INTRODUCTION:The current study tested the efficacy of the Deep South Interactive Voice Response (IVR) System-Supported Active Lifestyle (DIAL) intervention. STUDY DESIGN:A randomized controlled trial was conducted in 2020-2024. Data were analyzed in 2025-2026. SETTING/PARTICIPANTS:245 adults were recruited from 6 rural Alabama counties. INTERVENTION:Participants were randomly assigned to the DIAL intervention or wait-list control arms. MAIN OUTCOME MEASURES:Moderate-vigorous physical activity (MVPA) was assessed at baseline and 6 months. RESULTS:The sample was comprised of rural (100%) non-Hispanic Black (97.55%) women (91.02%). DIAL participants reported significantly greater MVPA increases from baseline to 6 months (M =>60 min/week more, based on 7-Day Physical Activity Recalls and Godin Leisure Time Exercise Questionnaires), compared to control participants (p<0.001). The DIAL arm was also significantly more likely to reach national physical activity guidelines at 6 months, compared to the control arm, based on the Godin findings (OR = 5.38, 95% CI= 1.67-17.28, p<0.01), but not the 7 -Day Physical Activity Recall (OR=2.85, 95% CI= 0.94-8.65, p= 0.06) or accelerometer data (OR=2.25, 95% CI= .097-5.20, p=0.06). Accelerometer data showed no significant changes in MVPA over time, yet trends in the data indicated that the percentage meeting national guidelines increased for the DIAL arm and decreased for the control arm. CONCLUSIONS:Findings support the efficacy of DIAL among rural adults in the Deep South. IVR-automated phone counseling represents a high-reach, low-cost strategy for addressing physical inactivity and related health disparities in underserved rural communities. TRIAL REGISTRATION:This study is registered at www. CLINICALTRIALS:gov [NCT03903874; 4-4-2019] ETHICAL APPROVAL: University of Alabama at Birmingham Institutional Review Board (IRB-300003238; 4-26-2019).
BACKGROUND:Breast cancer survivors often experience physical and mental side effects posttreatment, compromising their quality of life (QoL). The increasing number of survivors coping with long-term side effects creates public health concerns, emphasizing the need for supportive interventions. Although physical activity (PA) benefits cancer survivors, few studies examine the effect that cancer-related factors have on the relationship between PA levels and QoL among breast cancer survivors. Understanding the associations that cancer-related factors may have on the QoL response to PA is crucial for developing effective interventions. METHODS:Baseline data from 341 postprimary treatment breast cancer survivors enrolled in a web-based diet and/or exercise intervention randomized controlled trial were analyzed. PA measures included accelerometry and self-reported moderate to vigorous PA (MVPA). QoL was assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) global QoL and EuroQOL-5D-5L questionnaires. Pearson correlation coefficient tests and multiple linear regression assessed associations between MVPA and QoL and whether cancer-related factors moderated these associations. RESULTS:The EuroQOL-5D-5L QoL index (and 4 out of 5 domains) showed statistically significant associations with self-reported MVPA. PROMIS physical health was correlated with both MVPA measures. Survivors > 24 months postdiagnosis had stronger associations between accelerometry-measured MVPA levels and EuroQOL-5D-5 L QoL index (β = 0.0004, P = .003). Survivors receiving hormone therapy exhibited stronger associations between self-reported MVPA levels and PROMIS-physical health QoL domain compared with those not (β = 0.0121, P = .028). CONCLUSION:Greater MVPA was modestly associated with better QoL, with stronger associations observed in survivors receiving hormone therapy or >24 months postdiagnosis. There are potential QoL benefits in implementing interventions immediately postdiagnosis and tailoring to treatment histories.
