Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function.

BACKGROUND: Many persons with a history of smoking tobacco have clinically significant respiratory symptoms despite an absence of airflow obstruction as assessed by spirometry. They are often treated with medications for chronic obstructive pulmonary disease (COPD), but supporting evidence for this treatment is lacking. METHODS: We randomly assigned persons who had a tobacco-smoking history of at least 10 pack-years, respiratory symptoms as defined by a COPD Assessment Test score of at least 10 (scores range from 0 to 40, with higher scores indicating worse symptoms), and preserved lung function on spirometry (ratio of forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ≥0.70 and FVC ≥70% of the predicted value after bronchodilator use) to receive either indacaterol (27.5 µg) plus glycopyrrolate (15.6 µg) or placebo twice daily for 12 weeks. The primary outcome was at least a 4-point decrease (i.e., improvement) in the St. George's Respiratory Questionnaire (SGRQ) score (scores range from 0 to 100, with higher scores indicating worse health status) after 12 weeks without treatment failure (defined as an increase in lower respiratory symptoms treated with a long-acting inhaled bronchodilator, glucocorticoid, or antibiotic agent). RESULTS: A total of 535 participants underwent randomization. In the modified intention-to-treat population (471 participants), 128 of 227 participants (56.4%) in the treatment group and 144 of 244 (59.0%) in the placebo group had at least a 4-point decrease in the SGRQ score (difference, -2.6 percentage points; 95% confidence interval [CI], -11.6 to 6.3; adjusted odds ratio, 0.91; 95% CI, 0.60 to 1.37; P = 0.65). The mean change in the percent of predicted FEV1 was 2.48 percentage points (95% CI, 1.49 to 3.47) in the treatment group and -0.09 percentage points (95% CI, -1.06 to 0.89) in the placebo group, and the mean change in the inspiratory capacity was 0.12 liters (95% CI, 0.07 to 0.18) in the treatment group and 0.02 liters (95% CI, -0.03 to 0.08) in the placebo group. Four serious adverse events occurred in the treatment group, and 11 occurred in the placebo group; none were deemed potentially related to the treatment or placebo. CONCLUSIONS: Inhaled dual bronchodilator therapy did not decrease respiratory symptoms in symptomatic, tobacco-exposed persons with preserved lung function as assessed by spirometry. (Funded by the National Heart, Lung, and Blood Institute and others; RETHINC ClinicalTrials.gov number, NCT02867761.).

Relative reinforcement from physical activity in real-world environments: a novel application of behavioral economics.

Behavioral economics suggests that individuals are likely to engage in a behavior if it is more reinforcing and readily available than other possible options. In real-world environments, sedentary behaviors are often more reinforcing and easily available than physical activities. In order to promote regular physical activity in an environment with sedentary alternatives, it is important to understand the proportion of overall reinforcement that is derived from physical activity (i.e., relative reinforcement, RR). Conceptually similar laboratory-research supports this notion, but applications to individual, real-world environments remain understudied. The current study used a novel survey-based approach to estimate the RR of common physical activities. Healthy adults (N = 348, M age = 39.0 ± 8.7) from the United States completed an online survey between April-May 2020, including a modified activity survey with ten physically active and ten sedentary activities. Regression analysis showed that total RR of physical activity was related to greater physical activity levels when controlling for enjoyment and other covariates. Four factors were identified (household, conditioning, sports, and outdoor activities) using exploratory structural equation modeling, but internal consistency was limited when items were constrained to each factor in the structural equation model. Previous laboratory findings on overall RR of physical activity were replicated with the survey-based measure, but further improvement for relative reinforcement of different sub-domains of physical activity is needed. Researchers and practitioners can use this survey to determine attractive physical activities on the individual level that can compete with sedentary leisure activities.

The Role of Alcohol-Related Proactive Dietary Restriction to Feel the Psychoactive Effects of Alcohol Faster on Binge Drinking Frequency among Freshmen College Students.

