Contemporary Clinical Trials[JOURNAL]
Sun
200 papers
The sequential cohort randomized clinical trial: A study design for community-engaged clinical research in a rural American Indian community.
Skewes MC, Gonzalez VM, Webber E … +3 more , Gameon JA, Oosterhoff B, Adams AK
Contemp Clin Trials · 2026 Jul · PMID 42401232 · Publisher ↗
Health disparities facing American Indian and Alaska Native (AI/AN) populations warrant effective behavioral health interventions that are grounded in culture and Indigenous worldviews, but AI/AN people remain underrepre...
Health disparities facing American Indian and Alaska Native (AI/AN) populations warrant effective behavioral health interventions that are grounded in culture and Indigenous worldviews, but AI/AN people remain underrepresented in clinical trials. Rigorous scientific methods are needed to determine the efficacy of new interventions, particularly in small rural communities with high treatment need and low access to care. However, many AI/AN communities prefer study designs that ensure all participants receive an intervention, and logistical constraints, such as small population sizes and limited staffing, can impede fully powered randomized controlled trials. This manuscript presents the Sequential Cohort Randomized Clinical Trial (SC-RCT), a study design developed through an academic-community partnership to test the efficacy of a behavioral intervention for substance use disorders in a rural AI reservation community. The SC-RCT differs from existing staggered rollout designs (e.g., stepped wedge, dynamic wait-listed) by using sequential cohort enrollment with individual-level randomization, allowing sample size to accrue over time while standardizing waitlist duration and intervention dosage across participants. This approach preserves a randomized comparison between immediate and delayed treatment conditions while accommodating staffing and recruitment constraints. The SC-RCT offers a feasible and culturally responsive option when traditional designs are not practical, and may be especially useful in small or under-resourced populations where equitable access and limited implementation capacity are key considerations. In AI/AN and other communities, this design may help overcome logistical barriers to research and support ethical and effective interventions in community settings. Clinicaltrials.gov ID number: NCT05612061.
Rationale, design, and statistical analysis plan for a randomized, double-blind, placebo-controlled trial of Limosilactobacillus reuteri to support mother-infant bonding and maternal socioemotional functioning in postpartum women at increased risk for postpartum depression.
Becetti I, Lamont H, Dysart L … +13 more , Asanza E, Tolley C, Holman K, Mitchell C, Dekel S, Hadjikhani N, Lee H, Ravichandran CT, Carter CS, Kingsbury MA, Erdman SE, Plessow F, Lawson EA
Contemp Clin Trials · 2026 Jul · PMID 42398703 · Publisher ↗
BACKGROUND: Postpartum depression (PPD) is common and can impair early mother-infant bonding. Oxytocin (OXT) supports socioemotional adaptation, yet intranasal OXT yields supraphysiological exposure and mixed results. Th...
BACKGROUND: Postpartum depression (PPD) is common and can impair early mother-infant bonding. Oxytocin (OXT) supports socioemotional adaptation, yet intranasal OXT yields supraphysiological exposure and mixed results. The probiotic Limosilactobacillus reuteri (L. reuteri) increases endogenous oxytocin levels in rodents, suggesting that it may enhance OXT signaling via gut-brain pathways in humans. We designed a proof-of-concept trial to test whether postpartum L. reuteri improves early mother-infant bonding and maternal mental health, impulse control, and emotion recognition. METHODS: In this randomized, double-blind, placebo-controlled trial, mothers aged ≥18 years at elevated PPD risk (history of depression, prior PPD, and/or increased prenatal depressive symptoms) received 6 weeks of once-daily L. reuteri or placebo, stratified by delivery mode (vaginal/Cesarean section). The primary endpoint is mother-infant bonding quality at Week 6; secondary endpoints include maternal mental health, impulse control, and emotion recognition at Week 6. Salivary OXT at Week 2 serves as a mechanistic endpoint. RESULTS: Forty-six participants (mean age ± SD: 34.3 ± 4.5 years) were enrolled and randomized; 38 (82.6%) completed the Week-6 visit. Baseline characteristics are reported. CONCLUSION: This trial evaluates whether a lactation-compatible L. reuteri intervention targeting endogenous OXT improves early mother-infant bonding and maternal well-being. Findings will inform feasibility, safety, and effect size estimates, clarify OXT's mechanistic role in PPD pathophysiology, and guide development of microbiome-based therapeutics for perinatal mental health. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT04472065.
Effectiveness of clinical trial recruitment strategies in a safety-net hospital.
Barnick K, Jacobs J, Wood W … +5 more , Garcia L, Santana Y, Labellarte P, Margellos-Anast H, Wagener C
Contemp Clin Trials · 2026 Jul · PMID 42392502 · Publisher ↗
BACKGROUND: Recruitment of underserved populations into clinical trials is difficult. Understanding which recruitment methods are most effective is essential to increasing recruitment yields. Moreover, knowledge of how m...
