Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol.

BACKGROUND: As many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411-93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1-3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside 'one-stop-shop' approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic's current practice of usual care, which includes comprehensive patient navigation. METHODS: A quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the "simplified care" pathway (intervention group) or the "usual care" pathway (control group). Block randomization will be performed with a 1:1 randomization. DISCUSSION: Previous research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID. TRIAL REGISTRATION: We have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.

Fatness but Not Fitness Linked to BrainAge: Longitudinal Changes in Brain Aging during an Exercise Intervention.

PURPOSE: Fitness, physical activity, body composition, and sleep have all been proposed to explain differences in brain health. We hypothesized that an exercise intervention would result in improved fitness and body composition and would be associated with improved structural brain health. METHODS: In a randomized controlled trial, we studied 485 older adults who engaged in an exercise intervention ( n = 225) or a nonexercise comparison condition ( n = 260). Using magnetic resonance imaging, we estimated the physiological age of the brain (BrainAge) and derived a predicted age difference compared with chronological age (brain-predicted age difference (BrainPAD)). Aerobic capacity, physical activity, sleep, and body composition were assessed and their impact on BrainPAD explored. RESULTS: There were no significant differences between experimental groups for any variable at any time point. The intervention group gained fitness, improved body composition, and increased total sleep time but did not have significant changes in BrainPAD. Analyses of changes in BrainPAD independent of group assignment indicated significant associations with changes in body fat percentage ( r (479) = 0.154, P = 0.001), and visceral adipose tissue (VAT) ( r (478) = 0.141, P = 0.002), but not fitness ( r (406) = -0.075, P = 0.129), sleep ( r (467) range, -0.017 to 0.063; P range, 0.171 to 0.710), or physical activity ( r (471) = -0.035, P = 0.444). With linear regression, changes in body fat percentage and VAT significantly predicted changes in BrainPAD ( ß = 0.948, P = 0.003) with 1-kg change in VAT predicting 0.948 yr of change in BrainPAD. CONCLUSIONS: In cognitively normal older adults, exercise did not appear to impact BrainPAD, although it was effective in improving fitness and body composition. Changes in body composition, but not fitness, physical activity, or sleep impacted BrainPAD. These findings suggest that focus on weight control, particularly reduction of central obesity, could be an interventional target to promote healthier brains.

Barriers and facilitators to self-measured blood pressure monitoring among US-resettled Arab refugees with hypertension: a qualitative study.

BACKGROUND: Minoritized communities including refugees are at an increased risk of poorly controlled hypertension. Evidence indicates that self-measured blood pressure monitoring (SMBP) is an effective method to improve blood pressure control in patients with hypertension. However, it has not been studied among refugee populations. The objective of this study is to examine barriers and facilitators to SMBP among Arab refugees resettled in the United States (US) with diagnosed hypertension. METHODS: A total of 109 participants were recruited through a Federally Qualified Health Center system that is a major provider of healthcare to refugees in San Diego, California. Participants completed a questionnaire and were interviewed using in-depth, semi-structured interviews. Interviews were transcribed and translated, and data were coded using inductive thematic analysis and organized based on the theory of care-seeking behavior. RESULTS: Several barriers to engaging in effective SMBP monitoring were identified. Clinical and sociodemographic barriers included reliance on public monitors and poor hypertension literacy. Psychosocial barriers of affect, norms, and habits included fear and anxiety from hypertension, cultural stigma of illness, and conditional SMBP with symptoms, respectively. Utility psychosocial barriers included lack of SMBP prioritization in treatment and perceived inaccuracy of home monitors. Family members' support with home monitoring served as an important facilitator to SMBP. CONCLUSIONS: There are several barriers to effective SMBP among the US-resettled Arab refugee population that may reflect unique cultural and care-seeking behaviors. Tailored public health and clinical interventions are needed to support refugee patients and providers to improve hypertension self-management behaviors for this unique population.

