Contemporary Clinical Trials[JOURNAL]
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200 papers
Protocol for the sequential multiple assignment randomized trial to reduce food insecurity and improve adherence in patients with hypertension (SMART-FI).
Palakshappa D, Stone RJ, Torres JB … +15 more , Berkowitz SA, Rhodes SD, Kirkendall ES, Dressler EV, Paredes Acosta LM, Williamson JD, Ard J, Ramirez B, Bundy R, Caudill N, Martin H, Hodge LD, Damon A, Caicedo-Dussan L, Rigdon J
Contemp Clin Trials · 2026 Jul · PMID 42061553 · Publisher ↗
BACKGROUND: Food insecurity is a barrier to patients adhering to prescribed hypertension treatments and is strongly associated with worse blood pressure. Health systems are implementing interventions to assist patients w...
BACKGROUND: Food insecurity is a barrier to patients adhering to prescribed hypertension treatments and is strongly associated with worse blood pressure. Health systems are implementing interventions to assist patients with food insecurity, but rather than providing a single intervention, a stepped-care approach to providing interventions could be a more effective strategy. Our objective is to determine the effectiveness of a stepped-care food insecurity intervention on blood pressure and adherence among patients with uncontrolled hypertension. METHODS/DESIGN: We will conduct a sequential multiple assignment randomized trial. Adults (≥18 years) with uncontrolled hypertension (>130/80) who report food insecurity will be randomized to one of two first-stage interventions: 1) information about community resources or 2) community health worker (CHW) support. Participants who do not have ≥10 mmHg improvement in systolic blood pressure after 3 months will be re-randomized to one of two second-stage interventions for an additional 3 months: 1) CHW support or 2) delivery of medically tailored meals. In Aim 1, we will determine which first-stage intervention is more effective in improving blood pressure and adherence. In Aim 2, we will evaluate which intervention is the best next step for those who do not respond to the initial intervention. In Aim 3, we will advance our understanding of how and why participants achieved improvements through qualitative and quantitative data analysis. CONCLUSIONS: This will be the first study to test the effectiveness of a stepped-care food insecurity intervention. Given the growing interest among health systems, an efficacious, stepped-care food insecurity intervention could be broadly disseminated. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov (NCT07031739) on June 22, 2025.
Protocol for a pilot trial assessing the acceptability, feasibility, and psychoeducation effectiveness of a single-session online parent-focused intervention targeting predictors of body image disturbance in young children.
Love AA, Domoff SE, Yager Z … +2 more , Timko CA, Hormes JM
Contemp Clin Trials · 2026 Jul · PMID 42055111 · Publisher ↗
Body image concerns have been linked longitudinally to mental health issues, including disordered eating. Body image and weight concerns can emerge as early as between the ages of three to nine; however, few parent-focus...
Body image concerns have been linked longitudinally to mental health issues, including disordered eating. Body image and weight concerns can emerge as early as between the ages of three to nine; however, few parent-focused interventions aim to prevent body image and weight concerns in young children. This study, informed by the results of a previously conducted needs assessment, seeks to demonstrate acceptability and feasibility, as well as psychoeducation effectiveness, of parent training related to early prevention of eating disorder risk. Using evidence-based materials, a four-module intervention for parents of young children will be developed. In Phase 1 of data collection, parents (12 mothers, 12 fathers) of two- to six-year-olds residing in the U.S. will fill out an online survey on the platform Prolific and will be randomly assigned to take one of four modules of the intervention (Body Image Development, Food Talk, Mealtime and Picky Eating, and Media Usage and Social Comparison), and will provide detailed qualitative feedback. In Phase 2 of data collection, 100 parents will be a part of the treatment group or the control group (50 in each group). The treatment group will view the entire intervention and complete knowledge checks and will fill out measures of acceptability and feasibility. The control group will only complete the knowledge checks. Thus, the control group's performance on the knowledge checks will be compared to the performance of the treatment group as a measure of initial psychoeducation effectiveness. Results will guide the creation of a future efficacy trial. ClinicalTrials.gov registration: NCT07179068.
Two equivalent formulations of conditional power and predictive probability of success in interim monitoring.
Xu Q, Yan X, Zheng J … +1 more , Kong M
Contemp Clin Trials · 2026 Jun · PMID 42034266 · Publisher ↗
Conditional power (CP) and predictive probability of success (PPoS) are key metrics used for interim monitoring, futility or efficacy stopping, and sample size re-estimation in clinical trials. CP is defined as the proba...
Conditional power (CP) and predictive probability of success (PPoS) are key metrics used for interim monitoring, futility or efficacy stopping, and sample size re-estimation in clinical trials. CP is defined as the probability of achieving a successful final outcome given the current interim data under a specified assumed treatment effect. PPoS extends this concept by averaging CP over the distribution of the true treatment effect, typically using the posterior or predictive distribution. In this article, we compare two formulations: a traditional approach (Jennison and Turnbull, 2000) and a post-interim-data-based approach (Kundu et al., 2024). We demonstrate that, under a normal model with matching priors, the two approaches yield identical CP and PPoS values. We provide a practical example demonstrating the use of these approaches and conclude with guidance on how to pre-specify the effect size and prior, as well as how to interpret results using CP and PPoS.
Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Upstream Systems Change (COMPASS+): A Hybrid Type 2 Cluster Randomized Trial.
Turco A, Feinberg E, Chu A … +8 more , Williams D, Barber de Brito AS, Silverstein M, Schlichting LE, Sharma S, Pineda J, Diaz ZM, Miller ES
Contemp Clin Trials · 2026 Jun · PMID 42031232 · Full text
Perinatal mood and anxiety disorders (PMADs) are the most common complication of pregnancy, affecting 600,000 to 900,000 birthing people in the United States annually. Less-than-optimal outcomes necessitates innovations...
Perinatal mood and anxiety disorders (PMADs) are the most common complication of pregnancy, affecting 600,000 to 900,000 birthing people in the United States annually. Less-than-optimal outcomes necessitates innovations in care delivery to better meet the needs of birthing people. The perinatal Collaborative Care Model (pCCM) represents one promising approach to improving patient outcomes. The pCCM includes a Care Manager, patient registry, and weekly clinical huddles, collectively designed to reflect the committment to ensuring all patients referred to the pCCM achieve remission of their mental health symptoms. While CCMs show great success in Primary Care settings, research on their efficacy in obstetric clinics is limited. In addition, while the CCM is an acceptable and accessible model of care, community based participatory research practices can optimize these implementation outcomes by centering the voices of the community the program intends to serve. Community engagement has led to the creation of an adapted version of the pCCM, COMPASS PLUS (Collaborative Care Model for Perinatal Wellness Support Services - Population Level Equity-Centered Systems Change). Herein, we describe the design of a stepped wedge randomized trial with an effectiveness-implementation design to assess the effectiveness of COMPASS+ and evaluate implementation strategies for the COMPASS+ model.
Design of a multicomponent intervention to reduce the risk of exposure to high concentrations of fluoride in children in Huila, Colombia.
García-Rojas CL, Perdomo AKF, Martínez JO … +6 more , Losada-Farfán W, Llanos AB, Mendez YAL, Robledo MCG, Martínez-Mier EÁ, Colmenares GG
Contemp Clin Trials · 2026 Jun · PMID 42031231 · Publisher ↗
INTRODUCTION: Systemic exposure to fluoride represents a significant challenge for global public health. Although it prevents dental caries, prolonged high concentrations affect organs and systems, especially teeth. Desp...
INTRODUCTION: Systemic exposure to fluoride represents a significant challenge for global public health. Although it prevents dental caries, prolonged high concentrations affect organs and systems, especially teeth. Despite preventive strategies, evidence of their effectiveness is limited. This protocol describes a randomized controlled trial to evaluate a multicomponent intervention in parents and children that reduces the risk of exposure to high concentrations of fluoride in children. METHODS: Randomized trial in kindergartens in municipalities in the Department of Huila, Colombia. The intervention group will receive a five-component program: installation of water filters to reduce fluoride consumption; educational sessions for parents and children to promote awareness and healthy practices; outreach activities to strengthen collective knowledge; and a maintenance phase for sustainability. The control group will participate in a conventional educational strategy on cariogenic diet, flossing, and hand washing, focused on the parent-child dyad. Measurements will be taken at four points in time: baseline (pre-intervention) and post-intervention at 3, 6, and 12 months. The evaluation will include fluoride concentration in children's urine, levels in water (filter validation), and changes in parental knowledge, attitudes, and practices. DISCUSSION: The trial will evaluate the effectiveness of the multicomponent intervention in reducing fluoride exposure. With comprehensive methodological approaches and objective measurements, it will demonstrate significant improvements in fluoride levels in children and in parental knowledge, attitudes, and practices. It will contribute to child health programs, strengthen preventive strategies in oral health, impact public policy and community health, and open new lines of research on fluoride. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT07232888 Link:https://clinicaltrials.gov/study/NCT07232888.
A cognitive dissonance-based intervention to reduce ultra-processed food intake: Protocol for a pilot randomized controlled trial.
Hagerman C, Choo-Kang D, LaFata E … +2 more , Rohde P, Butryn M
Contemp Clin Trials · 2026 Jun · PMID 42031230 · Publisher ↗
BACKGROUND: Despite their harmful mental and physical health effects, ultra-processed foods (UPFs) are highly prevalent in the US. To maximize profits, the UPF industry designs these foods to be hyperpalatable, markets t...
BACKGROUND: Despite their harmful mental and physical health effects, ultra-processed foods (UPFs) are highly prevalent in the US. To maximize profits, the UPF industry designs these foods to be hyperpalatable, markets them aggressively, and influences government policies to prevent their regulation. To combat this powerful influence, individuals must be highly motivated to reduce their UPF intake. If participants learn about the harms of the UPF industry and publicly denounce the industry, they are expected to experience strong cognitive dissonance and motivation to reduce their intake of these foods. METHODS: Through a 2 × 2 factorial design, adults with overweight/obesity (N = 60) will be randomly assigned to receive standard dietary change strategies (ON/OFF) and dissonance-based strategies (ON/OFF). All participants will receive an introductory educational workshop on UPFs. Those assigned to receive at least one of the interventions (i.e., SDC, dissonance, or both) will attend weekly group sessions for weeks 2-8. DISCUSSION: We expect that receiving either of the strategies will lead to meaningful reductions in UPF intake, improvement in dietary quality, and reduction in weight, and that the combined effects of these strategies will be synergistic. Additionally, dissonance-inducing strategies are hypothesized to reduce outcome disparity for individuals with socio-structural barriers to healthy eating. If successful, the intervention will be tested in a larger trial with a longer intervention and follow-up. TRIAL REGISTRATION NUMBER: NCT07226336.