BACKGROUND: Recruitment of underserved populations into clinical trials is difficult. Understanding which recruitment methods are most effective is essential to increasing recruitment yields. Moreover, knowledge of how many contact attempts should be conducted before a patient is considered non-responsive is also of interest as it can guide prioritization of patient outreach. METHODS: The Improving Diabetes Equity and Advancing care study is a randomized controlled trial of diabetes management strategies among Black and/or Latine patients. Patients were recruited using four methods (in-person, phone, flyer, community health worker [CHW] referral). We calculated enrollment rates, number of contact attempts needed to enroll, and sociodemographic differences by recruitment method. RESULTS: We screened 30,772 patients for eligibility, contacted 789 patients who met eligibility criteria, and enrolled 104 patients into the study for an enrollment rate of 13.2%. Twenty-nine percent, 8%, 14%, 14%, and 7% of patients were enrolled in the study in-person, by phone, by a combination of methods, by flyer, and by CHW referral, respectively. Two-thirds of enrolled patients enrolled on the first or second contact attempt. Latine patients and patients of low socioeconomic status were more likely to be recruited in person. CONCLUSIONS: In-person recruitment had the highest rate of enrollment success. The combination approach was less effective than in-person alone, and flyer and CHW referral strategies showed minimal success. Regardless of method, enrollment success waned after two contact attempts. Planning for recruitment protocol based on study population and method effectiveness is essential to maximizing yield in clinical trials.
Are older adult research participants representative of the general population? Results from 19 clinical studies at one academic research center.
Neiberg RH, Leng X, Houston DK … +8 more , Beavers KM, Miller ME, Kennedy K, Fanning J, Irby MB, Kitzman DW, Kritchevsky SB, Nicklas BJ
Contemp Clin Trials · 2026 Jun · PMID 42364729 · Publisher ↗
BACKGROUND: To implement strategies for enhancing research participation across a broad range of personal characteristics, additional data are needed regarding the degree of underrepresentation of specific individuals in...
BACKGROUND: To implement strategies for enhancing research participation across a broad range of personal characteristics, additional data are needed regarding the degree of underrepresentation of specific individuals in research. METHODS: This study analyzed data from 3671 older (mean age 69 yrs) individuals enrolled in 19 studies conducted from 2002 to 2023 at Wake Forest University School of Medicine. Study inclusion was limited to those with a minimum age eligibility of 50 years. Demographic data of enrolled participants were compared to 1) individuals phone screened for participation and 2) US Census data of older individuals residing in the zip codes of the catchment area. RESULTS: There were 11 studies with screening data available, and the overall enrollment yield was 11.1% (n = 2207 of n = 19,895 screened). Those enrolled were similar in age to those who screened out, and a greater proportion of males (14.5%) versus females (12.4%) and White (22.3%) versus Black participants (19.4%) were enrolled after screening. Compared to Census estimates of older adults, individuals that were 75+ years at enrollment were underrepresented (Census 29%, enrolled 18%; PPR = 0.6), older adults with at least some college education were overrepresented (Census 24%, enrolled 80%; PPR = 3.27) and individuals who specified Black or African American ethnicity were slightly overrepresented (Census 14%, enrolled 19%; PPR = 1.31). Older adults who were 65 years or older, female, or had White ethnicity had proportional representation at enrollment. CONCLUSIONS: The research participants included across these studies had underrepresentation of adults older than 75 years and overrepresentation of college-educated and Black or African American race.
Multi-site feasibility of a web-based and telephone navigation intervention to connect lung cancer caregivers in community oncology settings with resources: Protocol for the WF-2301CD Caregiver Oncology Needs Evaluation Tool (CONNECT) trial.
Nightingale CL, Snavely AC, Levine BJ … +12 more , Turner JC, Farris MK, Tingen MS, Foust M, Graves K, Danai J, Price SN, Asad SS, Adonizio CS, Lesser GJ, Childrey L, Weaver KE
Contemp Clin Trials · 2026 Jun · PMID 42364728 · Publisher ↗
BACKGROUND: Family caregivers of patients with lung cancer experience high levels of unmet needs, burden, and distress, yet systematic processes to identify and connect caregivers with resources are lacking in community...
BACKGROUND: Family caregivers of patients with lung cancer experience high levels of unmet needs, burden, and distress, yet systematic processes to identify and connect caregivers with resources are lacking in community oncology. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a hybrid intervention delivered through a combination of web-based components and telephone-based navigation to inform caregivers about resources, assess their needs, and connect them to tailored supportive care services. Initial pilot testing at a single academic center demonstrated feasibility and acceptability, but feasibility in community settings remains untested. In this study, we aim to assess the multi-site feasibility of CONNECT. METHODS: This multi-site, randomized controlled pilot trial (WF-2301CD) is conducted through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Lung cancer caregiver-patient dyads (N = 120) are recruited from 12 community oncology practices and randomized to: CONNECT, generic resource list, or usual care. The primary objective is to assess multi-site feasibility, measured by caregiver retention at 12-weeks. Secondary objectives include evaluating caregiver accrual, participation, retention at 24-weeks, and acceptability, as well as process metrics. Exploratory objectives assess patient accrual, participation and retention. Data are collected via surveys at baseline, 12-, and 24-weeks, with additional process tracking by site staff and navigators. DISCUSSION: This trial will provide critical data on the multi-site feasibility of implementing CONNECT in community oncology practices to inform protocol and design refinements for a future efficacy trial. If feasible, future efficacy testing will focus on the impact of CONNECT on caregiver burden and distress.NCT06383988.
