1,884 results match your criteria Contemporary clinical trials[Journal]


A text message delivered smoking cessation intervention: Design and rationale of the Text My Quit Study.

Contemp Clin Trials 2019 Apr 15. Epub 2019 Apr 15.

Live Inspired LLC, Washington, DC, United States.

Introduction: Smoking cessation interventions delivered through mobile technologies offer promise as an effective intervention tool. However, most existing programs have not been empirically tested, were not developed with end-user participation, and/or do not address evidence-based cognitive and behavioral variables shown to enhance smoking cessation in clinical trials. In addition, many programs tested in research trials have required users to access the internet and/or a smartphone app to access all program features, limiting the potential reach of those programs. Read More

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http://dx.doi.org/10.1016/j.cct.2019.04.010DOI Listing

Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial.

Contemp Clin Trials 2019 Apr 15. Epub 2019 Apr 15.

National Center for PTSD, Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. Electronic address:

Posttraumatic stress disorder (PTSD) is a debilitating disorder with limited medication treatment options. Recent reports have described the dearth of research on new drug development as a crisis in the pharmacotherapy of PTSD. There are only two PTSD medications approved by the U. Read More

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http://dx.doi.org/10.1016/j.cct.2019.04.009DOI Listing

Incentivizing healthy lifestyle behaviors to reduce cardiovascular risk in people with serious mental illness: An equipoise randomized controlled trial of the wellness incentives program.

Contemp Clin Trials 2019 Apr 13. Epub 2019 Apr 13.

Division of Behavioral Health, New Hampshire Department of Health and Human Services, Concord, NH, United States of America.

Background: Medicaid recipients with serious mental illness die 25-30 years earlier than people in the general population due to health conditions that are modifiable through lifestyle changes. Cardiovascular diseases from excess weight, smoking, and sedentary lifestyle contribute substantially to this life expectancy disparity. The current study evaluated the impact of incentives on participation in weight management programming (for overweight and obese adults) and smoking cessation treatment (for regular smokers). Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183055
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http://dx.doi.org/10.1016/j.cct.2019.04.005DOI Listing
April 2019
1 Read

A randomized trial to reduce smoking among American Indians in South Dakota: The walking forward study.

Contemp Clin Trials 2019 Apr 12. Epub 2019 Apr 12.

Regional Cancer Care Institute, Rapid City Regional Hospital, 353 Fairmount Blvd, Rapid City, SD 57701, USA. Electronic address:

Background: Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, "Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?"

Methods: Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Read More

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http://dx.doi.org/10.1016/j.cct.2019.04.007DOI Listing

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON).

Contemp Clin Trials 2019 Apr 12. Epub 2019 Apr 12.

New York University School of Medicine, Department of Population Health, United States of America; New York University School of Medicine, Department of Medicine, United States of America. Electronic address:

Background: Extended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183056
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http://dx.doi.org/10.1016/j.cct.2019.04.006DOI Listing
April 2019
1 Read

Corrigendum to "Design of VA Cooperative Study #591: CERV-PTSD, Comparative Effectiveness Research in Veterans with PTSD" [Contemp. Clin. Trials 41 (2015) 75-84].

Contemp Clin Trials 2019 Apr 5. Epub 2019 Apr 5.

VA Cooperative Studies Program Coordinating Center, Palo Alto, CA, USA; Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA.

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http://dx.doi.org/10.1016/j.cct.2019.04.003DOI Listing
April 2019
1 Read

Social incentives to encourage physical activity and understand predictors (STEP UP): Design and rationale of a randomized trial among overweight and obese adults across the United States.

Contemp Clin Trials 2019 Apr 4;80:55-60. Epub 2019 Apr 4.

Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States; The Wharton School, University of Pennsylvania, Philadelphia, PA, United States; The Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia, PA, United States; Crescenz Veterans Affairs Medical Center, Philadelphia, PA, United States. Electronic address:

Background: Less than half of adults in the United States (US) obtain the recommended level of physical activity. Social incentives, the influences that impact individuals to adjust their behaviors based on social ties or connections, are ubiquitous and could be leveraged within gamification interventions to provide a scalable, low-cost approach to increase engagement. Gamification, or the use of game design in non-game situations, is commonly used in the real world, but in most cases has not appropriately leveraged principles from theories of health behavior. Read More

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http://dx.doi.org/10.1016/j.cct.2019.04.001DOI Listing
April 2019
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Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics.

Contemp Clin Trials 2019 Apr 2. Epub 2019 Apr 2.

VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, United States; Regenstrief Institute, Indianapolis, IN, United States; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States.

Chronic pain is prevalent, costly, and a leading cause of disability. Pain self-management (i.e. Read More

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http://dx.doi.org/10.1016/j.cct.2019.04.002DOI Listing

Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol.

Contemp Clin Trials 2019 Mar 25;80:48-54. Epub 2019 Mar 25.

Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA; Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.

Introduction: Most smokers see a physician each year, but few use any assistance when they try to quit. Text messaging programs improve smoking cessation in community and school settings; however, their efficacy in a primary care setting is unclear. The current trial assesses the feasibility and preliminary clinical outcomes of text messaging and mailed nicotine replacement therapy (NRT) among smokers in primary care. Read More

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http://dx.doi.org/10.1016/j.cct.2019.03.006DOI Listing
March 2019
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Specialized tobacco quitline and basic needs navigation interventions to increase cessation among low income smokers: Study protocol for a randomized controlled trial.

Contemp Clin Trials 2019 Mar 20;80:40-47. Epub 2019 Mar 20.

Washington University, Brown School, Health Communication Research Laboratory, United States of America.

Smoking in the United States follows a clear socioeconomic gradient: low-income Americans smoke more and quit less than those with more education and income. Evidence-based interventions like tobacco quitlines are designed to make effective cessation services available on a population basis to all smokers. However, these interventions do not address many of the unique challenges faced by low-income smokers, including unmet basic needs like food, housing, personal safety and money for necessities that often supersede health needs. Read More

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http://dx.doi.org/10.1016/j.cct.2019.03.009DOI Listing

Dose-response analysis of ranibizumab as-needed regimens for visual improvement in patients with diabetic macular edema using a modelling approach.

Contemp Clin Trials 2019 Mar 21;80:34-39. Epub 2019 Mar 21.

Novartis Pharma AG, Basel, Switzerland; Department of Cardiology and Angiology I, Heart Center Freiburg University, Faculty of Medicine, University of Freiburg, Germany. Electronic address:

Background: Ranibizumab and aflibercept are anti-vascular endothelial growth factor therapies for diabetic macular edema (DME) but have only been directly compared in one study: the Protocol T study, a 24-month randomized controlled trial which compared the safety and efficacy of three anti-VEGF agents (ranibizumab 0.3 mg, aflibercept 2.0 mg and bevacizumab 1. Read More

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http://dx.doi.org/10.1016/j.cct.2019.03.008DOI Listing
March 2019
2 Reads

Evaluation of worldwide clinical trials by gender: An FDA perspective.

Contemp Clin Trials 2019 Mar 16;80:16-21. Epub 2019 Mar 16.

Office of Women's Health, OC, FDA (Address: 10903 New Hampshire Avenue, WO32-2333, Silver Spring, MD 20993, USA. Electronic address:

Introduction: The US Food and Drug Administration (FDA) has undertaken efforts to promote representation of women in clinical trials. The objectives of this research are to assess women's participation in clinical trials from a global perspective and to analyze the demographic characteristics of clinical trial participants.

Methods: FDA's Center for Drug Evaluation and Research-Professional Affairs and Stakeholder Engagement (CDER/PASE) and Office of Women's Health (OWH) collaborated to evaluate demographic data (race, ethnicity, gender, and age) of pivotal trials of New Molecular Entities (NMEs) approved in 2015-2016 by geographic location. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183067
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http://dx.doi.org/10.1016/j.cct.2019.03.007DOI Listing
March 2019
9 Reads

Care partner problem solving training (CP-PST) for care partners of adults with traumatic brain injury during inpatient rehabilitation: Study protocol for a multisite, randomized, single-blind clinical feasibility trial.