Virtual health coaching to improve self-care among informal caregivers of hospitalized older adults during a transition in care: Randomized controlled trial study protocol.
Hirschman KB, Weiss CR, Brown S … +8 more , Samuels C, Bowles KH, Carthon JMB, Huang L, Ramsburg H, Walser TJ, Naylor MD, Riegel B
Contemp Clin Trials · 2026 Jun · PMID 42031229 · Publisher ↗
BACKGROUND: Informal caregivers play a critical role in supporting older adults with multiple chronic conditions (MCCs), particularly during transitions from hospital to home. These transitions are often marked by increa...
BACKGROUND: Informal caregivers play a critical role in supporting older adults with multiple chronic conditions (MCCs), particularly during transitions from hospital to home. These transitions are often marked by increased stress and reduced self-care among caregivers and heightened risk for poor outcomes in both caregivers and patients. The Virtual Caregiver Coach for You (ViCCY) intervention, grounded in the Transactional Model of Stress and Coping, aims to improve caregiver self-care through tailored virtual health coaching. METHODS: This single-site, three-hospital, Phase III randomized controlled trial is enrolling 250 informal caregivers of hospitalized older adults with MCCs. Participants are randomized to receive either ViCCY plus digital health information (tailored information from health, self-care, and caregiving websites) or digital health information alone. ViCCY is provided virtually by a trained health coach over a six-month period. Synchronous sessions focus on stress management, self-care, and adaptive coping. Primary outcomes include caregiver self-care, with secondary outcomes of stress, coping, preparedness, and perceived health status. Patient outcomes, including acute care utilization and associated costs, will also be evaluated. DISCUSSION: This trial addresses a critical gap in transitional care by focusing on the well-being of informal caregivers. By testing a scalable, virtual intervention tailored to individual caregiver needs, the study aims to improve caregiver outcomes and inform future models of caregiver support. The findings will contribute to the evidence base for virtual health coaching and its role in promoting self-care among caregivers, as well as potentially reducing acute care resource use in patients.
Safe treatment for emergency presentation for suicidal ideation and behavior (SAFE STEPS): Protocol for randomized controlled trial.
Asarnow JR, B Goldston D, Spirito A … +17 more , Keeshin B, Miller I, Belin T, Ahmadi N, Meza J, Carlisle C, Cheek S, Chung B, Comulada WS, Garcia RE, Garrett C, Gaudiano B, Giles L, Jones F, López R, Wells K, Zullo L
Contemp Clin Trials · 2026 Jul · PMID 42031228 · Publisher ↗
BACKGROUND: Suicide is currently the second leading cause of death among youth ages 13-24 in the United States. Youths presenting to Emergency Departments (EDs) with suicidal ideation and/or behavior have elevated risk f...
BACKGROUND: Suicide is currently the second leading cause of death among youth ages 13-24 in the United States. Youths presenting to Emergency Departments (EDs) with suicidal ideation and/or behavior have elevated risk for subsequent suicide attempts and deaths, yet optimal approaches to emergency care remain unclear and too many youths receive inadequate follow-up treatment after discharge. METHODS: Using a community partnered participatory research model, this multi-site single-blinded randomized comparative effectiveness trial investigates two strategies for enhancing emergency care for 1600 adolescents and young adults (ages 13-24) presenting with suicide attempts and/or suicidal ideation: 1) ED care enhanced by increased access to a developmentally tailored approach to safety planning; and 2) a combined approach that supplements enhanced ED care with brief therapeutic contacts with youths and parents/significant others for 12 months after ED-discharge. These contacts by phone/video/text/letter feature support, brief intervention, and case management. Youths will be recruited from four geographically diverse locations, and assessed at baseline and 3, 6, and 12-month follow-ups. Parent assessments will be at: baseline; 12-month follow-ups; and when youth report is unavailable. Outcomes will be assessed in two domains: 1) clinical [suicide attempts primary, self-harm (suicide attempts+nonsuicidal self-harm) secondary]; 2) service use (linkage to outpatient mental health care primary, treatment dose secondary). Exploratory outcomes and heterogeneity of treatment effects will be evaluated. DISCUSSION: The trial is designed to have public health impact by clarifying the added value of therapeutic follow-up contacts after discharge, relative to ED care emphasizing evaluation, safety planning, and referral for follow-up care.
How ultra-processed foods modulate cardiometabolic risk: A 2 × 2 factorial randomized controlled trial protocol in healthy adults.
Rochette M, Charest A, Gigleux I … +3 more , Couture P, Provencher V, Lamarche B
Contemp Clin Trials · 2026 Jun · PMID 42019675 · Publisher ↗
BACKGROUND: Despite growing evidence linking overconsumption of ultra-processed foods (UPFs) to numerous adverse health outcomes, there is still no consensus regarding whether all UPFs are equally concerning for cardiova...