Effects of an mHealth physical activity intervention to prevent osteoporosis in premenopausal women. A randomized controlled trial.

OBJECTIVES: It is critical to develop prevention strategies for osteoporosis that reduce the burden fractures place on individuals and health systems. This study evaluated the effects of an mHealth intervention that delivered and monitored a non-supervised exercise program on bone mineral density (BMD). DESIGN: Randomized controlled trial. METHODS: 60 premenopausal women aged 35-50 years were divided into an intervention group (IG) and a control group (CG). The IG followed a 6-month intervention aimed at increasing osteogenic physical activity, guided by two daily goals: walking at least 10,000 steps and completing 60 impacts over 4 g of acceleration. These goals were monitored using a wearable accelerometer linked to an mHealth app. The CG maintained their regular lifestyle and wore the accelerometer without feedback. BMD was estimated using dual-energy X-ray absorptiometry (DXA) scans at baseline and after 6 months, with group-by-time analyses conducted using ANCOVA. The intervention's impact on physical fitness and activity habits was also evaluated. RESULTS: 46 participants completed the study (IG = 24; CG = 22). The IG showed significant improvements compared to the CG in femoral neck BMD (IG: +0.003 ±â€¯0.029 g/cm2 vs CG: -0.027 ±â€¯0.031 g/cm2), trochanter BMD (IG: +0.004 ±â€¯0.023 g/cm2 vs CG: -0.026 ±â€¯0.030 g/cm2), and total hip BMD (IG: +0.006 ±â€¯0.043 g/cm2 vs CG: -0.040 ±â€¯0.048 g/cm2). The IG also demonstrated significant improvements in physical fitness measures, including peak torque and power at various speeds and positions. No adverse events related to the intervention were reported. CONCLUSIONS: This non-supervised physical activity intervention delivered by wearable-technology and an mHealth app was effective in improving BMD, suggesting its potential for osteoporosis prevention.

Impact of United States refugee ban and discrimination on the mental health of hypertensive Arabic-speaking refugees.

Background: Hypertension is a global leading cause of death which disproportionately affects refugees. This chronic disease increases the risk of heart disease, stroke, brain, and other end-organ disease, if left uncontrolled. The 2017 United States travel or "Muslim" ban prevented immigrants and refugees from seven Muslim-majority countries from entering the United States, including Syria and Iraq; two major contributors to the global refugee population. As of 2020, the United States has admitted more than 133,000 and 22,000 Iraqi and Syrian refugees, respectively. Studies on the health effects of this policy on refugees are lacking. This study qualitatively explores the impact of the refugee ban on United States resettled Syrian and Iraqi refugees with hypertension. Methods: Participants were recruited through a federally qualified health center system that is the largest healthcare provider for refugees in San Diego, CA. All participants were Arabic-speaking refugees diagnosed with hypertension from Syria and Iraq. In-depth interviews took place between April 2021 and April 2022. Inductive thematic analysis was used to analyze data from semi-structured interviews. Results: Participants (N = 109) include 53 women and 56 men (23 Syrian, 86 Iraqi). The average age was 61.3 years (SD: 9.7) and stay in the United States was 9.5 years (SD 5.92). Four themes emerged linking the travel ban's impact on health, in line with the society to cells framework: (1) family factors: the refugee ban resulted in family separation; (2) physiological factors: the refugee ban worsened participants' mental health, exacerbating hypertension and perceived health outcomes; (3) community factors: perpetuation of Islamophobia, xenophobia, and perceived discrimination were structural barriers with links to poorer health; and (4) individual factors: trickle down consequences led to worsened participant self-image and self-perception within their host community. Discussion: The refugee ban negatively impacted the mental and physical health of United States resettled Arabic-speaking refugees through perceived discrimination, stress, and poor social integration. It continues to have long-lasting effects years after the ban was instated. Centering family reunification within the United States Refugee Admissions Program and tailoring interventions through the healthcare and public health systems are warranted to reduce hypertension disparities in this growing and overlooked population.