Contemp Clin Trials 2019 Mar 16;80:9-15. Epub 2019 Mar 16.

Department of Physical Medicine & Rehabilitation, University of Texas Southwestern Medical Center, Dallas, TX, United States.

Traumatic brain injury (TBI) often leads to immediate and chronic functional impairments that affect care partners, or those providing physical and/or emotional support to individuals with TBI. The many challenges associated with being a care partner often lead to caregiver burden and can compromise the well-being and quality of life of care partners and individuals with TBI under their care. Equipping care partners with problem-solving skills could facilitate and sustain their transition into this supportive role. Read More

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http://dx.doi.org/10.1016/j.cct.2019.03.004DOI Listing

Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study.

Contemp Clin Trials 2019 Mar 15;80:22-33. Epub 2019 Mar 15.

California Pacific Medical Center Research Institute, San Francisco, CA, USA; University of California, San Francisco, San Francisco, CA, USA.

Introduction: While the Accreditation Council for Graduate Medical Education limited first year resident-physicians to 16 consecutive work hours from 2011 to 2017, resident-physicians in their second year or higher were permitted to work up to 28 h consecutively. This paper describes the Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) study, a clustered-randomized crossover clinical trial designed to evaluate the effectiveness of eliminating traditional shifts of 24 h or longer for second year or higher resident-physicians in pediatric intensive care units (PICUs).

Methods: ROSTERS was a multi-center non-blinded trial in 6 PICUs at US academic medical centers. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183076
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http://dx.doi.org/10.1016/j.cct.2019.03.005DOI Listing
March 2019
11 Reads

Design and patient characteristics of the randomized controlled trial TExT-MED + FANS A test of mHealth augmented social support added to a patient-focused text-messaging intervention for emergency department patients with poorly controlled diabetes.

Contemp Clin Trials 2019 Mar 14;80:1-8. Epub 2019 Mar 14.

School of Social Work, University of Southern California, United States.

Although diabetes is a nationwide epidemic, US Latinos are a particularly vulnerable population. Culturally appropriate interventions can combat this disparity, especially those that increase social support. However, these interventions face significant cost and time barriers, which mHealth (mobile health) may overcome. Read More

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http://dx.doi.org/10.1016/j.cct.2019.03.003DOI Listing
March 2019
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Trial design and methodology for a non-restricted sequential multiple assignment randomized trial to evaluate combinations of perinatal interventions to optimize women's health.

Contemp Clin Trials 2019 Apr 6;79:111-121. Epub 2019 Mar 6.

Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA. Electronic address:

Pre-pregnancy overweight/obesity and excessive gestational weight gain (GWG) independently predict negative maternal and child health outcomes. To date, however, interventions that target GWG have not produced lasting improvements in maternal weight or health at 12-months postpartum. Given that interventions solely aimed at addressing GWG may not equip women with the skills needed for postpartum weight management, interventions that address health behaviors over the perinatal period might maximize maternal health in the first postpartum year. Read More

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http://dx.doi.org/10.1016/j.cct.2019.03.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436999PMC
April 2019
2 Reads

The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes.

Contemp Clin Trials 2019 Apr 4;79:80-88. Epub 2019 Mar 4.

Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA; Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, New York University School of Medicine, New York, NY, USA. Electronic address:

Weight loss reduces the risk of type 2 diabetes mellitus (T2D) in overweight and obese individuals. Although the physiological response to food varies among individuals, standard dietary interventions use a "one-size-fits-all" approach. The Personal Diet Study aims to evaluate two dietary interventions targeting weight loss in people with prediabetes and T2D: (1) a low-fat diet, and (2) a personalized diet using a machine-learning algorithm that predicts glycemic response to meals. Read More

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http://dx.doi.org/10.1016/j.cct.2019.03.001DOI Listing

The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease.

Contemp Clin Trials 2019 Apr 3;79:98-103. Epub 2019 Mar 3.