BACKGROUND: Despite growing evidence linking overconsumption of ultra-processed foods (UPFs) to numerous adverse health outcomes, there is still no consensus regarding whether all UPFs are equally concerning for cardiovascular health, regardless of their nutrient profile. OBJECTIVE: This 2 × 2 factorial randomized controlled trial aim to determine which feature(s) of UPFs, namely their poor nutrient profile or their underlying industrial processes, contribute to cardiometabolic risk. METHOD: 120 adults, men and women, are randomly assigned to one of the four experimental 6-week diets: 1- Low-UPF diet (5% total energy) low in saturated fats (SFAs), added sugars and sodium; 2- Low-UPF diet (5% total energy) rich in SFAs, added sugars and sodium; 3- High UPF diet (75% total energy) low in SFAs, added sugars and sodium; 4- High UPF diet (75% total energy) rich in SFAs, added sugars and sodium. All foods and beverages are provided to participants under isoenergetic conditions. The high UPF diets are largely comprised of commercial foods with variable amounts of SFAs, added sugars and sodium. The low UPF diets are custom prepared with varying amounts of SFAs, added sugars and sodium to match the nutrient values of the high UPFs diets. Primary outcomes measured at baseline and post treatment are fasting LDL-C concentrations, insulin sensitivity (HOMA-IR) and daytime systolic ambulatory blood pressure (dtSBP). CONCLUSION: This randomized controlled trial will be the first to use fully controlled feeding conditions to disentangle out the individual effects of the industrial processing techniques from the poor nutrient content of UPFs on cardiometabolic risk. TRIAL REGISTRATION: ClinicalTrials.gov (ID NCT06538831), registered July 31, 2024.
Enhanced recruitment methods for a dietary intervention trial aimed at reducing risk of colorectal cancer.
Harvin S, Guetterman TC, Hirko KA … +10 more , Flores E, Bhargava A, Poore K, Adwere-Boamah R, Orr J, June K, MacDonald M, Djuric Z, Buis L, Mitchell J
Contemp Clin Trials · 2026 Jun · PMID 42019674 · Full text
This study developed and evaluated strategies to optimize recruitment and retention to a mobile health-supported dietary intervention trial, the MyBestGI Study. This included instituting a Personal Technology Assistant a...
This study developed and evaluated strategies to optimize recruitment and retention to a mobile health-supported dietary intervention trial, the MyBestGI Study. This included instituting a Personal Technology Assistant and enhancing the study website with three short videos. The Personal Technology Assistant was available to address potential digital literacy barriers. The videos provided information about the study, introduced the research staff, and provided directions to the study location. Each of the videos also addressed concerns related to privacy, security and ethics that can curtail trust in research. Evaluation of these strategies was done utilizing semi-structured interviews. Study participants reported joining the study to improve their own health and/or to help others who are at risk for colorectal cancer. Technological assistance was not requested for use of the MyBestGI app, but it was useful for completing the online dietary recalls that were required for study eligibility. Themes identified from the interviews included that participants appreciated knowing that technological support would be available if needed and that it was helpful in completing the dietary recalls. Themes identified regarding the utility of the videos included that the videos increased participant comfort with study procedures and the staff, and that the videos did influence their decision to join the study. Although the strategies implemented facilitated the enrollment process to the study, they unfortunately did not enhance the diversity of the MyBestGI study population. Despite this, the benefits uncovered from the staff and participant interviews do support the implementation of these strategies for recruitment enhancement.
Knowledge of clinical trials by disease status: A Health Information National Trends Survey (HINTS) study.
Hussain Z, Plante TB, Ngige AA … +6 more , Miller HN, Chepkorir J, Juraschek SP, Martin SS, Hays AG, Michos ED
Contemp Clin Trials · 2026 Jun · PMID 42013979 · Publisher ↗
BACKGROUND: While clinical trials (CTs) are crucial for advancing healthcare, public knowledge remains limited. Individuals with cancer may be more engaged with experimental treatments than those with other chronic condi...
BACKGROUND: While clinical trials (CTs) are crucial for advancing healthcare, public knowledge remains limited. Individuals with cancer may be more engaged with experimental treatments than those with other chronic conditions like cardiovascular disease (CVD). Whether CVD patients have comparable CT knowledge, and how this varies by sociodemographic factors, remains unclear. OBJECTIVES: To examine CT knowledge variation between individuals with cancer and CVD and identify sociodemographic correlates of knowledge within CVD population. METHODS: HINTS is a nationally representative survey of U.S. adults aged ≥18 years. Participants self-reported cancer history, CVD status, and CT knowledge. Logistic regression assessed associations between disease status and CT knowledge, adjusting for sociodemographic and health factors. Within CVD group, variables with P < 0.25 in univariable models were retained in multivariable model. Analyses applied sampling weights. RESULTS: Among a weighted sample (n = 3772) representing ∼250 million (mean [SD] age, 57 [17.0] years; 50% women), 6% reported cancer and 8% CVD. CT knowledge was 61% in CVD and cancer groups; 35% of CVD group were low-income. In adjusted models, CT knowledge among cancer-only (OR 1.09, 95%CI 0.70-1.68) and CVD-only (OR 1.26, 95%CI 0.73-2.18) groups did not differ significantly from adults without CVD or cancer. Among CVD population, lower income participants (OR 0.24, 95%CI 0.06-0.98) had significantly lower odds of CT knowledge. CONCLUSION: Most adults with CVD and cancer lacked CT knowledge, underscoring need for broader education. Reduced income was independently associated with diminished knowledge, suggesting targeted efforts may benefit underserved patients and expand access to innovative therapies.
