Predictors of Health-Related Quality of Life Among Women Participating in an Appointment-Based Cardiac Rehabilitation Program.

BACKGROUND: An alternative patient-centered appointment-based cardiac rehabilitation (CR) program has led to significant improvements in health outcomes for patients with cardiovascular disease. However, less is known about the effects of this approach on health-related quality of life (HRQoL), particularly for women. OBJECTIVE: We examined the effects of a patient-centered appointment-based CR program on HRQoL by sex and examined predictors of HRQoL improvements specifically for women. METHODS: Data were used from an urban single-center CR program at Yale New Haven Health (2012-2017). We collected information on patient demographics, socioeconomic status, and clinical characteristics. The Outcome Short-Form General Health Survey (SF-36) was used to measure HRQoL. We evaluated sex differences in SF-36 scores using t tests and used a multivariate linear regression model to examine predictors of improvements in HRQoL (total SF-36 score) for women. RESULTS: A total of 1530 patients with cardiovascular disease (23.7% women, 4.8% Black; mean age, 64 ± 10.8 years) were enrolled in the CR program. Women were more likely to be older, Black, and separated, divorced, or widowed. Although women had lower total SF-36 scores on CR entry, there was no statistically significant difference in CR adherence or total SF-36 score improvements between sexes. Women who were employed and those with chronic obstructive pulmonary disease were more likely to have improvements in total SF-36 scores. CONCLUSION: Both men and women participating in an appointment-based CR program achieved significant improvements in HRQoL. This approach could be a viable alternative to conventional CR to optimize secondary outcomes for patients.

How can trial designs better serve the needs of children and young people with juvenile idiopathic arthritis?

In juvenile idiopathic arthritis we have seen remarkable progress in the number of available licensed biological and small molecule treatments in the past two decades, leading to improved outcomes for patients. Designing clinical trials for these therapeutics is fraught with ethical, legislative, and practical challenges. However, many aspects of current clinical trial design in juvenile idiopathic arthritis do not meet the needs of patients and clinicians. Commonly used withdrawal trial designs raise substantial ethical concerns for patients and families who believe that they do not enable evidence-based and patient-centred decisions around medication choices. In this Viewpoint, we present the personal views of a patient and parent network that is of the opinion that current trial design in juvenile idiopathic arthritis is failing children and young people with juvenile idiopathic arthritis and set out the need for change informed by lived experience.

A Decision Aid to Support Tubal Sterilization Decision-Making Among Pregnant Women: The MyDecision/MiDecisión Randomized Clinical Trial.

Importance: Tubal sterilization is common, especially among individuals with low income. There is substantial misunderstanding about sterilization among those who have undergone the procedure, suggesting suboptimal decision-making about a method that permanently ends reproductive capacity. Objective: To test the efficacy of a web-based decision aid for improving tubal sterilization decision quality. Design, Setting, and Participants: This randomized clinical trial conducted between March 2020 and November 2023 included English- or Spanish-speaking pregnant cisgender women aged 21 to 45 years who had Medicaid insurance and were contemplating tubal sterilization after delivery. Participants were recruited from outpatient obstetric clinics in 3 US cities. Intervention: Participants were randomized 1:1 to usual care (control arm) or to usual care plus a web-based decision aid (MyDecision/MiDecisión) (intervention arm). The aid includes written, audio, and video information about tubal sterilization procedures; an interactive table comparing contraceptive options; values-clarifying exercises; knowledge checks; and a summary report. Main Outcomes and Measures: The co-primary outcomes were tubal sterilization knowledge and decisional conflict regarding the contraceptive decision. Knowledge was measured as the percentage of correct responses to 10 true-false items. Decisional conflict was measured using the low-literacy Decision Conflict Scale, with lower scores on a range from 0 to 100 indicating less conflict. Results: Among the 350 participants, mean (SD) age was 29.7 (5.1) years. Compared with the usual care group, participants randomized to the decision aid had significantly higher tubal sterilization knowledge (mean [SD] proportion of questions answered correctly, 76.5% [16.9%] vs 55.6% [22.6%]; P < .001) and lower decisional conflict scores (mean [SD], 12.7 [16.6] vs 18.7 [20.8] points; P = .002). The greatest knowledge differences between the 2 groups were for items about permanence, with more participants in the intervention arm answering correctly that tubal sterilization is not easily reversible (90.1% vs 39.3%; odds ratio [OR], 14.2 [95% CI, 7.9-25.4]; P < .001) and that the tubes do not spontaneously "come untied" (86.6% vs 33.7%; OR, 13.0 [95% CI, 7.6-22.4]; P < .001). Conclusions and Relevance: MyDecision/MiDecisión significantly improved tubal sterilization decision-making quality compared with usual care only. This scalable decision aid can be implemented into clinical practice to supplement practitioner counseling. These results are particularly important given the recent increase in demand for permanent contraception after the US Supreme Court decision overturning federal abortion protections. Trial Registration: ClinicalTrials.gov Identifier: NCT04097717.

