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.

The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring.

Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.

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.

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/ .

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.

Response to the Coronavirus Disease 2019 Pandemic Among People Experiencing Homelessness in Congregant Living Settings in San Diego, California.

During April 2020-August 2020, a preemptive testing strategy combined with accessible isolation and symptom screening among people experiencing homelessness in congregant living settings in San Diego, California, contributed to a low incidence proportion of coronavirus disease 2019 (0.9%). Proactively addressing challenges specific to a vulnerable population may prove impactful.

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.

Modelling multiple health behavior change with network analyses: results from a one-year study conducted among overweight and obese adults.

This study examined the between-person associations of seven health behaviors in adults with obesity participating in a weight loss intervention, as well as the covariations between these behaviors within-individuals across the intervention. The present study included data from a 12-month weight loss trial (N = 278). Seven health behaviors (physical activity, sedentary behavior, sleep duration, and consumption of fruits, vegetables, total fat and added sugar) were measured at baseline, 6- and 12-months. Between- and within-participants network analyses were conducted to examine how these behaviors were associated through the 12-month intervention and covaried across months. At the between-participants level, associations were found within the different diet behaviors and between total fat and sedentary behaviors. At the within-participants level, covariations were found between sedentary and diet behaviors, and within diet behaviors. Findings suggest that successful multiple health behaviors change interventions among adults with obesity will need to (1) simultaneously target sedentary and diet behaviors; and (2) prevent potential compensatory behaviors in the diet domain.

Text messaging and brief phone calls for weight loss in overweight and obese English- and Spanish-speaking adults: A 1-year, parallel-group, randomized controlled trial.

BACKGROUND: Weight loss interventions based solely on text messaging (short message service [SMS]) have been shown to be modestly effective for short periods of time and in some populations, but limited evidence is available for positive longer-term outcomes and for efficacy in Hispanic populations. Also, little is known about the comparative efficacy of weight loss interventions that use SMS coupled with brief, technology-mediated contact with health coaches, an important issue when considering the scalability and cost of interventions. We examined the efficacy of a 1-year intervention designed to reduce weight among overweight and obese English- and Spanish-speaking adults via SMS alone (ConTxt) or in combination with brief, monthly health-coaching calls. ConTxt offered 2-4 SMS/day that were personalized, tailored, and interactive. Content was theory- and evidence-based and focused on reducing energy intake and increasing energy expenditure. Monthly health-coaching calls (5-10 minutes' duration) focused on goal-setting, identifying barriers to achieving goals, and self-monitoring. METHODS AND FINDINGS: English- and Spanish-speaking adults were recruited from October 2011 to March 2013. A total of 298 overweight (body mass index [BMI] 27.0 to 39.9 kg/m2) adults (aged 21-60 years; 77% female; 41% Hispanic; 21% primarily Spanish speaking; 44% college graduates or higher; 22% unemployed) were randomly assigned (1:1) to receive either ConTxt only (n = 101), ConTxt plus health-coaching calls (n = 96), or standard print materials on weight reduction (control group, n = 101). We used computer-based permuted-block randomization with block sizes of three or six, stratified by sex and Spanish-speaking status. Participants, study staff, and investigators were masked until the intervention was assigned. The primary outcome was objectively measured percent of weight loss from baseline at 12 months. Differences between groups were evaluated using linear mixed-effects regression within an intention-to-treat framework. A total of 261 (87.2%) and 253 (84.9%) participants completed 6- and 12-month visits, respectively. Loss to follow-up did not differ by study group. Mean (95% confidence intervals [CIs]) percent weight loss at 12 months was -0.61 (-1.99 to 0.77) in the control group, -1.68 (-3.08 to -0.27) in ConTxt only, and -3.63 (-5.05 to -2.81) in ConTxt plus health-coaching calls. At 12 months, mean (95% CI) percent weight loss, adjusted for baseline BMI, was significantly different between ConTxt plus health-coaching calls and the control group (-3.0 [-4.99 to -1.04], p = 0.003) but not between the ConTxt-only and the control group (-1.07 [-3.05 to 0.92], p = 0.291). Differences between ConTxt plus health-coaching calls and ConTxt only were not significant (-1.95 [-3.96 to 0.06], p = 0.057). These findings were consistent across other weight-related secondary outcomes, including changes in absolute weight, BMI, and percent body fat at 12 months. Exploratory subgroup analyses suggested that Spanish speakers responded more favorably to ConTxt plus health-coaching calls than English speakers (Spanish contrast: -7.90 [-11.94 to -3.86], p < 0.001; English contrast: -1.82 [-4.03 to 0.39], p = 0.107). Limitations include the unblinded delivery of the intervention and recruitment of a predominantly female sample from a single site. CONCLUSIONS: A 1-year intervention that delivered theory- and evidence-based weight loss content via daily personalized, tailored, and interactive SMS was most effective when combined with brief, monthly phone calls. TRIAL REGISTRATION: ClinicalTrials.gov NCT01171586.