The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study: Design and methods for a pharmacy-led trial implemented in low-income populations.
Mallisetty Y, Shah R, Kerby T … +12 more , Mamudu HM, Bailey JE, Dowling-McClay K, Kovesdy CP, Kaplan C, Chamberlin S, Hawkins A, Tolley EA, Graff JC, Grant CC, Butterworth SW, Surbhi S
Contemp Clin Trials · 2026 Jun · PMID 42009102 · Publisher ↗
BACKGROUND: Medication nonadherence disproportionately affects low-income populations, especially during care transitions, by increasing readmissions, emergency visits, and mortality. These populations face financial, tr...
BACKGROUND: Medication nonadherence disproportionately affects low-income populations, especially during care transitions, by increasing readmissions, emergency visits, and mortality. These populations face financial, transportation, and coordination barriers that traditional medication therapy management often fails to address, highlighting the need for innovative solutions. We are conducting a pragmatic randomized controlled trial to determine the effectiveness of the patient-centered Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) intervention to improve medication adherence and healthcare utilization among low-income patients with multiple chronic conditions (MCC). METHODS: Low-income adults (≤ 200% federal poverty level) with MCC or using two or more chronic disease medications (N = 388) from two Tennessee hospitals are randomized to usual care or the Med AAAction intervention. Recruitment began in April 2024. This multicomponent intervention provides free (zero-copay) chronic disease medications with bedside and home delivery, health coaching, and care coordination by certified pharmacy technicians to assist with rapid and ongoing primary care follow-up after hospital discharge. The primary outcome is medication adherence measured using pill counts at 3, 6, 9, and 12-month by comparing doses taken with prescription supply and fill dates. Secondary outcomes include 14-day primary care follow-up, 30-day readmissions, and one-year hospitalizations, emergency visits, and healthcare costs. DISCUSSION: By addressing medication affordability, accessibility, and availability, this trial tests whether a patient-centered multicomponent intervention improves medication adherence and reduces healthcare use among low-income adults with MCC. If effective, Med AAAction could be implemented across health systems to support high-risk patients and enhance health outcomes while lowering costs.
Protocol for Afterschool Rx 2.0: A pilot randomized crossover trial to determine the feasibility of prescriptions to afterschool care for children with cardiovascular risk factors.
von Klinggraeff L, Harris RA, Estabrooks P … +2 more , Coughlin S, Armstrong B
Contemp Clin Trials · 2026 Jun · PMID 42009101 · Publisher ↗
BACKGROUND: CVD risk factors in childhood, including obesity and hypertension, can be mitigated with physical activity and a healthy diet. Existing community-based afterschool programs provide an important opportunity to...
BACKGROUND: CVD risk factors in childhood, including obesity and hypertension, can be mitigated with physical activity and a healthy diet. Existing community-based afterschool programs provide an important opportunity to increase physical activity and improve cardiovascular health, but access remains limited for many families. The Afterschool Rx program enables healthcare providers to prescribe free afterschool care for children with CVD risk factors from families at or below 250% of the federal poverty level. METHODS: This study will employ an ORBIT Phase IIb randomized crossover design to conduct a preliminary trial of Afterschool Rx. Participating children (ages 5-11 years; n = 48) will be randomly assigned to receive a voucher for afterschool care at existing community-based programs (e.g., YMCA, Boys & Girls Clubs) along with enrollment assistance, in either the fall or spring semester, with the opposite semester serving as the comparison period (treatment as usual). Primary outcomes will examine the reach and potential for dissemination of the program using the PRISM/RE-AIM framework. Exploratory outcomes include health behaviors (e.g., physical activity, sedentary behavior, sleep, screen use, and diet quality) and cardiovascular health indicators (e.g., cardiorespiratory fitness, blood glucose, blood pressure, HbA1c, and cholesterol levels). Exploratory analyses will examine within-person differences in change between semesters. DISCUSSION: This study will be the first randomized controlled trial to evaluate the reach and feasibility of disseminating afterschool care prescriptions as a clinical strategy for addressing cardiovascular risk factors. Results will inform further testing and development of the Afterschool Rx intervention.
Geroprotective effects of diet and exercise plus metformin in frail older veterans with obesity: The DEMFOS randomized trial protocol.
Klonis N, Duremdes Nava ML, Aguilar M … +7 more , Viola V, Davila V, Teo S, Bryant MS, Armamento-Villareal R, Qualls C, Villareal DT
Contemp Clin Trials · 2026 Jun · PMID 42009100 · Full text
BACKGROUND: Frailty and obesity frequently coexist in older adults, particularly among Veterans, contributing to loss of independence, physical disability, and increased healthcare utilization. Lifestyle interventions im...