Harbor-UCLA Medical Center, 1124 W. Carson St., Torrance, CA, 90509, United States.

Background: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10-20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients.

Objectives: The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.008DOI Listing
April 2019
3 Reads

Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study).

Contemp Clin Trials 2019 Apr 1;79:44-54. Epub 2019 Mar 1.

Institute for Dementia Research and Prevention, Pennington Biomedical Research Center, Baton Rouge, LA, USA. Electronic address:

Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436980PMC
April 2019
4 Reads

Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial.

Contemp Clin Trials 2019 Apr 27;79:73-79. Epub 2019 Feb 27.

School of Nursing, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address:

Background: Chronic insomnia is associated with poor asthma control. Cognitive-behavioral treatment for insomnia (CBT-I) is an efficacious and durable treatment for comorbid insomnia in medical and psychiatric disorders. However, the efficacy and potential accompanying mechanisms of CBT-I have not been examined in asthma. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.011DOI Listing
April 2019
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A randomized controlled trial of buprenorphine for probationers and parolees: Bridging the gap into treatment.

Contemp Clin Trials 2019 Apr 20;79:21-27. Epub 2019 Feb 20.

Department of Psychology, University of Maryland, College Park, MD, USA.

Background: Buprenorphine can be effective in a variety of community substance use treatment settings outside of methadone programs, including outpatient programs and medical practices. In these settings, it has been found to be effective in reducing opioid use and retaining patients in treatment. Despite its effectiveness and safety, it is rarely provided to individuals with opioid use disorders in probation and parole settings. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436986PMC
April 2019
1.986 Impact Factor

PCI Alternative Using Sustained Exercise (PAUSE): Rationale and trial design.

Contemp Clin Trials 2019 Apr 20;79:37-43. Epub 2019 Feb 20.

Veterans Affairs Palo Alto Health Care System, Division of Cardiovascular Medicine, Stanford University, United States of America.

Cardiovascular disease (CVD) currently claims nearly one million lives yearly in the US, accounting for nearly 40% of all deaths. Coronary artery disease (CAD) accounts for the largest number of these deaths. While efforts aimed at treating CAD in recent decades have concentrated on surgical and catheter-based interventions, limited resources have been directed toward prevention and rehabilitation. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.010DOI Listing
April 2019
1 Read
1.986 Impact Factor

Does outpatient palliative care improve patient-centered outcomes in Parkinson's disease: Rationale, design, and implementation of a pragmatic comparative effectiveness trial.

Contemp Clin Trials 2019 Apr 16;79:28-36. Epub 2019 Feb 16.

Division of Neurology, University of Alberta, 11350-83 Avenue, 7-112 Clinical Sciences Building, Edmonton, AB T6G 2G3, Canada. Electronic address:

Patients with Parkinson's disease and related disorders (PDRD) and their families have considerable unmet needs including non-motor symptom management, caregiver support, spiritual wellbeing, advance care planning, and end-of-life care. There is increasing interest in applying palliative care (PC) models to better meet these needs. While PC has been shown to improve care and quality of life (QOL) for people with cancer and heart failure, few studies have evaluated the role of PC for people with PDRD. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.005DOI Listing
April 2019
14 Reads

Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.

Contemp Clin Trials 2019 Apr 14;79:55-65. Epub 2019 Feb 14.

NorthShore University HealthSystem, University of Illinois at Chicago, United States.

Objective: To describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago.

Methods: Child/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.006DOI Listing
April 2019
3 Reads

Arriba por la Vida Estudio (AVE): Study protocol for a standing intervention targeting postmenopausal Latinas.

Contemp Clin Trials 2019 Apr 13;79:66-72. Epub 2019 Feb 13.

University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America.

Background: Postmenopausal Latinas are a growing population group in the US who are at high risk for cardiovascular disease. Epidemiological studies have shown that excessive sitting is related to cardiovascular disease risk. Older women sit for prolonged periods and most individuals do not meet physical activity guidelines. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.004DOI Listing
April 2019
2 Reads

A randomized trial of a multi-level intervention to increase water access and appeal in community recreation centers.