BACKGROUND: There is a positive cross-sectional relationship between alcohol-related proactive dietary restriction to feel the effects of alcohol faster (APDR) and binge drinking, a health and safety issue impacting college students. Objective: To examine: 1) the longitudinal predictive ability of varying levels of APDR on binge drinking frequency; and 1a) the strength of the relationship between varying levels of APDR and binge drinking frequency during freshman year of college (n = 1,149). METHODS: Ordinal logistic regression was used to model the relationship between APDR and binge drinking frequency. RESULTS: Main findings suggest APDR of students who reported eating less than usual (low APDR) prior to drinking to feel the effects of alcohol faster was a significant predictor of binge drinking frequency (1.27 (95% CI, 0.06 to 0.42), Wald χ2 (1) = 8.46, p=.009) at baseline, but not at 7-month follow-up (1.02 (95% CI, -0.18 to 0.23), Wald χ2 (1) = .51, p=.83). APDR for students who reported skipping one or more meals (high APDR) to feel the effects of alcohol faster was not a significant predictor of binge drinking frequency at baseline nor at 7-month follow-up. CONCLUSION: Low APDR is a significant predictor of binge drinking frequency that is established early in the first semester of college with no significant change occurring in binge drinking frequency over the course of students' freshman year at 7-month follow-up. Campus health professionals are urged to emphasize the detrimental health effects of low APDR early in the first semester of college.

Latent Profiles of Health Behaviors in Rural Children with Overweight and Obesity.

OBJECTIVE: The objectives were to identify profiles of school-age children with overweight and obesity (OW/OB) from rural counties based on patterns of diet, activity, and sleep, to examine demographic predictors, and to examine whether profiles were differentially associated with psychosocial functioning. METHODS: Participants included 163 children (Mage = 9.8) and parents. Children wore accelerometers to assess physical activity and sleep duration. Consumption of fruits and vegetables (F/V) and sugar-sweetened beverages (SSB) was assessed with a food frequency questionnaire. Self-report of emotional, social, and academic health-related quality of life (HRQOL), peer victimization, social skills, and social problem behaviors was collected, as well as parent-report of HRQOL. Latent variable mixture modeling (LVMM) was conducted. RESULTS: Sleep did not significantly contribute to profile differentiation and was removed. Four profiles emerged: (a) Low F/V + Low SSB + Low activity, (b) Low F/V + Low SSB + Moderate activity, (c) High F/V + High SSB + Low activity, and (d) Moderate F/V + Moderate SSB + High activity. Older children were more likely to be in profile 1. After controlling for child age, parents of children in profile 1 reported significantly lower child social HRQOL than parents of children in profiles 2 and 4. Children in profile 4 reported experiencing significantly lower victimization than those in profile 3. CONCLUSIONS: There are subgroups of rural children with OW/OB that engage in various combinations of healthy and unhealthy behaviors. LVMM has the potential to inform future interventions and identify needs of groups of children with OW/OB.

A content analysis of food advertising in Arab Gulf countries during Ramadan.

Research has explored the link between exposure to marketing of foods high in energy and low in nutrients, and obesity in Western countries. The prevalence of obesity in Arab Gulf countries is similar to that of Western countries, yet the influence of advertising and frequency of exposure to advertising of foods on subsequent food choices and health is largely unexplored. This project sought to examine the number and quality of foods advertised on television during Ramadan in Arab Gulf countries. Television programming (36 h total), 12 h each for three stations, Alwatan, Dubai and MBC, was recorded. Food and restaurant advertisements (ads) were classified, totaled and analysed for dietary healthfulness using the Model SSCg3d. Of the total ads aired (n = 1473), food and restaurant ads were the most common (20.4%). The ad type and frequency varied among channels with restaurant ads most common on Alwatan, drinks and soda ads on Dubai, and sweet snacks and desserts ads on MBC (p < 0.001). Channels also differed regarding the frequency of dairy food ads (p < 0.001). Most food ads promoted less healthy foods similar to marketing practices in other countries with high rates of obesity. Many ads promoted foods high in energy, saturated fat, sodium and added sugar. This work signals the need to further understand the relationship between advertising of nutrient-poor foods, food behaviours and obesity in Arab Gulf countries and how advertising regulations may address this public health issue.

Pre-surgical stress and social support predict post-surgical percent excess weight loss in a population of bariatric surgery patients.