Automated HEART score determination via ChatGPT: Honing a framework for iterative prompt development.

Objectives: This study presents a design framework to enhance the accuracy by which large language models (LLMs), like ChatGPT can extract insights from clinical notes. We highlight this framework via prompt refinement for the automated determination of HEART (History, ECG, Age, Risk factors, Troponin risk algorithm) scores in chest pain evaluation. Methods: We developed a pipeline for LLM prompt testing, employing stochastic repeat testing and quantifying response errors relative to physician assessment. We evaluated the pipeline for automated HEART score determination across a limited set of 24 synthetic clinical notes representing four simulated patients. To assess whether iterative prompt design could improve the LLMs' ability to extract complex clinical concepts and apply rule-based logic to translate them to HEART subscores, we monitored diagnostic performance during prompt iteration. Results: Validation included three iterative rounds of prompt improvement for three HEART subscores with 25 repeat trials totaling 1200 queries each for GPT-3.5 and GPT-4. For both LLM models, from initial to final prompt design, there was a decrease in the rate of responses with erroneous, non-numerical subscore answers. Accuracy of numerical responses for HEART subscores (discrete 0-2 point scale) improved for GPT-4 from the initial to final prompt iteration, decreasing from a mean error of 0.16-0.10 (95% confidence interval: 0.07-0.14) points. Conclusion: We established a framework for iterative prompt design in the clinical space. Although the results indicate potential for integrating LLMs in structured clinical note analysis, translation to real, large-scale clinical data with appropriate data privacy safeguards is needed.

The importance of rhythms for maintaining consent in diagnostic encounters to detect cervical cancer.

Diagnostic encounters can be seen as complex socio-material processes. Drawing on the new materialist ideas of Barad, we studied how an innovative technology became part of the intra-actions between different human and non-human materialities in a cervical cancer diagnostic process. While researching the development of a technology intended to improve cervical cancer detection, we carried out a series of observations of diagnostic encounters involving clinicians, patients and the device in a hospital. The intra-actions between the different materialities had rhythmic properties, repeated activities and timings that varied in intensity, for example, movements, exchanged looks, and talk that helped co-produce the diagnosis and maintain consent. Sadly, the device interfered with the rhythms, undermining the clinicians' desire to adopt it, despite it being more accurate at diagnosing ill health than previous assistive technologies. Studying rhythms as part of diagnostic encounters could help with the design and subsequent integration of novel technologies in healthcare, because they encompass relationships created by human and non-human materialities. Importantly, highlighting the role of rhythms contributes another way diagnostic encounters are co-produced between clinicians and patients, and how they can be disrupted, improving the understanding of how consent is maintained or lost.

Feasibility Testing of a Web-Based Reproductive Decision Support Tool for Cystic Fibrosis.