Rationale and design of a CArdiac rehabilitation program on the prevention of CardioTOXicity in breast Cancer patients undergoing treatment with anthracyclines and/or trastuzumab (CARPTOX-BC) trial: A randomized, active control group, open-label trial.
Santa-Ana-Bayona MJ, Ponce-Acosta C, Acosta-Gutierrez GH … +10 more , Morales-Alvarez P, Guerra EC, Gonzalez-Trejo A, Espinosa-Fernandez JR, Solis Flores NJ, Ilarraza-Lomelí H, Alexanderson-Rosas E, Leyva-López Y, Antonio-Villa NE, Espinola-Zavaleta N
Contemp Clin Trials · 2026 Jun · PMID 42342071 · Publisher ↗
BACKGROUND: Breast cancer (BC) remains a leading cause of cancer-related deaths among women. Administration of anthracyclines and/or anti-human epidermal growth factor receptor-2 (HER2) antibodies has been associated wit...
BACKGROUND: Breast cancer (BC) remains a leading cause of cancer-related deaths among women. Administration of anthracyclines and/or anti-human epidermal growth factor receptor-2 (HER2) antibodies has been associated with chemotherapy-induced cardiotoxicity. Cardio-oncology rehabilitation programs aim to mitigate these outcomes. However, their preventive role in cancer therapy-related cardiac dysfunction (CTRCD) remains uncertain. OBJECTIVES: To evaluate the effectiveness of a structured exercise program compared with only exercise recommendation in preventing CTRCD, defined by the 2022 European Society of Cardiology criteria, as a left ventricular ejection fraction above 50%, with a relative decrease in global longitudinal strain exceeding 15% from baseline and/or a newly detected elevation in cardiac troponin I or T or natriuretic peptides. Secondary outcomes include the impact on systolic and diastolic echocardiographic parameters, cardiometabolic biomarkers, quality of life, and exploring the role of traditional cardiovascular risk factors in CTRCD onset. METHODS: CARPTOX-BC is a randomized, open-label clinical trial with an active control group. Women aged 18-70 years with stage I-III BC scheduled for neoadjuvant or adjuvant therapy with anthracyclines and/or trastuzumab will be eligible. The intervention includes three supervised out of five weekly aerobic and resistance exercise. A total of 284 participants will be randomized 1:1 to intervention or control arms. RESULTS: Results will be disclosed at completion. CONCLUSIONS: We expect a structured exercise program may reduce the incidence of CTRCD associated with anthracycline and/or HER2 antibody and provide a potential non-pharmacological therapy that could also enhance cardiometabolic markers and quality of life among this population. TRIAL REGISTRATION: NCT06881940 (registered March 18th, 2025).
Evaluating clinical outcomes of using Undermyfork mobile app with Dexcom G7: Protocol for CGM-Undermyfork randomized controlled trial.
Brown K, Ushakov M, Molodkin E … +3 more , Spierling Bagsic SR, Bell C, Philis-Tsimikas A
Contemp Clin Trials · 2026 Jun · PMID 42336271 · Publisher ↗
BACKGROUND: Mobile health apps have the potential to enhance education for glycemic management in individuals with type 2 diabetes (T2D). The growing desire to use diabetes-related mobile applications indicates the indus...
BACKGROUND: Mobile health apps have the potential to enhance education for glycemic management in individuals with type 2 diabetes (T2D). The growing desire to use diabetes-related mobile applications indicates the industry's broad effort in leveraging technology to improve health outcomes in diabetes patients. However, many available applications still lack evidence-based features, and applications that go through clinical validation often do not include an active control in their studies. The purpose of this in-progress trial is to evaluate the effectiveness of a novel photo-based food diary smartphone app (Undermyfork) that visually connects meals to glucose excursions to promote behavior change. METHODS: This is a randomized, controlled, prospective, parallel-group trial with an active comparator, enrolling N = 90 adults with T2D, elevated HbA1c, and continuous glucose monitoring (CGM) naivety in a real-world community-based health system. Participants complete a run-in/screening period, and if eligible, are randomized into the intervention to use CGM alone (Group 1) or to use the Undermyfork mobile app in addition to CGM (Group 2). The trial will examine comparative effectiveness in improving CGM metrics, HbA1c, and diabetes self-care behaviors over 4 months. DISCUSSION: We hypothesize that Group 2 will have more evident improvements in CGM metrics and HbA1c given Undermyfork's focus on utilizing CGM data to understand meal-related decisions that may allow participants to gain insights into the relationship between their dietary choices and glucose fluctuations throughout the day. This trial may have implications for improved glycemic management, reduced risk of diabetes-related complications, and enhanced well-being for individuals with T2D. CLINICAL TRIAL REGISTRATION: Clinicaltrials.govNCT06501612https://clinicaltrials.gov/study/NCT06501612.
Outcomes of dyadic recruitment in the promoting re-engagement in meaningful activity (PRIMA) trial.
Chang PS, Katz AJ, Gao S … +5 more , Yang Z, Passey RT, Brehm A, Apostolova LG, Lu Y
Contemp Clin Trials · 2026 Jun · PMID 42336270 · Publisher ↗
INTRODUCTION: Recruitment plays a critical role in the success of a clinical trial, but recruiting older persons with cognitive impairment (PwCI)-caregiver (CG) dyads for behavioral intervention studies during the COVID-...