Although bariatric surgery is an effective treatment of morbid obesity, many patients fail to lose significant weight or regain weight over time. This study examined pre-surgical psychosocial predictors (stress, social support for healthy eating, emotion regulation, and sleep quality/quantity) of three-month post-surgical percent excess weight loss (EWL) in a population of adult bariatric surgery patients. Overall, findings suggest higher levels of stress (B = -.248, p =.017) and less social support for healthy eating (B =.311, p =.013) predict lower three-month post-surgery percent EWL. Emotion regulation, and sleep measures did not predict post-surgery percent EWL. Therefore, level of stress and social support should be assessed prior to bariatric surgery and considered important pre-surgical intervention targets.

Featured Article: Behavior Interventions Addressing Obesity in Rural Settings: The E-FLIP for Kids Trial.

OBJECTIVE: To assess the effectiveness of behavioral parent-only (PO) and family-based (FB) interventions on child weight, dietary intake, glycated hemoglobin, and quality of life in rural settings. METHODS: This study was a three-armed, randomized controlled trial. Participants were children (age 8-12 years) with overweight or obesity and their parents. A FB (n = 88), a PO (n = 78) and a health education condition (HEC) (n = 83) each included 20 group contacts over 1 year. Assessment and treatment contacts occurred at Cooperative Extension Service offices. The main outcome was change in child body mass index z-score (BMIz) from baseline to year 2. RESULTS: Parents in all conditions reported high treatment satisfaction (mean of 3.5 or higher on a 4-point scale). A linear mixed model analysis of change in child BMIz from baseline to year 1 and year 2 found that there were no significant group by time differences in child BMIz (year 2 change in BMIz for FB = -0.03 [-0.1, 0.04], PO = -0.01 [-0.08, 0.06], and HEC = -0.09 [-0.15, -0.02]). While mean attendance across conditions was satisfactory during months 1-4 (69%), it dropped during the maintenance phase (42%). High attendance for the PO intervention was related to greater changes in child BMIz (p < .02). Numerous barriers to participation were reported. CONCLUSION: Many barriers exist that inhibit regular attendance at in-person contacts for many families. Innovative delivery strategies are needed that balance treatment intensity with feasibility and acceptability to families and providers to facilitate broad dissemination in underserved rural settings.ClinicalTrials.gov Identifier: NCT01820338.

Prevalence and correlates of food insecurity among U.S. college students: a multi-institutional study.

BACKGROUND: College students may be vulnerable to food insecurity due to limited financial resources, decreased buying power of federal aid, and rising costs of tuition, housing, and food. This study assessed the prevalence of food insecurity and its sociodemographic, health, academic, and food pantry correlates among first-year college students in the United States. METHODS: A cross-sectional study was conducted among first-year students (n = 855) across eight U.S. universities. Food security status was assessed using the U.S. Department of Agriculture Adult Food Security Survey Module. Cohen's Perceived Stress Scale, Pittsburgh Sleep Quality Index, and Eating Attitudes Test-26 were used to assess perceived stress, sleep quality, and disordered eating behaviors, respectively. Participants self-reported their grade point average (GPA) and completed questions related to meal plan enrollment and utilization of on-campus food pantries. RESULTS: Of participating students, 19% were food-insecure, and an additional 25.3% were at risk of food insecurity. Students who identified as a racial minority, lived off-campus, received a Pell grant, reported a parental education of high school or less, and did not participate in a meal plan were more likely to be food-insecure. Multivariate logistic regression models adjusted for sociodemographic characteristics and meal plan enrollment indicated that food-insecure students had significantly higher odds of poor sleep quality (OR = 2.32, 95% CI: 1.43-3.76), high stress (OR = 4.65, 95% CI: 2.66-8.11), disordered eating behaviors (OR = 2.49, 95% CI: 1.20-4.90), and a GPA < 3.0 (OR = 1.91, 95% CI: 1.19-3.07) compared to food-secure students. Finally, while half of the students (56.4%) with an on-campus pantry were aware of its existence, only 22.2% of food-insecure students endorsed utilizing the pantry for food acquisition. CONCLUSIONS: Food insecurity among first-year college students is highly prevalent and has implications for academic performance and health outcomes. Higher education institutions should screen for food insecurity and implement policy and programmatic initiatives to promote a healthier college experience. Campus food pantries may be useful as short-term relief; however, its limited use by students suggest the need for additional solutions with a rights-based approach to food insecurity. TRIAL REGISTRATION: Retrospectively registered on ClinicalTrials.gov , NCT02941497.