A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial.

BACKGROUND: The clinical burden of Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI) is increasing. There is a critical need to advance understanding of the effectiveness and sustainability of innovative approaches to clinical care of patients having these conditions. METHODS: We aim to assess the effectiveness of a Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) in a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial in which 20 consenting clinicians across primary care clinics in a Federally Qualified Health Center system in San Diego, CA, will be randomized at a ratio of 1:1 to either participate in (1) weekly multi-disciplinary team-based case consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO (Extension for Community Healthcare Outcomes)) with monthly interactive webinars and quarterly short courses or (2) monthly interactive webinars and quarterly short courses alone (a control group); 856 patients will be assigned to participating clinicians (42 patients per clinician). Patient outcomes will be evaluated according to the study arm of their respective clinicians. Quantitative and qualitative outcomes will be measured at 3- and 6-months post-baseline for clinicians and every 3-months post assignment to a participating clinician for patients. The primary patient outcome is change in physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Analyses of differences in outcomes at both the patient and clinician levels will include a linear mixed model to compare change in outcomes from baseline to each post-baseline assessment between the randomized study arms. A concurrent prospective cohort study will compare the LC&FIRP patient population to the population enrolled in a university health system. Longitudinal data analysis approaches will allow us to examine differences in outcomes between cohorts. DISCUSSION: We hypothesize that weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to the control group. This study will provide much needed evidence on the effectiveness of a technology-enabled multi-disciplinary team-based care model for the management of Long COVID, ME/CFS, and other PIFI within a federally qualified health center. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05167227 . Registered on December 22, 2021.

COVID-19 monoclonal antibody treatment impact on symptoms and post-COVID conditions among high-risk patients at a Federally Qualified Health Center.

BACKGROUND: Monoclonal antibody (mAb) treatment for COVID-19 is associated with improved clinical outcomes. However, there is limited information regarding the impact of treatment on symptoms and the prevalence of post-COVID Conditions (PCC). Understanding of the association between time to mAb infusion and the development of PCC is also limited. METHODS: This longitudinal study was conducted among patients with COVID-19 who received mAb infusions at a Federally Qualified Health Center in San Diego, CA. A series of telephone interviews were conducted at baseline and follow-up (14 days and 28+ days). A comprehensive symptom inventory was completed and physical and mental health status were measured using PROMIS-29 and PHQ-2. Pearson's Chi-squared tests and independent two-sample t-tests were performed to test for association between time to mAb infusion and outcomes at follow-up. A Poisson regression model was used to analyze whether time to mAb infusion predicts risk of developing PCC. RESULTS: Participants (N = 411) were 53% female, ranged in age from 16 to 92 years (mean 50), and a majority (56%) were Latino/Hispanic. Cross-sectional findings revealed a high symptom burden at baseline (70% of patients had cough, 50% had fever, and 44% had headache). The prevalence of many symptoms decreased substantially by the final follow-up survey (29% of patients had cough, 3% had fever, and 28% had headache). Longitudinal findings indicated that 10 symptoms decreased in prevalence from baseline to final follow-up, 2 remained the same, and 14 increased. The severity of symptoms and most patient-reported physical and mental health measure scores decreased over time. The prevalence of PCC was 69% when PCC was defined as ≥ 1 symptom at final follow-up. Time to mAb infusion was not significantly associated with any outcome at follow-up. Time to infusion was not associated with PCC status at final follow-up in the crude or adjusted Poisson regression models. CONCLUSIONS: The prevalence of PCC was high among this patient population following COVID-19 mAb treatment. Time to mAb infusion did not predict the development of PCC. Further research in these areas is essential to answer urgent clinical questions about effective treatments of COVID-19.

Recommendations for Identifying Valid Wear for Consumer-Level Wrist-Worn Activity Trackers and Acceptability of Extended Device Deployment in Children.

