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Background: The Structured Days Hypothesis posits that structure protects children against obesogenic behaviors (e.g., physical inactivity, unhealthy dietary intake) and, ultimately, prevents the occurrence of excessive weight gain. The hours following school (i.e., 3-6 pm school days) and summer vacation are two "windows of vulnerability" when children may experience less structure. Programs that provide a healthy structured environment and may prevent BMI gain exist for both time periods (i.e., after-school programs and summer day camps). Unfortunately, these programs are cost prohibitive for children from low-income families to attend. This study will test the impact of providing vouchers to access existing, community-operated after-school and summer programs on BMI z-score, body composition, and obesogenic behaviors (i.e., physical activity, screen use, diet, and sleep) of children (5-12 years) from schools that primarily serve families with low income., Methods: The study will employ a 2x2 factorial design. Participants (N = 480) attending 4 elementary schools in one school district will be randomly assigned to a no treatment control, after-school program voucher only, summer day camp voucher only, or after-school and summer day camp vouchers. Vouchers will cover the full cost of attending a pre-existing community-based after-school or summer camp program. The primary outcome (BMI z-score) will be measured at baseline (before end of school year, ~ May), 3-month follow-up (after summer, ~ August), and 12-month follow-up (end the following school year, ~ May). Secondary outcomes include body composition (i.e., whole-body fat mass, fat free mass, and percent body fat) and obesogenic behaviors (i.e., physical activity, sedentary time, sleep, screen-time, and diet). The study will also employ a rigorous process evaluation which will consider after-school and summer camp program attendance and content. Analyses will examine differences between the four groups in BMI z-score, body composition, and obesogenic behaviors. Incremental cost effectiveness ratios will determine the cost effectiveness of the intervention., Discussion: The current study will provide critical information for researchers, practitioners, and policy makers seeking to combat the childhood obesity epidemic in children from families with low-income during the school year and summer., Trial Registration: NCT05880901 . Registered 27 May 2023., (© 2024. The Author(s).)

Importance: Children experience accelerated gains in body mass index (BMI) during the summer months when school is not in session. Children from low-income households are most susceptible. Accelerated BMI gain in summer may be due to the removal of the health-promoting structure provided by schools. During summer, a common form of health-promoting structure is summer day camps (SDCs). Summer day camps are predominately fee for service, which creates a financial barrier for children from low-income households. One solution to mitigate accelerated BMI gain is providing free access to an existing SDC., Objective: To investigate whether providing free access to an existing community SDC can mitigate accelerated BMI z score (zBMI) gain in elementary school-age children., Design, Setting, and Participants: This randomized clinical trial was conducted during the summers of 2021, 2022, and 2023 in the southeastern United States. Participants were children (kindergarten through fourth grade) from predominantly low-income households who were randomized to attend an SDC operated by a parks and recreation commission or continue summer as usual (control)., Intervention: Free SDC every weekday (Monday through Friday) for 8 to 10 weeks., Main Outcomes and Measures: The primary outcome was between-group differences in change of zBMI measured before school ended (May) and on return to school from summer (late August). Secondary analyses examined the dose response of zBMI change with parent-reported child attendance at SDCs during the summer for all children (intervention and control)., Results: A total of 422 children (mean [SD] age, 8.2 [1.5] years; 202 [48%] female, 220 [52%] male, 292 [69%] at or below 200% federal poverty level, 127 [30%] with food insecurity) were randomized to 1 of 2 conditions: summer as usual (control, n = 199) or free SDC (n = 223). Intent-to-treat analysis indicated mean (SE) change in zBMI at the end of the summer was 0.046 (0.027) for the control and -0.048 (0.025) for the intervention group, representing a significant between-group difference of -0.094 (95% CI, -0.166 to -0.022). Dose-response analyses indicated that every 1 day per week increase in attending an SDC resulted in a -0.034 to -0.018 zBMI reduction, which translates to a gain of 0.046 to 0.080 zBMI for children never attending summer programming vs -0.09 to -0.04 zBMI reduction for children attending summer programming every weekday., Conclusions and Relevance: Providing children free access to existing community summer programming can have a meaningful effect on children's zBMI gain during the summer. Future studies should replicate these findings across different regions and identify the optimal dose of programming to mitigate unhealthy zBMI gains., Trial Registration: ClinicalTrials.gov Identifier: NCT04072549.

Background: Guidelines recommend that adolescents should accumulate an average of 60 min per day of moderate-to-vigorous physical activity (MVPA). However, using only this cut-off could hide important information. For instance, from a population-level point of view, increasing physical activity for those with no or low physical activity could provide more health benefits than increasing physical activity for those with intermediate levels. Also, including a more sensitive cut-point of ≥1 days per week could be an additional strategy for identifying those with low access/opportunities for physical activity practice. Thus, the current study aims to estimate the prevalence of ≥60 min of MVPA ≥1 days per week among adolescents globally, and to describe any relevant gender inequalities., Methods: We used representative datasets from 146 countries/territories collected between 2003 and 2019. MVPA was self-reported. Participants were grouped into younger (≤14 years old) and older (>14 years old) adolescents. Crude Poisson regression models were used to identify the relative differences in ≥60 min of MVPA ≥1 days per week between boys and girls, and random-effects meta-analysis models were used to identify the pooled estimates. Analyses were stratified by country and region., Results: Approximately 80% of both younger and older adolescents reported ≥60 min of MVPA ≥1 days per week. This prevalence was ≥94% in Europe and Central Asia and North America, while the estimates for the other regions were <77%. The prevalence of ≥60 min of MVPA ≥1 days per week was higher among boys than girls, with the largest differences occurring among the oldest adolescents (Prevalence ratio ≤14y = 1.04 (95% confidence interval (95%CI)): 1.03‒1.04) vs. Prevalence ratio >14y = 1.09 (95%CI: 1.08‒1.10))., Conclusion: Approximately 8 out of 10 adolescents reported accumulating ≥60 min of MVPA ≥1 days per week, with notable differences between regions. Gender differences were observed in several countries, especially among the oldest adolescents. Priorities for physical activity promotion among adolescents should include increasing access/opportunities for physical activity among those who do not achieve ≥60 min of MVPA ≥1 days per week and reducing gender inequalities., (Copyright © 2024. Production and hosting by Elsevier B.V.)