BACKGROUND: People with cystic fibrosis (CF) are increasingly considering their reproductive goals. We developed MyVoice:CF, a web-based patient-centered reproductive decision support tool and assessed its implementation in CF care. METHODS: We conducted a feasibility trial among 18-44-year-old women with CF and multidisciplinary CF providers. Prior to CF clinic visit, patient participants completed a baseline survey, used MyVoice:CF, and assessed acceptability, appropriateness, and usability. After clinic, participants rated impact on reproductive health communication. At 3 months post-use, participants assessed impact on reproductive health outcomes. Provider participants completed a survey and focus group regarding MyVoice:CF feasibility/implementation. We assessed outcomes descriptively. We compared MyVoice:CF's impact on outcomes from baseline to follow-up using McNemar's and Wilcoxon signed rank tests as appropriate. RESULTS: Forty-three patient participants completed baseline surveys and 40 rated MyVoice:CF's feasibility; 10 providers participated. Patient participants rated MyVoice:CF's acceptability as 4.48±0.50 out of 5, appropriateness as 4.61±0.48 out of 5, and usability as 82.25±11.02 ('A'/excellent). After MyVoice:CF use, participants reported improved reproductive health communication self-efficacy vs. baseline (3.54±1.17vs.3.95±0.93, p<0.001). At baseline, 36% of participants reported any discussion of reproductive goals/plans with their CF team in the past year compared to 59% after first visit post-MyVoice:CF use (p=0.049). Provider participants similarly rated MyVoice:CF as feasible and reported no negative impacts on clinic flow after implementation. CONCLUSIONS: MyVoice:CF is acceptable, appropriate, and usable for those with CF. Preliminary effectiveness evaluation suggests that MyVoice:CF improves self-efficacy in and frequency of reproductive health communication. Future studies should further assess MyVoice:CF's impact on reproductive health communication and outcomes.

Young Women With Acute Myocardial Infarction: Risk Prediction Model for 1-Year Hospital Readmission.

Background: Although young women ( aged ≤ 55 years) are at higher risk than similarly aged men for hospital readmission within 1 year after an acute myocardial infarction (AMI), no risk prediction models have been developed for them. The present study developed and internally validated a risk prediction model of 1-year post-AMI hospital readmission among young women that considered demographic, clinical, and gender-related variables. Methods: We used data from the US Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study (n = 2007 women), a prospective observational study of young patients hospitalized with AMI. Bayesian model averaging was used for model selection and bootstrapping for internal validation. Model calibration and discrimination were respectively assessed with calibration plots and area under the curve. Results: Within 1-year post-AMI, 684 women (34.1%) were readmitted to the hospital at least once. The final model predictors included: any in-hospital complication, baseline perceived physical health, obstructive coronary artery disease, diabetes, history of congestive heart failure, low income ( < $30,000 US), depressive symptoms, length of hospital stay, and race (White vs Black). Of the 9 retained predictors, 3 were gender-related. The model was well calibrated and exhibited modest discrimination (area under the curve = 0.66). Conclusions: Our female-specific risk model was developed and internally validated in a cohort of young female patients hospitalized with AMI and can be used to predict risk of readmission. Whereas clinical factors were the strongest predictors, the model included several gender-related variables (ie, perceived physical health, depression, income level). However, discrimination was modest, indicating that other unmeasured factors contribute to variability in hospital readmission risk among younger women.

