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Contemporary Clinical Trials Communications

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https://www.readbyqxmd.com/read/29333504/community-based-physical-activity-as-adjunctive-smoking-cessation-treatment-rationale-design-and-baseline-data-for-the-lifestyle-enhancement-program-leap-randomized-controlled-trial
#1
Mark W Vander Weg, Mace Coday, Michelle B Stockton, Barbara McClanahan, George Relyea, Mary C Read, Nancy Wilson, Stephanie Connelly, Phyllis Richey, Karen C Johnson, Kenneth D Ward
Despite advances in behavioral and pharmacological treatment for tobacco use and dependence, quit rates remain suboptimal. Increasing physical activity has shown some promise as a strategy for improving cessation outcomes. However, initial efficacy studies focused on intensive, highly structured exercise programs that may not be applicable to the general population of smokers. We describe the rationale and study design and report baseline participant characteristics from the Lifestyle Enhancement Program (LEAP), a two-group, randomized controlled trial...
March 2018: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29333503/the-effect-of-a-vegan-versus-aha-diet-in-coronary-artery-disease-evade-cad-trial-study-design-and-rationale
#2
Binita Shah, Lisa Ganguzza, James Slater, Jonathan D Newman, Nicole Allen, Edward Fisher, John Larigakis, Francisco Ujueta, Eugenia Gianos, Yu Guo, Kathleen Woolf
Background: Multiple studies demonstrate the benefit of a vegan diet on cardiovascular risk factors when compared to no intervention or usual dietary patterns. The aim of this study is to evaluate the effect of a vegan diet versus the American Heart Association (AHA)-recommended diet on inflammatory and glucometabolic profiles in patients with angiographically defined coronary artery disease (CAD). Study Design: This study is a randomized, open label, blinded end-point trial of 100 patients with CAD as defined by ≥50% diameter stenosis in a coronary artery ≥2 mm in diameter on invasive angiography...
December 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29214229/feasibility-trial-of-a-psychoeducational-intervention-for-parents-with-personality-difficulties-the-helping-families-programme
#3
Crispin Day, Jackie Briskman, Mike J Crawford, Lucy Harris, Paul McCrone, Mary McMurran, Paul Moran, Lou Morgan, Stephen Scott, Daniel Stahl, Paul Ramchandani, Timothy Weaver
The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks...
December 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29170758/design-and-rationale-for-a-technology-based-healthy-lifestyle-intervention-in-older-adults-grieving-the-loss-of-a-spouse
#4
Sarah T Stahl, James Emanuel, Steven M Albert, Mary Amanda Dew, Richard Schulz, Gregg Robbins-Welty, Charles F Reynolds
Introduction: Experiencing the death of a spouse during late life is associated with an increased risk of developing debilitating mental health problems. Healthy lifestyle practices, such as regular exercise, healthy eating, and good sleep hygiene are promising strategies to influence the mental health and associated physical symptoms of late-life spousal bereavement. Objective: This paper describes the design and rationale of an intervention development study addressing selective and indicated prevention of depression, anxiety, and/or complicated grief disorder(s) among adults 60 years and older who are grieving the recent loss (within 8 months) of a spouse or partner...
December 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29075673/healthy-lifestyle-intervention-for-african-american-uterine-cancer-survivors-study-protocol
#5
Jessica Lynn Stewart, Gina B Besenyi, Lovoria B Williams, Victoria Burt, Judith C Anglin, Sharad A Ghamande, Steven Scott Coughlin
BACKGROUND: Cancer of the uterine corpus is the most common gynecologic malignancy and the fourth most common cancer in U.S. women. There is a racial disparity in the survival from endometrial cancer and this may be addressed by culturally-tailored lifestyle interventions to help African American (AA) endometrial cancer survivors lose weight or maintain a healthy weight. OBJECTIVE: The overall purpose of this pilot study is to develop and evaluate a culturally-tailored lifestyle intervention to help AA uterine cancer survivors reduce their risk of cancer recurrence and improve their quality of life through healthy eating, physical activity, and weight management...