BACKGROUND: Self-reported physical activity is often inaccurate. Wearable devices utilizing multiple sensors are now widespread. The aim of this study was to determine acceptability of Fitbit Charge HR for children and their families, and to determine best practices for processing its objective data. METHODS: Data were collected via Fitbit Charge HR continuously over the course of 3 weeks. Questionnaires were given to each child and their parent/guardian to determine the perceived usability of the device. Patterns of data were evaluated and best practice inclusion criteria recommended. RESULTS: Best practices were established to extract, filter, and process data to evaluate device wear, r and establish minimum wear time to evaluate behavioral patterns. This resulted in usable data available from 137 (89%) of the sample. CONCLUSIONS: Activity trackers are highly acceptable in the target population and can provide objective data over longer periods of wear. Best practice inclusion protocols that reflect physical activity in youth are provided.

Accuracy and Precision of Energy Expenditure, Heart Rate, and Steps Measured by Combined-Sensing Fitbits Against Reference Measures: Systematic Review and Meta-analysis.

BACKGROUND: Although it is widely recognized that physical activity is an important determinant of health, assessing this complex behavior is a considerable challenge. OBJECTIVE: The purpose of this systematic review and meta-analysis is to examine, quantify, and report the current state of evidence for the validity of energy expenditure, heart rate, and steps measured by recent combined-sensing Fitbits. METHODS: We conducted a systematic review and Bland-Altman meta-analysis of validation studies of combined-sensing Fitbits against reference measures of energy expenditure, heart rate, and steps. RESULTS: A total of 52 studies were included in the systematic review. Among the 52 studies, 41 (79%) were included in the meta-analysis, representing 203 individual comparisons between Fitbit devices and a criterion measure (ie, n=117, 57.6% for heart rate; n=49, 24.1% for energy expenditure; and n=37, 18.2% for steps). Overall, most authors of the included studies concluded that recent Fitbit models underestimate heart rate, energy expenditure, and steps compared with criterion measures. These independent conclusions aligned with the results of the pooled meta-analyses showing an average underestimation of -2.99 beats per minute (k comparison=74), -2.77 kcal per minute (k comparison=29), and -3.11 steps per minute (k comparison=19), respectively, of the Fitbit compared with the criterion measure (results obtained after removing the high risk of bias studies; population limit of agreements for heart rate, energy expenditure, and steps: -23.99 to 18.01, -12.75 to 7.41, and -13.07 to 6.86, respectively). CONCLUSIONS: Fitbit devices are likely to underestimate heart rate, energy expenditure, and steps. The estimation of these measurements varied by the quality of the study, age of the participants, type of activities, and the model of Fitbit. The qualitative conclusions of most studies aligned with the results of the meta-analysis. Although the expected level of accuracy might vary from one context to another, this underestimation can be acceptable, on average, for steps and heart rate. However, the measurement of energy expenditure may be inaccurate for some research purposes.

Evaluation of Social Isolation, Loneliness, and Cardiovascular Disease Among Older Women in the US.