Contemp Clin Trials 2019 Apr 13;79:14-20. Epub 2019 Feb 13.

School of Medicine, Stanford University, Stanford, CA, USA; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, CA, USA.

Introduction: Improving children's tap water intake and reducing sugar-sweetened beverage (SSB) consumption is beneficial for health and health equity, particularly in low-income communities and communities of color. Existing community level interventions to improve the intake of tap water have predominantly occurred in schools and have focused on promoting water consumption in cafeterias during lunch or snack periods.

Methods: The "Hydrate Philly" intervention was developed to target multiple environmental and social factors to improve tap water consumption in community recreation centers in low-income communities: replacing old and unappealing water fountains with appealing water-bottle-filling "hydration stations", conducting water safety testing and publicizing results, disseminating reusable water bottles, promoting tap water, and discouraging SSB consumption. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.003DOI Listing
April 2019
2 Reads

Multi-pronged intervention to increase secondary student participation in school lunch: Design and rationale.

Contemp Clin Trials 2019 Mar 13;78:133-139. Epub 2019 Feb 13.

University of California, Berkeley, United States. Electronic address:

Background: In the United States, the National School Lunch Program (NSLP) is the healthiest lunch option for students, yet participation is suboptimal and fruit and vegetable waste remains high. Improving school meal convenience, engaging teachers in the school-lunch program, and enhancing the cafeteria environment are promising strategies to improve participation and dietary intake, yet little evidence is available on their impact.

Methods/design: The Multi-Pronged Intervention to Increase Secondary Student Participation in School Lunch (MPI) is a 3-year quasi-experimental study in a large urban school district in California. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.013DOI Listing

Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan.

Contemp Clin Trials 2019 Mar 7;78:126-132. Epub 2019 Feb 7.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University Milan, Italy. Electronic address:

Objective: Few randomized trials have evaluated the use of non-invasive ventilation (NIV) for early acute respiratory failure (ARF) in non-intensive care unit (ICU) wards. The aim of this study is to test the hypothesis that early NIV for mild-moderate ARF in non-ICU wards can prevent development of severe ARF.

Design: Pragmatic, parallel group, randomized, controlled, multicenter trial. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.001DOI Listing
March 2019
6 Reads

Study protocol and baseline sample characteristics: From clinic to community: Using peer support as a transition model for improving long-term diabetes-related health outcomes.

Contemp Clin Trials 2019 Apr 7;79:104-110. Epub 2019 Feb 7.

Division of Endocrinology, Department of Medicine, The University of British Columbia, Canada. Electronic address:

Background: The objective of this randomized controlled trial is to examine the effects of a 12-month telephone-based peer-led diabetes self-management support (DSMS) intervention on long-term diabetes-related health outcomes.

Methods: In total, 197 participants with type 2 diabetes were recruited from specialty care settings (diabetes and endocrinology clinics). They were randomly assigned to 1) a 12-month Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS) in the first 3 months, followed by 18 biweekly telephone support contacts over the last 9 months, or 2) usual care. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183064
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http://dx.doi.org/10.1016/j.cct.2019.02.002DOI Listing
April 2019
4 Reads

Intervention Comparative Effectiveness for Adult Cognitive Training (ICE-ACT) Trial: Rationale, design, and baseline characteristics.

Contemp Clin Trials 2019 Mar 31;78:76-87. Epub 2019 Jan 31.

Florida State University, Department of Psychology, Tallahassee, FL, United States.

Age-related perceptual and cognitive declines are associated with difficulties performing everyday tasks required to remain independent. Encouraging improvements in cognitive abilities have been shown for various short-term interventions but there is little evidence for direct impact on independence. This project compares the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.014DOI Listing
March 2019
1 Read
1.986 Impact Factor

A brief intervention to increase uptake and adherence of an online program for depression and anxiety: Protocol for the Enhancing Engagement with Psychosocial Interventions (EEPI) Randomized Controlled Trial.

Contemp Clin Trials 2019 Mar 31;78:107-115. Epub 2019 Jan 31.