INTRODUCTION: Recruitment plays a critical role in the success of a clinical trial, but recruiting older persons with cognitive impairment (PwCI)-caregiver (CG) dyads for behavioral intervention studies during the COVID-19 pandemic presented challenges. We explore recruitment strategies and sources for an evidence- and telephone-based, tailored activity engagement, and skill-building randomized control trial involving older PwCI-CG dyads. METHODS: Multiple recruitment sources and strategies were used, including direct/in-clinic referrals, healthcare system databases, and advertisements through established internal and external connections, and research partnerships. RESULTS: A total of 210 PwCI-CG dyads were enrolled into the study. The most successful recruitment sources for making initial contact, reaching, screening, and enrolling eligible dyads were a healthcare system database and a volunteer participant registry (46% and 37%, respectively). DISCUSSION: Future studies should consider utilizing healthcare system databases and state-volunteer participant registries when conducting dyadic recruitment, as these sources greatly improved initial outreach and enrollment rates. CLINICALTRIALS: gov ID NCT04515875.
Overview of the linking exercise for advancing daily stress (LEADS) management and resilience randomized controlled trial in African American families.
Wilson DK, Martin P, Sweeney AM … +9 more , White T, Wood V, Gantt M, Quattlebaum M, Grieco A, Yang CH, Zarrett N, Gadson B, Van Horn ML
Contemp Clin Trials · 2026 Jun · PMID 42323046 · Publisher ↗
BACKGROUND: Chronic stressors place African American (AA) adolescents at greater risk for developing chronic diseases. Resilience-based interventions that empower youth to cope with daily chronic stressors have shown imp...
BACKGROUND: Chronic stressors place African American (AA) adolescents at greater risk for developing chronic diseases. Resilience-based interventions that empower youth to cope with daily chronic stressors have shown improvements across a broad range of outcomes, however, no previous study has evaluated a family-based resilience-stress and coping plus positive parenting intervention on improving physical activity (PA) in AA families. OBJECTIVE: To describe the design and methodology of the Linking Exercise for Advancing Daily Stress (LEADS) Management and Resilience trial, for evaluating the efficacy of a family-based intervention to address chronic stressors and promote behavioral skills for increasing PA in overweight AA adolescents. METHODS: The LEADS trial uses a randomized group cohort design and will involve 330 AA adolescents with a BMI percentile ≥70% and a caregiver. The trial tests the efficacy of a 10-week online family-based intervention (vs. health education) and draws from Stress and Coping, Family Systems, and Social Cognitive Theories to integrate components that build coping skills for engaging in PA. The primary outcome is change in daily minutes of moderate-to-vigorous PA (MVPA) at post-intervention and 6-month follow-up among adolescents. Secondary outcomes include changes at post-intervention and 6-month follow-up in MVPA in caregivers, as well as changes in light PA (LPA), dietary intake, family mealtime, body mass index, waist circumference, and blood pressure in adolescents and caregivers. CONCLUSION: This trial will evaluate an online family-based resilience-stress and coping plus positive parenting intervention and is expected to inform best practices for promoting health among AA families.
Protocol for a randomized, controlled trial of a bioactive dietary polyphenol preparation to promote resilience in healthy individuals.
Marchidan MM, Rizk M, Karpman E … +12 more , Lizzano A, Fremont R, Dobbs MF, Lee JH, Irizar H, Lyu W, Yin Z, Wu Q, Simon J, Ferruzzi M, Pasinetti G, Murrough JW
Contemp Clin Trials · 2026 Jun · PMID 42320787 · Publisher ↗
Botanicals and nutritional supplements have gained tremendous popularity as natural approaches to enhancing physical and mental health. However, alongside this trend, there is a growing recognition of the importance of r...
Botanicals and nutritional supplements have gained tremendous popularity as natural approaches to enhancing physical and mental health. However, alongside this trend, there is a growing recognition of the importance of rigorous human studies to validate the absorption, bioavailability, safety and physiological effects of these botanicals. Understanding the effects of these compounds on stress-related outcomes is crucial for ensuring their efficacy and safety to promote stress resilience and overall health. This report describes the design of a parallel arm, randomized, double-blind, placebo-controlled clinical trial to assess the absorption and bioavailability of a 5-week intervention of a daily Bioactive Dietary Polyphenol Preparation (BDPP) consisting of Concord grape juice (CGJ), grape seed polyphenol extract (GSPE), and trans-resveratrol (RSV). Healthy adults (ages 18-55 years) are randomized to receive low, medium, or high doses of BDPP or matching placebo. In addition to pharmacokinetic profiling, the study will evaluate the effects of BDPP on immune function and behavioral measures of stress. The trier social stress test (TSST) will probe acute response to stress. Findings from this trial are intended to lay the foundation for future, larger studies of BDPP and other natural polyphenol-rich products investigating the clinical utility of phenolic supplements for stress resilience and health.
Ultra-high dose radiation for Liver metastasis using MR-guided TReatment with stereotactic Ablative Single-fraction (ULTRAS): Study protocol for a phase III randomized controlled trial.