Background: Children's physical activity and screen time behaviours impact their physical health and well-being. In Australia, less than half of children meet daily physical activity recommendations and only one-third meet daily screen time recommendations. Nearly half a million Australian school children aged 5-12 attend Outside School Hours Care (OSHC) weekly, activities undertaken at OSHC play a key role in meeting these recommendations. Currently, physical activity and screen time practices in OSHC vary and lack policy guidance. The Activated OSHC program is a policy-based intervention that supports OSHC services to implement the physical activity and screen time guidelines., Methods: 192 OSHC services across Australia will be recruited. 96 services will be randomly allocated to receive the Activated OSHC program. OSHC coordinators will complete online surveys examining physical activity and screen time scheduling, cost, acceptability, and feasibility. Primary outcome; changes in the proportion of intervention and control services meeting OSHC sector physical activity and screen time guidelines, and secondary outcomes; changes in children's physical activity and screen time behaviours; changes in staff behaviour will be assessed using mixed-effects regression models., Discussion: The aim of this study is to examine the impact of the Activated OSHC program on children's physical activity and screen time., Impact: Recent Australian research in Outside School Hours Care (OSHC) has identified significant inconsistency in practices related to physical activity and screen time, compounded by an absence of explicit policy guidance. The Activated OSHC program is a policy-based intervention that supports OSHC services to implement the Australian OSHC physical activity and screen time guidelines. This study will assess the implementation and effectiveness of the Activated OSHC program in an effectiveness-implementation hybrid type 2 trial design. Implementation of outside school hours care sector physical activity and screen time guidelines may improve children's physical activity and screen time behaviours., (© 2024. The Author(s).)

Background: Among elementary-aged children (5-12yrs), summer vacation is associated with accelerated gains in Body Mass Index (BMI). A key behavioral driver of BMI gain is a lack of physical activity (PA). Previous studies indicate PA decreases during summer, compared to the school year but whether this difference is consistent among boys and girls, across age, and by income status remains unclear. This study examined differences in school and summer movement behaviors in a diverse cohort of children across three years., Methods: Children (N = 1,203, age range 5-14 years, 48% girls) wore wrist-placed accelerometers for a 14-day wear-period during school (April/May) and summer (July) in 2021 to 2023, for a total of 6 timepoints. Mixed-effects models examined changes in school vs. summer movement behaviors (moderate-to-vigorous physical activity [MVPA], sedentary) for boys and girls, separately, and by age and household income groups (low, middle, and upper based on income-to-poverty ratio)., Results: Children provided a total of 35,435 valid days of accelerometry. Overall, boys (+ 9.1 min/day, 95CI 8.1 to 10.2) and girls (+ 6.2 min/day, 95CI 5.4 to 7.0) accumulated more MVPA during school compared to summer. Boys accumulated less time sedentary (-9.9 min/day, 95CI -13.0 to -6.9) during school, while there was no difference in sedentary time (-2.7 min/day, 95CI -5.7 to 0.4) for girls. Different patterns emerged across ages and income groups. Accumulation of MVPA was consistently greater during school compared to summer across ages and income groups. Generally, the difference between school and summer widened with increasing age, except for girls from middle-income households. Accumulation of sedentary time was higher during school for younger children (5-9yrs), whereas for older children (10-14yrs), sedentary time was greater during summer for the middle- and upper-income groups. For boys from low-income households and girls from middle-income households, sedentary time was consistently greater during summer compared to school across ages., Conclusions: Children are less active and more sedentary during summer compared to school, which may contribute to accelerated BMI gain. However, this differs by biological sex, age, and income. These findings highlight the complex factors influencing movement behaviors between school and summer., (© 2024. The Author(s).)

We examined the comparability of children's nocturnal sleep estimates using accelerometry data, processed with and without a sleep log. In a secondary analysis, we evaluated factors associated with disagreement between processing approaches. Children (n = 722, age 5-12 years) wore a wrist-based accelerometer for 14 days during Autumn 2020, Spring 2021, and/or Summer 2021. Outcomes included sleep period, duration, wake after sleep onset (WASO), and timing (onset, midpoint, waketime). Parents completed surveys including children's nightly bed/wake time. Data were processed with parent-reported bed/wake time (sleep log), the Heuristic algorithm looking at Distribution of Change in Z-Angle (HDCZA) algorithm (no log), and an 8 p.m.-8 a.m. window (generic log) using the R-package 'GGIR' (version 2.6-4). Mean/absolute bias and limits of agreement were calculated and visualised with Bland-Altman plots. Associations between child, home, and survey characteristics and disagreement were examined with tobit regression. Just over half of nights demonstrated no difference in sleep period between sleep log and no log approaches. Among all nights, the sleep log approach produced longer sleep periods (9.3 min; absolute mean bias [AMB] = 28.0 min), shorter duration (1.4 min; AMB = 14.0 min), greater WASO (11.0 min; AMB = 15.4 min), and earlier onset (13.4 min; AMB = 17.4 min), midpoint (8.8 min; AMB = 15.3 min), and waketime (3.9 min; AMB = 14.8 min) than no log. Factors associated with discrepancies included smartphone ownership, bedroom screens, nontraditional parent work schedule, and completion on weekend/summer nights (range = 0.4-10.2 min). The generic log resulted in greater AMB among sleep outcomes. Small mean differences were observed between nights with and without a sleep log. Discrepancies existed on weekends, in summer, and for children with smartphones and screens in the bedroom., (© 2023 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.)