December 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29308436/effect-of-personal-activity-trackers-on-weight-loss-in-families-enrolled-in-a-comprehensive-behavioral-family-lifestyle-intervention-program-in-the-federally-qualified-health-center-setting-a-randomized-controlled-trial
#6
Juan Espinoza, Alexander Chen, Jazminne Orozco, Alexis Deavenport-Saman, Larry Yin
Background: Childhood obesity continues to be a substantial problem despite major public health efforts, and disproportionately impacts children from low-income families. Digital health tools and consumer technology offer promising opportunities for interventions, but few studies have evaluated how they might be incorporated into existing interventions or used to create new types of interventions. It remains unclear which approaches would be most beneficial for underserved pediatric populations...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29250605/successful-collection-of-stool-samples-for-microbiome-analyses-from-a-large-community-based-population-of-elderly-men
#7
Melanie Abrahamson, Elizabeth Hooker, Nadim J Ajami, Joseph F Petrosino, Eric S Orwoll
The relationship of the gastrointestinal microbiome to health and disease is of major research interest, including the effects of the gut microbiota on age related conditions. Here we report on the outcome of a project to collect stool samples on a large number of community dwelling elderly men using the OMNIgene-GUT stool/feces collection kit (OMR-200, DNA Genotek, Ottawa, Canada). Among 1,328 men who were eligible for stool collection, 982 (74%) agreed to participate and 951 submitted samples. The collection process was reported to be acceptable, almost all samples obtained were adequate, the process of sample handling by mail was uniformly successful...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29226266/the-influence-of-race-and-ethnicity-on-becoming-a-human-subject-factors-associated-with-participation-in-research
#8
Mary A Garza, Sandra Crouse Quinn, Yan Li, Luciana Assini-Meytin, Erica T Casper, Craig S Fryer, James Butler, Natasha A Brown, Kevin H Kim, Stephen B Thomas
INRODUCTION: The purpose of this study was to explore factors associated with willingness of African Americans and Latinos to participate in biomedical and public health research and to delineate factors that influences the decision to become a human subject. METHODS: We present results from a 2010 random digit-dial telephone survey of 2,455 African American (N= 1,191) and Latino (N= 1,264) adults. We used standard measures to assess knowledge of research, terminology, informed consent procedures, previous participation in research, health care experiences, social support, risk perception, religiousness, and trust...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29124236/implementation-recruitment-and-baseline-characteristics-a-randomized-trial-of-combined-treatments-for-smoking-cessation-and-weight-control
#9
Terry Bush, Jennifer Lovejoy, Harold Javitz, Stacey Mahuna, Alula Jimenez Torres, Ken Wassum, Brooke Magnusson, Cody Benedict, Bonnie Spring
Background: Two-thirds of treatment-seeking smokers are obese or overweight. Most smokers are concerned about gaining weight after quitting. The average smoker experiences modest post-quit weight gain which discourages many smokers from quitting. Although evidence suggests that combined interventions to help smokers quit smoking and prevent weight gain can be helpful, studies have not been replicated in real world settings. Methods: This paper describes recruitment and participant characteristics of the Best Quit Study, a 3-arm randomized controlled trial testing tobacco cessation treatment alone or combined with simultaneous or sequential weight management...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29062975/a-placebo-controlled-bayesian-dose-finding-design-based-on-continuous-reassessment-method-with-application-to-stroke-research
#10
Chunyan Cai, Mohammad H Rahbar, Md Monir Hossain, Ying Yuan, Nicole R Gonzales
Traditional dose-finding designs do not require assignment of patients to a control group. Motivated by SHRINC (Safety of Pioglitazone for hematoma resolution in intracerebral hemorrhage), we developed a placebo-controlled dose-finding study to identify the maximum tolerated dose for pioglitazone in stroke patients with spontaneous intracerebral hemorrhage. We designed an extension of the continuous reassessment method that allowed to incorporate information from the control group (i.e., the standard of care), and utilized it to determine the maximum tolerated dose in the SHRINC trial...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28798964/design-of-phase-ii-non-inferiority-trials