Associations between reliable changes in depression and changes in BMI, total body fatness and visceral adiposity during a 12-month weight loss trial.

We investigated associations between changes in depression and body composition over a 12-month weight loss trial. Of the 298 adults (BMI > 27 m/kg2), 219 with complete depression and body composition data were included. A 10-item Center for Epidemiologic Studies Depression Scale measured depression; dual-energy X-ray absorptiometry measured body composition. Multinomial logistic regression predicted reliable changes in depression by BMI, body fat (BF) and visceral adiposity (VAT). Multiplicative interaction terms tested modification by sex and ethnicity. Participants with increases in body composition were less likely to experience improvements in depression (BMI: RRR = 0.79 (0.68-0.91), p < 0.01; BF: RRR = 0.97 (0.94 - 0.99), p = 0.01; VAT: RRR = 0.99 (0.98-1.00), p = 0.02), but not worsening of depression (BMI: RRR = 1.29 (0.96-1.73), p = 0.10; BF: RRR = 1.04 (0.99-1.09), p = 0.15; VAT: RRR = 1.01 (1.00-1.03), p = 0.18). Sex and ethnicity interaction terms were not significant. However, the relationship was only significant among females, among non-Latinos for BMI and BF, and among Latinos for VAT. Our study supports the association between depression and obesity and highlights the need for longitudinal studies investigating VAT and depression in diverse ethnic groups.

Longitudinal Decline in Cardiorespiratory Fitness With Age Among Male Firefighters in San Diego, California, 2005-2015.

OBJECTIVES: To determine age-associated changes in cardiorespiratory fitness (CRF) among firefighters. METHODS: Male firefighters (n = 1169) underwent annual evaluations from 2005 to 2015 in San Diego, California. We assessed CRF, the ability to deliver and use oxygen, during a maximal graded exercise test and recorded it in metabolic equivalents (METs; 1 MET = 3.5 ml/kg/min). We investigated differences in baseline CRF among 10-year age groups and patterns of change over follow-up using cross-sectional and longitudinal analyses, respectively. RESULTS: Both analyses support an inverse relationship between CRF and age. Mean baseline CRF decreased from 15.7 ±1.7 to 11.7 ±1.9 METs in the younger than 30 years and 50 years and older age groups, respectively. There was no interaction between body fat and age in predicting CRF (Page × body fat = .09). Longitudinally, there was a nonlinear decrease in CRF, which differed across age groups: the youngest age group demonstrated the greatest decrease in CRF. CONCLUSIONS: Results support a negative, nonlinear association between age and CRF without modification by body fatness. Public Health Implications. Fire departments should recognize the health and safety risks of declining CRF and institutionalize programs to promote firefighter fitness.

Planned care for obesity and cardiovascular risk reduction using a stepped-down approach: A randomized-controlled trial.