Validation of a photographic seafood portion guide to assess fish and shrimp intakes.

OBJECTIVE: To validate a novel photographic portion guide as a tool to estimate consumption of fish and shrimp. Application of such a validated tool can facilitate accurate individual and community seafood intake assessments and provide meaningful data relative to health benefits and hazard assessment, particularly in response to environmental contamination and disasters. DESIGN: A photographic fish and shrimp portion guide presenting a stepped range of cooked portion sizes was used by participants to estimate their typical portion sizes. Participants selected their typical portion size from the photographic guide and also from a selection of freshly cooked reference meals. Photographic portions selections were compared with plated reference portions for each participant. SETTING: Academic sensory testing laboratory in the USA. SUBJECTS: Separate groups of adults (25-64 years) contributed to fish (n 54) and shrimp (n 53) portion size comparison studies. RESULTS: In the fish study, there was no difference between photographic portion selections (6·59 (sd 2·65) oz (186·8 (sd 75·1) g)) and reference plate selections (7·04 (sd 2·63) oz (199·6 (sd 74·6) g); P=0·384). Similarly in the shrimp study, there was no difference between photographic portion selections (6·88 (sd 3·40) oz (195·0 (sd 96·4) g)) and reference plate selections (6·06 (sd 2·65) oz (171·8 (sd 75·1) g); P=0·159). Photographic portions predicted plated reference portions for both fish and shrimp based on linear regression (P<0·001). Bland-Altman plot analyses showed good agreement between the two methods, <1 oz (<28·3 g) bias, in both fish and shrimp studies. CONCLUSIONS: This validated photographic seafood portion guide provides a utilitarian tool for accurately assessing fish and shrimp intake in a community setting.

Income differences in social control of eating behaviors and food choice priorities among southern rural women in the US: A qualitative study.

The role of social influences on rural women's food choice is not well understood. Rural adults experience high rates of obesity and poor diet quality prompting exploration of how social factors influence food choice in this population. Semi-structured qualitative interviews were conducted with 20 women in rural North Central Florida. Women were purposively sampled and stratified by race and income. Lower income was defined as household income at or below 185% of the federal poverty level (FPL). Women at or below 185% poverty level (BPL) experienced direct social control of their eating behaviors, which occurred when social network members explicitly regulated or otherwise sanctioned eating behaviors or food choices. Women above 185% of the federal poverty level (APL) internalized social norms and self-regulated their eating behaviors to maintain healthy habits. APL women described choosing foods for health reasons whereas BPL women offered a variety of reasons including taste, convenience, family history, price, health, and routine. Findings suggest that women in different income groups have different social influences working to help them regulate eating behaviors as well as diverse priorities influencing their food choices. Future interventions to promote healthy eating may be more effective by incorporating social network members and framing intervention messages so they are consistent with priorities.

Incorporating Halal Into Healthy and Equitable Dietary Patterns to Address Food and Nutrition Security Among K-12 and University Students: A Perspective.

Food and nutrition insecurity exist at an alarming rate in the US educational system, ranging from 17% among K-12 students up to 58.8% among university students. Many Muslim American students face food and nutrition insecurity due, in part, to a lack of acknowledgment of student adherence to halal dietary guidelines and the availability of certified halal options at school. This has implications for health, learning, and social outcomes. In this perspective paper, we provide short-term, mid-term, and long-term recommendations to address food and nutrition insecurity among halal-observant students to advance healthy dietary patterns.

The Functional and Psychosocial Consequences of COPD.

COPD is a chronic respiratory disease that commonly coexists with other chronic conditions. These comorbidities have been shown to influence overall disease burden and mortality in COPD, and these comorbidities have an important impact on functional status and other psychosocial factors. Mental health disorders, especially anxiety and depression are common comorbidities in COPD. However, the mechanisms and interactions of anxiety and depression in COPD are poorly understood and these conditions are often underdiagnosed. The interplay between anxiety and depression and COPD is likely multifactorial and complex. An obvious mechanism is the expected psychological consequences of having a chronic illness. However, there is increasing interest in other potential biological processes, such as systemic inflammation, smoking, hypoxia, and oxidative stress. Recognition and diagnosis of comorbid anxiety and depression in patients with COPD is often challenging because there is no consensus on the appropriate screening tools or rating scales to use in this patient population. Despite the challenges in accurate assessment of anxiety and depression, there is growing evidence to support that these comorbid mental health conditions in COPD result in worse outcomes, including poor health-related quality of life, increased exacerbations with associated health-care utilization and cost, increased functional disability, and increased mortality. There are limited data of variable quality on effective treatment and management strategies, both pharmacologic and non-pharmacologic, for anxiety and depression in COPD. However, cumulative evidence demonstrates that complex psychological and lifestyle interventions, which include a pulmonary rehabilitation component, may offer the greatest benefit. The high prevalence and negative impact of depression and anxiety highlights the need for comprehensive, innovative, and standardized chronic disease management programs for individuals with COPD.