Background: Lack of physical activity is a concern for children across diverse backgrounds, particularly affecting those in rural areas who face distinct challenges compared to their urban counterparts. Community-derived interventions are needed that consider the unique context and additional physical activity barriers in under-resourced rural settings. Therefore, a prospective pre-post pilot/feasibility study of Hoosier Sport was conducted over 8-weeks with 6th and 7th grade children in a low-socioeconomic rural middle school setting. The primary objective of the present study was to assess trial- and intervention-related feasibility indicators; and the secondary objective was to collect preliminary assessment data for physical activity levels, fitness, psychological needs satisfaction, and knowledge of physical activity and nutrition among participating youth., Methods: This prospective 8-week pilot/feasibility study took place in the rural Midwestern United States where twenty-four middle school students participated in a mixed-methods pre-post intervention during physical education classes. The intervention included elements like sport-based youth development, individualized goal setting, physical activity monitoring, pedometer usage, and health education. Data were collected at baseline (T1) and post-intervention (T3), with intermediate measures during the intervention (T2). Qualitative data were integrated through semi-structured interviews. Analytical methods encompassed descriptive statistics, correlations, repeated measures ANOVA, and thematic analysis., Results: Key findings indicate robust feasibility, with intervention-related scores (FIM, AIM, and IAM) consistently surpassing the "good" threshold and 100% retention and recruitment success. Additionally, participants showed significant physical performance improvement, shifting from the 25th to the 50th percentile in the 6-minute walk test (p < 0.05). Autonomy and competence remained high, reflecting positive perceptions of program practicality. Nutrition knowledge, initially low, significantly improved at post-intervention (p < 0.01), highlighting the efficacy of targeted nutritional education in Hoosier Sport., Conclusions: This study pioneers a community-engaged model for physical activity intervention in under-resourced rural settings. Positive participant feedback, coupled with improvements in physical fitness and psychosocial factors, highlights the potential of the co-design approach. The findings offer valuable insights and a practical template for future community-based research, signaling the promising impact of such interventions on holistic well-being. This research lays the foundation for subsequent phases of the ORBIT model, emphasizing collaborative, community-driven approaches to address the complex issue of declining physical activity levels among adolescents., (© 2024. The Author(s).)

Introduction: Evidence suggests that adolescents engage in less physical activity during the summer break. Less is known regarding physical activity during the summer months of the COVID-19 pandemic., Methods: Utilizing data from the Adolescent Brain Cognitive Development study, the authors examined daily activity measured by Fitbit Charge 2 devices before and after the onset of the COVID-19 pandemic during school and summer months. Linear models estimated activity during pre-COVID-19 school, pre-COVID-19 summer, COVID-19 school, and COVID-19 summer., Results: Participants (N=7,179, aged 11.96 years, 51% female, 51% White) accumulated 8,671.0 (95% CI=8,544.7; 8,797.3) steps, 32.5 (95% CI=30.8, 32.3) minutes of moderate-to-vigorous physical activity, and 507.2 (95% CI=504.2, 510.2) minutes of sedentary time. During COVID-19 school, adolescents accumulated fewer daily steps and minutes of moderate-to-vigorous physical activity (-1,782.3 steps [95% CI= -2,052.7; -1,511.8] and -6.2 minutes [95% CI= -8.4, -4.0], respectively). Adolescents accumulated more minutes of daily sedentary time (29.6 minutes [95% CI=18.9, 40.3]) during COVID-19 school months than during the pre-COVID-19 school months. During pre-COVID-19 summer months, adolescents accumulated 1,255.1 (95% CI=745.3; 1,765.0) more daily steps than during COVID-19 months. Boys accumulated more daily steps and moderate-to-vigorous physical activity (2,011.5 steps [95% CI=1,271.9; 2,751.0] and 7.9 minutes [95% CI=1.4, 14.4], respectively) during the summer before COVID-19 than in summer during COVID-19. Both girls and boys accumulated more minutes of sedentary time during COVID-19 school months (47.4 [95% CI=27.5, 67.3] and 51.2 [95% CI=22.8, 79.7], respectively) than during COVID-19 summer months., Conclusions: Societal restrictions during COVID-19 negatively impacted activity levels in the U.S., particularly during the summer months during COVID-19., (© 2024 The Authors.)

Introduction: Current wearables that collect heart rate and acceleration were not designed for children and/or do not allow access to raw signals, making them fundamentally unverifiable. This study describes the creation and calibration of an open-source multichannel platform (PATCH) designed to measure heart rate and acceleration in children ages 3-8 yr., Methods: Children (N = 63; mean age, 6.3 yr) participated in a 45-min protocol ranging in intensities from sedentary to vigorous activity. Actiheart-5 was used as a comparison measure. We calculated mean bias, mean absolute error (MAE) mean absolute percent error (MA%E), Pearson correlations, and Lin's concordance correlation coefficient (CCC)., Results: Mean bias between PATCH and Actiheart heart rate was 2.26 bpm, MAE was 6.67 bpm, and M%E was 5.99%. The correlation between PATCH and Actiheart heart rate was 0.89, and CCC was 0.88. For acceleration, mean bias was 1.16 mg and MAE was 12.24 mg. The correlation between PATCH and Actiheart was 0.96, and CCC was 0.95., Conclusions: The PATCH demonstrated clinically acceptable accuracies to measure heart rate and acceleration compared with a research-grade device., (Copyright © 2024 by the American College of Sports Medicine.)