Primary care-based approaches to address concurrent obesity and cardiovascular disease risk factors (CVDRFs) that begin with a high intensity intervention that is subsequently decreased (i.e., stepped-down) if weight loss is achieved have not been rigorously examined. Our study is a 20-month, single-blind randomized controlled trial at five primary care clinics in San Diego, CA, in 2013, where 262 obese adults (aged 25-70 years; 32.1% male; 59.2% white) with at least one CVDRF were enrolled into planned care for obesity and risk reduction (PCORR) using a stepped-down approach or enhanced usual care (EUC). All patients received physician recommendations for weight loss and CVDRFs. EUC patients (n = 132) received an individual session with a health educator every 4 months. PCORR patients (n = 130) received individual and group sessions (in-person, mail, telephone, and email) in three steps, characterized by less contact if success was achieved. At 20 months, 40.7%, 23.8%, and 15.4% of PCORR patients were in steps 1, 2, and 3, respectively (25.2% were lost to follow-up). PCORR resulted in a between-group difference in reduction in body weight of 6.1% [95% CI, 5.3 to 6.9] compared to EUC 2.8% [95% CI, 2.0 to 3.6] p = 0.007, with a greater reduction in BMI (35.2 [95% CI, 34.4 to 35.9] to 33.7 [95% CI, 32.9 to 34.5] kg/m2) than EUC (36.0 [95% CI, 35.3 to 36.8] to 35.1 [95% CI, 34.3 to 35.9] kg/m2), as indicated by a significant treatment by time interaction (p = 0.009). PCORR resulted in greater weight loss over 20 months than EUC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01134029.

Frailty, Kidney Function, and Polypharmacy: The Atherosclerosis Risk in Communities (ARIC) Study.

BACKGROUND: Frail individuals are at increased risk for poor outcomes, including adverse drug events. Kidney function is often compromised in frailty and is a key consideration in medication choice and dosing; however, creatinine-based measures of kidney function may be biased in frail individuals. STUDY DESIGN: Observational study. SETTING & PARTICIPANTS: 4,987 community-dwelling older men and women with complete data who participated in visit 5 of the Atherosclerosis Risk in Communities (ARIC) Study (2011-2013). PREDICTORS: Kidney measures included glomerular filtration rate (GFR) estimated using serum creatinine (eGFRcr) and serum cystatin C level (eGFRcys) and urine albumin-creatinine ratio. OUTCOME: Frailty, defined using established criteria of 3 or more frailty characteristics (weight loss, slowness, exhaustion, weakness, and low physical activity). RESULTS: 341 (7%) participants were classified as frail, 1,475 (30%) had eGFRcr<60mL/min/1.73m2, 2,480 (50%) had eGFRcys<60mL/min/1.73m2, and 1,006 (20%) had albuminuria with albumin excretion ≥ 30mg/g. Among frail participants, prevalences of eGFRcr and eGFRcys<60mL/min/1.73m2 were 45% and 77%, respectively. Adjusted for covariates, frailty showed a moderate association with eGFRcr and a strong association with eGFRcys and albumin-creatinine ratio. Frail individuals with eGFRcr of 60 to <75mL/min/1.73m2 were frequently reclassified to lower eGFR categories using eGFRcys (49% to 45-<60, 32% to 30-<45, and 3% to <30mL/min/1.73m2). Hyperpolypharmacy (taking ≥10 classes of medications) was more common in frail individuals (54% vs 38% of nonfrail), including classes requiring kidney clearance (eg, digoxin) and associated with falls and subsequent complications (eg, hypnotic/sedatives and anticoagulants). LIMITATIONS: Cross-sectional study design. CONCLUSIONS: Frail individuals had a high prevalence of reduced kidney function, with large discrepancies when reduced kidney function was classified by eGFRcys versus eGFRcr. Given the substantial medication burden and uncertainty in chronic kidney disease classification, confirmation of kidney function with alternative biomarkers may be warranted to ensure careful prescribing practices in this vulnerable population.

Lifestyle Advice Combined with Personalized Estimates of Genetic or Phenotypic Risk of Type 2 Diabetes, and Objectively Measured Physical Activity: A Randomized Controlled Trial.

