Weight management in rural health clinics: Results from the randomized midwest diet and exercise trial.

Introduction: Rural living adults have higher rates of obesity compared with their urban counterparts and less access to weight management programs. Previous research studies have demonstrated clinically relevant weight loss in rural living adults who complete weight management programs delivered by university affiliated interventionists. However, this approach limits the potential reach, adoption, implementation, and maintenance of weight management programs for rural residents.

Remote delivery of a weight management intervention for adults with intellectual disabilities: Results from a randomized non-inferiority trial.

Background: Remote delivery of multi-component weight management interventions results in clinically meaningful weight loss in adults without intellectual disabilities (ID), but the effectiveness of remotely delivered weight management interventions in adults with ID has not previously been evaluated.

Objective: To determine if a weight management intervention delivered remotely could achieve weight loss (kg) at 6 months that is non-inferior to in-person visits in adults with ID and overweight or obesity (BMI ≥25 kg/m).

Methods: Participants were randomized to a 24-mo.

A randomized trial comparing diet and delivery strategies for weight management in adolescents with intellectual disabilities.

Background: The literature evaluating multi-component interventions for long-term weight loss in adolescents with intellectual disabilities (ID) is extremely limited.

Objectives: To compare the effectiveness of two delivery strategies, face-to-face (FTF) or remote delivery (RD), and two diets, enhanced Stop Light diet (eSLD) or conventional diet (CD) on weight change across 12 and 18 months. in response to an 18 months.

Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.

Importance: African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels.

Objectives: To evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers.

Design, Setting, And Participants: The Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City.

An Exploratory Study of Cognitive Function and Central Adiposity in Men Receiving Androgen Deprivation Therapy for Prostate Cancer.

Objectives: To prospectively assess cognitive function, anthropomorphic measures, and bone mineral density in men receiving androgen deprivation therapy (ADT) for prostate cancer; explore relationships between cognitive function and central adiposity; and gather preliminary data from a personalized education, exercise, and nutrition intervention.

Sample & Setting: 33 participants consented from a randomized controlled intervention trial.

Methods & Variables: Neurocognitive performance and self-report of cognitive function were assessed at baseline and 6 and 12 months.

A Randomized Trial Evaluating Exercise for the Prevention of Weight Regain.

Objective: This study aimed to evaluate the effectiveness of three levels of exercise on weight regain subsequent to clinically meaningful weight loss (WL).

Methods: Adults with overweight or obesity (n = 298) initiated a 3-month behavioral WL intervention, which included reduced energy intake, increased exercise, and weekly behavioral counseling. Participants achieving ≥5% WL (n = 235) began a 12-month behavioral WL maintenance intervention and were randomized to 150 min/wk (n = 76), 225 min/wk (n = 80), or 300 min/wk (n = 79) of partially supervised moderate-to-vigorous-intensity exercise.

Weight Loss Interventions for Adolescents With Intellectual Disabilities: An RCT.

Objectives: In this randomized trial, we compared the effectiveness of 2 diets (enhanced stop light diet [eSLD] versus conventional meal plan diet [CD]) and 2 delivery strategies (face-to-face [FTF] versus remote delivery [RD]) on weight loss across 6 months in adolescents with intellectual and developmental disabilities who were overweight or obese.

Methods: Participants were randomly assigned to 1 of 3 arms (FTF/CD, RD/CD, or RD/eSLD) and asked to attend one-on-one sessions with a health educator every 2 weeks to aid in maintaining compliance with recommendations for a reduced-energy diet and increased physical activity. The CD followed the US dietary guidelines.

A framework for personalized mammogram screening.

Breast cancer screening guidelines serve as crucial evidence-based recommendations in deciding when to begin regular screenings. However, due to developments in breast cancer research and differences in research interpretation, screening guidelines can vary between organizations and within organizations over time. This leads to significant lapses in adopting updated guidelines, variable decision making between physicians, and unnecessary screening for low to moderate risk patients (Jacobson and Kadiyala, 2017; Corbelli et al.