Importance: Social isolation and loneliness are increasing public health concerns and have been associated with increased risk of cardiovascular disease (CVD) among older adults. Objective: To examine the associations of social isolation and loneliness with incident CVD in a large cohort of postmenopausal women and whether social support moderated these associations. Design, Setting, and Participants: This prospective cohort study, conducted from March 2011 through March 2019, included community-living US women aged 65 to 99 years from the Women's Health Initiative Extension Study II who had no history of myocardial infarction, stroke, or coronary heart disease. Exposures: Social isolation and loneliness were ascertained using validated questionnaires. Main Outcomes and Measures: The main outcome was major CVD, which was physician adjudicated using medical records and included coronary heart disease, stroke, and death from CVD. Continuous scores of social isolation and loneliness were analyzed. Hazard ratios (HRs) and 95% CIs for CVD were calculated for women with high social isolation and loneliness scores (midpoint of the upper half of the distribution) vs those with low scores (midpoint of the lower half of the distribution) using multivariable Cox proportional hazards regression models adjusting for age, race and ethnicity, educational level, and depression and then adding relevant health behavior and health status variables. Questionnaire-assessed social support was tested as a potential effect modifier. Results: Among 57 825 women (mean [SD] age, 79.0 [6.1] years; 89.1% White), 1599 major CVD events occurred over 186 762 person-years. The HR for the association of high vs low social isolation scores with CVD was 1.18 (95% CI, 1.13-1.23), and the HR for the association of high vs low loneliness scores with CVD was 1.14 (95% CI, 1.10-1.18). The HRs after additional adjustment for health behaviors and health status were 1.08 (95% CI, 1.03-1.12; 8.0% higher risk) for social isolation and 1.05 (95% CI, 1.01-1.09; 5.0% higher risk) for loneliness. Women with both high social isolation and high loneliness scores had a 13.0% to 27.0% higher risk of incident CVD than did women with low social isolation and low loneliness scores. Social support was not a significant effect modifier of the associations (social isolation × social support: r, -0.18; P = .86; loneliness × social support: r, 0.78; P = .48). Conclusions and Relevance: In this cohort study, social isolation and loneliness were independently associated with modestly higher risk of CVD among postmenopausal women in the US, and women with both social isolation and loneliness had greater CVD risk than did those with either exposure alone. The findings suggest that these prevalent psychosocial processes merit increased attention for prevention of CVD in older women, particularly in the era of COVID-19.

Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes.

BACKGROUND: By 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant's individual needs with a greater focus on health behavior change. METHODS: This is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions. DISCUSSION: Our comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability. TRIAL REGISTRATION: NCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699 .

Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings.

BACKGROUND: Excess weight gain in young adulthood is associated with future weight gain and increased risk of chronic disease. Although multimodal, technology-based weight-loss interventions have the potential to promote weight loss among young adults, many interventions have limited personalization, and few have been deployed and evaluated for longer than a year. We aim to assess the effects of a highly personalized, 2-year intervention that uses popular mobile and social technologies to promote weight loss among young adults. METHODS: The Social Mobile Approaches to Reducing Weight (SMART) 2.0 Study is a 24-month parallel-group randomized controlled trial that will include 642 overweight or obese participants, aged 18-35 years, from universities and community colleges in San Diego, CA. All participants receive a wearable activity tracker, connected scale, and corresponding app. Participants randomized to one intervention group receive evidence-based information about weight loss and behavior change techniques via personalized daily text messaging (i.e., SMS/MMS), posts on social media platforms, and online groups. Participants in a second intervention group receive the aforementioned elements in addition to brief, technology-mediated health coaching. Participants in the control group receive a wearable activity tracker, connected scale, and corresponding app alone. The primary outcome is objectively measured weight in kilograms over 24 months. Secondary outcomes include anthropometric measurements; physiological measures; physical activity, diet, sleep, and psychosocial measures; and engagement with intervention modalities. Outcomes are assessed at baseline and 6, 12, 18, and 24 months. Differences between the randomized groups will be analyzed using a mixed model of repeated measures and will be based on the intent-to-treat principle. DISCUSSION: We hypothesize that both SMART 2.0 intervention groups will significantly improve weight loss compared to the control group, and the group receiving health coaching will experience the greatest improvement. We further hypothesize that differences in secondary outcomes will favor the intervention groups. There is a critical need to advance understanding of the effectiveness of multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults. Our findings should inform the implementation of low-cost and scalable interventions for weight loss and risk-reducing health behaviors. TRIAL REGISTRATION: ClinicalTrials.gov NCT03907462 . Registered on April 9, 2019.

Day-to-day associations between sleep and physical activity: a set of person-specific analyses in adults with overweight and obesity.