BACKGROUND:The number of cancer survivors is growing rapidly, and >70% are overweight or obese. Given their increased risk for obesity-related conditions (eg, cardiovascular disease, second malignancies), weight-loss interventions are a priority for this population, yet few have access. PATIENTS AND METHODS:We conducted a 2-arm, single-blinded, randomized controlled trial to test whether a 24-week, fully automated, web-based diet intervention would significantly improve body weight and other health-related outcomes compared with a waitlist control among cancer survivors. The AiM, PLan, and act on LIFestYles (AMPLIFY) diet intervention offered serialized, tailored guidance to achieve a 0.5 kg per week weight loss and improve diet quality. Survivors of 1 of 9 obesity-related cancers with >70% 5-year survival, aged ≥50 years, and with a body mass index of 25 to <50 kg/m2 enrolled in the trial across the United States (n=349). Participants were randomly assigned to the AMPLIFY-Diet intervention (n=151) or waitlist control (n=198). The primary outcome was weight loss; secondary outcomes included other health indices and diet quality. Intervention delivery and assessments (baseline, 3 months, and 6 months) occurred from 2020 to 2024. RESULTS:Intent-to-treat analyses showed significantly greater weight loss among intervention versus waitlist participants (percent weight change, -4.75%; 95% CI, -6.04% to -3.46%), with higher proportions attaining 3%, 5%, and 10% weight loss benchmarks (P<.001 for all). Significant between-arm differences were also observed for waist circumference (-3.47 cm; 95% CI, -4.86 to -2.08; P<.001), circulating leptin (-2,050.5 pg/mL; 95% CI, -3,049.5 to -1,051.6; P<.001), cognitive function (2.22; 95% CI, 0.30 to 4.15; P=.02), and systolic blood pressure (intention-to-treat: -3.54 mm Hg; 95% CI, -7.30 to 0.27; P=.07, sensitivity analysis: -5.10 mm Hg; 95% CI, -9.09 to -1.10; P=.013). Furthermore, significant decreases in caloric intake (-288 kcal/d; 95% CI, -391.5 to -184.6; P<.001) and improvements in diet quality were observed. CONCLUSIONS:The magnitude of weight loss achieved with AMPLIFY is the highest reported to date for any fully automated intervention and produced significant benefits. Continued optimization and research to integrate the AMPLIFY-Diet intervention into broader use and clinical practice are warranted.
ABSTRACT Background Recruiting cancer survivors to research studies requires multiple steps that may be differentially challenging across groups of survivors. Aims We examined associations between progression through recruitment steps and sociodemographic and clinical characteristics of survivors invited to participate in the Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) Cancer Survivor Health randomized control trial of web‐based healthy lifestyle interventions. Materials and Methods Survivors from two population‐based cancer registries and a hospital registry (n = 23,270) were mailed an AMPLIFI invitation letter then called by recruiters. Outcomes included being (1) reached by recruiters, (2) screened for eligibility, (3) deemed eligible, and (4) consented. Bivariate and logistic regression analyses examined associations with sociodemographic and clinical factors. Results 7742 (33.3%) survivors were reached. Being reached was positively associated with being female, age 65+, African American, urban resident, and < 2 years from cancer diagnosis; negatively associated with colorectal cancer. Among those reached, 7438 were offered screening and 2278 (30.6%) were screened. Being screened was positively associated with being female, African American, and < 2 years from diagnosis; negatively associated with age 65+, resident in high disadvantage areas, survivor of colorectal cancer. Of survivors screened, 716 (32%) were eligible. Being eligible was positively associated with < 2 years from diagnosis; negatively associated with colorectal and kidney cancer. Of those eligible, 438(61.2%) consented to participate. Being consented was negatively associated with being African American and from high disadvantage areas. Discussion and Conclusion Outcomes across recruitment steps vary by survivors' characteristics indicating that opportunities exist for tailored approaches to promote greater overall diversity in clinical trials.
