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Contemporary Clinical Trials

Francisco I Salgado García, Karen J Derefinko, Zoran Bursac, Robert C Klesges, Jon O Ebbert, Catherine R Womack, Rebecca A Krukowski
While smoking cessation leads to significant improvements in both mortality and morbidity, post-cessation weight gain partially attenuates this benefit. Even though post-cessation weight gain is small (4.7 kg on average), it is a stated reason to delay cessation attempts and is associated with smoking relapse. Fit & Quit is a randomized, controlled efficacy trial that aims to examine the ability of a weight stability intervention and a weight loss intervention to reduce post-cessation weight gain. For this purpose, Fit & Quit will randomize participants to three conditions: (a) Small Changes, a weight gain prevention intervention; (b) Look AHEAD Intensive Lifestyle Intervention; and (c) a lower-intensity bibliotherapy intervention...
November 13, 2018: Contemporary Clinical Trials
Kelly A Borges, Jianliang Dai, Neehar D Parikh, Myron Schwartz, Mindie H Nguyen, Lewis R Roberts, Alex S Befeler, Sudhir Srivastava, Jo Ann Rinaudo, Ziding Feng, Jorge A Marrero, K Rajender Reddy
BACKGROUND: Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the current surveillance strategy for patients at risk. The available biomarkers for detecting this cancer at an early stage have inadequate sensitivity and specificity. METHODS: The Hepatocellular carcinoma Early Detection Strategy (HEDS) study, a multi-center initiative of the National Cancer Institutes' (NCI) Early Detection Research Network (EDRN), launched an effort to establish what has become the nation's largest comprehensive biorepository and database on patients at high risk of developing HCC...
November 12, 2018: Contemporary Clinical Trials
Dustin C Krutsinger, Jacqueline McMahon, Alisa J Stephens-Shields, Brian Bayes, Steven Brooks, Brian L Hitsman, Su Fen Lubitz, Celine Reyes, Robert A Schnoll, S Ryan Greysen, Ashley Mercede, Mitesh S Patel, Catherine Reale, Fran Barg, Jason Karlawish, Daniel Polsky, Kevin G Volpp, Scott D Halpern
INTRODUCTION: The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs...
November 8, 2018: Contemporary Clinical Trials
Douglas E Levy, Emily D Gelsomin, Eric B Rimm, Mark Pachucki, Jenny Sanford, Emma Anderson, Charles Johnson, Rose Schutzberg, Anne N Thorndike
BACKGROUND/AIMS: Behavioral nudges in the food environment increase healthy choices, but it is unknown if they improve diet and health. The ChooseWell 365 study will determine if an automated, personalized worksite intervention to nudge healthier choices improves overall diet and cardiometabolic health. DESIGN: Randomized controlled trial of 602 hospital employees who regularly use on-site cafeterias and pay with an employee ID. INTERVENTION: The intervention combines an environmental strategy (traffic-light labeling) with objective feedback and personalized nudges (health/lifestyle tips, social norms, incentives) to promote healthy food choices...
November 7, 2018: Contemporary Clinical Trials
Michael G Perri, Aviva H Ariel-Donges, Meena N Shankar, Marian C Limacher, Michael J Daniels, David M Janicke, Kathryn M Ross, Linda B Bobroff, A Daniel Martin, Tiffany A Radcliff, Christie A Befort
Obesity is a major contributor to the greater prevalence of chronic disease morbidity and mortality observed in rural versus nonrural areas of the U.S. Nonetheless, little research attention has been given to modifying this important driver of rural/urban disparities in health outcomes. Although lifestyle treatments produce weight reductions of sufficient magnitude to improve health, the existing research is limited with respect to the long-term maintenance of treatment effects and the dissemination of services to underserved populations...
November 5, 2018: Contemporary Clinical Trials
Jake P Mann, Anita Vreugdenhil, Piotr Socha, Wojciech Jańczyk, Ulrich Baumann, Sanjay Rajwal, Thomas Casswall, Claude Marcus, Indra van Mourik, Stephen O'Rahilly, David B Savage, Gabriele Noble-Jamieson, Florence Lacaille, Myriam Dabbas, Béatrice Dubern, Deirdre A Kelly, Valerio Nobili, Quentin M Anstee
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder in children and has the potential to progress to advanced fibrosis/cirrhosis, end-stage liver disease and hepatocellular carcinoma. However, the natural history of the condition is poorly understood and there are no approved treatments. The European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD) is a multi-centre registry of paediatric NAFLD that will serve as a prospective, observational, natural history study and provide a tractable back-bone to support recruitment into subsequent interventional trials...
