BackgroundEnvironmental exposure, including green-blue space and walkability, may influence mental health through various physiological pathways. Traditional methods have limitations in capturing dynamic environmental exposure effects on mental health.ObjectiveThis study aims to investigate the associations between minute-level environmental exposure and stress-related biomarkers using GPS-based measurements and wrist-worn biosensors in an urban population.MethodsIn this prospective observational study, we will recruit 750 participants (aged 18-80 years) in Hong Kong from September 2024 to December 2026. This includes a pilot study supported by internal funds starting in September 2024 and external funding from the Health and Medical Research Fund by the Hong Kong Health Bureau in July 2025. Participants will undergo a 1-week experiment wearing biosensors and carrying GPS devices while completing daily surveys and entry and exit questionnaires. Primary outcomes include digital biomarkers (electrodermal activity, blood volume pulse, and skin temperature) from wrist-worn sensors and associations with the environmental exposures of air pollution, urban density, and green-blue space access. Secondary outcomes comprise questionnaire responses, physical activity metrics from accelerometer data, and environmental exposure assessments, including mobility barriers, land use mix, road accessibility, and thermal conditions. Focus groups will be conducted to refine study protocol and assess device-wearing experience.ResultsThe study received ethical approval from the Human Ethic Research Committee (award numbers: EA240125 and EA240514). As of June 30, 2025, a total of 150 participants completed the pilot study (September 2024 onwards), achieving a 94% (141/150) completion rate with strong device compliance (141/150, 94% valid biosensor days; 137/150, 91% daily questionnaires). Protocol refinements based on participant feedback were implemented without altering core instruments. The main study supported by the Health and Medical Research Fund, commenced in July 2025, with 30 participants enrolled as of September 2025. Data collection for 750 participants will continue until December 2026. We are at an early stage of data cleaning and preprocessing for the pilot study. Data analysis is expected to be completed by June 2027, with results anticipated to be published in 2027 and 2028.ConclusionsThis study’s innovative integration of continuous environmental monitoring and stress-related biomarker may provide new insights into environment–health relationships. Findings will inform public health initiatives for mental well-being promotion and urban planning interventions.International Registered Report Identifier (IRRID)DERR1-10.2196/84919

BackgroundSARS-CoV-2, a novel coronavirus, initially appeared in Wuhan, China, at the end of 2019 and has infected more than 31 million people worldwide. Infection can range from asymptomatic to multiorgan failure requiring prompt treatment. Overall, 80% of patients with SARS-CoV-2 experienced mild to moderate illness, while 5% developed serious illness. Physicians can evaluate a patient’s digestive system (Koshtha), digestive capacity (Agni), strength (Bala), and longevity (Ayu) using the body constitution (Deha Prakriti). It also helps doctors estimate a patient’s illness risk, severity, disease activity scores, and hematological, pathological, and biochemical changes. The study investigated the association between body composition (Deha Prakriti) and severity, as shown by structural lung abnormalities in patients with SARS-CoV-2.ObjectiveThis study aims to study the correlation between the severity of Prakriti and structural alterations in the lungs of patients with SARS-CoV-2.MethodsThis is a retrospective cross-sectional study of patients with SARS-CoV-2. The research data will be retrospectively collected from hospital records between September 1, 2020, and May 11, 2021, a period during which India experienced the second wave of the pandemic. The data will come from the Acharya Vinoba Bhave Rural Hospital in Sawangi (Meghe), Wardha, Maharashtra, India. Patients will be contacted via telephone and encouraged to visit the outpatient department and inpatient department at these institutions or in rural and urban areas of Wardha city. A structured case pro forma and a Prakriti assessment questionnaire will be used to evaluate lung structural changes during the COVID-19–positive period.ResultsThe study is not funded by any organization. The study was initiated on March 4, 2023, and as of July 1, 2024, a total of 265 patients have been recruited. Results will be recorded from the observations of subjective and objective parameters. The study’s primary outcome is to establish a relationship between abnormalities in the structure of the lungs in patients with COVID-19 and body constitution (Prakriti). The study’s secondary outcome will help identify which body constitution is most susceptible to structural changes and disease severity in patients with COVID-19 and will also offer insights into preventive medicine.ConclusionsStatistical investigation will lead to the conclusion that there is a specific association between structural abnormalities in the lungs of patients with COVID-19 and their body constitution. We hypothesize that Prakriti will be identified as being more prone to structural changes and severity in patients with COVID-19, offering insights into preventive therapy.

