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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/29330083/rationale-and-design-of-the-clinic-and-community-approaches-to-healthy-weight-randomized-trial
#1
Lauren Fiechtner, Meghan Perkins, Vincent Biggs, Nancy Langhans, Mona Sharifi, Giselle O'Connor, Sarah Price, Joseph Locascio, Karen Kuhlthau, Jo-Ann Kwass, Candace Nelson, Thomas Land, Matt Longjohn, Valerie Lawson, Katherine Hohman, Elsie M Taveras
BACKGROUND: Recent studies have demonstrated the effectiveness of family-centered, pediatric weight management programs in reducing childhood obesity. Yet, programs to optimize the care of low-income children with obesity are needed. We sought to examine the comparative effectiveness of two, potentially scalable pediatric weight management programs delivered to low-income children in a clinical or community setting. MATERIALS AND METHODS: The Clinic and Community Approaches to Healthy Weight trial is a randomized trial in two communities in Massachusetts that serve a large population of low-income children and families...
January 9, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29330082/clinical-trials-recruitment-planning-a-proposed-framework-from-the-clinical-trials-transformation-initiative
#2
Grant D Huang, Jonca Bull, Beth Harper, Elizabeth Mahon, Kelly McKee, Jamie N Roberts
Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies...
January 9, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29330081/optimization-of-a-technology-supported-physical-activity-intervention-for-breast-cancer-survivors-fit2thrive-study-protocol
#3
Siobhan M Phillips, Linda M Collins, Frank J Penedo, Kerry S Courneya, Whitney Welch, Alison Cottrell, Gillian R Lloyd, Kara Gavin, David Cella, Ronald T Ackermann, Juned Siddique, Bonnie Spring
Fit2Thrive is a theory-guided physical activity promotion trial using the Multiphase Optimization Strategy (MOST) to test efficacy for improving physical activity of five technology-supported physical activity promotion intervention components among breast cancer survivors. This trial will recruit 256 inactive breast cancer survivors nationwide. All participants will receive the core intervention which includes a Fitbit and standard self-monitoring Fit2Thrive smartphone application which will be downloaded to their personal phone...
January 9, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29306047/unified-protocol-for-the-discontinuation-of-long-term-serotonin-reuptake-inhibitors-in-obsessive-compulsive-disorder-study-protocol-and-methods
#4
Christina L Boisseau, Steven A Rasmussen
Obsessive-compulsive disorder (OCD) is chronic psychiatric disorder associated with high rates of functional impairment and decreased quality of life. Although serotonin reuptake inhibitors have demonstrated efficacy in the treatment of OCD, little data is available to guide clinicians on how to manage these medications long-term. Cognitive-behavioral approaches provide a promising avenue for helping OCD patients discontinue maintenance SRIs while minimizing the potential for symptom worsening. This manuscript describes the rationale and methods for pilot feasibility study designed to a unified, cognitive-behavioral strategy for discontinuing long-term SRIs in OCD...
January 3, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29292045/corrigendum-to-design-and-participant-characteristics-for-a-randomized-effectiveness-trial-of-an-intensive-lifestyle-intervention-to-reduce-cardiovascular-risk-in-adults-with-type-2-diabetes-the-i-d-health-study-contemp-clin-trials-46-2016-114-121
#5
David T Liss, Emily A Finch, Dyanna L Gregory, Andrew Cooper, Ronald T Ackermann
No abstract text is available yet for this article.
December 29, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29289702/study-protocol-for-log2lose-a-feasibility-randomized-controlled-trial-to-evaluate-financial-incentives-for-dietary-self-monitoring-and-interim-weight-loss-in-adults-with-obesity
#6
Corrine I Voils, Erica Levine, Jennifer M Gierisch, Jane Pendergast, Sarah L Hale, Megan A McVay, Shelby D Reed, William S Yancy, Gary Bennett, Elizabeth M Strawbridge, Allison C White, Ryan J Shaw
The obesity epidemic has negative physical, psychological, and financial consequences. Despite the existence of effective behavioral weight loss interventions, many individuals do not achieve adequate weight loss, and most regain lost weight in the year following intervention. We report the rationale and design for a 2×2 factorial study that involves financial incentives for dietary self-monitoring (yes vs. no) and/or interim weight loss (yes vs. no). Outpatients with obesity participate in a 24-week, group-based weight loss intervention...