Refining digital health programs with end-user feedback is essential throughout program lifecycles to ensure user-centered perspectives are incorporated during all program development. Results from beta-testing "think aloud" interviews exploring program engagement, satisfaction, motivation, and usefulness may be leveraged to support development of interview questions for a subsequent user-centered process evaluation implemented during program efficacy testing. We describe how results from beta-testing "think aloud" interviews were utilized to inform the design of user-centered process evaluation interview questions for implementation during program efficacy testing of AMPLIFY, a web-based diet and exercise program for older cancer survivors. Beta-testers (n = 15) were asked to complete three "think aloud" interviews via a videoconference platform over a 6-month period; 40 interviews were completed, accounting for early dropouts. Transcripts were analyzed using a multi-step process: 1) suggested refinements from beta-testing "think aloud" interview results were catalogued and organized according to whether the program feature was liked, disliked, or confusing to the beta-tester; and 2) suggestions for refinements were categorized based on feasibility to adopt (feasible/not feasible), the type of recommended change (formatting/content), and underlying improvement goal (engagement, satisfaction, motivation, usefulness). Refinements considered feasible to adopt were categorized into formatting refinements (changes to the presentation/organization of the program) and content refinements (additions, deletions, or changes to the information provided in the program). Refinements were also categorized by relationship to four process evaluation constructs: engagement, satisfaction, motivation, and usefulness. Results informed user-centered process evaluation interview questions for implementation during program efficacy testing; such that, subsequent semi-structured interview questions were developed based on these evaluation constructs and underlying improvement goals. The application of beta-testing results to refinements and process evaluation provide a potential guide for other researchers developing and evaluating digital health interventions.
BACKGROUND:Chronic pain, which affects over 50 million adults in the United States, has stimulated growing interest in natural and nutrition-based remedies as adjuncts to pharmacologic therapies. Evidence suggests that turmeric and related extracts (i.e., curcuminoids) may provide pain relief, albeit often at levels above dietary ranges, while piperine from black pepper exhibits bioenhancer characteristics of relevance with dietary exposures. OBJECTIVE:To test the effectiveness of dietarily relevant amounts of turmeric with and without black pepper on self-reported pain ratings among adults with chronic pain. METHODS:A randomized, crossover clinical trial tested the effectiveness of turmeric only (one of three amounts within culinary ranges) or turmeric with black pepper to influence pain in adults ≥ 40 years of age. Participants (n = 30, with moderate pain: 4-7 on 0-10-point scale) were enrolled in a 21-day trial, and an experience sampling methodology approach was used. Participants were prompted to report current pain using the numeric pain rating scale (NPRS; 0-10) via text message three times per day for the full study period. Data were averaged and analyzed via linear mixed effects models for repeated measurements. RESULTS:Pain ratings from baseline to week 3 were reduced and statistically significant (p < 0.001) but not statistically different between groups. The provided turmeric, both with and without black pepper, and varying amounts of turmeric (300 mg, 1 g, and 3 g, n = 10 participants/amount) did not show statistically significant differences in pain ratings (p = 0.157 and p = 0.338, respectively). CONCLUSIONS:Consuming dietarily relevant amounts of turmeric, either alone or with black pepper, appears to improve average pain ratings. This result suggests a feasible dietary option for further study of nutritional interventions for chronic pain management.
Purpose: Recent studies have shown that high-intensity interval training (HIIT) can improve cardiometabolic health in individuals with spinal cord injury (SCI); however, many barriers remain for individuals with spinal cord injury to participate in exercise such as lack of time, accessible equipment and facilities, and transportation. The use of telehealth interventions may be a form of exercise delivery that can ease the burden on the participant and lead to greater exercise participation. Thus, the purpose of this study was to determine the feasibility and efficacy of a home-based telehealth HIIT arm crank exercise training program for individuals with spinal cord injury. Methods: Participants were randomly assigned to 16 weeks of telehealth HIIT arm crank exercise training or a no-exercise control group. Body composition, resting energy expenditure (REE), blood lipids, insulin sensitivity, blood pressure, aerobic capacity (VO2 max), and a qualitative interview were assessed at baseline and at 16 weeks post intervention. Results: Six individuals (four male and two female, mean age 52.7 +/- 10.2 years) with spinal cord injury were recruited for this study. Four out of five HIIT participants showed improvements in aerobic capacity, insulin sensitivity, and resting energy expenditure. Three qualitative themes emerged: (1) convenience and perceived benefits were critical elements of engagement; (2) high-intensity exercise elicited time-sensitive responses; and (3) trainers played a key role in promoting strong program adherence. Conclusions: Overall, we found that this program could be easily implemented and per-formed at home in individuals with spinal cord injury. We also found that participants enjoyed the 1:1 training sessions with a telecoach and that the intervention was easy to adhere to, as demonstrated by participant attendance. There is a need for future randomized controlled trials to determine the efficacy of telehealth exercise training for improving cardiometabolic health in spinal cord injury.