BackgroundHIV counseling support staff (CSS) play a crucial role in HIV care outcomes, providing essential access to HIV test counseling, linkage-to-care support, adherence counseling, peer support, and navigation. Effective training in evidence-based interventions like motivational interviewing (MI) is imperative to maximize the impact of CSS in enhancing HIV care outcomes. MI is a collaborative, goal-oriented communication method aimed at bolstering an individual’s motivation and movement toward specific goals by eliciting and exploring personal arguments for change. MI has demonstrated efficacy across various medical and mental health outcomes, including its significant impact on the status-neutral HIV Care Continuum.ObjectiveThe objective of this study is to develop and pilot an interactive internet-based MI training program for HIV counseling support staff (iMI4HIV), aiming to enhance their communication skills in HIV care interactions.MethodsThe iMI4HIV Study will have 2 phases. In phase 1, Development, we will conduct formative focus groups (FGs) with CSS (n=16) to identify HIV care interactions for demonstration videos and to assess acceptability of gamification components; create MI demonstration videos depicting key interactions from status-neutral HIV Care Continuum; program iMI4HIV (including skills development tasks, gamification components, etc); and pilot a virtual MI (VMI) workshop followed by iMI4HIV (n=8). We will also conduct qualitative interviews with 8 leaders from HIV care agencies to explore their use of existing online MI training programs, acceptability of iMI4HIV, and possible facilitators and impediments to its adoption for training HIV CSS. In phase 2, pilot randomized controlled trial (RCT), we will randomize 30 CSS at a 2:1 ratio (VMI workshop + iMI4HIV vs VMI workshop + waitlist control) to assess the feasibility and acceptability of iMI4HIV and to pilot the RCT processes and assessments for a future efficacy trial. We will also explore the preliminary impact of iMI4HIV on MI skills acquisition.ResultsThe CSS focus groups began in August 2024, and programming of the training is near completion. We plan to conduct a pilot with 8 participants by the end of 2025, to obtain feedback and conclude phase 1 of the study. The phase 2 pilot RCT is expected to be launched in February 2026, with all data collection to be completed by October 2026.ConclusionsOur pilot study aims to demonstrate the feasibility and acceptability of an internet-based MI training program for HIV CSS. If successful, this training program has the potential to enhance the delivery of evidence-based interventions in HIV care settings, ultimately improving patient outcomes and adherence to treatment protocols. Further research and larger trials will be needed to confirm these findings and refine the training approach.International Registered Report Identifier (IRRID)DERR1-10.2196/82241

BackgroundSedentary lifestyles, as a nursing diagnosis, are prevalent in the life patterns of community-dwelling older adults, who have been shown to be the most sedentary and physically inactive subgroup. Prolonged low energy expenditure during waking hours leads to an increased risk of noncommunicable diseases and impairs physical functioning in older adults, negatively impacting their health outcomes. Therefore, interventions targeting changes in sedentary lifestyles are necessary to improve health behaviors in older adults.ObjectiveThis study aimed to investigate the effect of the multi-theory model–based stepped behavior change intervention on sedentary lifestyle among community-dwelling older adults.MethodsThis study is designed as a community-based, parallel-arm, assessor-blinded randomized controlled trial. Sixty participants were enrolled in this study and randomly assigned to the intervention group (received theory-based sedentary lifestyle change intervention) and the control group (received conventional behavioral change advice). End points were collected at baseline, immediately after the end of the intervention, week 12, and week 18. The primary endpoint is the change in self-reported sedentary time. Secondary endpoints include the changes in step count, time spent in light-intensity physical activity and moderate-to-vigorous-intensity physical activity, Measuring Change in Physical Activity Questionnaire score, Short Physical Performance Battery score, BMI, waist circumference, blood pressure, and Short-Form Health Survey-12-Version 2 score.ResultsThe study was initiated in May 2024. As of May 2025, the project had completed participant recruitment and data collection. The final manuscript with findings is expected to be submitted for publication in September 2025.ConclusionsThis study uses a multi-theory model as its theoretical framework and adopts stepped sedentary lifestyle change as the intensity gradient of exercise behavior, creating a behavioral change pattern from sitting to standing and movement to light-intensity physical activity, to moderate-to-vigorous-intensity physical activity, and ultimately improving the sedentary lifestyle and obtaining health benefits, to provide community-dwelling older adults with individualized behavior change programs that are easy to adhere to and more applicable to daily activity patterns.

