients with T2D and overweight/obesity. Results will provide critical data on the metabolic and behavioral responses to each IF approach, informing future strategies to personalize nutrition therapy in T2D.
The TRaditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) trial: design and baseline characteristics of participants.
Mowry EM, Qian P, Meador W … +33 more , Lynch S, Narayan R, Borazanci A, Robertson D, Qureshi S, Graves J, Silversteen J, Esch M, Tornes L, Riley C, Kaisey M, Sicotte N, Pawate S, Gyang T, Rempe T, Obeidat AZ, Ganesh G, Ryerson LZ, Smith T, Rose J, Carass A, Chalayon O, Kruse-Hoyer M, Salami M, Liu A, Dewey B, Chen JM, Ogburn E, Koch C, Prince J, Cassard SD, Newsome SD, TREAT-MS Trial Team
Contemp Clin Trials · 2025 Dec · PMID 41135813 · Full text
BACKGROUND: Whether early use of higher-efficacy disease-modifying therapy (DMT) reduces later risk of disability in multiple sclerosis (MS) has not been studied as a prospective treatment strategy. Herein, we describe t...
BACKGROUND: Whether early use of higher-efficacy disease-modifying therapy (DMT) reduces later risk of disability in multiple sclerosis (MS) has not been studied as a prospective treatment strategy. Herein, we describe the TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial design and provide the baseline characteristics of the enrolled population. METHODS: TREAT-MS is a pragmatic, randomized, rater-blinded trial of DMT strategies in treatment-naive people aged 18-60 years with relapsing-remitting MS (RRMS). Participants were randomized (1:1, stratified by site and long-term disability risk classification) to one of two treatment strategies: higher-efficacy or traditional DMT; the specific DMT within the assigned strategy was chosen by the clinician/patient pair. Participants could switch DMT for breakthrough disease occurring after 6 months on DMT. The primary outcome is sustained worsening of the Expanded Disability Status Scale (EDSS)-plus, a composite endpoint that includes the EDSS and the timed 25-ft walk and 9-hole peg tests. RESULTS: TREAT-MS includes 900 people with the following baseline characteristics: mean age 36 ± 10 years; 629 (70 %) female gender; 648 (72 %) white, 168 (19 %) Black/African American race, and 105 (12 %) Hispanic or Latino. Mean time since MS symptom onset was 2.6 (± 4.5) years, and mean EDSS score was 2.5 (± 1.3). CONCLUSION: TREAT-MS seeks to address how early DMT strategy influences MS disability and related outcomes. The results will be generalizable to future individuals newly diagnosed with RRMS who, with their clinicians, will be able to use them to make data-driven DMT decisions about how to maximize their intermediate-term function.
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