Study Objectives: Evaluate wrist-placed accelerometry predicted heartrate compared to electrocardiogram (ECG) heartrate in children during sleep., Methods: Children (n=82, 61% male, 43.9% Black) wore a wrist-placed Apple Watch Series 7 (AWS7) and ActiGraph GT9X during a polysomnogram. 3-Axis accelerometry data was extracted from AWS7 and the GT9X. Accelerometry heartrate estimates were derived from jerk (the rate of acceleration change), computed using the peak magnitude frequency in short time Fourier Transforms of Hilbert transformed jerk computed from acceleration magnitude. Heartrates from ECG traces were estimated from R-R intervals using R-pulse detection. Lin's Concordance Correlation Coefficient (CCC), mean absolute error (MAE) and mean absolute percent error (MAPE) assessed agreement with ECG estimated heartrate. Secondary analyses explored agreement by polysomnography sleep stage and a signal quality metric., Results: The developed scripts are available on Github. For the GT9X, CCC was poor at -0.11 and MAE and MAPE were high at 16.8 (SD=14.2) beats/minute and 20.4% (SD=18.5%). For AWS7, CCC was moderate at 0.61 while MAE and MAPE were lower at 6.4 (SD=9.9) beats/minute and 7.3% (SD=10.3%). Accelerometry estimated heartrate for AWS7 was more closely related to ECG heartrate during N2, N3 and REM sleep than lights on, wake, and N1 and when signal quality was high. These patterns were not evident for the GT9X., Conclusions: Raw accelerometry data extracted from AWS7, but not the GT9X, can be used to estimate heartrate in children while they sleep. Future work is needed to explore the sources (i.e., hardware, software, etc.) of the GT9X's poor performance., (© The Author(s) 2024. Published by Oxford University Press on behalf of Sleep Research Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Preliminary studies play a prominent role in the development of large-scale behavioral interventions. Though recommendations exist to guide the execution and interpretation of preliminary studies, these assume optimal scenarios which may clash with realities faced by researchers. The purpose of this study was to explore how principal investigators (PIs) balance expectations when conducting preliminary studies. We surveyed PIs funded by the National Institutes of Health to conduct preliminary behavioral interventions between 2000 and 2020. Four hundred thirty-one PIs (19% response rate) completed the survey (November 2021 to January 2022, 72% female, mean 21 years post-terminal degree). Most PIs were aware of translational models and believed preliminary studies should precede larger trials but also believed a single preliminary study provided sufficient evidence to scale. When asked about the relative importance of preliminary efficacy (i.e. changes in outcomes) and feasibility (i.e. recruitment, acceptance/adherence) responses varied. Preliminary studies were perceived as necessary to successfully compete for research funding, but among PIs who had peer-reviewed federal-level grants applications (n = 343 [80%]), responses varied about what should be presented to secure funding. Confusion surrounding the definition of a successful, informative preliminary study poses a significant challenge when developing behavior interventions. This may be due to a mismatch between expectations surrounding preliminary studies and the realities of the research enterprise in which they are conducted. To improve the quality of preliminary studies and advance the field of behavioral interventions, additional funding opportunities, more transparent criteria in grant reviews, and additional training for grant reviewers are suggested., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society of Behavioral Medicine.)

Background: Twenty-four hour movement behaviors (ie, physical activity [PA], screen time [ST], and sleep) are associated with children's health outcomes. Identifying day-level contextual factors, such as child care, that positively influence children's movement behaviors may help identify potential intervention targets, like improving access to child care programs. This study aimed to examine the between- and within-person effects of child care on preschoolers' 24-hour movement behaviors., Methods: Children (N = 74, 4.7 [0.9] y, 48.9% girls, 63.3% White) wore an Axivity AX3 accelerometer on their nondominant wrist 24 hours per day for 14 days to measure PA and sleep. Parents completed surveys each night about their child's ST and child care attendance that day. Linear mixed effects models predicted day-level 24-hour movement behaviors from hours spent in child care., Results: Children spent an average of 5.0 (2.9) hours per day in child care. For every additional hour of child care above their average, children had 0.3 hours (95% CI, -0.3 to -0.2) less ST that day. Between-person effects showed that compared with children who attended fewer overall hours of child care, children who attended more hours had less overall ST (B = -0.2 h; 95% CI, -0.4 to 0.0). Child care was not significantly associated with PA or sleep., Conclusions: Child care attendance was not associated with 24-hour PA or sleep; however, it was associated with less ST. More research utilizing objective measures of ST and more robust measures of daily schedules or structure is necessary to better understand how existing infrastructure may influence preschool-aged children's 24-hour movement behaviors. In addition, future research should consider how access to child care may influence child care attendance.

Aim: Canadian guidelines recommend metformin as first-line therapy for incident uncomplicated type 2 diabetes and the vast majority of patients are treated accordingly. However, only 54% 65% remain on treatment after 1 year, with the highest discontinuation rates within the first 3 months. The purpose of this study was: (a) to identify individual and clinical factors associated with metformin discontinuation among patients with newly diagnosed uncomplicated type 2 diabetes in Alberta, Canada, and (b) describe glycated haemoglobin (HbA1c) trajectories in the first 12 months after initiation of pharmacotherapy, stratified by metformin usage pattern., Materials and Methods: We conducted a retrospective cohort study using linked administrative datasets from 2012 to 2017 to define a cohort of individuals with uncomplicated incident type 2 diabetes. Using logistic regression, we determined individual and clinical characteristics associated with metformin discontinuation. We categorized individuals based on patterns of metformin use and then used mean HbA1c measurements over a 12-month follow-up period to determine glycaemic trajectories for each pattern., Results: Characteristics associated with metformin discontinuation were younger age, lower baseline HbA1c and having fewer comorbidities. Sex, income and location (urban/rural) were not significantly associated with metformin discontinuation. Individuals who continued metformin with higher adherence and individuals who discontinued metformin entirely had lowest HbA1c values at 12 months from treatment initiation. Those who changed therapy or had additional therapies added had higher HbA1c values at 12 months., Conclusion: Identifying characteristics associated with discontinuation of metformin and individuals' medication usage patterns provide an opportunity for targeted interventions to support patients' glycaemic management., (© 2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Background: Drivers of summer body mass index (BMI) gain in children remain unclear. The Circadian and Circannual Rhythm Model (CCRM) posits summer BMI gain is biologically driven, while the Structured Days Hypothesis (SDH) proposes it is driven by reduced structure. Objectives: Identify the mechanisms driving children's seasonal BMI gain through the CCRM and SDH. Methods: Children's ( N  = 147, mean age = 8.2 years) height and weight were measured monthly during the school year, and once in summer (July-August). BMI z-score (zBMI) was calculated using CDC growth charts. Behaviors were measured once per season. Mixed methods regression estimated monthly percent change in children's height (%HΔ), weight (%WΔ), and monthly zBMI for school year vs. summer vacation, seasonally, and during school months with no breaks vs. school months with a break ≥1 week. Results: School year vs. summer vacation analyses showed accelerations in children's %WΔ (Δ = 0.9, Standard Error (SE) = 0.1 vs. Δ = 1.4, SE = 0.1) and zBMI (Δ = -0.01, SE = 0.01 vs. Δ = 0.04, SE = 0.3) during summer vacation, but %HΔ remained relatively constant during summer vacation compared with school (Δ = 0.3, SE = 0.0 vs. Δ = 0.4, SE = 0.1). Seasonal analyses showed summer had the greatest %WΔ (Δ = 1.8, SE = 0.4) and zBMI change (Δ = 0.05, SE = 0.03) while %HΔ was relatively constant across seasons. Compared with school months without a break, months with a break showed higher %WΔ (Δ = 0.7, SE = 0.1 vs. Δ = 1.6, SE = 0.2) and zBMI change (Δ = -0.03, SE = 0.01 vs. Δ = 0.04, SE = 0.01), but %HΔ was constant (Δ = 0.4, SE = 0.0 vs. Δ = 0.3, SE = 0.1). Fluctuations in sleep timing and screen time may explain these changes. Conclusions: Evidence for both the CCRM and SDH was identified but the SDH may more fully explain BMI gain. Interventions targeting consistent sleep and reduced screen time during breaks from school may be warranted no matter the season.