December 28, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29288740/rationale-design-and-pilot-feasibility-results-of-a-smartphone-assisted-mindfulness-based-intervention-for-smokers-with-mood-disorders-project-msmart-mind
#7
Haruka Minami, Hannah R Brinkman, Shadi Nahvi, Julia H Arnsten, Monica Rivera-Mindt, David W Wetter, Erika Litvin Bloom, Lawrence H Price, Carlos Vieira, Remington Donnelly, Lauren M McClain, Katherine A Kennedy, Erica D'Aquila, M Fine, Danielle E McCarthy, J Graham Thomas, Jacki Hecht, Richard A Brown
BACKGROUND: Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment...
December 27, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29287669/a-multidisciplinary-approach-to-oncology-trials-study-conduct-of-the-anthalya-trial
#8
Youssef Ghazi, Christine Laurent, Julien Dupin, David Pau, Sabine Balouet, Yara Rocha, Florence Joly, Roman Rouzier, Violette Menguy
Clinical trials that combine medical therapy and surgical treatment pose a number of challenges. The ANTHALYA trial investigated the efficacy and safety of adding bevacizumab to neoadjuvant carboplatin-paclitaxel chemotherapy prior to interval debulking surgery (IDS) in patients with ovarian cancer. The success of the trial depended on the efficacy and the safety of the combination and on the surgical effort. Furthermore, at the time of study design, neoadjuvant bevacizumab had not been investigated in ovarian cancer patients and it was unknown if neoadjuvant angiogenic therapy would be well tolerated or would negatively impact the success of IDS...
December 26, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29287668/development-of-a-novel-integrated-cognitive-behavioral-therapy-for-co-occurring-posttraumatic-stress-and-substance-use-disorders-a-pilot-randomized-clinical-trial
#9
Anka A Vujanovic, Lia J Smith, Charles E Green, Scott D Lane, Joy M Schmitz
Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are complex psychiatric conditions that commonly co-occur. No evidence-based, 'gold standard' treatments for PTSD/SUD comorbidity are currently available. The present pilot randomized clinical trial was designed to evaluate the feasibility and preliminary efficacy of a novel, integrated cognitive-behavioral treatment approach for PTSD/SUD, entitled Treatment of Integrated Posttraumatic Stress and Substance Use (TIPSS), as compared to standard cognitive-behavioral treatment (CBT) for SUD...
December 26, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29287667/a-cluster-randomized-trial-of-a-college-health-center-based-alcohol-and-sexual-violence-intervention-giftss-design-rationale-and-baseline-sample
#10
Kaleab Z Abebe, Kelley A Jones, Dana Rofey, Heather L McCauley, Duncan B Clark, Rebecca Dick, Theresa Gmelin, Janine Talis, Jocelyn Anderson, Carla Chugani, Gabriela Algarroba, Ashley Antonio, Courtney Bee, Clare Edwards, Nadia Lethihet, Justin Macak, Joshua Paley, Irving Torres, Courtney Van Dusen, Elizabeth Miller
INTRODUCTION: Sexual violence (SV) on college campuses is common, especially alcohol-related SV. This is a 2-arm cluster randomized controlled trial to test a brief intervention to reduce risk for alcohol-related sexual violence (SV) among students receiving care from college health centers (CHCs). Intervention CHC staff are trained to deliver universal SV education to all students seeking care, to facilitate patient and provider comfort in discussing SV and related abusive experiences (including the role of alcohol)...
December 26, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29287666/agreement-in-reporting-between-trial-publications-and-current-clinical-trial-registry-in-high-impact-journals-a-methodological-review
#11
Sarah Daisy Kosa, Lawrence Mbuagbaw, Victoria Borg Debono, Mohit Bhandari, Brittany B Dennis, Gabrielle Ene, Alvin Leenus, Daniel Shi, Michael Thabane, Sara Valvasori, Thuva Vanniyasingam, Chenglin Ye, Elgene Yranon, Shiyuan Zhang, Lehana Thabane
OBJECTIVES: The primary objective of this systematic survey was to examine the percentage of studies in which there was agreement in the reporting of the primary outcome between the currently updated version of the clinical trial registry and the published paper. We also investigated the factors associated with agreement in reporting of the primary outcome. METHODS: We searched PubMed for all randomized control trials (RCT)s published in 2012-2015 in the top five general medicine journals (based on the 2014 impact factor)...