Wong H, Ng SSW, Mohamad I … +15 more , Alborz J, Stanescu T, Liu ZA, De Leon J, Tan H, Ng SP, Radhakrishna G, Bahij R, Intven M, Kirichenko A, Mesci A, Yan M, Dawson L, Augilera T, Hosni A
Contemp Clin Trials · 2026 Jun · PMID 42309387 · Publisher ↗
INTRODUCTION: Liver metastases are common in several malignancies, with only 15-20% of patients eligible for surgical resection. For non-surgical candidates, stereotactic body radiation therapy (SBRT) is an effective alt...
INTRODUCTION: Liver metastases are common in several malignancies, with only 15-20% of patients eligible for surgical resection. For non-surgical candidates, stereotactic body radiation therapy (SBRT) is an effective alternative with acceptable local control (LC) rates. Higher biologically effective doses (BED10 > 100 Gy) are associated with improved LC, and single-fraction ultra-high dose SBRT (35-40 Gy) has demonstrated excellent LC with minimal toxicity. MR-guided adaptive SBRT enhances precision and may optimizing single-fraction SBRT for liver metastases. METHODS AND ANALYSIS: ULTRAS is a multi-center, phase III randomized trial evaluating whether ultra-high dose MR-guided single-fraction SBRT (38 Gy, BED10 ≈ 180 Gy) improves LC of liver oligometastases/oligoprogression compared to high-dose MR-guided single-fraction SBRT (27 Gy, BED ≈ 100 Gy). Primary endpoint is LC of treated intrahepatic target lesion(s). Secondary endpoints include overall survival (OS), progression-free survival (PFS), intrahepatic and extrahepatic progression, toxicity (CTCAE v5.0 and PRO-CTCAE v1.0), and quality of life (QOL) (EORTC QLQ-C15-PAL, EORTC QLQ-LM21). Patients will be randomized 1:1 to receive either 27 Gy or 38 Gy, stratified by primary tumor site/histology, lesion characteristics, and prior systemic therapy. A total of 114 patients (57 per arm) will be enrolled over three years, with two years of follow-up. Assessments at predefined intervals will monitor response and toxicity. LC will be analyzed using cumulative incidence function. Widespread and intrahepatic progression will be assessed using Fine & Gray regression; OS and PFS via Cox models; toxicity and QOL via Chi-squared test and mixed-effects model. ETHICS AND DISSEMINATION: The ULTRAS trial obtained ethical approval from the University Health Network and will follow ICMJE reporting standards. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06362395.
A cooking skills intervention for long-term weight loss in young adults with intellectual disabilities: Rationale and design for a randomized trial.
Ptomey LT, Danon JC, Catley D … +9 more , Washburn RA, Bodde A, Diaz FJ, Helsel BC, Rice AM, Sherman JR, Koester M, McKinney W, Donnelly JE
Contemp Clin Trials · 2026 Jun · PMID 42288222 · Publisher ↗
Young adults with intellectual disability (ID) are an underserved population with a high prevalence of obesity, obesity-related health conditions, and reduced ability to complete instrumental and basic activities of dail...
Young adults with intellectual disability (ID) are an underserved population with a high prevalence of obesity, obesity-related health conditions, and reduced ability to complete instrumental and basic activities of daily living (I/ADLs). After leaving the structured environment of public school, many young adults with ID spend more time at home or in day programs, begin living more independently, or enter the workforce. These transitions may increase reliance on fast or processed foods and reduce opportunities for physical activity, contributing to accelerated weight gain. Previous research has demonstrated clinically meaningful short- and long-term weight loss (18-24 months) in adults with mild-to-moderate ID and overweight/obesity using multi-component behavioral interventions. However, similar approaches have not achieved long-term success in younger adults with ID. Limited evidence suggests that cooking-skills training is feasible and may improve diet quality in young adults with ID, yet no adequately powered trial has tested its impact on long-term weight loss in this population. This randomized trial will evaluate whether adding a cooking-skills program to a multicomponent weight-management intervention improves long-term weight loss in young adults with ID and overweight/obesity. We will randomize 114 participants (1:1) to a standard weight-loss program or a standard weight-loss program plus cooking skills sessions for an 18-month intervention with a 6-month no-contact follow-up period. The primary aim is to compare weight loss at 18 months; Secondarily, we will compare between-arm changes in body composition, cardiometabolic biomarkers, I/ADLs, cooking skills, and caregiver strain. Exploratory analyses will examine mediators and moderators of weight change.
Achieving completed revascularization via inferior mini-sternotomy versus conventional median sternotomy for CABG in patients with multivessel CAD (the ACRIS-MICABG trial): Rationale and design of a multicentre, randomized controlled trial.
Ju F, Li B, Wu H … +1 more , Sun H
Contemp Clin Trials · 2026 Jun · PMID 42276410 · Publisher ↗
INTRODUCTION: A critical barrier to advancing minimally invasive coronary artery bypass grafting (CABG) lies in achieving complete revascularization (CR) in multivessel disease (MVD) patients. Contrasting with other mini...