November 5, 2018: Contemporary Clinical Trials
Amelie G Ramirez, Kipling J Gallion, Arely Perez, Edgar Munoz, Dorothy Long Parma, Patricia I Moreno, Frank J Penedo
Latino cancer survivors have lower survival rates for most cancers relative to non-Latino whites, including, colorectal, prostate, and breast. In addition, Latinos experience health disparities in both access to care and quality of care. Experts recommend providing psychosocial services as an integral part of quality cancer care; however, there continues to be a paucity of information on the efficacy of Patient Navigators (PNs) in linking Latino cancer survivors to appropriate psychosocial services. Redes En Acción: The National Latino Cancer Research Network partnered with LIVESTRONG Cancer Navigation Services Patient Navigation program (PN-LCNS) to provide an intervention to improve wellness and increase access to psychosocial services among non-metastatic Latino cancer survivors from Texas and Chicago using trained bilingual, bicultural PNs...
November 3, 2018: Contemporary Clinical Trials
Nancy P Barnett, Melissa A Clark, Shannon R Kenney, Graham DiGuiseppi, Matthew K Meisel, Sara Balestrieri, Miles Q Ott, John Light
Heavy drinking and its consequences among college students represent a serious public health problem, and peer social networks are a robust predictor of drinking-related risk behaviors. In a recent trial, we administered a Brief Motivational Intervention (BMI) to a small number of first-year college students to assess the indirect effects of the intervention on peers not receiving the intervention. OBJECTIVES: To present the research design, describe the methods used to successfully enroll a high proportion of a first-year college class network, and document participant characteristics...
November 1, 2018: Contemporary Clinical Trials
Bryan Rudolph, Nicole Bjorklund, Nadia Ovchinsky, Debora Kogan-Liberman, Adriana Perez, Mark Liszewski, Terry L Levin, Michelle Ewart, Qiang Liu, Xiaonan Xue, Shankar Viswanathan, Howard D Strickler
BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is strongly associated with obesity and is the most common liver disease in the developed world. In children with suspected NAFLD, present guidelines suggest consideration of alternative diagnoses via extensive blood testing, though the yield of this work up is unknown. Furthermore, the gold standard diagnostic test for NAFLD remains liver biopsy, making the development of non-invasive tests critically important. OBJECTIVES: Our objectives are: 1) to determine the accuracy of elastography and multiple serum biomarkers - each assessed individually and as algorithms (including those previously tested in adults) - for the diagnosis of nonalcoholic steatohepatitis (NASH) and early fibrosis in children and (2) to examine the utility of extensive testing for rare alternative diagnoses in overweight or obese children with elevated alanine aminotransferase (ALT) suspected to have NAFLD...
October 27, 2018: Contemporary Clinical Trials
Kean J Hsu, Kayla Caffey, Derek Pisner, Jason Shumake, Semeon Risom, Kimberly L Ray, Jasper A J Smits, David M Schnyer, Christopher G Beevers
Theoretical models and empirical research point to negatively biased attention as a maintaining factor in depression. Although preliminary studies suggest experimentally modifying attentional biases (i.e., attentional bias modification; ABM) reduces depression symptoms and depression risk, relatively few rigorous studies with clinical samples have been completed. This clinical trial examines the impact of ABM on a sample of adults (N = 123) with elevated depression severity who also exhibit at least modest levels of negatively biased attention prior to treatment...
October 26, 2018: Contemporary Clinical Trials
Jason L Vassy, Charles A Brunette, Nilla Majahalme, Sanjay Advani, Lauren MacMullen, Cynthia Hau, Andrew J Zimolzak, Stephen J Miller
BACKGROUND: The association between the SLCO1B1 rs4149056 variant and statin-associated muscle symptoms (SAMS) is well validated, but the clinical utility of its implementation in patient care is unknown. DESIGN: The Integrating Pharmacogenetics in Clinical Care (I-PICC) Study is a pseudo-cluster randomized controlled trial of SLCO1B1 genotyping among statin-naïve primary care and women's health patients across the Veteran Affairs Boston Healthcare System. Eligible patients of enrolled primary care providers are aged 40-75 and have elevated risk of cardiovascular disease by American College of Cardiology/American Heart Association (ACC/AHA) guidelines...
October 24, 2018: Contemporary Clinical Trials
Yihan Li, Xin Wang, Deli Wang, Walter Offen
Multiplicity adjustment plays a critical role for testing multiple endpoints and/or multiple doses in clinical trials. Under the clinical trial setting, multiple hypotheses are usually grouped into primary and secondary families and hierarchically ordered between and within families. The determination of the order and grouping of the hypotheses depends on the objectives of the trial. In such scenarios, strong control of the family-wise error rate (FWER) can be achieved via either gatekeeping procedures or the graphical approach to sequential testing procedures...
October 19, 2018: Contemporary Clinical Trials
Hannah G Lane, Rachel Deitch, Yan Wang, Maureen M Black, Genevieve F Dunton, Linda Aldoory, Lindsey Turner, Elizabeth A Parker, Shauna C Henley, Brit Saksvig, Hee-Jung Song, Erin R Hager
Schools are a recommended place for childhood obesity prevention. Local Wellness Policies (LWPs) establish guidelines for schools to provide opportunities for students to access nutritious foods and be physically active. Little is known about the impact of LWPs, when implemented, on students' behavior and body mass index (BMI). The Wellness Champions for Change trial assesses the student-level impact of providing theory-based training and technical assistance to help schools implement LWPs. This 3-arm, cluster randomized controlled trial will take place in 30 low- or middle-income schools (15 elementary and 15 middle) in five Maryland school districts...