December 26, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29287665/tobacco-dependence-treatment-in-the-emergency-department-a-randomized-trial-using-the-multiphase-optimization-strategy
#12
Steven L Bernstein, James Dziura, June Weiss, Ted Miller, Katrina A Vickerman, Lauretta E Grau, Michael V Pantalon, Lorien Abroms, Linda M Collins, Benjamin Toll
BACKGROUND: Tobacco dependence remains the leading preventable cause of death in the developed world. Smokers are disproportionately from lower socioeconomic groups, and may use the hospital emergency department (ED) as an important source of care. A recent clinical trial demonstrated the efficacy of a multicomponent intervention to help smokers quit, but the independent contributions of those components is unknown. METHODS: This is a full-factorial (16-arm) randomized trial in a busy hospital ED of 4 tobacco dependence interventions: brief motivational interviewing, nicotine replacement therapy, referral to a telephone quitline, and a texting program...
December 26, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29287664/a-sequential-multiple-assignment-randomized-trial-for-cocaine-cessation-and-relapse-prevention-tailoring-treatment-to-the-individual
#13
Joy M Schmitz, Angela L Stotts, Anka Vujanovic, Michael Weaver, Jin Yoon, Jessica Vincent, Charles Green
Drug addiction is a chronic, devastating, but treatable disorder. A core principle of drug addiction treatment states that no single treatment is appropriate for everyone (NIDA, 2012); treatments need to adjust based on patient characteristics and response in order to be maximally effective. For cocaine use disorders (CUD), specifically, the most potent intervention currently available for initiating abstinence is behavior therapy using contingency management (CM) procedures, with early cessation being a robust predictor of future abstinence...
December 26, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29277316/the-flexible-lifestyle-empowering-change-flex-intervention-for-self-management-in-adolescents-with-type-1-diabetes-trial-design-and-baseline-characteristics
#14
Jessica C Kichler, Michael Seid, Jamie Crandell, David M Maahs, Franziska K Bishop, Kimberly A Driscoll, Debra Standiford, Christine M Hunter, Elizabeth Mayer-Davis
The Flexible Lifestyle Empowering Change (FLEX) Intervention Study is a multi-site randomized controlled trial to test the efficacy of an adaptive behavioral intervention to promote self-management for youth with type 1 diabetes mellitus (T1D). This paper details FLEX design, demographic characteristics of the sample, and outcome variables at baseline. Participants were randomized to either an intervention or control arm after their baseline standardized measurement visit. Baseline data for the primary (glycemic levels) and secondary outcome variables (e...
December 22, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29274894/the-physical-activity-daily-pad-trial-the-rationale-and-design-of-a-randomized-controlled-trial-evaluating-an-internet-walking-program-to-improve-maximal-walking-distance-among-patients-with-peripheral-arterial-disease
#15
Anjana M Kumar, Angela K Lyden, Noelle E Carlozzi, Ananda Sen, Caroline R Richardson, Elizabeth A Jackson
BACKGROUND: Despite established guidelines for regular walking as a first line therapy for adults with peripheral arterial disease (PAD), most patients do not walk routinely. This paper presents the design specifications for a randomized clinical trial to examine the effectiveness of an internet-based walking program compared to a telephone intervention, or the combination (internet-based with telephone counseling) for promotion of regular walking in patients with PAD. METHODS: Sedentary adults with documented lower extremity PAD are being recruited from the University of Michigan Health System and the surrounding area...
December 21, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29274893/cognitive-and-self-regulatory-mechanisms-of-obesity-study-cosmos-study-protocol-for-a-randomized-controlled-weight-loss-trial-examining-change-in-biomarkers-cognition-and-self-regulation-across-two-behavioral-treatments
#16
M A W Hawkins, Janna Colaizzi, John Gunstad, Joel W Hughes, Larry L Mullins, Nancy Betts, Caitlin E Smith, Natalie G Keirns, Kathleen D Vohs, Shirley M Moore, Evan Forman, William R Lovallo
Obesity is a global epidemic, yet successful interventions are rare. Up to 60% of people fail to achieve clinically meaningful, short-term weight loss (5-10% of start weight), whereas up to 72% are unsuccessful at achieving long-term weight loss (5-10% loss for ≥5years). Understanding how biological, cognitive, and self-regulatory factors work together to promote or to impede weight loss is clearly needed to optimize obesity treatment. This paper describes the methodology of the Cognitive and Self-regulatory Mechanisms of Obesity Study (the COSMOS trial)...