Contexte: Bien que les femmes jeunes (≤ 55 ans) présentent un risque plus élevé que les hommes du même âge de réadmission à l'hôpital dans l'année suivant un infarctus aigu du myocarde (IAM), il n'existe pas de modèle de prédiction des risques conçu spécialement pour elles. Dans le cadre de la présente étude, on a créé et validé à l'interne un modèle de prédiction des risques de réadmission à l'hôpital dans l'année suivant un IAM chez les femmes jeunes en tenant compte de variables démographiques, cliniques et associées au genre. Méthodologie: Nous avons utilisé les données de l'étude américaine VIRGO (variation du rétablissement : le rôle du genre dans les résultats des jeunes patientes ayant subi un IAM) (n = 2007 femmes), une étude observationnelle prospective menée auprès de jeunes patientes hospitalisées pour un IAM. Un modèle bayésien d'établissement de la moyenne a été utilisé pour la sélection du modèle et la méthode bootstrap a été utilisée pour la validation interne. L'étalonnage et la discrimination du modèle ont été évalués respectivement au moyen des courbes d'étalonnage et de la surface sous la courbe. Résultats: Dans l'année suivant l'IAM, 684 femmes (34,1 %) ont été réadmises à l'hôpital au moins une fois. Les facteurs prédictifs finaux du modèle sont notamment : toute complication survenue à l'hôpital, l'état de santé physique perçu au départ, la coronaropathie obstructive, le diabète, les antécédents d'insuffisance cardiaque congestive, le faible revenu (< 30 000 $ US), les symptômes dépressifs, la durée du séjour à l'hôpital et l'ethnie (blanc par rapport à noir). Parmi les neuf facteurs prédictifs retenus, trois sont associés au genre. Le modèle est bien étalonné et présente une discrimination modeste (surface sous la courbe = 0,66). Conclusions: Notre modèle de risque propre aux femmes a été conçu et validé à l'interne auprès d'une cohorte de femmes jeunes hospitalisées pour un IAM et peut être utilisé pour prédire le risque de réadmission. Bien que les facteurs cliniques soient les facteurs prédictifs les plus puissants, le modèle inclut plusieurs variables liées au genre (p. ex., état de santé physique perçu, dépression, revenu). Cependant, la discrimination étant modeste, d'autres facteurs non mesurés contribuent à la variabilité du risque de réadmission à l'hôpital chez les femmes plus jeunes.

Pregnancy loss and risk of incident CVD within 5 years: Findings from the Women's Health Initiative.

Background: Previous studies have demonstrated an increased risk of cardiovascular disease (CVD) in women with a history of pregnancy loss. Less is known about whether pregnancy loss is associated with age at the onset of CVD, but this is a question of interest, as a demonstrated association of pregnancy loss with early-onset CVD may provide clues to the biological basis of the association, as well as having implications for clinical care. We conducted an age-stratified analysis of pregnancy loss history and incident CVD in a large cohort of postmenopausal women aged 50-79 years old. Methods: Associations between a history of pregnancy loss and incident CVD were examined among participants in the Women's Health Initiative Observational Study. Exposures were any history of pregnancy loss (miscarriage and/or stillbirth), recurrent (2+) loss, and a history of stillbirth. Logistic regression analyses were used to examine associations between pregnancy loss and incident CVD within 5 years of study entry in three age strata (50-59, 69-69, and 70-79). Outcomes of interest were total CVD, coronary heart disease (CHD), congestive heart failure, and stroke. To assess the risk of early onset CVD, Cox proportional hazard regression was used to examine incident CVD before the age of 60 in a subset of subjects aged 50-59 at study entry. Results: After adjustment for cardiovascular risk factors, a history of stillbirth was associated with an elevated risk of all cardiovascular outcomes in the study cohort within 5 years of study entry. Interactions between age and pregnancy loss exposures were not significant for any cardiovascular outcome; however, age-stratified analyses demonstrated an association between a history of stillbirth and risk of incident CVD within 5 years in all age groups, with the highest point estimate seen in women aged 50-59 (OR 1.99; 95% CI, 1.16-3.43). Additionally, stillbirth was associated with incident CHD among women aged 50-59 (OR 3.12; 95% CI, 1.33-7.29) and 60-69 (OR 2.06; 95% CI, 1.24-3.43) and with incident heart failure and stroke among women aged 70-79. Among women aged 50-59 with a history of stillbirth, a non-significantly elevated hazard ratio was observed for heart failure before the age of 60 (HR 2.93, 95% CI, 0.96-6.64). Conclusions: History of stillbirth was strongly associated with a risk of cardiovascular outcomes within 5 years of baseline in a cohort of postmenopausal women aged 50-79. History of pregnancy loss, and of stillbirth in particular, might be a clinically useful marker of cardiovascular disease risk in women.