INTRODUCTION: A critical barrier to advancing minimally invasive coronary artery bypass grafting (CABG) lies in achieving complete revascularization (CR) in multivessel disease (MVD) patients. Contrasting with other minimally invasive approaches, inferior mini-sternotomy (IMS) offers distinct advantages in addressing complex multivessel disease and concomitant cardiac pathologies, which is similar to conventional median sternotomy (CMS) approach. The primary aim of this trial is to test the hypothesis that the CR rates of IMS-CABG could approximate that of CMS-CABG in MVD patients. METHODS AND ANALYSIS: This study is a prospective, multicenter, open-label, randomized controlled, blinded endpoint, non-inferiority trial conducted across four sites in China. 260 patients aged 18-80 are randomly assigned to either the intervention or control arm. All operations are performed through IMS in the intervention arm and CMS in the control arm. The primary outcome is postoperative complete revascularization assessed by postoperative coronary computed tomography angiography (CCTA). Patient enrollment began at the first hospital in May 2023 and is expected to be completed by August 2025. ETHICS AND DISSEMINATION: The Ethics Committee at Fuwai Hospital has approved this study. Expedited ethical approval was obtained for the other three subsidiary centers after that. Trial Registration Information. CLINICALTRIALS: gov (NCT05835167).
Testing community-based strategies to increase hypertension screening in Nigeria: a protocol for an effectiveness-implementation hybrid type III cluster-randomized trial.
Olawepo JO, Ezeanolue EE, Cohen DJ … +11 more , Ejim EC, Green B, Huguet N, Holderness H, Idemili-Aronu N, Lindner S, Marino M, Odili AN, Onwuekwe I, Orafa ST, DeVoe JE
Contemp Clin Trials · 2026 Jun · PMID 42250852 · Full text
BACKGROUND: Hypertension is a major risk factor for cardiovascular disease and stroke, with a growing burden in Nigeria. Limited access to blood pressure (BP) screenings, low awareness, and barriers to healthcare drive l...
BACKGROUND: Hypertension is a major risk factor for cardiovascular disease and stroke, with a growing burden in Nigeria. Limited access to blood pressure (BP) screenings, low awareness, and barriers to healthcare drive low diagnosis rates. Community-based screenings for other conditions have been successful and could improve diagnosis and care linkage. This study evaluates the effectiveness of a community-based screening and referral intervention to increase hypertension detection and facilitate connections to healthcare. METHODS: This cluster-randomized effectiveness-implementation hybrid type III trial in Nigeria tests the implementation and effectiveness of a community-based BP screening intervention. There are two arms: 1). Core: community screenings supported by mobile health technology with referral to a healthcare facility for participants with at least one elevated BP reading, and 2.) Core+ (enhanced): additional support from community health advisors to help participants link to healthcare facilities. Participants with elevated BP will be informed about medication vouchers if diagnosed with hypertension and prescribed medication. Community gathering sites hosting screenings leverage local engagement structures. The study will assess the proportion of individuals identified to have elevated BP, rates of linkage to healthcare facilities, and factors influencing intervention uptake and sustainability. DISCUSSION: To address gaps in hypertension detection and management utilizing community-based strategies, findings will provide insights into the feasibility and effectiveness of implementing a scalable, community-driven approach to hypertension screening and linkages to healthcare in Nigeria. If successful, this model could be adapted to other resource-limited settings in the United States and globally to improve detection and reduce hypertension-related complications. NAME OF REGISTRY: CLINICALTRIALS.GOV: Trial Registration NCT06659900. Registered 26 October 2024, prospectively registered. https://clinicaltrials.gov/study/NCT06659900?id=NCT06659900&rank=1.
Design and rationale of the pERSonalized cardIovascuLar dIsease prEvention, treatmeNt, and CarE (RESILIENCE) study.
Rennyson K, Kenjale A, Chiswell K … +15 more , Li Y, Uchehara B, Armstrong S, Goldstein B, Kelsey M, Hurdle M, McGarrah R, Nelson AJ, Patel M, Peterson ED, Roberts J, Truskey G, Douglas PS, Shah S, Pagidipati NJ
Contemp Clin Trials · 2026 Jun · PMID 42248410 · Publisher ↗
BACKGROUND: Obesity is a growing epidemic associated with cardiovascular disease (CVD). The RESILIENCE study aimed to understand the factors underlying heterogeneity in CVD development among individuals with obesity as w...
BACKGROUND: Obesity is a growing epidemic associated with cardiovascular disease (CVD). The RESILIENCE study aimed to understand the factors underlying heterogeneity in CVD development among individuals with obesity as well as the variability in response to weight loss interventions in this population, with a focus on branched-chain amino acids (BCAA). METHODS: Four cohorts were recruited: individuals with obesity (BMI ≥ 30 kg/m) and either high (≥20%) or low (<7.5%) 10-year atherosclerotic CVD (ASCVD) risk (calculated by the Pooled Cohorts Equation), and individuals with normal weight (BMI 18-25 kg/m) and either high or low ASCVD risk. Clinical, behavioral, and molecular characteristics were collected at baseline between the four groups to assess heterogeneity between obesity and risk for CVD. Participants with obesity then participated in a 6-month remote weight loss intervention to evaluating predictors of response to the weight loss intervention. Our primary hypothesis was that BCAA are associated with CVD risk and obesity and that similarly, BCAA will predict response to weight loss interventions. RESULTS: 598 participants were recruited between 2019 and 2022 within the Duke University Health System. 100 had normal weight and low ASCVD risk, 103 had normal weight and high ASCVD risk, 196 patients had obesity and low ASCVD risk, and 199 patients had obesity and high ASCVD risk. CONCLUSIONS: This two-stage design (stratified baseline cohort with nested intervention) enables independent evaluation of the mechanisms linking obesity, CVD risk, and BCAA, among other variables. This approach will clarify how these factors influence cardiovascular disease variability and weight loss outcomes. TRIAL REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov), NCT04551872.