December 21, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29274892/role-of-resistant-starch-on-diabetes-risk-factors-in-people-with-prediabetes-design-conduct-and-baseline-results-of-the-starch-trial
#17
Kara L Marlatt, Ursula A White, Robbie A Beyl, Courtney M Peterson, Corby K Martin, Maria L Marco, Michael J Keenan, Roy J Martin, Kayanush J Aryana, Eric Ravussin
Dietary resistant starch (RS) might alter gastrointestinal tract function in a manner that improves human health, particularly among adults at risk for diabetes. Here, we report the design and baseline results (with emphasis on race differences) from the STARCH trial, the first comprehensive metabolic phenotyping of people with prediabetes enrolled in a randomized clinical trial testing the effect of RS on risk factors for diabetes. Overweight/obese participants (BMI≥27kg/m2 and weight≤143kg), age 35-75y, with confirmed prediabetes were eligible...
December 21, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29242108/a-multi-level-intervention-in-worksites-to-increase-fruit-and-vegetable-access-and-intake-rationale-design-and-methods-of-the-good-to-go-cluster-randomized-trial
#18
Patricia M Risica, Gemma Gorham, Laura Dionne, William Nardi, Doug Ng, Reese Middler, Jennifer Mello, Rahmet Akpolat, Katelyn Gettens, Kim M Gans
BACKGROUND: Fruit and vegetable (F&V) consumption is an important contributor to chronic disease prevention. However, most Americans do not eat adequate amounts. The worksite is an advantageous setting to reach large, diverse segments of the population with interventions to increase F&V intake, but research gaps exist. No studies have evaluated the implementation of mobile F&V markets at worksites nor compared the effectiveness of such markets with or without nutrition education. METHODS: This paper describes the protocol for Good to Go (GTG), a cluster randomized trial to evaluate F&V intake change in employees from worksites randomized into three experimental arms: discount, fresh F&V markets (Access Only arm); markets plus educational components including campaigns, cooking demonstrations, videos, newsletters, and a web site (Access Plus arm); and an attention placebo comparison intervention on physical activity and stress reduction (Comparison)...
December 11, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29233720/a-pragmatic-randomized-comparative-effectiveness-trial-of-transitional-care-for-a-socioeconomically-diverse-population-design-rationale-and-baseline-characteristics
#19
Christine Schaeffer, Caroline Teter, Emily A Finch, Courtney Hurt, Mary Kate Keeter, David T Liss, Angela Rogers, Avani Sheth, Ronald Ackermann
Transitional care programs have been widely used to reduce readmissions and improve the quality and safety of the handoff process between hospital and outpatient providers. Very little is known about effective transitional care interventions among patients who are uninsured or with Medicaid. This paper describes the design and baseline characteristics of a pragmatic randomized comparative effectiveness trial of transitional care. Northwestern Medical Group- Transitional Care (NMG-TC) care model was developed to address the needs of patients with multiple medical problems that required lifestyle changes and were amenable to office-based management...
December 9, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29233719/a-randomized-study-of-dietary-composition-during-weight-loss-maintenance-rationale-study-design-intervention-and-assessment
#20
Cara B Ebbeling, Gloria L Klein, Patricia K Luoto, Julia M W Wong, Lisa Bielak, Ralph G Eddy, Sarah K Steltz, Courtenay Devlin, Megan Sandman, Bridget Hron, Kim Shimy, Steven B Heymsfield, Robert R Wolfe, William W Wong, Henry A Feldman, David S Ludwig
BACKGROUND: While many people with overweight or obesity can lose weight temporarily, most have difficulty maintaining weight loss over the long term. Studies of dietary composition typically focus on weight loss, rather than weight-loss maintenance, and rely on nutrition education and dietary counseling, rather than controlled feeding protocols. Variation in initial weight loss and insufficient differentiation among treatments confound interpretation of results and compromise conclusions regarding the weight-independent effects of dietary composition...
December 9, 2017: Contemporary Clinical Trials
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