Theoretical Investigation of the X-ray Stark Effect in Small Molecules.

We have studied the Stark effect in the soft x-ray region for various small molecules by calculating the field-dependent x-ray absorption spectra. This effect is explained in terms of the response of molecular orbitals (core and valence), the molecular dipole moment, and the molecular geometry to the applied electric field. A number of consistent trends are observed linking the computed shifts in absorption energies and intensities with specific features of the molecular electronic structure. We find that both the virtual molecular orbitals (valence and/or Rydberg) as well as the core orbitals contribute to observed trends in a complementary fashion. This initial study highlights the potential impact of x-ray Stark spectroscopy as a tool to study electronic structure and environmental perturbations at a submolecular scale.

Changes in corneal thickness, corneal volume, and densitometry after long-term orthokeratology wear.

PURPOSE: To investigate changes in the corneal volume, corneal densitometry and pachymetry of young myopes wearing over-night orthokeratology (OK) contact lenses. METHODS: The medical records of 28 right eyes of young myopes wearing OK between 2013 and 2018 were reviewed retrospectively. The baseline refractive error, best corrected visual acuities at baseline and uncorrected visual acuity at the most recent visit were recorded. Corneal volume of the central 10 mm cornea; densitometry at central, nasal and temporal cornea; and pachymetry along the horizontal and vertical meridians were collected from the Pentacam® HR at baseline, after one night of lens wear, and at the latest visit. RESULTS: The mean age of subjects was 12.03 ± 3.80 years at the time of OK lens fitting and wore OK overnight for a mean duration of 666 days (range 206-1736 days). The baseline spherical equivalent refractive error was -3.03 ± 1.56 D (range -1.00 to -6.00 D). The corneal volume increased significantly after OK wear (p = 0.001). Corneal densitometry increased after OK wear, but the change did not reach statistical significance (p = 0.113). Pachymetry in the central cornea did not change significantly across all visits (p > 0.05) but increased significantly in the mid-peripheral regions of the cornea. Baseline refractive error was not found to be correlated with the changes in corneal volume, corneal densitometry, or pachymetry. CONCLUSION: The increase in corneal volume and densitometry and no significant change in the central corneal thickness may indicate the presence of corneal oedema from long-term OK wear. The baseline refraction was not correlated with the changes in corneal volume, densitometry or pachymetry.

Partner perspectives on women's sexual and reproductive healthcare in cystic fibrosis.

BACKGROUND: Women with cystic fibrosis (CF) face many sexual and reproductive health (SRH) concerns. Studies suggest that educating and involving partners in SRH care can improve outcomes. This study investigated partners' perceptions of and preferences for women's SRH care in CF. METHODS: We surveyed partners of women with CF from ten United States (U.S.) CF centers regarding their attitudes and preferences related to CF SRH care. Items assessed experiences with SRH care, sexual relationships, family planning, pregnancy, fertility, and parenthood. We used descriptive statistics to assess results related to the timing, content, setting and delivery of CF SRH care. RESULTS: A total of 94 partners completed the survey (94% male; average age 36±1 years; 70% married; 36% parents). Among those who/whose partners experienced a pregnancy, 48% received preconception counseling and 29% fertility testing/treatment. One-third of all respondents (32%) worried their children would have CF and 86% would undergo CF genetic testing if their CF partner became pregnant. One-third (34%) indicated that they did not have any SRH conversations with their partner's CF team, while 70% would like to have such discussions. The topics that respondents would most like to discuss were pregnancy (50%), fertility (43%), sexual functioning (36%), sexual activity (31%) and parenthood (29%). CONCLUSIONS: Partners report gaps in SRH care and counseling despite the majority wanting to discuss SRH concerns with their partner's CF team. CF partners serve as key supports for women with CF and results can be used to design patient-centered interventions to optimize CF SRH care.