Combining Behavioral Activation and repetitive Transcranial magnetic stimulation in Late-Life Depression (COMBAT-LLD study): Study protocol for a randomized controlled trial.
de Wijs I, Tendolkar I, van Beek MHCT … +15 more , van Belkum S, Dalhuisen I, Dlabac-de Lange JJ, van Eijndhoven P, van Exel E, Houwert-Zuidema M, Jeuring HW, Kool RB, Legemaat A, Oostelbos P, Rhebergen D, van Velsen H, Wijnen B, Hendriks GJ, Carlier A
Contemp Clin Trials · 2026 Jun · PMID 42248409 · Publisher ↗
BACKGROUND: Late-life depression (LLD) is common and associated with reduced quality of life, increased cognitive impairment, elevated mortality risk, and substantial healthcare costs. Despite available pharmacological a...
BACKGROUND: Late-life depression (LLD) is common and associated with reduced quality of life, increased cognitive impairment, elevated mortality risk, and substantial healthcare costs. Despite available pharmacological and psychotherapeutic treatments, a substantial proportion of older patients with depression experience insufficient improvement. Repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in treating LLD, albeit full remission of LLD by rTMS is limited. Preliminary evidence suggest synergistic effects of rTMS with psychotherapy. Combining rTMS and behavioral activation (BA), a structured and effective psychological intervention promoting engagement in rewarding activities, may enhance outcome in the treatment of LLD. However, this has not been specifically investigated in older adults. METHODS: This multicenter, assessor-blind, randomized controlled trial will assess the (cost-) effectiveness of combining low-frequency rTMS targeting the right dorsolateral prefrontal cortex (DLPFC) with BA in individuals 60 years and older with treatment-resistant LLD. 148 participants will be randomized to receive rTMS with either BA or neutral conversations over six weeks, with follow-up assessments at 3, 6, and 12 months. The primary objective is to determine whether rTMS with BA leads to greater symptom reduction and superior cost-effectiveness than rTMS without BA. Secondary outcomes include relapse quality of life, treatment acceptability, behavioral engagement, and levels of anhedonia, apathy, and cognitive functioning. DISCUSSION: We hypothesize that rTMS with BA is more (cost-)effective than rTMS without BA. Findings will show whether BA-assisted rTMS is effective. Next, we provide practical insights for integrating BA into routine rTMS care for older adults. TRIAL REGISTRATION: Dutch Clinical Trial Register, NL-OMON57840.
Texas strength through resilience in diabetes education (TX STRIDE): Protocol for a non-randomized cluster-controlled trial among African American adults with type 2 diabetes.
Welsh A, Smith J, Lehrer HM … +5 more , Montero-Zamora P, Dubois SK, Harrison L, Tanaka H, Steinhardt M
Contemp Clin Trials · 2026 Jun · PMID 42242624 · Full text
OBJECTIVE: African American (AA) adults have the highest prevalence of type 2 diabetes mellitus (T2DM) and face more severe complications compared with Hispanic and non-Hispanic White populations. Lifestyle interventions...
OBJECTIVE: African American (AA) adults have the highest prevalence of type 2 diabetes mellitus (T2DM) and face more severe complications compared with Hispanic and non-Hispanic White populations. Lifestyle interventions that address the distress inherent in T2DM and unique stressors faced by AAs that worsen diabetes-related health outcomes are critically needed. We describe the protocol of a non-randomized cluster-controlled trial that uses a resilience-based diabetes self-management education and support (RB-DSMES) intervention to help participants manage the psychosocial and behavioral demands of T2DM. PARTICIPANTS: A total of 284 AA adults were recruited through 27 churches in Austin, TX, and the surrounding areas using church announcements and on-site glucose screenings. METHODS: Churches were allocated to a comparison (standard diabetes self-management education and support; DSMES) or intervention (DSMES plus resilience resource integration; RB-DSMES) arm. Following baseline data collection, both arms received 8 educational classes, 8 support groups, and 2 booster sessions. OUTCOMES: T2DM physical (primary outcome HbA1c) and mental (primary outcome depressive symptoms) health outcomes in intervention vs. comparison arms will be compared at 6-, 12-, and 24-months post-study entry. We also will examine potential mediators of treatment effects at 24 months via changes in resilience resources at 6 months and T2DM self-management and hypothalamic-pituitary-adrenal (HPA) axis function at 12 months. DISCUSSION: If successful, this project will provide crucial guidance for addressing the T2DM burden among AAs by establishing the real-world efficacy of the RB-DSMES program and identifying behavioral and biological mechanisms through which the program impacts T2DM health outcomes.
Design for a cluster randomized controlled trial to evaluate the impact of a school-based fruit and vegetable co-op on cardiometabolic health of children and parents in a persistent poverty area.
Sharma S, Senn M, Chuang RJ … +8 more , Perkison WB, Crichlow K, Markham C, Ramphul R, Shete S, Basen-Engquist K, McNeill L, Rechis R
Contemp Clin Trials · 2026 Jun · PMID 42229798 · Publisher ↗
BACKGROUND: In 2022, the National Cancer Institute funded five centers nationally to prevent cancer in persistent poverty areas, including one in Houston, TX reducing obesity-related cancers in Acres Homes. This paper de...