BACKGROUND: Frailty and obesity frequently coexist in older adults, particularly among Veterans, contributing to loss of independence, physical disability, and increased healthcare utilization. Lifestyle interventions improve mobility and function but often lead to loss of lean mass and bone density. Metformin, a widely used antidiabetic agent with geroprotective properties, may mitigate these adverse effects by targeting cellular mechanisms of aging. OBJECTIVE: To determine whether adding metformin to lifestyle therapy (diet-induced weight loss and supervised multicomponent exercise) improves physical function and musculoskeletal health, compared with lifestyle therapy alone and with a healthy-lifestyle program combined with metformin. DESIGN: Six-month, randomized, double-blind, placebo-controlled, three-arm clinical trial. SETTING AND PARTICIPANTS: Conducted at the Michael E. DeBakey VA Medical Center (Houston, TX) in 114 older Veterans (aged 65-85 years) with obesity (BMI ≥30 kg/m) and mild-to-moderate frailty (Physical Performance Test [PPT] 18-31). INTERVENTIONS: Participants are randomized to (1) Lifestyle Therapy + Metformin, (2) Lifestyle Therapy + Placebo, or (3) Healthy Lifestyle + Metformin. The lifestyle intervention includes dietary counseling targeting a 500-750 kcal/day deficit and supervised aerobic and resistance exercise three times per week. Metformin or placebo is titrated to 1500 mg daily and dispensed under blinded conditions. PRIMARY OUTCOME: Change in PPT score from baseline to 6 months. CONCLUSION: The Diet and Exercise plus Metformin to Treat Frailty in Obese Seniors (DEMFOS) study evaluates whether combining lifestyle therapy with a pharmacologic aging modulator can improve function and musculoskeletal integrity beyond either intervention alone, addressing a critical need in geriatric obesity care.
Promoting adherence to weight-related behaviors in young adults: Design of the Nudge microrandomized trial.
Valle CG, Nezami BT, Hatley KE … +5 more , Diamond MA, Polzien K, Wasser HM, O'Shea NG, Tate DF
Contemp Clin Trials · 2026 Jun · PMID 41997542 · Full text
BACKGROUND: Just-in-time adaptive interventions (JITAIs) may improve multiple weight-related behaviors by providing highly adaptive, tailored messages. However, evidence regarding what types of JITAI messages are efficac...
BACKGROUND: Just-in-time adaptive interventions (JITAIs) may improve multiple weight-related behaviors by providing highly adaptive, tailored messages. However, evidence regarding what types of JITAI messages are efficacious and under what conditions is limited. We describe the rationale and design of the Nudge microrandomized trial to optimize JITAI messages that deliver distinct behavior change techniques (i.e., BCT messages) and promote daily achievement of weight-related behavioral goals among young adults. METHODS: Young adults with overweight or obesity (n = 201) will receive a 6-month behavioral weight loss intervention using our Nudge mobile app, which integrates self-monitoring data from smart scales, activity trackers, and a food log for tracking "red" (high-calorie) foods, and includes weekly lessons, tailored feedback, and daily BCT messages. Participants will have three daily weight-related behavioral goals: weigh daily, meet an active minutes goal, and stay at/under a red food limit. At three daily decision points, participants will be microrandomized to receive or not receive one of seven BCT messages. We will test the effects of BCT messages on daily proximal outcomes: weighing (assessed by smart scale), meeting an active minutes goal (assessed by activity tracker), and staying at/under a red food limit (assessed by food log). Weight will be assessed at 0, 3, and 6 months. CONCLUSIONS: This study evaluates the effects of just-in-time BCT messages on multiple weight-related behaviors. Findings will expand our understanding of what BCT messages are efficacious, when they are efficacious, and for whom, and also guide how BCT messages are integrated into future JITAIs for weight loss. CLINICALTRIALS: gov Identifier:NCT05625061https://clinicaltrials.gov/study/NCT05625061.
Combined effectiveness of omega-3 PUFA-rich fish oil supplementation and high-intensity interval training in obesity associated metabolic dysfunction: Protocol for a double-blind, randomized clinical trial.
Azari H, Combs D, Galindo S … +6 more , Jafarabadi GS, Chemitiganti R, Park OH, Moustaid-Moussa N, Dhanasekara CS, Albracht-Schulte K
Contemp Clin Trials · 2026 Jun · PMID 41997541 · Publisher ↗
BACKGROUND AND OBJECTIVE: Obesity rates continue to rise globally, highlighting the need for prevention and targeted treatment strategies. Chronic systemic low-grade inflammation and gut microbiota dysbiosis are key cont...