The objective of the present study was to estimate whether physical activity on one day was associated with both sleep quality and quantity the following night and to examine to what extent sleep on one night was associated with physical activity the next day. We collected data from 33 young adults who were overweight or obese and consistently wore a Fitbit Charge 3. A total of 7094 days and nights were analyzed. Person-specific models were conducted to test the bi-directional associations for each participant separately. Results suggest an absence of association between steps and sleep efficiency in the two directions. More heterogeneous results were observed for the association between steps and total sleep time, with 19 participants (58%) showing a negative association between total sleep time and next day steps, and 9 (27%) showing a negative association between steps and next day total sleep time. Taken together, these results suggest a potential conflicting association between total sleep time and physical activity for some participants. Pre- and post-print doi: https://doi.org/10.31236/osf.io/nfjqv ; supplemental material: https://osf.io/y7nxg/ .

Fatness, fitness and the aging brain: A cross sectional study of the associations between a physiological estimate of brain age and physical fitness, activity, sleep, and body composition.

Introduction: Changes in brain structure and function occur with aging. However, there is substantial heterogeneity both in terms of when these changes begin, and the rate at which they progress. Understanding the mechanisms and/or behaviors underlying this heterogeneity may allow us to act to target and slow negative changes associated with aging. Methods: Using T1 weighted MRI images, we applied a novel algorithm to determine the physiological age of the brain (brain-predicted age) and the predicted age difference between this physiologically based estimate and chronological age (BrainPAD) to 551 sedentary adults aged 65 to 84 with self-reported cognitive complaint measured at baseline as part of a larger study. We also assessed maximal aerobic capacity with a graded exercise test, physical activity and sleep with accelerometers, and body composition with dual energy x-ray absorptiometry. Associations were explored both linearly and logistically using categorical groupings. Results: Visceral Adipose Tissue (VAT), Total Sleep Time (TST) and maximal aerobic capacity all showed significant associations with BrainPAD. Greater VAT was associated with higher (i.e,. older than chronological) BrainPAD (r = 0.149 p = 0.001)Greater TST was associated with higher BrainPAD (r = 0.087 p = 0.042) and greater aerobic capacity was associated with lower BrainPAD (r = - 0.088 p = 0.040). With linear regression, both VAT and TST remained significant (p = 0.036 and 0.008 respectively). Each kg of VAT predicted a 0.741 year increase in BrainPAD, and each hour of increased TST predicted a 0.735 year increase in BrainPAD. Maximal aerobic capacity did not retain statistical significance in fully adjusted linear models. Discussion: Accumulation of visceral adipose tissue and greater total sleep time, but not aerobic capacity, total daily physical activity, or sleep quantity and/or quality are associated with brains that are physiologically older than would be expected based upon chronological age alone (BrainPAD).

Impact of the COVID-19 Pandemic on Objectively Measured Physical Activity and Sedentary Behavior Among Overweight Young Adults: Yearlong Longitudinal Analysis.

BACKGROUND: The COVID-19 pandemic has impacted multiple aspects of daily living, including behaviors associated with occupation, transportation, and health. It is unclear how these changes to daily living have impacted physical activity and sedentary behavior. OBJECTIVE: In this study, we add to the growing body of research on the health impact of the COVID-19 pandemic by examining longitudinal changes in objectively measured daily physical activity and sedentary behavior among overweight or obese young adults participating in an ongoing weight loss trial in San Diego, California. METHODS: Data were collected from 315 overweight or obese (BMI: range 25.0-39.9 kg/m2) participants aged from 18 to 35 years between November 1, 2019, and October 30, 2020, by using the Fitbit Charge 3 (Fitbit LLC). After conducting strict filtering to find valid data on consistent wear (>10 hours per day for ≥250 days), data from 97 participants were analyzed to detect multiple structural changes in time series of physical activity and sedentary behavior. An algorithm was designed to detect multiple structural changes. This allowed for the automatic identification and dating of these changes in linear regression models with CIs. The number of breakpoints in regression models was estimated by using the Bayesian information criterion and residual sum of squares; the optimal segmentation corresponded to the lowest Bayesian information criterion and residual sum of squares. To quantify the changes in each outcome during the periods identified, linear mixed effects analyses were conducted. In terms of key demographic characteristics, the 97 participants included in our analyses did not differ from the 210 participants who were excluded. RESULTS: After the initiation of the shelter-in-place order in California on March 19, 2021, there were significant decreases in step counts (-2872 steps per day; 95% CI -2734 to -3010), light physical activity times (-41.9 minutes; 95% CI -39.5 to -44.3), and moderate-to-vigorous physical activity times (-12.2 minutes; 95% CI -10.6 to -13.8), as well as significant increases in sedentary behavior times (+52.8 minutes; 95% CI 47.0-58.5). The decreases were greater than the expected declines observed during winter holidays, and as of October 30, 2020, they have not returned to the levels observed prior to the initiation of shelter-in-place orders. CONCLUSIONS: Among overweight or obese young adults, physical activity times decreased and sedentary behavior times increased concurrently with the implementation of COVID-19 mitigation strategies. The health conditions associated with a sedentary lifestyle may be additional, unintended results of the COVID-19 pandemic.