Centre for Mental Health Research, Research School of Population Health, The Australian National University, Australia.

Background: There is substantial evidence that psychosocial programs delivered online can be effective in treating and preventing mental health problems. However, use of evidence-based programs in the community is currently suboptimal, and there is a lack of evidence around how to increase engagement with existing evidence-based programs. Novel approaches to increasing the acceptability of online programs such as the use of brief engagement-facilitation interventions (EFI) require evaluation. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.015DOI Listing

The Healthy Pregnancies Project: Study protocol and baseline characteristics for a cluster-randomized controlled trial of a community intervention to reduce tobacco use among Alaska Native pregnant women.

Contemp Clin Trials 2019 Mar 28;78:116-125. Epub 2019 Jan 28.

Native American Cancer Initiatives, Inc., 3022 South Nova Road, Pine, CO 80470, USA. Electronic address:

Background: Tobacco use prevalence is high among pregnant Alaska Native (AN) women but few interventions have been evaluated for this group. The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women. This report describes the study protocol and participant baseline characteristics. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407629PMC
March 2019
1 Read

Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial.

Contemp Clin Trials 2019 Mar 21;78:88-100. Epub 2019 Jan 21.

School of Nursing, University of Wisconsin, Signe Skott Cooper Hall, 701 Highland Avenue, Madison, WI 53705, USA. Electronic address:

Young adults (18-39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension self-management programs are recommended to improve control, but have been targeted to middle-aged and older populations. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6387836PMC
March 2019
4 Reads

Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers.

Contemp Clin Trials 2019 Apr 19;79:89-97. Epub 2019 Jan 19.

Washington University School of Medicine, Department of Medicine, Division of Geriatrics and Nutritional Science, 660 S. Euclid, Campus Box 8083, St. Louis, MO 63110, United States.

Weight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus, the workplace offers a useful setting to target low-SES workers. The current paper presents the design of a study testing a workplace intervention aimed at low-SES employees. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.011DOI Listing
April 2019
1 Read

Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods.

Contemp Clin Trials 2019 Mar 16;78:27-33. Epub 2019 Jan 16.

Division of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States. Electronic address:

Asthma causes enormous suffering and cost for children in the US and around the world [1-3]. Co-morbid gastroesophageal reflux disease (GERD) makes asthma management more difficult due to increased symptoms. Proton pump inhibitor (PPI) drugs are effective at improving to GERD symptoms, however they have demonstrated only modest and variable effects on asthma control in the setting of co-morbid GERD. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183065
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http://dx.doi.org/10.1016/j.cct.2019.01.009DOI Listing
March 2019
4 Reads

An addiction-based mobile health weight loss intervention: protocol of a randomized controlled trial.

Contemp Clin Trials 2019 Mar 14;78:11-19. Epub 2019 Jan 14.

Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States.

Background: The notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.008DOI Listing
March 2019
12 Reads

Preliminary efficacy and feasibility of referral to exercise specialists, psychologists and provision of a technology-based behavior change support package to promote physical activity in school teachers 'at risk' of, or diagnosed with, type 2 diabetes: The 'SMART Health' Pilot Study Protocol.

Contemp Clin Trials 2019 Mar 11;78:53-62. Epub 2019 Jan 11.

University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia. Electronic address:

Introduction: Type 2 diabetes mellitus (T2DM) is a global public health concern. Aerobic physical activity (PA) and resistance training (RT) play significant roles in the prevention and management of T2DM. The aim of this pilot trial is to determine the preliminary efficacy and confirm feasibility of referral to exercise physiologists, psychologists, and provision of a technology-based behavior change support package to promote aerobic PA and RT in school teachers 'at risk' of or diagnosed with T2DM. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.007DOI Listing
March 2019
17 Reads

Minimally Invasive coronary surgery compared to STernotomy coronary artery bypass grafting: The MIST trial.

Contemp Clin Trials 2019 Mar 8;78:140-145. Epub 2019 Jan 8.