BACKGROUND AND OBJECTIVE: Obesity rates continue to rise globally, highlighting the need for prevention and targeted treatment strategies. Chronic systemic low-grade inflammation and gut microbiota dysbiosis are key contributors to obesity-associated metabolic diseases. Anti-inflammatory dietary components, such as fish oil rich in omega-3 polyunsaturated fatty acids (n-3 PUFAs), reduce inflammation and improve metabolic outcomes. Similarly, physical activity improves metabolic health and attenuates chronic systemic inflammation, with varying benefits according to exercise intensity. While both interventions independently modulate inflammation and gut microbiota, their combined effects warrant further research. This study investigates the combined impact of n-3 PUFA supplementation and high-intensity interval training (HIIT) on obesity-related inflammation and gut microbiota dysbiosis, hypothesizing that improvements in gut microbiota composition driven by n-3 PUFAs may enhance the metabolic benefits of exercise. DESIGN AND METHODS: Adults with a body mass index (BMI) ≥ 25 kg/m are randomized to receive either 4 g/day n-3 PUFA or safflower oil (placebo) for 10 weeks. During weeks 0-4, participants take the assigned supplement. Beginning in week 4, one n-3 PUFA group and one placebo group will additionally complete 4-weeks of HIIT. Control groups perform low-intensity training (LIT) for 4 weeks. The last two weeks are a detraining phase with continued supplementation. DISCUSSION: This study explores the benefits of combining short-term HIIT and n-3 PUFA supplementation in individuals with overweight or obesity. The findings inform measurable, time-efficient interventions that target systemic inflammation, gut microbiota dysbiosis, and metabolic dysfunctions.
Effects of supervised progressive resistance training on corticospinal excitability in persons with multiple sclerosis: A randomized controlled trial protocol for the NEXIMS study.
Andersen TM, Riis H, Tankisi H … +5 more , Mamoei S, Langeskov-Christensen M, Dalgas U, Lundbye-Jensen J, Hvid LG
Contemp Clin Trials · 2026 Jun · PMID 41991058 · Publisher ↗
BACKGROUND: Neurodegeneration is a hallmark of multiple sclerosis (MS) that affects both the structure (e.g., total or regional brain volume) and function (e.g., corticospinal excitability) of the central nervous system...
BACKGROUND: Neurodegeneration is a hallmark of multiple sclerosis (MS) that affects both the structure (e.g., total or regional brain volume) and function (e.g., corticospinal excitability) of the central nervous system (CNS), driving disability progression. Consequently, lower extremity neuromuscular function and physical function are preferentially affected, ultimately contributing to a reduced quality of life. While several studies have examined the effects of resistance training (RT) and other exercise modalities on CNS structure in persons with MS (pwMS), only a few studies have evaluated changes in CNS function, even though it may adapt much more rapidly than CNS structures. To our knowledge, no previous study has examined whether progressive RT (PRT) induces changes in corticospinal excitability (CSE) for the lower extremities of pwMS. METHODS: The present randomized controlled trial (RCT) will include 66 walking-impaired pwMS, equally randomized to 10 weeks of high-dose PRT (25 supervised sessions; HIGH-PRT), low-dose PRT (10 supervised sessions; LOW-PRT), or a waitlist control (CTRL) group. The primary outcome is CSE measured by motor-evoked potential (MEP) amplitudes using Transcranial Magnetic Stimulation (TMS) of the primary motor cortex. Secondary outcomes include additional neurophysiological and neuromuscular measures, physical function, and patient-reported outcomes. ETHICS AND DISSEMINATION: This study adheres to the Helsinki Declaration and is approved by the Central Denmark Region Committees on Health Research Ethics (1-10-72-9-24). All results (positive, negative, or inconclusive) will be published in peer-reviewed scientific journals and presented at relevant scientific conferences. The www. CLINICALTRIALS: gov ID is NCT06374108.
Effects of pistachio consumption on cognition, cardiometabolic risk factors, and life satisfaction in older adults: Protocol for a remote-based randomized controlled trial.
Park SJ, Gavilan IS, Li S … +6 more , Clar A, Lau J, Karbowski GC, Sarkissian AA, Cámara M, Sesso HD
Contemp Clin Trials · 2026 Jun · PMID 41991057 · Full text
BACKGROUND: Pistachios contain key nutrients and bioactive compounds that may be particularly relevant for cognition health. Although short-term pistachio intervention trials have demonstrated improvements in cardiometab...
BACKGROUND: Pistachios contain key nutrients and bioactive compounds that may be particularly relevant for cognition health. Although short-term pistachio intervention trials have demonstrated improvements in cardiometabolic risk factors implicated in cognitive decline, the potential cognitive effects of pistachio consumption remain to be adequately elucidated. METHODS AND DESIGN: This remote-based, 6-month randomized controlled trial will test the effects of a pistachio-enriched diet (1.25 oz./d), compared to usual diet, on cognitive function in older US adults (target n = 80). Key eligibility criteria include: active participation in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS), age 65-80 years, current nut intake of ≤1 serving/week, and being free of dementia or recent cardiovascular disease, cancer, or changes in relevant medications. The primary outcome is Mobile Toolbox fluid cognition composite scores, derived by averaging standardized test scores across five domains (associative memory, episodic memory, working memory, processing speed, executive function). Secondary outcomes include individual cognitive domain scores, cardiometabolic risk factors (body weight, waist circumference, blood pressure, fasting glucose, lipids, interleukin-6, insulin-like growth factor 1), and life satisfaction. DISCUSSION: Results from this trial will contribute to the growing literature on the cardiometabolic effects of pistachio consumption and may offer insight into its potential role in cognitive function, life satisfaction, and the mechanisms by which it could influence these interrelated domains of health in older adults. Findings will be interpreted in the context of a modest sample size and other pragmatic study design considerations. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov (Identifier: NCT06992544).