#11
Sin-Ho Jung
With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29082335/atrial-fibrillation-trial-to-evaluate-real-world-procedures-for-their-utility-in-helping-to-lower-stroke-events-after-pulse-study-protocol-for-a-randomized-controlled-trial
#12
Tsung-Ta Hsieh, Meng Lee, Wen-Yi Huang, Sung-Chun Tang, Sheng-Feng Sung, Kuo-Husan Chang, Jiann-Der Lee, Tsong-Hai Lee, Yung-Sung Huang, Jiann-Shing Jeng, Chang-Min Chung, Yi-Ling Wu, Bruce Ovbiagele
BACKGROUND: Enhancing detection of undiagnosed atrial fibrillation (AF) in hospitalized patients with a recent ischemic stroke is important because of the treatment implications; especially since presence of paroxysmal AF may not be picked up in a single 12-lead electrocardiogram (ECG) test. While several trials have shown improved detection of AF with prolonged ECG monitoring, this strategy is associated with relatively high cost, labor intensity, and patient inconvenience, thereby making it challenging to routinely implement in all hospitals...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29082334/development-and-pilot-testing-of-a-cognitive-behavioral-coping-skills-group-intervention-for-patients-with-chronic-hepatitis-c
#13
Donna M Evon, Carol E Golin, Rachel Ruffin, Michael W Fried
Psychosocial interventions for patients with chronic hepatitis C viral (HCV) infection are needed to attenuate the impact of extrahepatic symptoms, comorbid conditions, and treatment side effects on HCV health outcomes. We adapted empirically-supported interventions for similar patient populations to develop a Cognitive Behavioral Coping Skills group intervention for HCV patients (CBCS-HCV) undergoing treatment. The objectives of this paper are to describe the research activities associated with CBCS-HCV development and pilot testing, including: (1) formative work leading to intervention development; (2) preliminary study protocol; and (3) pilot feasibility testing of the intervention and study design...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29057368/intervention-development-for-the-indicated-prevention-of-depression-in-later-life-the-dil-protocol-in-goa-india
#14
Amit Dias, Fredric Azariah, Public Health, Alex Cohen, Stewart Anderson, Jennifer Morse, Pim Cuijpers, Miriam Sequeira, M A Psychology, Vithoba Gaude, Salvino Soares, Vikram Patel, Charles F Reynolds
Because depression is a major source of the global burden of illness- related disability, developing effective strategies for reducing its incidence is an important public health priority, especially in low-income countries, where resources for treating depression are scarce. We describe in this report an intervention development project, funded by the US National Institute of Mental Health, to address "indicated" prevention of depression in older adults attending rural and urban primary care clinics in Goa, India...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28944304/wearable-technology-to-reduce-sedentary-behavior-and-cvd-risk-in-older-adults-design-of-a-randomized-controlled-trial
#15
Lisa M Krehbiel, Andrew S Layne, Bhanuprasad Sandesara, Todd M Manini, Stephen D Anton, Thomas W Buford
Persons aged over 65 years account for over the vast majority of healthcare expenditures and deaths attributable to cardiovascular disease (CVD). Accordingly, reducing CVD risk among older adults is an important public health priority. Structured physical activity (i.e. exercise) is a well-documented method of decreasing CVD risk, but recent large-scale trials suggest that exercise alone is insufficient to reduce CVD events in high-risk populations of older adults. Thus adjuvant strategies appear necessary to reduce CVD risk...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28944303/resveratrol-and-exercise-to-treat-functional-limitations-in-late-life-design-of-a-randomized-controlled-trial
#16
Andrew S Layne, Lisa M Krehbiel, Robert T Mankowski, Stephen D Anton, Christiaan Leeuwenburgh, Marco Pahor, Bhanuprasad Sandesara, Samuel S Wu, Thomas W Buford
Skeletal muscle mitochondrial function declines with age and is a key factor in the maintenance of physical function among older adults. Research studies from animals and humans have consistently demonstrated that exercise improves skeletal muscle mitochondrial function in early and middle adulthood. However, mitochondrial adaptations to both acute and chronic exercise are attenuated in late life. Thus, there is an important need to identify adjuvant therapies capable of augmenting mitochondrial adaptations to exercise (e...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28752133/comparison-of-recruitment-and-retention-among-demographic-subgroups-in-a-large-diverse-population-study-of-diet