BACKGROUND: In 2022, the National Cancer Institute funded five centers nationally to prevent cancer in persistent poverty areas, including one in Houston, TX reducing obesity-related cancers in Acres Homes. This paper describes the design and framework of one of the center's research projects, a cluster-randomized controlled trial (CRCT) evaluating the impact of Brighter Bites (BB) nutrition intervention on child vegetable intake, glycosylated hemoglobin (HbA1c), and obesity among children in grades 1-3 from the Acres Homes region. METHODS: In this CRCT, 12 schools serving under-resourced children in Acres Homes were recruited and randomized into intervention and wait-list control groups across two waves during the 2024-2025 and 2025-2026 school years. In Wave 1 (2024-2025), six elementary schools were randomized (3 intervention, 3 wait-list), enrolling eligible 1st-3rd graders (n = 360). Children in the intervention schools are followed for two school years, while children in wait-list schools are followed for one school year. Grounded in the Social Cognitive Theory, the BB intervention includes 16 bi-weekly distributions of 20-25 pounds of fresh produce, recipe tastings, and nutrition education for children and parents. Outcome evaluation included in-person assessment of child metabolic markers, height, weight, and skin carotenoid levels, as well as parent self-report surveys. Primary outcomes are child HbA1c and vegetable intake. Secondary outcomes included anthropometric and metabolic measures, household food security status, parent and child dietary behaviors, and home access/availability of fruit and vegetables. CONCLUSION: This study will inform the implementation and evaluation of a school-based nutrition intervention to improve child nutrition and metabolic health outcomes. TRIAL REGISTRATION NUMBER: The clinical trial was registered on clinicaltrials.gov (NCT06570707) before the start of recruitment.
Protocol of a cluster randomized controlled trial of a village health worker care model to reduce cardiovascular disease risk among conflict-affected populations in eastern Myanmar.
Thwe SM, Mon Myint NE, Goyal R … +10 more , Win ZM, Long M, Myint SK, Kler Law SS, Zaw NT, Htoo E, Phyo Aung ZY, Traill T, Lee C, Richards A
Contemp Clin Trials · 2026 Jun · PMID 42229797 · Publisher ↗
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in many conflict-affected countries including Myanmar. Humanitarian health systems lack evidence of effective and efficient strategies to achieve hig...
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in many conflict-affected countries including Myanmar. Humanitarian health systems lack evidence of effective and efficient strategies to achieve high coverage of medications proven to reduce CVD risk among forcibly displaced populations in rural areas. This manuscript describes the rationale and design of a cluster randomized controlled trial (cRCT) to test the impact of an integrated village health worker (VHW) care model on medication adherence and costs, among individuals with CVD risk factors living in areas of active armed conflict in eastern Myanmar. METHODS: The hybrid effectiveness-implementation type 1 study centers on a cRCT that randomizes thirteen villages in rural Karen state to intervention and control groups. In intervention villages, mobile teams screen residents ≥40 years old for elevated CVD risk, medics initiate treatment with statins and anti-hypertensive medications, supported by a mobile clinical decision tool, and VHWs conduct monthly home visits to monitor blood pressure, adherence and side effects, and deliver medications. Control village residents receive usual facility-based care. The primary outcome is medication adherence; secondary outcomes include systolic blood pressure and predicted 10-year CVD risk. The study also evaluates the reach, acceptability, perceived sustainability and equity impacts of the intervention using the RE-AIM framework, and distributional cost-effective analysis. DISCUSSION: This cRCT tests an innovative community-based care delivery model to strengthen cardiovascular disease management for villagers experiencing armed conflict. The study newly employs simulation-based power analysis, health equity metrics, implementation science and cost-effectiveness analysis in a humanitarian emergency. Trial registration numberNCT06819839, Date of registration: 2025-01-25.
Bayesian adaptive cluster-randomized designs with long primary endpoints for pragmatic weight loss studies implemented in rural communities.
Bernal J, Wick J, Befort C … +1 more , Gajewski B
Contemp Clin Trials · 2026 Jun · PMID 42229796 · Full text
With the rise of obesity and other metabolic-related disorders since the early 2000s, there is a pressing need for innovative methods to reduce this trend. Many existing studies have long endpoints and protracted trial d...
With the rise of obesity and other metabolic-related disorders since the early 2000s, there is a pressing need for innovative methods to reduce this trend. Many existing studies have long endpoints and protracted trial durations, often requiring substantial implementation costs. To address this, we propose the use of an adaptive trial design. This approach, which is at the forefront of research methodology, can significantly reduce the total duration of a trial, enhance participant outcomes by determining treatment efficacy earlier, and increase the number of participants randomized to the beneficial treatment groups. We suggest using a Bayesian Adaptive Cluster Randomized design to redesign the REPOWER trial, a weight loss study comparing behavioral interventions on weight loss in rural communities. Our approach incorporates an arm-dropping technique and will stop the trial early for futility if sufficient weight loss differences are not observed. We illustrate this by calculating operating characteristics under six scenarios to compare to the design used in the original trial.
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