The effect of green tea amino acid L-theanine formulation on markers of stress and quality of sleep (THESleep project) - a study protocol for a pilot randomised control trial.
Bulman A, McKune A, Georgousopoulou E … +2 more , Sergi D, Naumovski N
Contemp Clin Trials · 2026 Jun · PMID 41991056 · Publisher ↗
L-theanine (L-THE) is a non-proteinogenic amino acid predominantly found in the leaves of the tea plant, Camelia sinensis, whose varieties produce green, white, oolong, black, aged Pu-erh, and ripened Pu-erh teas. The po...
L-theanine (L-THE) is a non-proteinogenic amino acid predominantly found in the leaves of the tea plant, Camelia sinensis, whose varieties produce green, white, oolong, black, aged Pu-erh, and ripened Pu-erh teas. The potential nootropic effects of L-THE, particularly for alleviating stress and anxiety and improving sleep quality, have seen an increase in its commercial application in products such as functional beverages and supplements despite the lack of conclusive evidence in the literature. The aim of this research project was to evaluate the effects of different concentrations of L-THE, in the form of a functional beverage sachet, on sleep and stress markers in individuals with mild to moderate sleep disturbances and determine an optimal concentration. In this randomised, double-blind, placebo-controlled, parallel-group, four-arm, dose response intervention trial, sixty healthy participants aged 18-65 with mild to moderate sleep disturbances were recruited to the study (UCHREC Approval Number: 2023-13247 and ACTRN12623000776606; Universal Trial Number (UTN) is U1111-1292-0328). Enrolled participants were randomly allocated to one of four treatment arms (100mg L-THE, 200mg L-THE, 400mg L-THE or placebo) in a 1:1:1:1 ratio, where they consumed a functional beverage for 14-days following a 7-day baseline period. The primary outcomes of this study were changes from baseline in objective and subjective sleep quality parameters alongside changes in secondary outcome measures of biochemical, physiological, and subjective stress markers relative to baseline. This clinical trial is the first to comprehensively evaluate the effectiveness (optimal dose) of L-THE at improving sleep quality and stress markers using a suite of objective, subjective, physiological, and biochemical tools.
The Imperial Prostate 9 - Approaches To Long-term Active Surveillance: Regular MRI scans versus standard of care (IP9-ATLAS) randomised controlled trial.
Gopalakrishnan A, Light A, Mayor N … +27 more , Cullen E, Rawlins F, Dalton R, Tanaka MB, Connor MJ, De Dios CC, Fiorentino F, Ali A, Akinyemi I, Klimowska-Nassar N, Sasikaran T, Monk R, Baker G, Andrews M, Sculpher M, Rothery C, Barrett T, Mangar S, Freeman A, Winkler M, Heer R, Shah TT, Sokhi HK, Giganti F, Punwani S, Emberton M, Ahmed HU
Contemp Clin Trials · 2026 Jun · PMID 41990428 · Publisher ↗
INTRODUCTION AND OBJECTIVES: Active surveillance is heterogenous using combinations of prostate specific antigen (PSA), digital rectal exam (DRE), magnetic resonance imaging (MRI) and biopsy. Using serial prostate MRI sc...
INTRODUCTION AND OBJECTIVES: Active surveillance is heterogenous using combinations of prostate specific antigen (PSA), digital rectal exam (DRE), magnetic resonance imaging (MRI) and biopsy. Using serial prostate MRI scans during active surveillance to inform when to conduct repeat biopsies might be effective to balance the burden of testing and detecting cancer progression early. IP9-ATLAS aims to determine whether regular MRI scans during active surveillance, compared to current standard of care (clinically-indicated MRI scans), will improve detection of cancer progression over 5 years. METHODS: IP9-ATLAS is a prospective, multi-centre RCT including patients with a histological diagnosis of Grade Group 1 or 2 disease on active surveillance. It compares UK NICE-defined standard of care (regular PSA and DRE when indicated with clinically-guided use of repeat MRI and biopsy), against the intervention arm (regular PSA and regular prostate MRI scans without intravenous contrast medium (i.e. biparametric), planned yearly for patients with an MRI-visible cancer lesion or Grade Group 2 cancer and every 2 years for all other patients). An internal pilot will determine the feasibility of the trial. 1263 patients will be recruited. Ethics committee approval has been granted by the Health Research Authority Research Ethics Committee Wales. RESULTS: The primary outcome is cancer progression rate, defined as higher risk cancer on biopsy (Grade Group ≥3) or a higher stage (≥T3 or ≥ N or ≥ M1) over 5 years. Secondary outcomes will include treatment rates without progression, adverse events, cost-effectiveness and functional outcomes. Recruitment started in May 2024 and is due to complete in June 2027, with follow-up until 2032. The trial is registered with the ISRCTN and Clinical Trials.gov (ISRCTN11447662 / NCT06280781). CONCLUSION: IP9-ATLAS aims to provide robust level 1 comparative data to improve active surveillance protocols and change practice.
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