Division of cardiac surgery, University of Ottawa Heart Institute, Ottawa, Canada. Electronic address:

Rationale: Minimally invasive cardiac surgery has emerged as a safe alternative to standard cardiac surgery. Minimally invasive coronary surgery (MICS CABG) was developed to allow adequate exposure and complete revascularization in CABG from a small thoracotomy incision without cardiopulmonary bypass. Multiple studies have reported significant shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183037
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http://dx.doi.org/10.1016/j.cct.2019.01.006DOI Listing
March 2019
13 Reads

Blood pressure checks and diagnosing hypertension (BP-CHECK): Design and methods of a randomized controlled diagnostic study comparing clinic, home, kiosk, and 24-hour ambulatory BP monitoring.

Contemp Clin Trials 2019 Apr 8;79:1-13. Epub 2019 Jan 8.

University of Washington, Department of Family Medicine, United States.

Background: The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.003DOI Listing
April 2019
3 Reads

Synthesis of researcher reported strategies to recruit adults of ethnic minorities to clinical trials in the United Kingdom: A systematic review.

Contemp Clin Trials 2019 Mar 8;78:1-10. Epub 2019 Jan 8.

Background: People from ethnic minorities are reported to have higher rates of physical illness (diabetes and ischemic heart disease) and mental disorders. Disparities relate not just to diagnosis, but also to care pathways and treatment outcomes. Despite this, they are underrepresented in clinical research. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.004DOI Listing
March 2019
1 Read

Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial.

Contemp Clin Trials 2019 Mar 7;78:34-45. Epub 2019 Jan 7.

Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States; Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address:

Background: Childhood obesity is highly prevalent and carries substantial health consequences. Childhood obesity interventions have had mixed results, which may be partially explained by the absence of theory that incorporates broader family context and methods that address implementation challenges in low-resource settings. Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.002DOI Listing
March 2019
14 Reads

iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children.

Contemp Clin Trials 2019 Mar 7;78:20-26. Epub 2019 Jan 7.

Department of Counseling, School, and Educational Psychology, Graduate School of Education, University at Buffalo - SUNY, 420 Baldy Hall, Buffalo, NY 14260, United States.

Children in rural areas are disproportionately affected by pediatric obesity. Poor access to healthcare providers, lack of nutrition education, lower socioeconomic status, and fewer opportunities to be physically active are all unique barriers that contribute to this growing health concern. There are very few pediatric obesity interventions that have been developed that target this unique population. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183053
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http://dx.doi.org/10.1016/j.cct.2019.01.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6387830PMC
March 2019
9 Reads

STRONG-D: Strength training regimen for normal weight diabetics: Rationale and design.

Contemp Clin Trials 2019 Mar 6;78:101-106. Epub 2019 Jan 6.

Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.

Background: Currently, there is a lack of data on effective lifestyle recommendations for normal-weight diabetics (NWD), who can represent up to 1 in 5 individuals with Type II Diabetes Mellitus (T2DM). NWD is especially prevalent in Asian populations and the elderly. Specific exercise treatment recommendations are needed for patients with normal-weight diabetes (NWD), as those in this category face higher mortality rates than overweight and obese diabetics. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183043
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http://dx.doi.org/10.1016/j.cct.2019.01.005DOI Listing
March 2019
6 Reads
1.986 Impact Factor

Link-me: Protocol for a randomised controlled trial of a systematic approach to stepped mental health care in primary care.

Contemp Clin Trials 2019 Mar 26;78:63-75. Epub 2018 Dec 26.

The Department of General Practice, Melbourne Medical School, University of Melbourne.

Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs. Link-me is testing whether a patient-completed Decision Support Tool (DST), which predicts future severity of depression and anxiety symptoms and triages individuals into care accordingly, is clinically effective and cost-effective relative to usual care. The trial is set in general practices, with English-speaking patients invited to complete eligibility screening in their general practitioner's waiting room. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.014DOI Listing
March 2019
2 Reads

Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era.

Contemp Clin Trials 2019 Feb 27;77:98-103. Epub 2018 Dec 27.

University of California San Francisco, San Francisco, CA.