Effectiveness of a Decentralized Hub and Spoke Model for the Treatment of Hepatitis C Virus in a Federally Qualified Health Center.

Hepatitis C virus (HCV) is a major cause of cirrhosis, liver cancer, and mortality in the United States. We assessed the effectiveness of decentralized HCV treatment delivered by nurse practitioners (NPs), primary care physicians (PMDs), or an infectious disease physician (ID MD) using direct-acting antivirals in a Federally Qualified Health Center (FQHC) in urban San Diego, CA. We conducted a cross-sectional analysis of 1,261 patients who received treatment from six NPs, 10 PMDs, and one ID MD practicing in 10 clinics between January 2014 and January 2020. Care was delivered based on the Extension for Community Healthcare Outcomes (Project ECHO) model with one hub and nine spokes. HCV was deemed cured if a patient had a sustained virologic response (SVR) after 12 weeks of treatment (SVR12). We evaluated differences in the prevalence of cure between provider types and hub or spoke status using Poisson regression. Patients were 34% Latino, 16% black, 63% were aged >50 years, and 59% were homeless; 53% had advanced fibrosis, 69% had genotype 1, and 5% were coinfected with human immunodeficiency virus. A total of 943 patients achieved SVR12 (96% per protocol and 73% intention to treat). Even after adjustment for demographics, resources, and disease characteristics, the prevalence of cure did not differ between the ID MD and PMDs (prevalence ratio [PR], 1.00; 95% confidence interval [CI], 0.95-1.04) or NPs (PR, 1.01; 95% CI, 0.96-1.05). Similarly, there were no differences between the hub and spokes (PR, 1.01; 95% CI, 0.98-1.04). Conclusion: Among a low-income and majority homeless cohort of patients at urban FQHC clinics, HCV treatment administered by nonspecialist providers was not inferior to that provided by a specialist.

Quantification of Scan Analysis Errors in GE Lunar DXA Visceral Adiposity in Adults.

Utilization of dual-energy X-ray absorptiometry is increasing in clinical settings and the fitness industry as a viable tool to assess total and regional body composition, including visceral adiposity. Previous research using small samples (<50) has described several pitfalls in patient positioning, scan acquisition, and/or analysis that alter regional body composition values. Our aim was to quantify the largest probable error in measures of total, android, gynoid, and visceral fat caused by incorrect placement of the head cut-line, in a large sample of adults. Total body images (N = 436) from 196 women and 67 men (20-85 years) scanned on a GE Lunar Prodigy densitometer were analyzed using enCORE software in 2 ways: (1) placing the head cut-line just beneath the bony protuberance of the chin according to manufacturer recommendation (correct method); (2) placing the head cut-line at the lowest point below the chin and just above the soft tissue at the shoulders (incorrect method). All other cut-lines were fixed. Mean differences in adiposity were examined using Lin's concordance correlation coefficient; equality of means and variances were evaluated using Bradley-Blackwood F-tests. The limits of agreement were displayed as Bland-Altman plots and calculated as the mean difference ±1.96 times the standard deviation of the difference. Correlation coefficients for paired comparisons of adiposity for correct vs incorrect cut-line placement ranged from 0.983-0.999 for all variables (all p < 0.001). Significant mean differences were 172 ± 130, 201 ± 168, 65 ± 122, and -143 ± 336 g for android, gynoid, visceral, and total fat mass, respectively (all p < 0.0001). These differences exceeded our site's least significant change in 66%, 37%, 29%, and 4% of participant scans for android, gynoid, visceral, and total fat mass, respectively. Our findings underscore the importance of careful review of the manufacturer's auto analysis and consistency in conducting serial scans to ensure accurate and precise measures of regional body fat.

