Native American Weight Loss Movement: Pilot Test of a Culturally Tailored Weight Loss Program for American Indians

American Indians (AIs) have higher rates of obesity than other racial/ethnic groups, placing them at heightened risk for cardiovascular diseases, diabetes, and certain cancers. Culturally appropriate weight loss interventions may be the key to reducing risk. The most successful program used in AI communities has been the Diabetes Prevention Program (DPP), which limits enrollment to individuals with a clinical diagnosis of pre-diabetes. The purpose of this pilot project was to modify and culturally tailor a weight loss intervention to AI communities in Kansas to improve weight loss related behaviors among those who do not qualify for the DPP. The Native American Weight Loss Movement (NAWLM) was developed from 2012-2014 using an iterative process with 4 sequential modifications to the program. Group 1 received a slightly modified version of the DPP that was originally tailored to African Americans. Each group received an improved program based on modifications from the previous group. Our analysis shows 36.1% (95% CI: 25.7, 47.5) of all participants (n=72) lost weight; a majority (63.9%, 95% CI: 52.8-75.0) maintained weight, gained weight, or dropped out. Among individuals who completed the program (n=34), 76.5% lost weight (95% CI: 61.4, 91.5). These individuals lost an average of 2.98% body weight (95% CI: 1.58, 4.37), with 6 participants losing \u3e7% body weight. While most participants who completed the program lost weight, more research is needed to determine factors that discourage drop-out and promote behavioral changes. NAWLM shows promise as a weight loss program for AIs who do not qualify for the DPP

Reliability, Responsiveness, and Validity of the Visual Analog Fatigue Scale to Measure Exertion Fatigue in People with Chronic Stroke: A Preliminary Study

Background and Purpose. Post-Stroke Fatigue (PSF) is a prevalent yet commonly neglected issue that impacts daily functions and quality of life in people post-stroke. To date no studies have attempted to validate a clinically-feasible and reliable instrument to quantify PSF. We developed the Visual Analog Fatigue Scale (VAFS) to eliminate difficulties and poor data validity in testing people post-stroke. The purpose of this study was to evaluate the reliability, responsiveness, and validity of the VAFS. Methods. Twenty-one people post-stroke (12 males, age  = 59.5 ± 10.3 years; time post-stroke  = 4.1 ± 3.5 years) participated. Subjects underwent a standardized fatigue-inducing exercise; fatigue level was assessed at rest, immediately after exercise, and after recovery. The same protocol was repeated after 14 days. Results. ICC values for the VAFS at rest was 0.851 (CI = 95%, 0.673 ∼ 0.936, P < .001), immediately after exercise was 0.846 (CI = 95%, 0.663 ∼ 0.934, P < .001), and 15 minutes after exercise was 0.888 (CI = 95%, 0.749 ∼ 0.953, P < .001). The ES values for at-rest to post-exercise and for post-exercise to post-recovery were 14.512 and 0.685, respectively. Using paired t-test, significant difference was found between VAFS scores at-rest and post-exercise (P < .001), and between post-exercise and post-recovery (P < .001). Conclusion. Our data suggests good reliability, responsiveness, and validity of the VAFS to assess exertion fatigue in people post-stroke

Commensurate Priors on a Finite Mixture Model for Incorporating Repository Data in Clinical Trials

Docosahexaenoic acid (DHA) is a good source of fat that can be taken up through food, such as fish, or taken as a supplement. Evidence is building that DHA provides a high-yield, low-risk strategy to reduce preterm birth and/or low birth weight. These births are great costs to society. A recently completed Phase III trial revealed that higher birth weight and gestational age were associated with DHA dosed at 600 mg/day. In this article, we take a posterior predictive approach to assess impacts of these findings on public health. Simple statistical models are not adequate for accurate posterior predictive distribution estimation. Of particular interest is that the joint distribution of birth weight and gestational age is well modeled by a finite mixture of three normal distributions. Data from our own clinical trial exhibit similar features. Using the mean and variance-covariance matrices from a previous study and flexible commensurate priors for the mixing parameters, we estimate the effect of DHA supplementation on over 20,000 infants born in hospitals demographically similar to the hospital where the clinical trial was conducted