The purpose of this study was to evaluate the reliability and validity of the raw accelerometry output from research-grade and consumer wearable devices compared to accelerations produced by a mechanical shaker table. Raw accelerometry data from a total of 40 devices (i.e., n = 10 ActiGraph wGT3X-BT, n = 10 Apple Watch Series 7, n = 10 Garmin Vivoactive 4S, and n = 10 Fitbit Sense) were compared to reference accelerations produced by an orbital shaker table at speeds ranging from 0.6 Hz (4.4 milligravity-mg) to 3.2 Hz (124.7mg). Two-way random effects absolute intraclass correlation coefficients (ICC) tested inter-device reliability. Pearson product moment, Lin's concordance correlation coefficient (CCC), absolute error, mean bias, and equivalence testing were calculated to assess the validity between the raw estimates from the devices and the reference metric. Estimates from Apple, ActiGraph, Garmin, and Fitbit were reliable, with ICCs = 0.99, 0.97, 0.88, and 0.88, respectively. Estimates from ActiGraph, Apple, and Fitbit devices exhibited excellent concordance with the reference CCCs = 0.88, 0.83, and 0.85, respectively, while estimates from Garmin exhibited moderate concordance CCC = 0.59 based on the mean aggregation method. ActiGraph, Apple, and Fitbit produced similar absolute errors = 16.9mg, 21.6mg, and 22.0mg, respectively, while Garmin produced higher absolute error = 32.5mg compared to the reference. ActiGraph produced the lowest mean bias 0.0mg (95%CI = -40.0, 41.0). Equivalence testing revealed raw accelerometry data from all devices were not statistically significantly within the equivalence bounds of the shaker speed. Findings from this study provide evidence that raw accelerometry data from Apple, Garmin, and Fitbit devices can be used to reliably estimate movement; however, no estimates were statistically significantly equivalent to the reference. Future studies could explore device-agnostic and harmonization methods for estimating physical activity using the raw accelerometry signals from the consumer wearables studied herein., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Unrelated to this work Dr. Weaver and Dr. Armstrong report board membership and ownership shares in Trackster LLC. Unrelated to this work Dr. de Zambotti reports grants from Noctrix Health and Verily Life Science LLC (Alphabet Inc.), and is a co-founder and Chief Scientific Officer at Lisa Health Inc. and has ownership of shares in Lisa Health., (Copyright: © 2024 White et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Physical activity (PA) promotion among school-aged youth is a global health priority. Recommendations for such promotion include implementing whole-of-school approaches that maximize resources across the school environment. This study examined schools' participation in an annual, government-led, and emirate-wide initiative in Dubai, called the Dubai Fitness Challenge, in which the goal is to accrue 30 minutes of PA every day for 30 days (as such, the initiative is colloquially referred to as "Dubai 30x30")., Methods: A mixed-methods design was employed for this study. Three schools were recruited using convenience sampling. Participants were 18 physical education teachers, 20 classroom teachers, 2 principals and 45 students. Data sources included surveys, focus groups, and interviews. Data were analyzed using descriptive statistics, multinomial logistic regression, and open and axial coding to develop themes., Results: School staff reported that most Dubai 30x30 activities were provided in physical education, at break times during school, and before and after school. Students reported that they mainly participated in Dubai 30x30 activities during physical education and occasionally participated in activities after school and on weekends. During school, students were more likely to reach higher PA intensity levels when they were in contexts other than the regular classroom setting. Among school staff, physical education teachers were most involved and classroom teachers were least involved in promoting Dubai 30x30. Parent engagement was high. Staff perceived that Dubai 30x30 brought the community together, but physical education teachers also indicated there was a lack of implementation guidance and they felt burdened. Participants believed Dubai 30x30 increased PA participation and helped to promote their schools., Discussion: This study provides an initial glimpse into schools' participation in Dubai 30x30 and suggests that a whole-of-school PA lens is useful in gleaning information that could help to increase and optimize PA opportunities for students., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 McMahon et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Objective measures of screen time are necessary to better understand the complex relationship between screen time and health outcomes. However, current objective measures of screen time (e.g., passive sensing applications) are limited in identifying the user of the mobile device, a critical limitation in children's screen time research where devices are often shared across a family. Behavioral biometrics, a technology that uses embedded sensors on modern mobile devices to continuously authenticate users, could be used to address this limitation., Objective: The purpose of this scoping review was to summarize the current state of behavioral biometric authentication and synthesize these findings within the scope of applying behavioral biometric technology to screen time measurement., Methods: We systematically searched five databases (Web of Science Core Collection, Inspec in Engineering Village, Applied Science & Technology Source, IEEE Xplore, PubMed), with the last search in September of 2022. Eligible studies were on the authentication of the user or the detection of demographic characteristics (age, gender) using built-in sensors on mobile devices (e.g., smartphone, tablet). Studies were required to use the following methods for authentication: motion behavior, touch, keystroke dynamics, and/or behavior profiling. We extracted study characteristics (sample size, age, gender), data collection methods, data stream, model evaluation metrics, and performance of models, and additionally performed a study quality assessment. Summary characteristics were tabulated and compiled in Excel. We synthesized the extracted information using a narrative approach., Results: Of the 14,179 articles screened, 122 were included in this scoping review. Of the 122 included studies, the most highly used biometric methods were touch gestures (n = 76) and movement (n = 63), with 30 studies using keystroke dynamics and 6 studies using behavior profiling. Of the studies that reported age (47), most were performed exclusively in adult populations (n = 34). The overall study quality was low, with an average score of 5.5/14., Conclusion: The field of behavioral biometrics is limited by the low overall quality of studies. Behavioral biometric technology has the potential to be used in a public health context to address the limitations of current measures of screen time; however, more rigorous research must be performed in child populations first., Systematic Review Registration: The protocol has been pre-registered in the Open Science Framework database ( https://doi.org/10.17605/OSF.IO/92YCT )., (© 2024. The Author(s).)