Coffee and cigarette smoking interactions with lamotrigine.

The objective of this analysis was to determine possible interactions between lamotrigine (LTG) and coffee or cigarette use. As part of the statistical analysis of factors influencing LTG pharmacokinetics (PK) in the Equigen chronic dose study, we collected prospective data from enrolled patients on their use of coffee and cigarettes. Subjects were part of a crossover replication study of generic LTG products with rigorous blood sampling and were instructed to not change their typical consumption of these products for the duration of the study.

Improving the efficiency of clinical trials by standardizing processes for Investigator Initiated Trials.

Early phase clinical trials are the first step in testing new medications and therapeutics developed by clinical and biomedical investigators. These trials aim to find a safe dose of a newly targeted drug (phase I) or find out more about the side effects and early signals of treatment efficacy (phase II). In a research institute, many biomedical investigators in oncology are encouraged to initiate such trials early in their careers as part of developing their research portfolio.

Perioperative Factors Affecting Ambulatory Outcomes Following Laparoscopic-Adjustable Gastric Banding.

Objective: Morbidly obese patients are traditionally hospitalised following bariatric surgery. However, laparoscopic-adjustable gastric banding (LAGB) is amenable for ambulatory care. We hypothesised that the majority of patients can receive an ambulatory LAGB and that both surgical and anaesthetic perioperative factors will significantly affect non-ambulatory LAGB outcomes.

Bioequivalence Between Generic and Branded Lamotrigine in People With Epilepsy: The EQUIGEN Randomized Clinical Trial.

Importance: Switching between generic antiepileptic drugs is a highly debated issue that affects both clinical care and overall health care costs.

Objective: To evaluate the single-dose pharmacokinetic bioequivalence of 3 (1 branded and 2 generic drugs) on-market, immediate-release lamotrigine drug products.

Design, Setting, And Participants: The Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy (EQUIGEN) single-dose study is a crossover, prospective, sequence-randomized, replicate pharmacokinetic study conducted at 5 US academic epilepsy centers.

Weight management in adults with intellectual and developmental disabilities: A randomized controlled trial of two dietary approaches.

Background: The prevalence of obesity among individuals with intellectual and developmental disabilities (IDD) is equal to or greater than the general population.

Methods: Overweight/obese adults (BMI ≥25 kg/m ) with mild-to-moderate intellectual and developmental disabilities were randomized to an enhanced stop light diet (eSLD = SLD + portion-controlled meals, n = 78) or a conventional diet (CD, n = 72) for an 18 months trial (6 months weight loss, 12 months maintenance). Participants were asked to increase physical activity (150 min/week), self-monitor diet and physical activity and attend counselling/educational sessions during monthly home visits.

Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial.

Background: Patients and clinicians share concerns that generic drug substitution might lead to loss of efficacy or emergence of adverse events. In this trial, we assessed US Food and Drug Administration (FDA) bioequivalence standards by studying the effects of switching between two disparate generic immediate-release lamotrigine products in patients with epilepsy.

Methods: The Equivalence among Generic Antiepileptic Drugs (EQUIGEN) chronic-dose study was a randomised, double-blind, crossover study that enrolled adults (aged ≥18 years) with epilepsy from six epilepsy centres at academic institutions across the USA who were receiving immediate-release lamotrigine dosed at 100 mg, 200 mg, 300 mg, or 400 mg twice daily.

Examining Smoking Dependence Motives among African American Light Smokers.

Introduction: Despite smoking fewer cigarettes per day, African American smokers have greater difficulty quitting compared to Caucasian smokers. Further elucidating the impact of smoking motivations on smoking behavior would contribute to understanding the factors that maintain smoking.

Aims: This study examined the factor structure of a brief assessment examining smoking dependence motives among a sample of African American light smokers.

Random-effects linear modeling and sample size tables for two special crossover designs of average bioequivalence studies: the four-period, two-sequence, two-formulation and six-period, three-sequence, three-formulation designs.

