Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis
We propose a Phase III trial that compares the effectiveness of an exercise training program delivered in a facility-based setting with direct, in-person supervision or a home-based setting with remote supervision via telerehabilitation for improving walking performance in persons with multiple sclerosis(MS) who have walking dysfunction and mobility disability. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 22, 2019 Category: Radiology Authors: Robert W. Motl, Deborah Backus, Whitney N. Neal, Gary Cutter, Louise Palmer, Robert McBurney, Hollie Schmidt, Francois Bethoux, Jeffrey Hebert, Alexander Ng, Kevin McCully, Prudence Plummer Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 21, 2019 Category: Radiology Source Type: research

Effectiveness of shortened time interval to postpartum visit in improving postpartum attendance: Design and rationale for a randomized controlled trial
This report discusses the unique aspects of a randomized controlled trial's (RCT) design, intervention, and strategies to maintain participant retention. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 18, 2019 Category: Radiology Authors: Saba W. Masho, Timothy O. Ihongbe, Wen Wan, Whitney C. Graves, Nicole Karjane, Pamela Dillon, Gloria Bazzoli, Elizabeth McGee Tags: Short Communication Source Type: research

The new US and European guidelines in hypertension: A multi-dimensional analysis
The Systolic Blood Pressure Intervention Trial (SPRINT) compared the clinical outcomes between target systolic blood pressure (SBP) levels between 140 and 120  mmHg or lower. Both,the 2017 ACC/AHA and the 2018 ESC/ESH guidelines in hypertension are derived from the SPRINT trial and advise initiation and/or intensification of treatment at lower blood pressure thresholds. The ACC/AHA guidance supersedes the 2014 Eight Joint National Committee guideline (J NC-8) which advised initiation of treatment when the BP was 140/90 mmHg or higher; in adults 60 years or over, the target was 150/90 mmHg. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 16, 2019 Category: Radiology Authors: Marcel G.M. Olde Rikkert, Michael Fernandes Source Type: research

Randomized trial evaluating the role of weight loss in overweight and obese men with early stage prostate Cancer on active surveillance: Rationale and design of the Prostate Cancer Active Lifestyle Study (PALS)
Active surveillance (AS) is increasingly used to monitor patients with low-risk prostate cancer; however, approximately 50% of AS patients experience disease reclassification requiring definitive treatment and little is known about patient characteristics that modify the risk of reclassification. Obesity may be one of the major contributing factors.The Prostate Cancer Active Lifestyle Study (PALS) is a clinical trial evaluating the impact of weight loss among overweight/obese (Body Mass Index (BMI)  ≥ 25 kg/m2) men with clinically localized prostate cancer on AS. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 16, 2019 Category: Radiology Authors: Jeannette M. Schenk, Marian L. Neuhouser, Sarah J. Beatty, Matthew VanDoren, Daniel W. Lin, Michael Porter, John L. Gore, Roman Gulati, Stephen R. Plymate, Jonathan L. Wright Source Type: research

A text message delivered smoking cessation intervention: Design and rationale of the Text My Quit Study
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 15, 2019 Category: Radiology Authors: Christopher Deutsch, Beth C. Bock, Ryan Lantini, Kristen Walaska, Rochelle K. Rosen, Joseph L. Fava, Ernestine G. Jennings, Robert Foster, William Flanagan Source Type: research

Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial
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.S. Food and Drug Administration, and both are serotonergic antidepressants. Therefore, there is a tremendous need to identify more effective and more rapidly acting pharmacotherapies for PTSD that work through novel neural mechanisms. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 15, 2019 Category: Radiology Authors: Chadi G. Abdallah, John D. Roache, Lynnette A. Averill, Stacey Young-McCaughan, Brenda Martini, Ralitza Gueorguieva, Timothy Amoroso, Steven M. Southwick, Kevin Guthmiller, Argelio L. L ópez-Roca, Karl Lautenschlager, Jim Mintz, Brett T. Litz, Douglas E. Source Type: research

Incentivizing healthy lifestyle behaviors to reduce cardiovascular risk in people with serious mental illness: An equipoise randomized controlled trial of the wellness incentives program
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). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 13, 2019 Category: Radiology Authors: Sarah I. Pratt, Mary F. Brunette, Rosemarie Wolfe, Emily A. Scherer, Haiyi Xie, Stephen Bartels, Joelle C. Ferron, Kelley Capuchino Source Type: research