Introduction: This study examined the potential of a device agnostic approach for predicting physical activity from consumer wearable accelerometry compared with a research-grade accelerometry., Methods: Seventy-five 5- to 12-year-olds (58% male, 63% White) participated in a 60-min protocol. Children wore wrist-placed consumer wearables (Apple Watch Series 7 and Garmin Vivoactive 4) and a research-grade device (ActiGraph GT9X) concurrently with an indirect calorimeter (COSMED K5). Activity intensities (i.e., inactive, light, moderate-to-vigorous physical activity) were estimated via indirect calorimetry (criterion), and the Hildebrand thresholds were applied to the raw accelerometer data from the consumer wearables and research-grade device. Epoch-by-epoch (e.g., weighted sensitivity, specificity) and discrepancy (e.g., mean bias, absolute error) analyses evaluated agreement between accelerometry-derived and criterion estimates. Equivalence testing evaluated the equivalence of estimates produced by the consumer wearables and ActiGraph., Results: Estimates produced by the raw accelerometry data from ActiGraph, Apple, and Garmin produced similar criterion agreement with weighted sensitivity = 68.2% (95% confidence interval (CI), 67.1%-69.3%), 73.0% (95% CI, 71.8%-74.3%), and 66.6% (95% CI, 65.7%-67.5%), respectively, and weighted specificity = 84.4% (95% CI, 83.6%-85.2%), 82.0% (95% CI, 80.6%-83.4%), and 75.3% (95% CI, 74.7%-75.9%), respectively. Apple Watch produced the lowest mean bias (inactive, -4.0 ± 4.5; light activity, 2.1 ± 4.0) and absolute error (inactive, 4.9 ± 3.4; light activity, 3.6 ± 2.7) for inactive and light physical activity minutes. For moderate-to-vigorous physical activity, ActiGraph produced the lowest mean bias (1.0 ± 2.9) and absolute error (2.8 ± 2.4). No ActiGraph and consumer wearable device estimates were statistically significantly equivalent., Conclusions: Raw accelerometry estimated inactive and light activity from wrist-placed consumer wearables performed similarly to, if not better than, a research-grade device, when compared with indirect calorimetry. This proof-of-concept study highlights the potential of device-agnostic methods for quantifying physical activity intensity via consumer wearables., (Copyright © 2023 by the American College of Sports Medicine.)

The purpose of this meta-analysis was to quantify the difference in physical activity and sleep estimates assessed via 1) movement, 2) heart rate (HR), or 3) the combination of movement and HR (MOVE+HR) compared to criterion indicators of the outcomes. Searches in four electronic databases were executed September 21-24 of 2021. Weighted mean was calculated from standardized group-level estimates of mean percent error (MPE) and mean absolute percent error (MAPE) of the proxy signal compared to the criterion measurement method for physical activity, HR, or sleep. Standardized mean difference (SMD) effect sizes between the proxy and criterion estimates were calculated for each study across all outcomes, and meta-regression analyses were conducted. Two-One-Sided-Tests method were conducted to metaanalytically evaluate the equivalence of the proxy and criterion. Thirty-nine studies (physical activity k = 29 and sleep k = 10) were identified for data extraction. Sample size weighted means for MPE were -38.0%, 7.8%, -1.4%, and -0.6% for physical activity movement only, HR only, MOVE+HR, and sleep MOVE+HR, respectively. Sample size weighted means for MAPE were 41.4%, 32.6%, 13.3%, and 10.8% for physical activity movement only, HR only, MOVE+HR, and sleep MOVE+HR, respectively. Few estimates were statistically equivalent at a SMD of 0.8. Estimates of physical activity from MOVE+HR were not statistically significantly different from estimates based on movement or HR only. For sleep, included studies based their estimates solely on the combination of MOVE+HR, so it was impossible to determine if the combination produced significantly different estimates than either method alone.

Children from low-income households, and who are overweight or obese (OWOB), are at risk of accelerated weight gain during summer. Summer day camps (SDCs) have the potential to mitigate accelerated weight gain during summer as these settings can positively influence children's obesogenic behaviors ( i.e., increase physical activity); however, barriers exist to attending, most notably cost. Little is known on whether low-income caregivers of children with OWOB would be interested in having their child attend SDC for free. Caregivers ( n  = 109, 82% mother respondents, >75% Medicaid and Minority Household) with a child attending pediatric endocrinology clinics completed a one-page survey to explore demand. Approximately 66% of respondents expressed interest for their child to attend SDC for free. Providing free SDC for children with OWOB and from low-income households is a possible strategy to tackle childhood obesity during summer.

Background: The kidney failure risk equation (KFRE) can be used to predict progression to end-stage kidney disease in a clinical setting., Objective: Evaluate implementation of a formalized risk-based approach in nephrologists' outpatient clinics and multidisciplinary chronic kidney disease (CKD) clinics to determine candidacy for multidisciplinary care, and the impact of CKD care selection on clinical outcomes., Design: Population-based descriptive cohort study., Setting: Alberta Kidney Care South., Patients: Adults attending or considered for a multidisciplinary CKD clinic between April 1, 2017, and March 31, 2019., Measurements: Exposure -The course of CKD care assigned by the nephrologist: management at multidisciplinary CKD clinic; management by a nephrologist or primary care physician. Primary Outcome -CKD progression, defined as commencement of kidney replacement therapy (KRT). Secondary Outcomes -Death, emergency department visits, and hospitalizations., Methods: We linked operational data from the clinics (available until March 31, 2019) with administrative health and laboratory data (available until March 31, 2020). Comparisons among patient groups, courses of care, and clinical settings with negative binomial regression count models and calculated unadjusted and fully adjusted incidence rate ratios. For the all-cause death outcome, we used Cox survival models to calculate unadjusted and fully adjusted hazard ratios., Results: Of the 1748 patients for whom a KFRE was completed, 1347 (77%) remained in or were admitted to a multidisciplinary CKD clinic, 310 (18%) were managed by a nephrologist only, and 91 (5%) were referred back for management by their primary care physician. There was a much higher kidney failure risk among patients who remained at or were admitted to a multidisciplinary CKD clinic (median 2-year risk of 34.7% compared with 3.6% and 0.8% who remained with a nephrologist or primary care physician, respectively). None of the people managed by their primary care physician alone commenced KRT, while only 2 (0.6%) managed by a nephrologist without multidisciplinary CKD care commenced KRT. The rates of emergency department visits, hospitalizations, and death were lower in those assigned to management outside the multidisciplinary CKD clinics when compared with those managed in the multidisciplinary care setting., Limitations: The follow-up period may not have been long enough to determine outcomes, and potentially limited generalizability given variability of care in multidisciplinary clinics., Conclusions: Our findings indicate that a portion of patients can be directed to less resource-intensive care without a higher risk of adverse events., Trial Registration: Not applicable., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)