AIM:To examine the feasibility of a seated virtual reality exercise telehealth intervention on physical activity and cardiometabolic health in young people with cerebral palsy (CP). METHOD:This was a randomized two-arm parallel group study: an immediate start group versus a waitlist control that continued usual activities of daily living. The home-based intervention targeted 150 minutes per week of moderate-intensity exergaming for 12 weeks, using Meta Quest virtual reality headsets and games, adapted for seated exercise. Data were collected remotely in weeks 0, 7, and 13. RESULTS:Thirty-two young people with CP enrolled (mean age 16 years 8 months [SD 3 years 8 months], 19 females, 13 males), with a 9.4% dropout rate. Immediate start completers (n = 13) averaged 144 minutes per week (SD 73 minutes per week) of total exercise but fell short of the moderate-exercise target (150 minutes per week) at week 3 by 25%, week 6 by 31%, and week 12 by 48%. Immediate start surveys demonstrated that moderate-to-vigorous physical activity increased by 166% and 108% at weeks 7 and 13 respectively. Immediate start insulin levels improved by 45.2% and triglycerides by 20.2% from week 0 to 7. Waitlist control insulin and high-sensitivity C-reactive protein worsened from week 0 to 13 by 42.8% and 40% respectively. INTERPRETATION:Seated virtual reality exercise is a feasible and safe intervention that significantly increases physical activity participation. It shows potential for favorably influencing certain cardiometabolic markers, although further research is needed to establish sustained benefits.
BackgroundChildhood obesity is a complex disease and adversely affects multiple organ systems and increases the risk for several health problems, including diabetes, cancer, atherosclerosis, and premature cardiovascular disease in adulthood. This study aimed to identify differences in volatile organic compounds (VOCs) between normal weight (NW) and overweight/obese (OW/OB) children, as well as between European American and African American children.MethodsA total of 159 children participated in this cross-sectional study. Urine samples were analyzed using solid-phase microextraction gas chromatography-mass spectrometry (SPME-GC-MS) following glucuronidase and sulfatase treatment to capture a broad range of urinary volatiles with diverse physicochemical properties. Multiple linear regression was used to examine associations between urinary VOCs and BMI z-scores, and to identify VOCs that differentiated NW from OW/OB children.ResultsSixty-five VOCs were identified as differing between NW and OW/OB children, with ten remaining significant predictors of obesity after adjusting for race and socioeconomic status. These compounds exhibited area under the curve values ranging from 0.503 and 0.737, with sensitivity and specificity above 0.60.ConclusionsKey VOCs, including benzaldehyde, furan, hexanal, 4-heptanone and 2-pentylfuran, were positively associated with BMI z-score and may contribute to the low-grade chronic inflammation characteristic of obesity. These findings highlight the potential of urinary VOCs as non-invasive biomarkers for childhood obesity.
BACKGROUND:Treatment of locally-advanced head and neck cancer (HNC) involves multiple therapeutic exposures that may directly or indirectly impact cognition. PURPOSE:To describe long-term cognitive impairment in a cohort of HNC survivors and to identify the cognitive domains most commonly affected. METHODS AND MATERIALS:This study enrolled patients with locally advanced or recurrent HNC who received radiation therapy (RT) and survived at least 2 years without recurrence. Participants completed a cognitive battery and quality of life measures. Performance in a cognitive domain was considered impaired if T < 35. Logistic regression was used to assess the relationship between treatment exposures and other variables with impairment in each cognitive domain. RESULTS:The final cohort consisted of 185 participants. The proportion of patients classified with cognitive impairment by domain was 36.8% for fine motor, 32.7% for verbal memory, 27.0% for executive function, 7.6% for vocabulary, and 7.0% for working memory. In the final model for impaired verbal memory, only radiation dose to the medial temporal lobe (OR = 1.06, 95% CI: 1.00-1.12) was significant. Time from RT (OR = 1.12, 95% CI: 1.01-1.24) and fatigue (OR = 3.45, 95% CI: 1.02-11.59) were associated with impaired working memory. Non-white race (OR = 8.44, 95% CI: 3.23-22.05) and fatigue (OR = 2.68, 95% CI: 1.24-5.81) were associated with impaired executive function. Impaired emotional function and fatigue, but not cognitive battery performance, were associated with perceived cognitive impairment. CONCLUSIONS:This study supports the hypothesis that many long-term HNC survivors experience cognitive impairment. Higher radiation dose to the medial temporal lobe was associated with lower verbal memory performance, and fatigue was associated with impaired executive function, perceived cognitive abilities, and overall role functioning.