#17
Gwen L Alexander, Sujata Dixit-Joshi, Lawrence H Kushi, Laura A Coleman, Maria E Sundaram, Heather A Clancy, Michelle Groesbeck, Nancy A Potischman, Sharon I Kirkpatrick, Thea P Zimmerman, Stephanie M George, Amy F Subar, Frances E Thompson
OBJECTIVE: We examined the feasibility of conducting a longitudinal study of diet among diverse populations by comparing rates of response throughout recruitment and retention phases by demographic and other characteristics. METHODS: Using quota sampling, participants were recruited from 3 geographically and demographically diverse integrated health systems in the United States. Overall, 12,860 adults, ages 20-70, were invited to participate via mail. Participation first required accessing the study's website and later meeting eligibility criteria via telephone interview...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28736754/age-related-macular-degeneration-in-a-randomized-controlled-trial-of-low-dose-aspirin-rationale-and-study-design-of-the-aspree-amd-study
#18
Liubov Robman, Robyn Guymer, Robyn Woods, Stephanie Ward, Rory Wolfe, James Phung, Lauren Hodgson, Galina Makeyeva, Khin Zaw Aung, Tom Gilbert, Jessica Lockery, Y-Anh Le-Pham, Suzanne Orchard, Elsdon Storey, Walter Abhayaratna, Daniel Reid, Michael E Ernst, Mark Nelson, Christopher Reid, John McNeil
PURPOSE: Although aspirin therapy is used widely in older adults for prevention of cardiovascular disease, its impact on the incidence, progression and severity of age-related macular degeneration (AMD) is uncertain. The effect of low-dose aspirin on the course of AMD will be evaluated in this clinical trial. DESIGN: A sub-study of the 'ASPirin in Reducing Events in the Elderly' (ASPREE) trial, ASPREE-AMD is a 5-year follow-up double-blind, placebo-controlled, randomized trial of the effect of 100 mg daily aspirin on the course of AMD in 5000 subjects aged 70 years or older, with normal cognitive function and without cardiovascular disease at baseline...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28670629/statistical-analysis-plan-for-stage-1-embarc-establishing-moderators-and-biosignatures-of-antidepressant-response-for-clinical-care-study
#19
Eva Petkova, R Todd Ogden, Thaddeus Tarpey, Adam Ciarleglio, Bei Jiang, Zhe Su, Thomas Carmody, Philip Adams, Helena C Kraemer, Bruce D Grannemann, Maria A Oquendo, Ramin Parsey, Myrna Weissman, Patrick J McGrath, Maurizio Fava, Madhukar H Trivedi
Antidepressant medications are commonly used to treat depression, but only about 30% of patients reach remission with any single first-step antidepressant. If the first-step treatment fails, response and remission rates at subsequent steps are even more limited. The literature on biomarkers for treatment response is largely based on secondary analyses of studies designed to answer primary questions of efficacy, rather than on a planned systematic evaluation of biomarkers for treatment decision. The lack of evidence-based knowledge to guide treatment decisions for patients with depression has lead to the recognition that specially designed studies with the primary objective being to discover biosignatures for optimizing treatment decisions are necessary...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28649668/metabolic-costs-of-daily-activity-in-older-adults-chores-xl-study-design-and-methods
#20
Duane B Corbett, Amal A Wanigatunga, Vincenzo Valiani, Eileen M Handberg, Thomas W Buford, Babette Brumback, Ramon Casanova, Christopher M Janelle, Todd M Manini
BACKGROUND: For over 20 years, normative data has guided the prescription of physical activity. This data has since been applied to research and used to plan interventions. While this data seemingly provides accurate estimates of the metabolic cost of daily activities in young adults, the accuracy of use among older adults is less clear. As such, a thorough evaluation of the metabolic cost of daily activities in community dwelling adults across the lifespan is needed. METHODS: The Metabolic Costs of Daily Activity in Older Adults Study is a cross-sectional study designed to compare the metabolic cost of daily activities in 250 community dwelling adults across the lifespan...
June 2017: Contemporary Clinical Trials Communications
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