Background: During the Coronavirus disease (COVID-19) pandemic, countries implemented border control and quarantine measures to reduce transmission. The Alberta Border Testing Pilot Program (ABTPP) allowed international travellers entering Alberta to reduce their quarantine period following two negative COVID-19 tests. We evaluated participant experiences with the ABTPP and implementation., Method: We used a parallel convergent mixed-methods design to explore participant experiences through electronic web-based questionnaires ( n  = 21,089; n  = 13,839) and semi-structured telephone interviews ( n  = 30). We evaluated implementation through three staff focus groups ( n  = 11). We analysed questionnaires using descriptive statistics and analysed interviews using inductive and deductive thematic analysis. We deductively coded focus group data using the 2009 Consolidated Framework for Implementation Research (CFIR)., Results: Questionnaires indicated minimal issues with registration forms (91.7%), symptom reports (95.5%), and COVID-19 testing (95.7%). Most respondents (95.1%) expressed willingness to participate in the ABTPP again. Interviews revealed three themes related to participant experience: program efficiency, clarity of information, and requisite effort. Focus groups identified key implementation facilitators including the single health information system, strong stakeholder partnerships, and good communication across partnerships. Barriers included program complexity, implementation timeline, and evolving external context., Discussion: Participants reported high satisfaction with the ABTPP. Border testing programs should have high efficiency, require low effort, and use messaging that is clear and consistent. The effective implementation of border testing programs may be facilitated by strong leadership, adaptability, automated components, good communication, and simple technology. Learnings from participants and staff may help improve the implementation of border control programs for future pandemics or other emergencies., Conclusions: The ABTTP was a novel border control measure during the COVID-19 pandemic. Our evaluation of both participant and staff experiences demonstrated high levels of traveller satisfaction and identified areas for improvement that can inform the development of future border control measures., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Kersen, Scory, Akeju, Weaver, Barnieh, Ronksley, Leal, Blue, O'Neill, Campbell, Tonelli and Lunney.)

Background: It is essential to quantify the accuracy and precision of bioelectrical impedance (BIA)-estimated percent body fat (%BF) to better interpret community-based research findings that utilize opportunistic measures. Methods: Study 1 measured the accuracy of a new dual-frequency foot-to-foot BIA device (Tanita DC-430U) compared with dual-energy X-ray absorptiometry (DXA) among healthy elementary school-aged children ( N  = 50). Study 2 examined the precision of BIA %BF estimates within and between days among children and adults ( N  = 38). Results: Regarding accuracy, Tanita DC-430U underestimated %BF by 8.0 percentage points compared with DXA (20.6% vs. 28.5%), but correctly ranked children in terms of %BF. Differences in %BF between BIA and DXA were driven by lower BIA-estimated fat mass (7.8 kg vs. 9.9 kg, p  < 0.05) and higher BIA-estimated fat-free mass (25.3 kg vs. 24.1 kg, p  < 0.05). The absolute agreement between BIA and DXA for estimated %BF was moderate (concordance correlation coefficients = 0.53). Regarding precision, measures taken at the same time, but on different days (root mean square standard deviation [RMSD] = 0.42-0.74) were more precise than the measures taken at different times within a single day (RMSD = 1.04-1.10). Conclusion: The Tanita DC-430U substantially underestimated %BF compared with DXA, highlighting the need to assess accuracy of new BIA devices when they are introduced to the market. Opportunistic measures of %BF estimates were most precise when taken at consistent times and in the morning, but may be utilized throughout the day with an understanding of within- and between-day variability.

Background: Guidelines, checklists, frameworks, and recommendations (GCFRs) related to preliminary studies serve as essential resources to assist behavioral intervention researchers in reporting findings from preliminary studies, but their impact on preliminary study reporting comprehensiveness is unknown. The purpose of this study was to conduct a scoping bibliometric review of recently published preliminary behavioral-focused intervention studies to (1) examine the prevalence of GCFR usage and (2) determine the associations between GCFR usage and reporting feasibility-related characteristics., Methods: A systematic search was conducted for preliminary studies of behavioral-focused interventions published between 2018 and 2020. Studies were limited to the top 25 journals publishing behavioral-focused interventions, text mined to identify usage of GCFRs, and categorized as either not citing GCFRs or citing ≥ 2 GCFRs (Citers). A random sample of non-Citers was text mined to identify studies which cited other preliminary studies that cited GCFRs (Indirect Citers) and those that did not (Never Citers). The presence/absence of feasibility-related characteristics was compared between Citers, Indirect Citers, and Never Citers via univariate logistic regression., Results: Studies (n = 4143) were identified, and 1316 were text mined to identify GCFR usage (n = 167 Citers). A random sample of 200 studies not citing a GCFR were selected and categorized into Indirect Citers (n = 71) and Never Citers (n = 129). Compared to Never Citers, Citers had higher odds of reporting retention, acceptability, adverse events, compliance, cost, data collection feasibility, and treatment fidelity (OR range = 2.62-14.15, p < 0.005). Citers also had higher odds of mentioning feasibility in purpose statements, providing progression criteria, framing feasibility as the primary outcome, and mentioning feasibility in conclusions (OR range = 6.31-17.04, p < 0.005) and lower odds of mentioning efficacy in purpose statements, testing for efficacy, mentioning efficacy in conclusions, and suggesting future testing (ORrange = 0.13-0.54, p < 0.05). Indirect Citers had higher odds of reporting acceptability and treatment fidelity (OR range = 2.12-2.39, p < 0.05) but lower odds of testing for efficacy (OR = 0.36, p < 0.05) compared to Never Citers., Conclusion: The citation of GCFRs is associated with greater reporting of feasibility-related characteristics in preliminary studies of behavioral-focused interventions. Researchers are encouraged to use and cite literature that provides guidance on design, implementation, analysis, and reporting to improve the comprehensiveness of reporting for preliminary studies., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Introduction: In hospitalized patients, continuous glucose monitoring (CGM) may improve glycemic control, prevent hypoglycemic events, and reduce staff workload compared with point-of-care (POC) capillary glucose monitoring., Methods: To evaluate CGM accuracy and safety of use in the inpatient setting, two versions of CGM sensors were placed on 43 and 34 adult patients with diabetes admitted to non-intensive care unit (ICU) medical wards, respectively. CGM accuracy relative to POC and safety of use were measured by calculating mean absolute relative difference (MARD) and by Clarke Error Grid (CEG) analysis., Results: CGM version 2 had improved accuracy compared with CGM version 1 with MARD 17.7 compared with 21.4%. CGM accuracy did not change with POC value or with time of sensor wear. On CEG, 98.8% of paired values fell within acceptable zones A and B., Conclusion: Despite reduced accuracy compared with the outpatient setting, both versions of CGMs had acceptable safety profiles in the inpatient setting.