Examining gender and the longitudinal effect of weight conscious drinking dimensions on body mass index among a college freshman cohort.

Objective: This study aims to: (1) examine gender differences for weight conscious drinking among college students accounting for the broader phenomenon (e.g. including the Alcohol Effects dimension); and (2) longitudinally examine the effect of weight conscious drinking behaviors on body mass index (BMI). Participants: United States freshmen students from eight participating universities (N= 1,149). Methods: Structural equation modeling was used to model the effect of gender on weight conscious drinking dimensions at 7-month follow-up. Results: Findings suggest a significant effect of gender on Alcohol Effects (ß = -.15, SE = .05, p = .005) at 7-month follow-up among college freshmen. Weight conscious drinking dimensions predicted no significant change in BMI at 7-month follow-up among college freshmen. Conclusion: Findings contribute to weight conscious drinking theory and provide campus weight conscious drinking prevention initiatives with evidence to tailor their programming to address female tendencies to engage in compensatory strategies to enhance the psychoactive effects of alcohol.

Dietary Composition, Angiographic Coronary Disease, and Cardiovascular Outcomes in the WISE Study (Women's Ischemia Syndrome Evaluation).

BACKGROUND: Studies relating diet to angiographic coronary artery disease (CAD) and subsequent major adverse cardiac events (MACE) in women are limited. Information on diet was collected in the Women's Ischemia Syndrome Evaluation (WISE), a prospective cohort study of symptomatic women referred for coronary angiography to evaluate suspected ischemic heart disease. METHODS: A consecutive subgroup (n = 201 of 936) of enrolled women completed the modified Block food frequency questionnaire (FFQ). Data on outcomes were collected and adjudicated after 8-year follow-up. A set of logistic regression models were fitted for non-obstructive versus obstructive coronary stenosis (<50% versus ≥50%). Cox proportional hazard regression models were fitted for outcomes, with each dietary composition variable adjusted for the degree of coronary stenosis. RESULTS: At baseline, the subgroup cohort was 58 ± 12 years old with a body mass index (BMI) of 30 ± 7 kg/m2. An increased proportion of calories consumed from protein was associated with higher levels of baseline obstructive coronary stenosis. Those individuals who ate a higher amount of protein, carotene, and servings of vegetables and meat, however, were each associated with lower subsequent adverse outcomes, respectively. CONCLUSIONS: Among women undergoing coronary angiography for suspected CAD, a higher percentage of protein intake was associated with higher baseline stenosis severity; however, the amount of protein intake, vegetable, meat, and carotene intake, was conversely associated with subsequent lower adverse cardiovascular outcome risk.

Sneakers and spokes: an assessment of the walkability and bikeability of U.S. postsecondary institutions.

The purpose of the study described in this article was to assess the walkability and bikeability of 15 U.S. postsecondary education campuses. The Centers for Disease Control and Prevention's evidence-based Healthier Worksite Initiative Walkability Audit was modified to rate campus walking and biking path segments for path safety, quality, and comfort. Universities (n = 13) assessed an average of 44 path segments, which earned a mean score of 72.71 +/- 10.77 SD (possible range 0 to 100). Postsecondary technical schools (n = 2) assessed 20 path segments, which received an average score of 76.56 +/- 13.15. About 70% of path segments received a grade A or B, but almost 1 in 10 received a failing or poor support score for walking and biking. Nearly half or more campus environments scored significantly below an acceptable score on many path safety and quality criteria. Postsecondary education campuses that are supportive of walking and biking offer numerous benefits to the environment and people. Findings from environmental assessments like the data reported here can provide valuable input to campus planners.