October 18, 2018: Contemporary Clinical Trials
Martha Y Kubik, Jayne A Fulkerson, John R Sirard, Ann Garwick, Judy Temple, Olga Gurvich, Jiwoo Lee, Bonnie Dudovitz
Rising levels of severe obesity among children, worsening disparities by race and ethnicity and reluctance of primary care clinicians' to provide obesity management to children are compelling reasons to consider alternatives to primary care management of childhood obesity. The Students Nurses and Parents Seeking Healthy Options Together (SNAPSHOT) trial will test the efficacy of an elementary school-based, school nurse-led, healthy weight management program to reduce excess weight gain among children, 8- to 12-years old with a body mass index (BMI) ≥75th percentile, by increasing healthy dietary practices and physical activity and decreasing sedentary behaviors...
October 18, 2018: Contemporary Clinical Trials
Dominique Kinnett-Hopkins, Robert Motl
BACKGROUND: Exercise training is a promising approach for managing multiple sclerosis (MS), but existing research has not focused on black individuals with MS. This is important as black individuals with MS may experience a more aggressive disease course, increased comorbidities, and have a poorer prognosis with disease modifying therapies. MATERIALS AND METHODS: Thirty-two black adults with mild-to-moderate MS related disability participated in a patient-informed, three-month, home-based, racially tailored, exercise program...
October 18, 2018: Contemporary Clinical Trials
Lauren B Shomaker, Lauren Gulley, Allison M Hilkin, Emma Clark, Shelly Annameier, Sangeeta Rao, Bonny Rockette-Wagner, Andrea Kriska, Kenneth P Wright, Eric Stice, Kristen J Nadeau, Megan M Kelsey
BACKGROUND: Depressive symptoms often manifest in adolescence and predict worsening insulin sensitivity, a key precursor in the path to β-cell failure and type 2 diabetes (T2D). OBJECTIVE: To assess the efficacy of a six-week cognitive-behavioral group versus six-week health education group for improving insulin sensitivity and preserving β-cell function in adolescent girls at-risk for T2D with depressive symptoms and evaluate mechanisms underlying the association between depression and insulin dynamics...
October 17, 2018: Contemporary Clinical Trials
Tonya M Palermo, William T Zempsky, Carlton D Dampier, Chitra Lalloo, Amos S Hundert, Lexa K Murphy, Nitya Bakshi, Jennifer N Stinson
Many adolescents with sickle cell disease (SCD) experience recurrent and chronic pain, which has a negative impact on their health-related quality of life (HRQL). Cognitive-behavioral therapy (CBT) interventions can lead to improvement in pain and HRQL, yet due to barriers to care, most youth with SCD will not receive these interventions. To address this need for innovative programs targeting youth with SCD pain, we developed iCanCope, a tailored smartphone and web-based program that delivers a pain self-management intervention to youth with SCD...
November 2018: Contemporary Clinical Trials
Kelly A Aschbrenner, John A Naslund, Amy A Gorin, Kim T Mueser, Emily A Scherer, Mark Viron, Allison Kinney, Stephen J Bartels
BACKGROUND: Individuals with serious mental illness (SMI) such as schizophrenia and bipolar disorder face a higher risk of early death due to cardiovascular disease and other preventable chronic illnesses. Young adulthood is a critical window of development for lifestyle interventions to improve the long-term health and quality of life in this population. Fit Forward is an NIH-funded randomized clinical trial examining the effectiveness of a group lifestyle intervention (PeerFIT) enhanced with mobile health technology compared to one-on-one mobile lifestyle coaching with Basic Education in fitness and nutrition supported by a wearable Activity Tracking device (BEAT) in achieving clinically significant weight loss and improved cardiorespiratory fitness in young adults with SMI...
November 2018: Contemporary Clinical Trials
Margaret C Fahey, G Wayne Talcott, Callie M Cox Bauer, Zoran Bursac, Leslie Gladney, Marion E Hare, Jean Harvey, Melissa Little, Deirdre McCullough, Ann S Hryshko-Mullen, Robert C Klesges, Mehmet Kocak, Teresa M Waters, Rebecca A Krukowski
No abstract text is available yet for this article.
November 2018: Contemporary Clinical Trials
Jocelyn Carter, Anne Walton, Karen Donelan, Anne Thorndike
BACKGROUND: In 2011, there were approximately 3.3 million adult 30-day all-cause hospital readmissions in the US generating $41.3 billion in hospital costs. Community health worker (CHW) care delivery is one of very few interventions demonstrated to reduce health care utilization among populations with chronic disease. While there are a number of studies demonstrating improved disease-specific outcomes with CHW interventions, studies examining the effect of CHW care delivery on 30-day readmission rates are rare...
November 2018: Contemporary Clinical Trials
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