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON)
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 formul ation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 12, 2019 Category: Radiology Authors: Mia Malone, Ryan McDonald, Alexandria Vittitow, Jenny Chen, Rita Obi, Dan Schatz, Babak Tofighi, Annie Garment, Keith Goldfeld, Heather Gold, Eugene Laska, John Rotrosen, Joshua D. Lee Source Type: research

A randomized trial to reduce smoking among American Indians in South Dakota: The walking forward study
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?” (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 12, 2019 Category: Radiology Authors: Mark B. Dignan, Kate Jones, Linda Burhansstipanov, Sheikh I. Ahamed, Linda U. Krebs, Drew Williams, G.M. Tanimul Ahsan, Ivor Addo, Michele Sargent, Kristin Cina, Kim Crawford, Doris Thibeault, Simone Bordeaux, Shalini Kanekar, Daniel Petereit Source Type: research

Corrigendum to “Design of VA Cooperative Study #591: CERV-PTSD, Comparative Effectiveness Research in Veterans with PTSD” [Contemp. Clin. Trials 41 (2015) 75–84]
The authors regret reporting on p. 77 that remission of PTSD would be defined as a score (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 5, 2019 Category: Radiology Authors: Paula P. Schnurr, Kathleen M. Chard, Josef I. Ruzek, Bruce K. Chow, Mei-Chiung Shih, Patricia A. Resick, Edna B. Foa, Brian P. Marx, Grant D. Huang, Ying Lu Tags: Corrigendum Source Type: research

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
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 4, 2019 Category: Radiology Authors: Joseph D. Harrison, Jeremy M. Jones, Dylan S. Small, Charles A.L. Rareshide, Gregory Szwartz, David Steier, James Guszcza, Pameljit Kalra, Brian Torio, Gregory Reh, Victoria Hilbert, Mitesh S. Patel Source Type: research

Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics
Chronic pain is prevalent, costly, and a leading cause of disability. Pain self-management (i.e., employing self-management strategies including behavioral modifications) is an effective, evidence-based treatment. However, implementation and delivery of a pain self-management model is challenging because of time and resources. Peer supported pain self-management offers a promising approach to implementing pain self-management programs using fewer clinical resources. Evaluation of a Peer Coach-Led Intervention for the Improvement of Pain Symptoms (ECLIPSE) is a randomized controlled trial testing effectiveness of peer coach...
Source: Contemporary Clinical Trials - April 2, 2019 Category: Radiology Authors: Marianne S. Matthias, Joanne Daggy, Jasma Adams, Tetla Menen, Stephanie McCalley, Marina Kukla, Alan B. McGuire, Susan Ofner, Emilee Pierce, Carol Kempf, Michele Heisler, Matthew J. Bair Source Type: research

Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 25, 2019 Category: Radiology Authors: G.R. Kruse, E. Park, J.E. Haberer, L. Abroms, N.N. Shahid, S.E. Howard, Y. Chang, J.S. Haas, N.A. Rigotti Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 24, 2019 Category: Radiology Source Type: research

Dose-response analysis of ranibizumab as-needed regimens for visual improvement in patients with diabetic macular edema using a modelling approach
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 1.25 mg). The ranibizumab dose used in Protocol T is not licensed for use outside of the US, where a higher ranibizumab dose of 0.5 mg is approved. Therefore, the relevance of the head-to-head Protocol T study findings to healthcare providers in Europe is limited. (Source:...
Source: Contemporary Clinical Trials - March 20, 2019 Category: Radiology Authors: Yuan Xiong, Etienne Pigeolet, Zufar Mulyukov, Philippe Margaron, Amy Racine, Andreas Clemens Source Type: research

Specialized tobacco quitline and basic needs navigation interventions to increase cessation among low income smokers: Study protocol for a randomized controlled trial
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 20, 2019 Category: Radiology Authors: Amy McQueen, Christina Roberts, Rachel Garg, Charlene Caburnay, Qiang Fu, Jacob Gordon, Terry Bush, Robin Pokojski, Tess Thompson, Matthew Kreuter Source Type: research

Evaluation of worldwide clinical trials by gender: An FDA perspective
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 16, 2019 Category: Radiology Authors: Emily Ayuso, Ruth J. Geller, Junyang Wang, John Whyte, Marjorie Jenkins Source Type: research