Goal and Aims: Evaluate the performance of a sleep scoring algorithm applied to raw accelerometry data collected from research-grade and consumer wearable actigraphy devices against polysomnography., Focus Method/technology: Automatic sleep/wake classification using the Sadeh algorithm applied to raw accelerometry data from ActiGraph GT9X Link, Apple Watch Series 7, and Garmin Vivoactive 4., Reference Method/technology: Standard manual PSG sleep scoring., Sample: Fifty children with disrupted sleep (M = 8.5 years, range = 5-12 years, 42% Black, 64% male)., Design: Participants underwent to single night lab polysomnography while wearing ActiGraph, Apple, and Garmin devices., Core Analytics: Discrepancy and epoch-by-epoch analyses for sleep/wake classification (devices vs. polysomnography)., Additional Analytics and Exploratory Analyses: Equivalence testing for sleep/wake classification (research-grade actigraphy vs. commercial devices)., Core Outcomes: Compared to polysomnography, accuracy, sensitivity, and specificity were 85.5, 87.4, and 76.8, respectively, for Actigraph; 83.7, 85.2, and 75.8, respectively, for Garmin; and 84.6, 86.2, and 77.2, respectively, for Apple. The magnitude and trend of bias for total sleep time, sleep efficiency, sleep onset latency, and wake after sleep were similar between the research and consumer wearable devices., Important Additional Outcomes: Equivalence testing indicated that total sleep time and sleep efficiency estimates from the research and consumer wearable devices were statistically significantly equivalent., Core Conclusion: This study demonstrates that raw acceleration data from consumer wearable devices has the potential to be harnessed to predict sleep in children. While further work is needed, this strategy could overcome current limitations related to proprietary algorithms for predicting sleep in consumer wearable devices., (Copyright © 2023 National Sleep Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The number of preliminary studies conducted and published has increased in recent years. However, there are likely many preliminary studies that go unpublished because preliminary studies are typically small and may not be perceived as methodologically rigorous. The extent of publication bias within preliminary studies is unknown but can prove useful to determine whether preliminary studies appearing in peer-reviewed journals are fundamentally different than those that are unpublished. The purpose of this study was to identify characteristics associated with publication in a sample of abstracts of preliminary studies of behavioral interventions presented at conferences., Methods: Abstract supplements from two primary outlets for behavioral intervention research (Society of Behavioral Medicine and International Society of Behavioral Nutrition and Physical Activity) were searched to identify all abstracts reporting findings of behavioral interventions from preliminary studies. Study characteristics were extracted from the abstracts including year presented, sample size, design, and statistical significance. To determine if abstracts had a matching peer-reviewed publication, a search of authors' curriculum vitae and research databases was conducted. Iterative logistic regression models were used to estimate odds of abstract publication. Authors with unpublished preliminary studies were surveyed to identify reasons for nonpublication., Results: Across conferences, a total of 18,961 abstracts were presented. Of these, 791 were preliminary behavioral interventions, of which 49% (388) were published in a peer-reviewed journal. For models with main effects only, preliminary studies with sample sizes greater than n = 24 were more likely to be published (range of odds ratios, 1.82 to 2.01). For models including interactions among study characteristics, no significant associations were found. Authors of unpublished preliminary studies indicated small sample sizes and being underpowered to detect effects as barriers to attempting publication., Conclusions: Half of preliminary studies presented at conferences go unpublished, but published preliminary studies appearing in peer-reviewed literature are not systematically different from those that remain unpublished. Without publication, it is difficult to assess the quality of information regarding the early-stage development of interventions. This inaccessibility inhibits our ability to learn from the progression of preliminary studies., (© 2023. The Author(s).)

Objectives: Preliminary studies play a key role in developing large-scale interventions but may be held to higher or lower scientific standards during the peer review process because of their preliminary study status., Study Design and Setting: Abstracts from 5 published obesity prevention preliminary studies were systematically modified to generate 16 variations of each abstract. Variations differed by 4 factors: sample size (n = 20 vs. n = 150), statistical significance (P < 0.05 vs. P > 0.05), study design (single group vs. randomized 2 groups), and preliminary study status (presence/absence of pilot language). Using an online survey, behavioral scientists were provided with a randomly selected variation of each of the 5 abstracts and blinded to the existence of other variations. Respondents rated each abstract on aspects of study quality., Results: Behavioral scientists (n = 271, 79.7% female, median age 34 years) completed 1,355 abstract ratings. Preliminary study status was not associated with perceived study quality. Statistically significant effects were rated as more scientifically significant, rigorous, innovative, clearly written, warranted further testing, and had more meaningful results. Randomized designs were rated as more rigorous, innovative, and meaningful., Conclusion: Findings suggest reviewers place a greater value on statistically significant findings and randomized control design and may overlook other important study characteristics., Competing Interests: Declaration of Competing Interest The authors have no competing interests or conflicts of interest to declare., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)