M. tuberculosis AlkX Encoded by rv3249c Regulates a Conserved Alkane Hydroxylase System That Is Important for Replication in Macrophages and Biofilm Formation.

Mycobacterium tuberculosis is a highly specialized human pathogen. The success of M. tuberculosis is due to its ability to replicate within host macrophages, resist host immune responses, and ultimately enter a persistent state during a latent tuberculosis infection. Understanding how M. tuberculosis adapts to and replicates in the intracellular environment of the host is crucial for the development of novel, targeted therapeutics. We report the characterization of an M. tuberculosis mutant lacking Rv3249c, a TetR transcriptional regulator. We show that Rv3249c directly represses the adjacent alkB-rubA-rubB operon encoding an alkane hydroxylase/rubredoxin system. For consistency with related systems, we have named the rv3249c gene alkX. The alkX mutant survived better than wild-type M. tuberculosis inside macrophages. This could be phenocopied by overexpression of the alkB-rubA-rubB locus. We hypothesized that the improved intracellular survival phenotype is a result of increased fitness of the mutant; however, we found that the alkX mutant had a defect when grown on some host-associated carbon sources in vitro. We also found that the alkX mutant had a defect in biofilm formation, also linked to the overexpression of the alkB-rubAB genes. Combined, these results define the primary role of AlkX as a transcriptional repressor of the alkB-rubAB operon and suggest the operon contributes to intracellular survival of the pathogen. IMPORTANCE Mycobacterium tuberculosis, the causative agent of tuberculosis (TB), is the leading cause of death worldwide due to a single infectious agent. It is important to understand how M. tuberculosis adapts to and replicates in the intracellular environment of the host. In this study, we characterized the TetR transcriptional regulator Rv3249c and show that it regulates a highly conserved alkane hydroxylase/rubredoxin system. Our data demonstrate that the AlkBRubAB system contributes to the success of the bacterium in host macrophages.

Interventions Targeted to Address Social Determinants of Health in Ischemic Heart Disease: A Sex- and Gender-Oriented Scoping Review.

The burden of ischemic heart disease (IHD) is a major health problem worldwide. The detrimental effect of gendered (ie, unevenly distributed between female and male) socioeconomic determinants of health (SDOH) on outcomes has been demonstrated, more so in female individuals. Therefore, addressing SDOH is a priority for the care implementation of patients with IHD. We conducted a scoping review to identify the types of SDOH-tailored interventions tested in randomised controlled trials (RCTs) among IHD patients, and whether the reporting of findings was sex-unbiased. We identified 8 SDOH domains: education, physical environment, health care system, economic stability, social support, sexual orientation, culture/language, and systemic racism. A total of 28 RCTs (2 ongoing) were evaluated. Since the 1990s, 26 RCTs have been conducted, mainly in the Middle East and Asia, and addressed only education, physical environment, health care system, and social support. The 77% of studies focused on patient-education interventions, and around 80% on SDOH-based interventions achieved positive effects on a variety of primary outcome(s). Among the limitations of the conducted RCTs, the most relevant were an overall low participation of female and racial/ethnical minority participants, a lack of sex-stratified analyses, and a missing opportunity of tailoring some SDOH interventions relevant for health. The SDOH-tailored interventions tested so far in RCTs, enrolling predominantly male patients and mainly targeting education and health literacy, were effective in improving outcomes among patients with IHD. Future studies should focus on a wider range of SDOH with an adequate representation of female and minority patients who would most benefit from such interventions.

Implementation of an Appointment-Based Cardiac Rehabilitation Approach: A Single-Center Experience.