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
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 15, 2019 Category: Radiology Authors: Shannon B. Juengst, Valeria Silva, Yelena Goldin, Keith Cicerone, Jean Lengenfelder, Nancy Chiaravalloti, Simon Driver, David Mellick, Georgianna Dart, Chung Lin Kew, Andrew Nabasny, Kathleen R. Bell Source Type: research

Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study
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 r esident-physicians in pediatric intensive care units (PICUs). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 15, 2019 Category: Radiology Authors: Terri Blackwell, Dana R. Kriesel, Eric Vittinghoff, Conor S. O'Brien, Jason P. Sullivan, Natalie C. Viyaran, Shadab A. Rahman, Steven W. Lockley, Laura K. Barger, Ann C. Halbower, Sue E. Poynter, Kenneth P. Wright, Pearl L. Yu, Phyllis C. Zee, Christopher Source Type: research

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
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. This trial examines the benefit of adding social support to an existing text-message based, patient-focused mHealth intervention for emergency department patients with poorly controlled diabetes. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 13, 2019 Category: Radiology Authors: Elizabeth Burner, Janisse Mercado, Antonio Saenz Hernandez, Anne Peters, Lourdes Baezconde-Garbanati, Sanjay Arora, Shinyi Wu Source Type: research

Trial design and methodology for a non-restricted sequential multiple assignment randomized trial to evaluate combinations of perinatal interventions to optimize women's health
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 6, 2019 Category: Radiology Authors: Lisa J. Germeroth, Maria T. Benno, Rachel P. Kolko Conlon, Rebecca L. Emery, Yu Cheng, Jennifer Grace, Rachel H. Salk, Michele D. Levine Source Type: research

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
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. Changes in body weight, body composition, and resting energy expenditure will be compared over a 6-month intervention period and a ...
Source: Contemporary Clinical Trials - March 4, 2019 Category: Radiology Authors: Collin J. Popp, David E. St-Jules, Lu Hu, Lisa Ganguzza, Paige Illiano, Margaret Curran, Huilin Li, Antoinette Schoenthaler, Michael Bergman, Ann Marie Schmidt, Eran Segal, Anastasia Godneva, Mary Ann Sevick Source Type: research

The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A phase III, randomized trial of second intravenous immunoglobulin versus infliximab for resistant Kawasaki disease
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 3, 2019 Category: Radiology Authors: Samantha C. Roberts, Sonia Jain, Adriana H. Tremoulet, Katherine K. Kim, Jane C. Burns, KIDCARE Multicenter Study Group, Vikram Anand, Marsha Anderson, Jocelyn Ang, Emily Ansusinha, Moshe Arditi, Negar Ashouri, Allison Bartlett, Archana Chatterjee, Robert Source Type: research

Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study)
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 1, 2019 Category: Radiology Authors: Amanda N. Szabo-Reed, Eric Vidoni, Ellen F. Binder, Jeffrey Burns, C. Munro Cullum, William P. Gahan, Aditi Gupta, Linda S. Hynan, Diana R. Kerwin, Heidi Rossetti, Ann M. Stowe, Wanpen Vongpatanasin, David C. Zhu, Rong Zhang, Jeffrey N. Keller Source Type: research

Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial
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. The purpose of this study is to test the efficacy of a CBT-I intervention on sleep and asthma control in adults with insomnia and asthma. We will also explore airway inflammation (i.e., exhaled nitric oxide, blood eosinophils) as a potential biological mechanism linking improvements in sleep with improvements in asth...
Source: Contemporary Clinical Trials - February 27, 2019 Category: Radiology Authors: Xiaojun Shi, Daniel J. Buysse, Lee M. Ritterband, Susan M. Sereika, Patrick J. Strollo, Sally E. Wenzel, Faith S. Luyster Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 21, 2019 Category: Radiology Source Type: research

PCI Alternative Using Sustained Exercise (PAUSE): Rationale and trial design
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. CAD is commonly treated using percutaneous coronary intervention (PCI), and this treatment has increased exponentially since its adoption over three decades ago. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 20, 2019 Category: Radiology Authors: Jonathan Myers, Holly Fonda, Minal Vasanawala, Kieran Chung, George Segall, Khin Chan, Patricia Nguyen Source Type: research