Obstacles to university food pantry use and student-suggested solutions: A qualitative study.

BACKGROUND: In the absence of federal programs and policies to alleviate college student food insecurity, the number of food pantries has grown rapidly in the United States. Yet, no studies, to date, have qualitatively examined students' experiences with this resource. OBJECTIVE: To explore college students' perspectives on barriers to using an on-campus food pantry and provide insights into student-suggested solutions. METHODS: In this qualitative study, 41 college students were recruited from a large public university in the southeastern US with a campus food pantry. Students participated in one-on-one, in-person, semi-structured interviews. All interviews were audio-recorded, transcribed verbatim, managed using NVivo 12, and analyzed using inductive, semantic thematic analysis. RESULTS: Most students were classified as food insecure (n = 33, 82.5%), and two-thirds identified as pantry users (at least once). The students' reasons for not using the food pantry indicated resistance and access barriers. Students either 'chose not to use' the campus food pantry due to (i) stigma and shame, (ii) perceived insufficient need, (iii) and unsuitable food or they experienced 'barriers' due to (i) lack of knowledge and (ii) limited food access. The main reason reported by food insecure non-pantry users was feelings of stigma and shame while that of food insecure pantry users was limited food access. Students suggested three solutions to minimize barriers experienced when utilizing the campus food pantry. These included (i) spreading awareness about the pantry through positive marketing messages that de-stigmatize use, (ii) improving accessibility of fresh produce and protein options, and (iii) improving access through satellite locations and online ordering systems. CONCLUSION: These barriers need to be systematically addressed to normalize food pantry use. Consideration of student recommendations by university program developers and policymakers may be of added value to expand access to food by college students with food insecurity.

Differences in Measured and Self-Categorized Food Security Status and Related Coping Strategies among College Students.

Qualitative studies suggest that college students with food insecurity (FI) experience stigma and misinterpret some of the USDA Adult Food Security Survey Module (AFSSM) questions, leading to misclassification of food security (FS) status. We aimed to evaluate differences in AFSSM-measured FS status and self-categorized FS status (based on USDA descriptions of the four FS levels) among college students, and to identify differences in the coping strategies and BMI of these students. Data were collected cross-sectionally from a convenience sample via web-based, self-reported surveys. Measured FS, self-categorized FS, coping strategies, and self-reported BMI were key variables of interest. Participants were 1003 undergraduate and graduate students (22.2 ± 4.6 years; 65.7% female). Of the participants measured as food insecure (40.0%), 57.8% self-categorized as food secure (MFI-SFS) and 42.2% self-categorized as food insecure (MFI-SFI). Significantly more MFI-SFI participants were AFSSM-categorized as having very low FS when compared to MFI-SFS participants (71.6% vs. 46.6%, p < 0.05). MFI-SFI participants reported significantly higher BMI (M = 24.7, SD ± 6.0 kg/m2) and coping strategies scores (M = 49.8, SD ± 7.5) when compared to MFI-SFS participants (M = 23.1, SD ± 3.6 kg/m2; M = 46.9, SD ± 7.5, respectively, p ≤ 0.01). Assessment of and interventions to address FI among college students should consider the potential influence of self-perception and students' interpretation of survey questions.

Life of a vegetarian college student: Health, lifestyle, and environmental perceptions.

Objective To examine health behavior and environmental perception differences among vegetarian and nonvegetarian students. Participants: First-year university students (n = 1078) from eight United States universities. Methods: Data were obtained from base 2015 and followup 2016 assessments. Vegetarians and nonvegetarians were compared for anthropometrics, lifestyle behaviors, and campus environmental perceptions (CEPS). Results: Vegetarians had smaller waist circumference, lower systolic blood pressure, higher fruit and vegetable consumption, lower percentage of energy obtained from fat, and higher perceived stress. Vegetarians expressed a lower rating of perceptions of health policies on campus. Conclusion: A clear difference in indicators of physical health does not appear, however, vegetarian students show positive dietary patterns which can promote positive health outcomes. Further, vegetarians had lower perceptions of health policies on campus. Results can be used by administrators to ensure policies are in place to support health of students as currently vegetarian students see limitations in the environmental health policies.

Impact of probiotic supplementation on exercise endurance among non-elite athletes: study protocol for a randomized, placebo-controlled, double-blind, clinical trial.