Background There has been a focus on alternative cardiac rehabilitation (CR) delivery models aimed at improving CR adherence and completion. We examined pre- and post-CR health outcomes, reasons for discharge, and predictors of completion using a patient-driven appointment-based CR approach that uses center-scheduled class start times. Methods and Results Data were used from an urban single-center CR program at Yale New Haven Health (2012-2017) that enrolled 2135 patients. We evaluated pre- and post-CR outcomes (12 weeks) using paired t tests and used a multivariable logistic regression model to examine predictors of CR completion (≥36 sessions) for the overall cardiovascular disease population. The mean age of participants was 65±12 years, 27.9% were women, and 5.1% were Black patients, and patients completed a median of 30 of 36 sessions. Patients achieved significant improvements in health outcomes, including across age and sex subgroups. The primary reason for discharge was completion of all 36 sessions of CR (46.4%). The final logistic regression model contained 12 predictors: age, sex, Black race, marital status, employment, number of physician-reported risk factors, dietary fat intake >30%, obesity, lack of exercise, benign prostatic hyperplasia, and self-reported stress and physical activity. Conclusions We demonstrated that patients participating in an appointment-based CR program achieved significant improvements in health outcomes and across sex/age subgroups. In addition, older individuals were more likely to complete CR. An appointment-based approach could be a viable alternative CR method to aid in optimizing the dose-response benefit of CR for patients with cardiovascular disease.

Understanding Physical Activity Patterns Across the School Day in Urban Pre-Kindergarten and Elementary Schoolchildren.

PURPOSE: Despite recommendations that children accrue ≥60 min/day of moderate-to-vigorous physical activity (MVPA), numerous barriers may exist. We examined school-day MVPA patterns in lower-income children (pre-K to 5th grade) to determine whether they were meeting the minimum school-day guidelines of at least 30-min/day of MVPA and to identify opportunities for intervention. METHODS: Students (N = 629, pre-K-5th grade) from 4 urban schools wore Actigraph GT3X+ accelerometers over 2 school days. Mixed effects models evaluated sex- and grade-specific differences in MVPA and sedentary time. RESULTS: Only 34.6% of elementary and 25.3% of pre-K students met the school-time MVPA recommendation. Among elementary-aged children, boys accrued more MVPA than girls (30.8 ± 13.3 vs. 23.5 ± 10.7 min/day; p < 0.0001) with similar sex differences observed among pre-K children (51.3 ± 17.1 vs 41.9 ± 17.5 min/day; p < 0.001). Sedentary time also increased significantly with grade among elementary-aged children (207.9 ± 34.7 vs. 252.0 ± 36.1 min/day for those in 1st and 5th grade, respectively; p < 0.001), with girls accruing more sedentary time than boys (242.5 ± 48.2 vs. 233.8 ± 46.8 min/day; p < 0.0001). CONCLUSION: MVPA declines across elementary school years, with sex disparities observed as early as pre-K. Extended sedentary bouts and clustering of activity highlight opportunities for more movement throughout the school day.

Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the JOIN for ME Family-Based Childhood Obesity Program in Low-Income Communities.

Background: Overweight and obesity in children is a public health crisis in the United States. Although evidence-based interventions have been developed, such programs are difficult to access. Dissemination of evidence-based pediatric weight management interventions (PWMIs) to families from diverse low-income communities is the primary objective of the CDC Childhood Obesity Research Demonstration (CORD) projects. Methods: The goal of the Rhode Island CORD 3.0 project is to adapt the evidence-based PWMI, JOIN for ME, for delivery among diverse families from low-income backgrounds and to test it in a hybrid effectiveness-implementation trial design in which the aims are to examine implementation and patient-centered outcomes. Children between the ages of 6 and 12 years with BMI ≥85th percentile and a caregiver will be recruited through two settings, a federally qualified health center, which serves as a patient-centered medical home, or low-income housing. Dyads will receive a remotely delivered group-based intervention that is 10 months in duration and includes 16 weekly sessions, followed by 4 biweekly and 4 monthly meetings. Assessments of child and caregiver weight status and child health-related quality of life will be conducted at baseline, and at 4 and 10 months after the start of intervention. Implementation outcomes assessing intervention acceptability, adoption, feasibility, fidelity, and penetration/reach will be collected to inform subsequent dissemination. Conclusions: If the adapted version of the JOIN for ME intervention can be successfully implemented and is shown to be effective, this project will provide a model for a scalable PWMI for families from low-income backgrounds. ClinicalTrials.gov no. NCT04647760.