Reliability of Peak Treadmill Exercise Tests in Mild Alzheimer Disease

This is an Accepted Manuscript of an article published by Taylor & Francis in International Journal of Neuroscience on August 2011, available online: http://www.tandfonline.com/10.3109/00207454.2011.574762.The prevalence of Alzheimer disease (AD) doubles every 5 years after the age of 65, reaching nearly 50% after age 85 (Evans et al., 1989). This, along with an unprecedented growth in the elderly population, is leading to dramatic increases in the incidence of AD. Thus, effective strategies for promoting healthy brain aging and preventing AD are increasingly important. One strategy that appears promising in promoting healthy brain aging is exercise and physical activity. Evidence is accumulating that endurance exercise is beneficial to brain health (Laurin, Verreault, Lindsay, MacPherson, & Rockwood, 2001), and increased cardiorespiratory fitness is associated with increased brain volume in subjects with very mild to mild AD (Burns et al., 2008). While enhancing cardiorespiratory fitness may be a strategy for preventing cognitive decline in AD, there is limited information available on the validity and reliability of cardiorespiratory fitness measures in this population. The gold standard measure of cardiorespiratory fitness is maximum oxygen consumption (VO2max) (Frankin, 2001), the highest rate of oxygen uptake attainable during maximal or exhaustive exercise (American College of Sports Medicine, 2005). If the subject becomes exhausted and ends the test prior to reaching the physiologic VO2max, the end of the test is called peak oxygen consumption (VO2peak). It is unknown if advanced age and cognitive difficulties in people with AD would limit their ability to fully participate in a standard graded exercise test to reliably assess VO2max or VO2peak. Treadmill exercise testing has been found to be reliable in subjects with traumatic brain injury and mental retardation, although these subjects were very young (Fernhall, Millar, Tymeson, & Burkett, 1990; Mossberg & Greene, 2005). Traumatic brain injury and mental retardation are different disease processes than AD and would be expected to result in static rather than progressive cognitive symptoms. With AD, memory is impaired as is the ability to follow commands, however patients in the earliest stages of AD would be expected to respond to prompting and reminders to follow testing procedures. To our knowledge, no studies have assessed the reliability of peak treadmill exercise testing in subjects with AD. In our previous research on patients with very mild to mild AD (Burns, et al., 2008), we have found them to be capable of ambulating on a treadmill and completing peak treadmill exercise testing with 3 participants out of 74 (126 total peak exercise tests) identified as having EKG changes during testing. All 3 participants had negative follow-up testing in cardiology. The purpose of this study was to investigate the reliability of a graded peak treadmill exercise test in elderly people with early AD

Bayesian accrual prediction for interim review of clinical studies: open source R package and smartphone application

Illustration of use of R accrual package. (DOCX 917 kb

Hyperbaric oxygen brain injury treatment (HOBIT) trial: a multifactor design with response adaptive randomization and longitudinal modeling

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/134231/1/pst1755_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/134231/2/pst1755.pd

Bayesian hierarchical EMAX model for doseâ response in early phase efficacy clinical trials

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/149669/1/sim8167_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/149669/2/sim8167.pd

Maternal Docosahexaenoic Acid Exposure Needed to Achieve Maternal–Newborn EQ

Achieving maternal docosahexaenoic acid (DHA) status equal to or greater than the infant’s DHA status at delivery is known as maternal–newborn DHA equilibrium (EQ) and is thought to be important for optimizing newborn DHA status throughout infancy. The objective of this study was to determine the daily DHA intake during pregnancy most likely to result in EQ. The participants (n = 1145) were from two randomized control trials of DHA supplementation in pregnancy. DHA intake was estimated using an abbreviated food frequency questionnaire. Total DHA exposure during pregnancy was calculated as a weighted average of the estimated DHA intake throughout pregnancy and the randomized DHA dose (200, 800, 1000 mg). Red blood cell DHA was measured from maternal and cord blood plasma at delivery and EQ status was calculated. The DHA intake required to achieve EQ was estimated by regression. In terms of DHA exposure, the point estimate and 95% confidence interval to achieve EQ was 643 (583, 735) mg of DHA/day. The results of our trial suggest an intake of 650 mg of DHA/day is necessary to increase the potential for EQ at delivery. The clinical benefits of achieving EQ deserves continued study