BACKGROUND: Some probiotics appear to improve athletic performance, endurance, and recovery after intense exercise. Other formulations may provide performance-related benefits via immune and gastrointestinal functions in athletic individuals. However, few formulations have been studied for both types of effects among non-elite athletes. The primary objective of this study is to assess the ergogenic effects of a probiotic on high-intensity endurance running performance in non-elite runners. Secondary objectives include assessment of perceived exertion, blood chemistry, immune and stress biomarkers, cold and flu symptoms, and gastrointestinal health after the probiotic intervention. METHODS: This 9-week randomized, placebo-controlled, double-blind, parallel trial will assess the ergogenic effects of a probiotic (5 billion colony-forming units/day, for 6 weeks) in healthy, non-elite runners (N=32; 18-45 years). Participants will be monitored via daily and weekly questionnaires during the 2-week pre-baseline, 6-week intervention, and 1-week washout. Questionnaires will inquire about activity, muscle soreness, gastrointestinal symptoms, cold and flu symptoms, stool form and frequency, and adverse events. During the pre-baseline visit, maximal oxygen uptake (V̇O2 max) is assessed to set appropriate individualized workload settings for the treadmill time-to-exhaustion endurance tests. These time-to-exhaustion endurance running tests will be completed at an intensity of 85% VO2max at baseline and final visits. During these tests, self-perceived exercise effort will be rated via the Borg Rating of Perceived Exertion scale and finger sticks assessing capillary blood glucose and lactate concentrations will be collected every 3 min. Additional questionnaires will assess diet and motivation to exercise. Body composition will be assessed using air displacement plethysmography at the baseline and final visits. Hypotheses will be tested using two-sided tests, and a linear model and with a type I error rate of α=0.05. Primary and secondary outcomes will be tested by comparing results between the intervention groups, adjusting for baseline values. DISCUSSION: These results will build evidence documenting the role of probiotics on running endurance performance and physiological responses to exercise in non-elite athletes. Understanding the potential mechanisms of probiotic effects and how they mitigate the intestinal or immune discomforts caused by running could provide additional strategy means to help runners improve their performance. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT04588142 . Posted on October 19, 2020. PROTOCOL VERSION: July 2, 2021, version 1.2.

Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma - Effect of Obesity.

Objective: Asthma in obese patients represents a specific phenotype that is associated with increased symptoms, more frequent and severe exacerbations, reduced responsiveness to treatment, and decreased quality of life. Marketing and placebos have been shown to alter subjective responses to interventions in both asthma and obesity. We evaluated obesity as a potential treatment effect modifier of the effects enhanced drug messaging or placebos on subjective asthma outcomes. Methods: We conducted a secondary analysis of a multicenter, randomized clinical trial that studied the effect of messaging and placebos on asthma outcomes. A total of 601 participants were randomized (1:1:1:1:1) to one of 5 groups: enhanced messaging with montelukast or placebo, neutral messaging with montelukast or placebo, or usual care and followed for 4 weeks after randomization. We compared baseline characteristics by obesity status for 600 participants with data on body weight. Obesity was evaluated as an effect modifier for enhanced messaging (versus neutral messaging) and on placebo effects (versus usual care) in 362 participants assigned to a placebo group or usual care for three asthma questionnaires: Asthma Control Questionnaire, Asthma Quality of Life Questionnaire and Asthma Symptoms Utility Index. Results: Overall, 227 (37%) of participants were obese. Obese participants were older (mean age 41 vs 34), more likely female (82% vs 67%) and self-identified as Black (44% vs 25%) than non-obese participants. As previously published, enhanced messaging was associated with improvements in patient-reported asthma scores, but there was no evidence for a placebo effect. Obesity status did not influence the message effects nor did it modify responses to placebo. Conclusion: Obesity has been shown to be an important factor associated with asthma outcomes and an effect modifier of drug treatment effects. We conducted a post hoc, subgroup analysis of data from a multicenter randomized trial of enhanced messaging and placebo associated with drug treatment on asthma outcomes. Our findings suggest that observed differences in treatment effects between obese and non-obese patients sometimes seen in trials of asthma treatments are unlikely to be due to different "placebo" effects of treatment and may reflect differential physiologic effects of active agents.