BACKGROUND: Information about genetic and phenotypic risk of type 2 diabetes is now widely available and is being incorporated into disease prevention programs. Whether such information motivates behavior change or has adverse effects is uncertain. We examined the effect of communicating an estimate of genetic or phenotypic risk of type 2 diabetes in a parallel group, open, randomized controlled trial. METHODS AND FINDINGS: We recruited 569 healthy middle-aged adults from the Fenland Study, an ongoing population-based, observational study in the east of England (Cambridgeshire, UK). We used a computer-generated random list to assign participants in blocks of six to receive either standard lifestyle advice alone (control group, n = 190) or in combination with a genetic (n = 189) or a phenotypic (n = 190) risk estimate for type 2 diabetes (intervention groups). After 8 wk, we measured the primary outcome, objectively measured physical activity (kJ/kg/day), and also measured several secondary outcomes (including self-reported diet, self-reported weight, worry, anxiety, and perceived risk). The study was powered to detect a between-group difference of 4.1 kJ/kg/d at follow-up. 557 (98%) participants completed the trial. There were no significant intervention effects on physical activity (difference in adjusted mean change from baseline: genetic risk group versus control group 0.85 kJ/kg/d (95% CI -2.07 to 3.77, p = 0.57); phenotypic risk group versus control group 1.32 (95% CI -1.61 to 4.25, p = 0.38); and genetic risk group versus phenotypic risk group -0.47 (95% CI -3.40 to 2.46, p = 0.75). No significant differences in self-reported diet, self-reported weight, worry, and anxiety were observed between trial groups. Estimates of perceived risk were significantly more accurate among those who received risk information than among those who did not. Key limitations include the recruitment of a sample that may not be representative of the UK population, use of self-reported secondary outcome measures, and a short follow-up period. CONCLUSIONS: In this study, we did not observe short-term changes in behavior associated with the communication of an estimate of genetic or phenotypic risk of type 2 diabetes. We also did not observe changes in worry or anxiety in the study population. Additional research is needed to investigate the conditions under which risk information might enhance preventive strategies. (Current Controlled Trials ISRCTN09650496; Date applied: April 4, 2011; Date assigned: June 10, 2011). TRIAL REGISTRATION: The trial is registered with Current Controlled Trials, ISRCTN09650496.

Spousal Influence on Physical Activity in Middle-Aged and Older Adults: The ARIC Study.

Low physical activity levels are a public health concern. Few studies have assessed the concordance of physical activity change among spouses. We studied this concordance during a 6-year period (baseline: 1987-1989; follow-up: 1993-1995) in 3,261 spousal pairs from the US-based Atherosclerosis Risk in Communities (ARIC) Study. Linear regression was used to examine the association between change in individuals' sport/exercise and leisure physical activity indices (ranging from 1 (low) to 5 (high)) and change in his or her spouse's indices. The association between individual and spousal changes in meeting physical activity recommendations was assessed with logistic regression. Individual changes in the sport/exercise and leisure indices were positively associated with spousal changes. For every standard deviation increase in their wives' sport/exercise index, men's exercise index increased by 0.09 (95% confidence interval: 0.05, 0.12) standard deviation; for every standard deviation increase in their wives' leisure index, men's leisure index increased by 0.08 standard deviation. Results were similar for women. Individuals had higher odds of meeting physical activity recommendations if their spouse met recommendations at both visits or just follow-up. In conclusion, changes in an individual's physical activity are positively associated with changes in his or her spouse's physical activity. Physical activity promotion efforts should consider targeting couples.

Awareness of physical activity in healthy middle-aged adults: a cross-sectional study of associations with sociodemographic, biological, behavioural, and psychological factors.

BACKGROUND: Interventions to promote physical activity have had limited success. One reason may be that inactive adults are unaware that their level of physical activity is inadequate and do not perceive a need to change their behaviour. We aimed to assess awareness of physical activity, defined as the agreement between self-rated and objective physical activity, and to investigate associations with sociodemographic, biological, behavioural, and psychological factors. METHODS: We conducted an exploratory, cross-sectional analysis of awareness of physical activity using baseline data collected from 453 participants of the Feedback, Awareness and Behaviour study (Cambridgeshire, UK). Self-rated physical activity was measured dichotomously by asking participants if they believed they were achieving the recommended level of physical activity. Responses were compared to objective physical activity, measured using a combined accelerometer and heart rate monitor (Actiheart®). Four awareness groups were created: overestimators, realistic inactives, underestimators, and realistic actives. Logistic regression was used to assess associations between awareness group and potential correlates. RESULTS: The mean (standard deviation) age of participants was 47.0 (6.9) years, 44.4% were male, and 65.1% were overweight (body mass index ≥ 25). Of the 258 (57.0%) who were objectively classified as inactive, 130 (50.4%) misperceived their physical activity by incorrectly stating that they were meeting the guidelines (overestimators). In a multivariable logistic regression model adjusted for age and sex, those with a lower body mass index (Odds Ratio (OR) = 0.95, 95% Confidence Interval (CI) = 0.90 to 1.00), higher physical activity energy expenditure (OR = 1.03, 95% CI = 1.00 to 1.06) and self-reported physical activity (OR = 1.13, 95% CI = 1.07 to 1.19), and lower intention to increase physical activity (OR = 0.69, 95% CI = 0.48 to 0.99) and response efficacy (OR = 0.53, 95% CI = 0.31 to 0.91) were more likely to overestimate their physical activity. CONCLUSIONS: Overestimators have more favourable health characteristics than those who are realistic about their inactivity, and their psychological characteristics suggest that they are less likely to change their behaviour. Personalised feedback about physical activity may be an important first step to behaviour change.