Abstract Background: Rapid molecular blood culture identification (BCID) enables earlier pathogen identification and targeted antibiotic therapy compared with traditional culture-based methods. Methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia is optimally treated with anti-staphylococcal β-lactam antibiotics; however, delays in bacterial identification frequently result in prolonged empiric anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy. Data evaluating the clinical impact of early MSSA identification remain limited. Methods: This retrospective, single-center, quasi-experimental program evaluation included adult patients with monomicrobial MSSA bacteremia. Patients were grouped based on identification by BCID or conventional culture-based methods. Automatic Infectious Diseases consultation was performed for all patients. The primary outcome was a desirability of outcome ranking incorporating treatment success, acute kidney injury (AKI), and inpatient mortality. Secondary outcomes included time-to-optimal therapy, duration of bacteremia, treatment success, and hospital length of stay. Results: A total of 300 patients were included (150 per cohort). BCID use was associated with earlier MSSA identification (0.8 vs 2.1 days; P < .001) and earlier initiation of targeted β-lactam therapy (1.9 vs 3.8 days; P < .001). The probability of a more desirable outcome with BCID was 58.5% (95% CI: 52.5% to 64.3%), and more individuals achieved the most desirable outcome (62.0% vs 46.0%; P = .005). AKI occurred less frequently in the BCID group (23.5% vs 44.2%; P < .001). Conclusions: Incorporation of rapid BCID into an established automatic Infectious Diseases consultation program improved outcomes in MSSA bacteremia by facilitating earlier β-lactam therapy and reducing nephrotoxicity. Antimicrobial stewardship programs should prioritize rapid diagnostics to optimize MSSA management.
Emerging technologies, such as artificial intelligence, emphasize the importance of quantitative methods and their applications when conducting increasingly data-intensive research. The scientific discipline of statistical practice is critical for achieving rigor in research addressing important domain-level questions. The misconception that statistical practice is not a science but rather a service threatens scientific rigor and compromises the quality of its contribution to clinical and translational research. The authors call on academic and research leadership to recognize statistical practice as a key scientific discipline and to further ensure that the field and its scientists are nurtured. To that end, academic homes for faculty of statistical practice and its scholarship need to be fostered with clear pathways to hire, retain, promote, and tenure faculty who are largely team scientists. This goal can be achieved inclusively by avoiding the creation of separate faculty lines that might imply differing levels of value. In contrast, we must recognize and appreciate equally significant intellectual contributions made by various types of faculty members. Additionally, engagement of statistical practitioners as peer scientists and coleaders in collaborative research will ensure higher quality and rigor of scientific endeavors. Finally, leaders of statistical practice must be included in critical discussions around strategic development for academic and other research organizations for those institutions to achieve their missions in this modern era of data-intensive research.