Precision medicine is expected to impact the care of people with asthma, given its high disease prevalence, heterogeneity of pathophysiologic mechanisms, and consequent clinical phenotypes. A novel phenotype-stratified clinical trial conducted by the NHLBI AsthmaNet Consortium, titled Steroids in Eosinophil Negative Asthma (SIENA), was a randomized, multicenter, clinical trial that prospectively stratified individuals according to their baseline level of sputum inflammation during a screening period. Two phenotypic strata were assigned based on an a priori defined extent of sputum eosinophilia (Eos Low versus Eos High). Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425934PMC
February 2019
9 Reads

Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial.

Contemp Clin Trials 2019 Feb 26;77:70-75. Epub 2018 Dec 26.

School of Nursing, The University of Hong Kong, Hong Kong. Electronic address:

Background: Novel approaches to engage community smokers in smoking cessation are needed as smokers typically lack motivation to quit or use evidence-based tobacco dependence treatment. Mobile instant messaging apps (e.g. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.013DOI Listing
February 2019
2 Reads

In-home obesity prevention in low-income infants through maternal and social transmission.

Contemp Clin Trials 2019 Feb 19;77:61-69. Epub 2018 Dec 19.

Research Center for Health Equity, Cedars-Sinai Medical Center, 116 N Robertson Blvd PACT Bldg 909, Los Angeles, CA 90048, United States. Electronic address:

Background: Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families.

Methods: This two-arm, parallel, randomized controlled trial (RCT) tests whether delivering obesity prevention, as part of an ongoing home visitation program (HVP), is an effective approach for primary (infants) and secondary (mothers) obesity prevention among low-income, underserved families. This RCT further examines the role of maternal and social factors as key mechanisms of transmission of infants' obesity risk, and the real-life costs of delivering obesity prevention as part of HVPs. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.010DOI Listing
February 2019
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Improving anti-platelet therapy adherence in the Veterans Health Administration: A randomized multi-site hybrid effectiveness-implementation study protocol.

Contemp Clin Trials 2019 Feb 19;77:104-110. Epub 2018 Dec 19.

VHA Eastern Colorado Health Care System, Denver, CO, United States.

Background: P2Y12 inhibitors are critical following percutaneous coronary intervention (PCI) with stent placement; they reduce the risk of stent thrombosis and myocardial infarction. Despite the importance of the therapy, non-adherence is common among Veterans.

Methods And Results: Our main objective is to conduct a multi-site randomized stepped wedge trial to test the effectiveness of a multi-faceted intervention to improve adherence to P2Y12 inhibitors and PCI outcomes as well as formatively evaluate and refine the intervention implementation process. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183040
Publisher Site
http://dx.doi.org/10.1016/j.cct.2018.12.005DOI Listing
February 2019
9 Reads

Enhancing individual placement and support (IPS) - Supported employment: A Type 1 hybrid design randomized controlled trial to evaluate virtual reality job interview training among adults with severe mental illness.

Contemp Clin Trials 2019 Feb 18;77:86-97. Epub 2018 Dec 18.

Thresholds Inc, USA; Chicago Department of Psychiatry, University of Illinois, USA.

Individual Placement and Support (IPS) is the evidence-based model of supported employment that increases employment rates in adults with severe mental illness (SMI). Although IPS is largely successful, over 80% of adults with SMI remain unemployed. An enhancement to high fidelity IPS could be an evidence-based job interview training component. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396298PMC
February 2019
2 Reads
1.986 Impact Factor

Rationale and design of Smart Walk: A randomized controlled pilot trial of a smartphone-delivered physical activity and cardiometabolic risk reduction intervention for African American women.

Contemp Clin Trials 2019 Feb 18;77:46-60. Epub 2018 Dec 18.

Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, 500 N 3rd St, Phoenix, AZ 85004, USA. Electronic address:

Background: African American (AA) women perform low levels of physical activity (PA) and are disproportionally burdened by cardiometabolic disease conditions when compared to White women and the U.S. population as a whole. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6344046PMC
February 2019
1 Read