Physical Therapists' Acceptance of a Wearable, Fabric-Based Sensor System (Motion Tape) for Use in Clinical Practice: Qualitative Focus Group Study.

BACKGROUND: Low back pain (LBP) is a costly global health condition that affects individuals of all ages and genders. Physical therapy (PT) is a commonly used and effective intervention for the management of LBP and incorporates movement assessment and therapeutic exercise. A newly developed wearable, fabric-based sensor system, Motion Tape, uses novel sensing and data modeling to measure lumbar spine movements unobtrusively and thus offers potential benefits when used in conjunction with PT. However, physical therapists' acceptance of Motion Tape remains unexplored. OBJECTIVE: The primary aim of this research study was to evaluate physical therapists' acceptance of Motion Tape to be used for the management of LBP. The secondary aim was to explore physical therapists' recommendations for future device development. METHODS: Licensed physical therapists from the American Physical Therapy Association Academy of Leadership Technology Special Interest Group participated in this study. Overall, 2 focus groups (FGs; N=8) were conducted, in which participants were presented with Motion Tape samples and examples of app data output on a poster. Informed by the Technology Acceptance Model, we conducted semistructured FGs and explored the wearability, usefulness, and ease of use of and suggestions for improvements in Motion Tape for PT management of LBP. FG data were transcribed and analyzed using rapid qualitative analysis. RESULTS: Regarding wearability, participants perceived that Motion Tape would be able to adhere for several days, with some variability owing to external factors. Feedback was positive for the low-profile and universal fit, but discomfort owing to wires and potential friction with clothing was of concern. Other concerns included difficulty with self-application and potential skin sensitivity. Regarding usefulness, participants expressed that Motion Tape would enhance the efficiency and specificity of assessments and treatment. Regarding ease of use, participants stated that the app would be easy, but data management and challenges with interpretation were of concern. Physical therapists provided several recommendations for future design improvements including having a wireless system or removable wires, customizable sizes for the tape, and output including range of motion data and summary graphs and adding app features that consider patient input and context. CONCLUSIONS: Several themes related to Motion Tape's wearability, usefulness, and ease of use were identified. Overall, physical therapists expressed acceptance of Motion Tape's potential for assessing and monitoring low back posture and movement, both within and outside clinical settings. Participants expressed that Motion Tape would be a valuable tool for the personalized treatment of LBP but highlighted several future improvements needed for Motion Tape to be used in practice.

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.

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.

Refugee Telehealth Utilization for Hypertension Management During the COVID-19 Pandemic.

Objectives: The COVID-19 pandemic limited refugees' access to healthcare. Increased use of telehealth could enable continuity of care but also create barriers to chronic disease management. This study explores refugees' experience with telehealth and hypertension management during the pandemic. Methods: We recruited 109 refugee participants diagnosed with hypertension. We conducted semi-structured interviews about their experience with telehealth during the COVID-19 pandemic. Interviews were transcribed, translated, and data was coded using inductive thematic analysis. Results: 86% used telehealth modalities at least once during the pandemic. Interviews highlighted three main themes: (1) Social isolation worsened mental health, affecting their motivation to manage their blood pressure; (2) telehealth alleviated discontinuity of care but posed logistical and cultural challenges; (3) participants relied on public blood pressure monitors that were not available during the pandemic which affected disease management. Conclusion: Refugees faced challenges managing their hypertension during the COVID-19 pandemic. Virtual community building may alleviate their stress and isolation. Telehealth must be adapted to account for language, cultural, and technological barriers. Communities with hypertension should increase access to personal or public blood pressure monitors.