Background Wheelchair users live predominantly sedentary lifestyles and have a substantially higher risk for cardiometabolic disease and mortality compared to people without disabilities. Exercise training has been found to be effective in improving cardiometabolic health (CMH) outcomes among people without disabilities, but research on wheelchair users is limited and of poor quality. Objective The primary aim of this study is to examine the immediate and sustained effects of a 24-week, telehealth, movement-to-music cardiovascular (M2M-C) exercise program on core indicators of CMH among adult wheelchair users compared to an active control group. The secondary aim is to explore the beneficial effects of M2M-C exercises on cardiovascular capacity, physical activity, and quality of life. Intervention components include tailored exercises and remote performance monitoring, delivered via live videoconference training by a telecoach and asynchronous videos. Methods This study’s design is a parallel-arm randomized controlled trial enrolling 132 physically inactive adult wheelchair users with poor cardiometabolic profiles. The M2M-C intervention group involves 24 weeks of virtual live and monitored home exercise training (3×/wk, 15-40 min/session), followed by a 12-week maintenance period where participants have access to an online media library of exercise videos. The control group involves 36 weeks of self-guided exercise through access to a media library of exercise videos, including videos for range of motion, muscle strength, and balance. The primary outcomes are cardiometabolic indicators of health, and assessors are blinded. Results Recruitment procedures started in January 2024 with the first participant enrolled on March 18, 2024. All data are anticipated to be collected by November 2027, and the main results of the trial are anticipated to be published by February 2028. Secondary analyses of data will be subsequently published. A total of 16 participants have been recruited as of paper submission. Conclusions The knowledge obtained from this trial will provide evidence to inform exercise prescriptions aimed at improving CMH among adult wheelchair users. Trial Registration ClinicalTrials.gov NCT05606432; https://clinicaltrials.gov/study/NCT05606432 International Registered Report Identifier (IRRID) DERR1-10.2196/57423
Introduction: Urine oxalate excretion influences the risk of calcium oxalate kidney stone formation and has been reported to positively correlate with body mass index (BMI) and body weight. The two major sources of urine oxalate are dietary oxalate absorption and endogenous oxalate synthesis (EOS). In this study, we investigated the association between EOS, as estimated by oxalate content of 24-hour urine collected while consuming an ultra-low oxalate diet, and measures of body size and composition. Methods: An analysis of prospectively performed studies conducted on adults consuming ultra-low oxalate diets between January 2018 and January 2025 at the University of Alabama at Birmingham was undertaken. All participants (n = 88) were healthy and had no history of kidney stone disease, hypertension, or diabetes. Participants underwent anthropomorphic measurements, and body composition was measured by bioelectrical impedance analysis. Urinary oxalate was measured by ion chromatography coupled to mass spectrometry. Results: Total urinary oxalate was positively correlated with body weight, BMI, lean body muscle mass, appendicular lean muscle mass, waist-to-hip ratio, and urinary creatinine excretion. There was no significant correlation between urinary oxalate excretion and body fat or age. Urinary oxalate excretion was different in males and females, even after adjusting for measures of lean body composition. Discussion: This analysis of low oxalate controlled diet studies in healthy participants suggests lean body mass, not body fat, is the major driver of EOS. This study also highlights that oxalate synthesis in lean body compartments is different in males and females.
RATIONALE: Lung cancer is a leading cause of cancer death among African Americans (AAs) in Alabama. Despite similar smoking rates, survival outcomes are significantly worse for AAs than other groups. This disparity underscores an urgent need for more effective lung cancer screening (LCS). Screening remains underutilized due to both lack of awareness and limited access. To address this gap, we developed, implemented and evaluated culturally tailored educational materials, facilitated by a Community Health Advisor (CHA). METHODS: We conducted a community-engaged pilot study to develop culturally tailored LCS-focused educational materials. Phase I included: (i) collaborating with a CHA to adapt LCS education utilizing Resnicow's framework; (ii) developing educational videos and supplemental materials featuring the CHA; (iii) pilot testing with five AA women from diverse backgrounds; and (iv) refining material using rapid qualitative analysis. Phase II involved recruiting screen-eligible individuals from a Federally Qualified Health Center (FQHC) to participate in the educational intervention. The CHA facilitated recruitment and delivered educational content. Participants completed pre- and post-educational surveys after engaging with the educational materials. Lung cancer screening knowledge, smoking-related stigma and socio-demographic variables were collected. Descriptive statistics was obtained, and pre-post-education was analyzed using the paired t-test for the overall change in knowledge. RESULTS: Phase I feedback indicated the educational materials were culturally relevant, approachable, and impactful. Participants wanted clear, jargon-free explanations paired with motivational storytelling.In Phase II participants were predominantly male (60%), Black (56%) and insured (82%). And reported high school or less (67%). Analysis revealed a notable increase in overall knowledge post-education (p = 0.0006). Participants better understood the importance of early detection (p = 0.0308) and the potential harms (p = 0.0107). They also gained insight into how CT scans could detect heart disease (p = 0.0374). We also explored specific attitudes towards smoking and its impact, including perceptions of blame, comfort in public spaces, and feelings of marginalization. While these changes were not statistically significant, they suggest potential trends and highlight important areas for further research. For example, the statement “Any negative impact that smoking causes is the smokers’ fault” saw a reduction in strong agreement from 36.36% pre-intervention to 22.22% post-intervention. CONCLUSION: A culturally tailored approach is crucial for reaching underserved populations and improving health outcomes. Future work will evaluate the effectiveness of these materials in broader clinical settings and measure their impact on LCS referral rates to validate and expand this model.