Due to concern and debate in the epilepsy medical community and to the current interest of the US Food and Drug Administration (FDA) in revising approaches to the approval of generic drugs, the FDA is currently supporting ongoing bioequivalence studies of antiepileptic drugs, the EQUIGEN studies. During the design of these crossover studies, the researchers could not find commercial or non-commercial statistical software that quickly allowed computation of sample sizes for their designs, particularly software implementing the FDA requirement of using random-effects linear models for the analyses of bioequivalence studies. This article presents tables for sample-size evaluations of average bioequivalence studies based on the two crossover designs used in the EQUIGEN studies: the four-period, two-sequence, two-formulation design, and the six-period, three-sequence, three-formulation design.

Utility of dexmedetomidine in sedation for radiofrequency ablation of atrial fibrillation.

The utility of dexmedetomidine (DEX) as an adjunct to conventional procedural sedation using midazolam and fentanyl was evaluated in 11 adult patients undergoing radiofrequency catheter ablation (RFCA) of atrial fibrillation. In a subsequent comparison to 11 demographically matched controls (n = 22) that previously received only midazolam- and fentanyl-based sedation, no significant differences in consumption of midazolam (median, 5 vs 10 mg; P = .3), fentanyl (median, 275 vs 400 mcg, P = .

Predictors of cessation in African American light smokers enrolled in a bupropion clinical trial.

Background: This is the first study to examine predictors of successful cessation in African American (AA) light smokers treated within a placebo-controlled trial of bupropion.

Methods: We analyzed data from a randomized, double-blind, placebo-controlled trial of bupropion and health education for 540 African American light smokers. African American light smokers (≤10 cigarettes per day, cpd) were randomly assigned to receive 150mg bid bupropion SR (n=270) or placebo (n=270) for 7weeks.

Evaluation of the brief questionnaire of smoking urges in Black light smokers.

Introduction: This study evaluated the factor structure of the Brief Questionnaire of Smoking Urges (QSU-Brief) within a sample of Black light smokers (1-10 cigarettes per day).

Methods: The QSU-Brief was administered to 540 (mean age = 46.5; 66.

Factors associated with smoking menthol cigarettes among treatment-seeking African American light smokers.

Background: Smoking menthol cigarettes is more prevalent among African Americans (AA) compared to Whites. Menthol has been found to be inversely related to smoking cessation among AA, yet little is known about the factors associated with menthol smoking among AA light smokers. This study examines baseline demographic, psychological, and smoking factors associated with smoking menthol cigarettes among AA light smokers (≤10 cigarettes per day).

Assessment of depression among African American light smokers.

Given the relationship between depression and smoking, we compared the two-item Patient Health Questionnaire (PHQ-2) and 10-item Center for Epidemiological Studies Depression Scale (CESD-10) in assessing depressive symptoms among African American light smokers in a clinical trial of bupropion. Of 539 participants, 21.3 percent reported significant depressive symptoms on the PHQ-2, 31.

Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data.

Background: African Americans experience significant tobacco-related health disparities despite the fact that over half of African American smokers are light smokers (use ≤ 10 cigarettes per day). African Americans have been under-represented in smoking cessation research, and few studies have evaluated treatment for light smokers. This paper describes the study design, measures, and baseline characteristics from Kick It at Swope III (KIS-III), the first treatment study of bupropion for African American light smokers.

Elevated FGF23 levels are associated with impaired calcium-mediated suppression of PTH in ESRD.

Context: The positive association of elevated fibroblast growth factor-23 (FGF23) with PTH levels in the setting of secondary hyperparathyroidism is paradoxical to the purported effects of FGF23 to suppress PTH secretion.

Objective: We used dynamic calcium-mediated suppression of PTH levels in hemodialysis (HD) patients to determine the relationship between FGF23 levels and parathyroid gland function.

Design: HD patients with elevated PTH were washed out of vitamin D analogs and/or calcimimetics and then exposed them to a high-calcium dialysate bath designed to suppress PTH.