Performance of a commercial multi-sensor wearable (Fitbit Charge HR) in measuring physical activity and sleep in healthy children.

PURPOSE: This study sought to assess the performance of the Fitbit Charge HR, a consumer-level multi-sensor activity tracker, to measure physical activity and sleep in children. METHODS: 59 healthy boys and girls aged 9-11 years old wore a Fitbit Charge HR, and accuracy of physical activity measures were evaluated relative to research-grade measures taken during a combination of 14 standardized laboratory- and field-based assessments of sitting, stationary cycling, treadmill walking or jogging, stair walking, outdoor walking, and agility drills. Accuracy of sleep measures were evaluated relative to polysomnography (PSG) in 26 boys and girls during an at-home unattended PSG overnight recording. The primary analyses included assessment of the agreement (biases) between measures using the Bland-Altman method, and epoch-by-epoch (EBE) analyses on a minute-by-minute basis. RESULTS: Fitbit Charge HR underestimated steps (~11.8 steps per minute), heart rate (~3.58 bpm), and metabolic equivalents (~0.55 METs per minute) and overestimated energy expenditure (~0.34 kcal per minute) relative to research-grade measures (p< 0.05). The device showed an overall accuracy of 84.8% for classifying moderate and vigorous physical activity (MVPA) and sedentary and light physical activity (SLPA) (sensitivity MVPA: 85.4%; specificity SLPA: 83.1%). Mean estimates of bias for measuring total sleep time, wake after sleep onset, and heart rate during sleep were 14 min, 9 min, and 1.06 bpm, respectively, with 95.8% sensitivity in classifying sleep and 56.3% specificity in classifying wake epochs. CONCLUSIONS: Fitbit Charge HR had adequate sensitivity in classifying moderate and vigorous intensity physical activity and sleep, but had limitations in detecting wake, and was more accurate in detecting heart rate during sleep than during exercise, in healthy children. Further research is needed to understand potential challenges and limitations of these consumer devices.

Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs).

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field.

The efficacy of electronic health interventions targeting improved sleep for achieving prevention of weight gain in adolescents and young to middle-aged adults: A systematic review.

Sleep is emerging as a modifiable risk factor in counteracting harmful weight gain. Electronic and mobile devices offer a channel for wide-reaching intervention delivery. This systematic review aimed to determine the efficacy of interventions that included sleep behaviour as part of health promotion for preventing weight gain. Seven databases were searched from 1 January 2000 until 28 June 2019. Eligible studies were controlled trials of weight gain prevention programs that addressed sleep in healthy participants aged 13 to 44 years of age. The primary outcome was change in measured or self-reported weight. From 824 publications located, only six eligible trials with a total of 3,277 participants were identified and all addressed multiple behaviours. One study demonstrated a decrease in weight for the intervention group, and two other studies showed a decreased prevalence of overweight and obesity. Only one trial showed improved sleep duration but failed to show differences in weight. No definitive conclusions concerning the efficacy of electronic weight gain prevention interventions that include sleep can be made, but future trials should provide more detail about intervention techniques used, employ objective sleep and physical activity measures and undertake mediation analysis to judge the contributions of changes in sleep to study outcomes. PROSPERO REGISTRATION: CRD42019121879.