The Fueling Learning Through Exercise Study Cluster RCT: Impact on Children's Moderate-to-Vigorous Physical Activity.

INTRODUCTION: Most children do not meet the recommendations for school-time and daily moderate-to-vigorous physical activity, with significant demographic disparities and declines over the elementary school years. Investigators examined the impact of Fueling Learning through Exercise study school-based physical activity programs on school-time and total daily moderate-to-vigorous physical activity among lower-income school children. DESIGN, PARTICIPANTS, AND INTERVENTION: Urban elementary schools (N=18) were cluster randomized to 100 Mile Club, Just Move, or control. Data collection and analyses occurred from 2015 to 2019 among third- and fourth-grade school children (N=1,008) across 2 academic years. MAIN OUTCOME MEASURES: Student's moderate-to-vigorous physical activity was measured by 7-day accelerometry (Actigraph GT3X+) at baseline (before intervention), midpoint (6 months), and endpoint (18 months). Mixed-effects linear regression models examined program impact on school-time and daily moderate-to-vigorous physical activity, adjusting for clustering, demographics, weight status, free/reduced-price lunch eligibility, school physical activity environment, wear time, and weather. Program reach by sex, weight status, race/ethnicity, and baseline activity levels was explored. RESULTS: Of the 979 participants analyzed (aged 8.7 [SD=0.7] years, 44% male, 60% non-White, 40% overweight/obese, 55% eligible for free/reduced-price lunch), 8.4% (18.2 [SD=7.9] minutes per day) and 19.8% (45.6 [SD=19.4] minutes per day) fulfilled the 30-minute school-time and 60-minute daily moderate-to-vigorous physical activity recommendations at baseline, respectively. Overall, daily moderate-to-vigorous physical activity decreased from baseline to 18 months (p<0.001, -5.3 minutes, 95% CI= -8.2, -2.4) with no effect of programming. However, for school-time moderate-to-vigorous physical activity, intervention schools maintained school-time moderate-to-vigorous physical activity across the 2 academic years, whereas school-time moderate-to-vigorous physical activity decreased in control schools (p=0.004, -2.3 minutes, 95% CI= -4.3, -0.4). Program reach on school-time moderate-to-vigorous physical activity appeared equitable by sex and weight status but was different by race/ethnicity (p<0.001). CONCLUSIONS: Two different school-based physical activity programs were effective in preventing the decline in school-time moderate-to-vigorous physical activity that is typical across the elementary years, with similar reach by sex and weight status. Multiple opportunities for physical activity during school are needed to promote meeting school-time moderate-to-vigorous physical activity recommendations among diverse children. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02810834.

Cx31.1 expression is modulated in HaCaT cells exposed to UV-induced damage and scrape-wounding.

Connexin31.1 (Cx31.1) is a gap junction protein associated with apoptosis. In the skin, apoptosis is modulated by diabetes. A HaCaT skin model investigated whether normal (NGI) and high glucose and insulin (HGI; diabetic) conditions altered Cx31.1 expression, and if these were apoptosis linked. Cx31.1 was found in HaCaT and HeLa Ohio cells, with HaCaT Cx31.1 protein increased in HGI conditions, and around apoptotic cells. HeLa Cx31.1 channels were noncommunicative. Post scrape-wounding, Cx31.1 increased at wound edges. Caspase 3/7 in scrape-wounds media (containing cells) elevated in HGI. UV exposure raised Cx31.1, and caspase 3/7, in NGI and HGI. UV reduced cell viability in NGI cells, although not significantly in HGI. Cx31.1 is modulated during HaCaT cell wound closure, and associated with 'diabetic' conditions. Cx31.1 expression matched apoptosis levels, higher in HGI cultures. Cx31.1 is noncommunicating, modulated after wounding, linked to apoptosis, and may be associated with tissue turn-over around diabetic wounds.