A randomized controlled trial of buprenorphine for probationers and parolees: Bridging the gap into treatment
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 20, 2019 Category: Radiology Authors: Michael S. Gordon, Frank J. Vocci, Faye Taxman, Marc Fishman, Bikash Sharma, Thomas R. Blue, Kevin E. O'Grady Source Type: research

Does outpatient palliative care improve patient-centered outcomes in Parkinson's disease: Rationale, design, and implementation of a pragmatic comparative effectiveness trial
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 16, 2019 Category: Radiology Authors: Benzi M. Kluger, Maya Katz, Nicholas Galifianakis, Steven Z. Pantilat, Jean S. Kutner, Stefan Sillau, Mark Gritz, Jacqueline Jones, Diane Fairclough, Malenna Sumrall, Kirk Hall, Janis Miyasaki Source Type: research

Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 14, 2019 Category: Radiology Authors: Giselle S. Mosnaim, Sally M. Weinstein, Oksana Pugach, Genesis Rosales, Angkana Roy, Surrey Walton, Molly A. Martin Source Type: research

Arriba por la vida Estudio (AVE): Study protocol for a standing intervention targeting postmenopausal Latinas
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. Reducing sitting through increased standing may improve cardiovascular risk. More research is needed on how to intervene to increase standing in older Latinas. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 13, 2019 Category: Radiology Authors: Michelle Takemoto, Megan Schechtman, Nicole Villa, Gregory Talavera, Dorothy D. Sears, Neville Owen, Dori E. Rosenberg, David Dunstan, Matthew Allison, Jacqueline Kerr Source Type: research

A randomized trial of a multi-level intervention to increase water access and appeal in community recreation centers
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 13, 2019 Category: Radiology Authors: Hannah G. Lawman, Xavier Lofton, Sara Grossman, Mica Root, Meka Perez, Gregory Tasian, Anisha Patel Source Type: research

Multi-pronged intervention to increase secondary student participation in school lunch: Design and rationale
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 12, 2019 Category: Radiology Authors: Stephanie Machado, Lorrene Ritchie, Hannah Thompson, Annie Reed, Ana Ibarra Castro, Marisa Neelon, Kristine Madsen Source Type: research

Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 7, 2019 Category: Radiology Authors: Luca Cabrini, Claudia Brusasco, Agostino Roasio, Francesco Corradi, Pasquale Nardelli, Matteo Filippini, Virginia Cotticelli, Alessandro Belletti, Lorenzo Ferrara, Elio Antonucci, Martina Baiardo Redaelli, Marco Lattuada, Sergio Colombo, Luigi Olper, Gius Source Type: research

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
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 7, 2019 Category: Radiology Authors: Tricia S. Tang, Rowshanak Afshar, Thomas Elliott, Jason Kong, Sabrina Gill Source Type: research

Intervention Comparative Effectiveness for Adult Cognitive Training (ICE-ACT) Trial: Rationale, design, and baseline characteristics
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 31, 2019 Category: Radiology Authors: Jong-Sung Yoon, Nelson A. Roque, Ronald Andringa, Erin R. Harrell, Katharine G. Lewis, Thomas Vitale, Neil Charness, Walter R. Boot Source Type: research

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
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 31, 2019 Category: Radiology Authors: Philip J. Batterham, Alison L. Calear, Matthew Sunderland, Frances Kay-Lambkin, Louise M. Farrer, Amelia Gulliver Source Type: research

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
This report describes the study protocol and participant baseline characteristics. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 28, 2019 Category: Radiology Authors: Christi A. Patten, Harry A. Lando, Chris A. Desnoyers, Yvette Barrows, Joseph Klejka, Paul A. Decker, Christine A. Hughes, Martha J. Bock, Rahnia Boyer, Kenneth Resnicow, Linda Burhansstipanov Source Type: research

Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial
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 old er populations. Young adults need hypertension self-management programs (i.e., home blood pressure monitoring and lifestyle modifications) tailored to their unique needs to lower blood pressure and reduce the risks and medication burden they may face over a lifetime. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 21, 2019 Category: Radiology Authors: Heather M. Johnson, Lisa Sullivan-Vedder, KyungMann Kim, Patrick E. McBride, Maureen A. Smith, Jamie N. LaMantia, Jennifer T. Fink, Megan R. Knutson Sinaise, Laura M. Zeller, Diane R. Lauver Source Type: research

Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers
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. Partnering with a large healthcare system and affiliated university, this project will test an innovative multi-level intervention ( “Working for You”) adap...
Source: Contemporary Clinical Trials - January 18, 2019 Category: Radiology Authors: Richard I. Stein, Jaime R. Strickland, Rachel G. Tabak, Ann Marie Dale, Graham A. Colditz, Bradley A. Evanoff Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 17, 2019 Category: Radiology Source Type: research

Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods
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. Importantly, PPI metabolism and efficacy depend on CYP2C19 genotype. The Genotype Tailored Treatment of Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA) study is a randomized, double-blind, placebo-c...
Source: Contemporary Clinical Trials - January 16, 2019 Category: Radiology Authors: Monica Tang, Kathryn V. Blake, John J. Lima, Edward B. Mougey, James Franciosi, Stephan Schmidt, Md Jobayer Hossain, Marjan Cobbaert, Bernard M. Fischer, Jason E. Lang Source Type: research

An addiction-based mobile health weight loss intervention: protocol of a randomized controlled trial
The notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30.7% of adolescents with obesity report food or eating addiction. Few weight management interventions have tested techniques based on addiction medicine principles. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 14, 2019 Category: Radiology Authors: Alaina P. Vidmar, Sarah Salvy, Robert Pretlow, Steven D. Mittelman, Choo Phei Wee, Cassandra Fink, D. Steven Fox, Jennifer K. Raymond Source Type: research

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
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 10, 2019 Category: Radiology Authors: Maria L. Murphy, David R. Lubans, Kristen E. Cohen, Sara L. Robards, Magdalena Wilczynska, Sarah G. Kennedy, Erica L. James, Wendy J. Brown, Kerry S. Courneya, Ronald J. Sigal, Ronald C. Plotnikoff Source Type: research

Minimally Invasive coronary surgery compared to STernotomy coronary artery bypass grafting: The MIST trial
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 significantly shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients. However, there have been no convincing clinical trials that demonstrate improvement in post-operative quality of life for patients who undergo MICS CAB...
Source: Contemporary Clinical Trials - January 9, 2019 Category: Radiology Authors: M. Guo, G.A. Wells, D. Glineur, J. Fortier, S. Gibson, M. Ruel Source Type: research

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
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 comparing the accuracy 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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 9, 2019 Category: Radiology Authors: Beverly B. Green, Melissa L. Anderson, Jerry Campbell, Andrea J. Cook, Kelly Ehrlich, Sarah Evers, Yoshio N. Hall, Clarissa Hsu, Dwayne Joseph, Predrag Klasnja, Karen L. Margolis, Jennifer B. McClure, Sean A. Munson, Mathew J. Thompson Source Type: research

Synthesis of researcher reported strategies to recruit adults of ethnic minorities to clinical trials in the United Kingdom: A systematic review
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. This reduces the generalisability of research findings across multi ethnic populations and hinders the development of accessible services. Researchers often face difficulties in recruiting ethnic minority participants to clinical research due to low levels of cultural competence and limited resources. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 9, 2019 Category: Radiology Authors: Yumna Masood, Peter Bower, Muhammad Wali Waheed, Gill Brown, Waquas Waheed Tags: Review Source Type: research

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
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. This protocol paper outlines the design, content, implementation, and evaluation of CHL. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - January 7, 2019 Category: Radiology Authors: Jacob P. Beckerman, Alyssa Aftosmes-Tobio, Nicole Kitos, Janine M. Jurkowski, Kindra Lansburg, Crystal Kazik, Adam Gavarkovs, Adrienne Vigilante, Begum Kalyoncu, Roger Figueroa, Rachel Klabunde, Rachel Barouch, Sebastien Haneuse, Elsie Taveras, Kirsten K. Source Type: research

iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children
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. iAmHealthy is a family-based behavioral, nutrition and physical activity intervention developed with input from rural children and families that capitalizes on the innovative use of mobile health applications (mHealth). (Sourc...
Source: Contemporary Clinical Trials - January 7, 2019 Category: Radiology Authors: Ann M. Davis, Gretchen Beaver, Meredith Dreyer Gillette, Eve-Lynn Nelson, Kandace Fleming, Rebecca Swinburne Romine, Debra K. Sullivan, Robert Lee, Kelley Pettee Gabriel, Kelsey Dean, Megan Murray, Myles Faith Source Type: research