Introduction:Oxalate-degrading intestinal bacteria, including the oxalate-degrading specialist, Oxalobacter formigenes (O formigenes), have the potential to reduce urinary oxalate excretion in humans, and thus limit the risk of calcium oxalate kidney stone formation. The aim of this proof-of-concept study, which was performed in healthy adults, was to demonstrate that ingestion of live O formigenes is safe, can establish sustainable gut colonization, and reduce urinary oxalate excretion. Methods:Twenty-two healthy adults without a history of kidney stones and not colonized with O formigenes ingested diets controlled in oxalate and calcium. In these participants, 24-hour urine and stool oxalate levels were quantified using ion chromatography coupled with mass spectrometry before and after ingestion of O formigenes. Results:All 22 participants were successfully colonized after a single dose of O formigenes (∼1010 cells); 10 remained colonized for at least 1 year. Colonization was lost in 11 participants, of whom 9 reported antibiotic use. Six participants who lost colonization were redosed, and 5 were successfully recolonized. Stool oxalate concentration and urine oxalate excretion significantly decreased by 54% and 14%, respectively, with varied responses after colonization. Microbiome molecular analyses of precolonized stool samples highlighted the abundance and diversity of other potential oxalate-degrading bacteria, which may have influenced the effect of O formigenes colonization on urinary oxalate excretion. Conclusion:These findings support future investigations to examine the effectiveness of O formigenes colonization in reducing urinary oxalate excretion in disease cohorts, including calcium oxalate kidney stone formers with enteric hyperoxaluria.
BACKGROUND:Breast cancer can negatively impact survivors' physical activity (PA). Social cognitive theory (SCT) constructs may be correlated with PA, but it is unclear if cancer-related factors affect these relationships. AIMS:To examine associations between PA, self-efficacy, social support, and exercise barriers interference in breast cancer survivors and whether cancer-related factors moderate these relationships. METHODS:Baseline data from 341 post-primary treatment breast cancer survivors in a web-based diet/exercise intervention trial were analyzed. SCT constructs, accelerometry-measured and self-reported moderate-to-vigorous physical activity (MVPA), and cancer-related factors (stage, time since diagnosis, history of chemotherapy, history of radiation, and hormone therapy status) were examined using Pearson correlation analysis and multivariable linear regression analyses. RESULTS:Exercise barriers interference was inversely associated with self-reported (r = -0.272, p < 0.001); and accelerometry-measured MVPA (r = -0.128, p = 0.020). No other statistically significant associations were found. Stage and history of chemotherapy moderated the association between social support and self-reported MVPA. The association was stronger among survivors diagnosed with DCIS/stage I versus stage II/III (β = 4.14, p = 0.043, CI = -2.20-10.49) and weaker among individuals who previously received chemotherapy versus no chemotherapy history (β = -5.02, p = 0.026, CI = -11.51-1.47); effects were independent of one another. CONCLUSIONS:Cancer stage and previous chemotherapy moderate the association between social support and MVPA. Targeting social support in early-stage breast cancer survivors or survivors that did not receive chemotherapy may improve intervention effectiveness.