BackgroundFEASible is a cross-sectional observational study that explores women’s daily living patterns through wearable devices and home environment sensors to validate the use of physical activity and indoor air quality data as indicators of risk for metabolic syndrome (MetS) and cardiovascular disease.ObjectiveLeveraging transdisciplinary expertise, we implement a low-cost, dense sampling approach among 800 adult women, 60% Hispanic or Latina, with a subgroup of 225 participants opting for neuroimaging to assess MetS-related brain vulnerability.MethodsParticipants residing in Central Texas use a smartwatch and a custom-built air quality sensor to monitor their activities and environment for two weeks. Other variables, such as social determinants of health, medical history, and lifestyle, are reported through surveys. During their initial visit, we gather blood pressure measurements, body composition, and lipid profile information.ResultsAs of August 2025, a total of 805 participants have completed the eligibility survey, of whom 204 have completed 2 weeks of sensor data collection, showing a diverse participant pool comprising 60% (210/348) Hispanic or Latinas, 39% (135/348) non-Hispanic or Latinas, and 1% (3/348) unknown. Participants are aged 18-40 years, with an average age of 27 years (SD 6 years). The study was funded in May 2023 (National Heart, Lung, and Blood Institute; grant R01HL168374), and data collection began in October 2023, with a projected completion date of May 2028. Ongoing analyses and publication of early cohorts are expected to occur throughout 2026 and 2027, with final analyses and dissemination of results anticipated by the end of the funding period in 2028.ConclusionsWe have established a feasible pipeline to collect data that will help yield valuable insights into MetS risk factors among Latina women, including brain scan magnetic resonance imaging data and environmental exposure measurements. This paper aims to provide a rationale for procedures and case examples from the first year of data collection leading to health risk modeling, thus informing future interventions on MetS, heart disease, and all-cause mortality among Latina women.International Registered Report Identifier (IRRID)DERR1-10.2196/82034

BackgroundMore than 12% of the world’s population and more than 1 million Canadians use walking aids to support mobility. Unsafe use of walking aids due to a lack of training may lead to injuries and an increased risk of falls. A novel interactive video-based feedback mobile app to train walking aid fitting and safe use, called ICanWALK (Improving Canadians’ Walking Aid Skills, Learning, and Knowledge), was recently developed.ObjectiveThe primary objective of this study is to explore the efficacy of the walking aid skills training app on the balance confidence of walking aid users. The secondary objective is to explore the influence of the mobile app on mobility and knowledge of walking aid users.MethodsA 2-site single-blind pragmatic randomized controlled trial is proposed. A total of 52 adults who use walking aids will be recruited through clinical and community organizations. Participants will complete measures of balance confidence (Activities-specific Balance Confidence scale; the primary outcome), mobility (6-Minute Walk Test and Timed Up and Go test), walking aid skills (Walking Aids Skills Test, WAST), and knowledge of and confidence in walking aid fit and use (self-reported questionnaire) at baseline (T1). Participants will then be randomly assigned to the experimental (ICanWALK app) or attention-matched control group (breathing activity app) and will complete two 20-minute sessions interacting with the assigned app. Participants will be reassessed 2 to 4 days after the intervention (T2) and again 4 weeks later (T3). Analysis of covariance will be performed for primary and secondary outcomes by using SPSS software.ResultsThe study protocols were approved by the institutional review boards of both recruitment sites in 2023 and 2024. A feasibility study was conducted from 2023 to 2024 across the 2 sites. As of November 2025, participant recruitment is ongoing and expected to conclude in December 2026. To date, 26 individuals have been enrolled and have successfully completed all 3 assessment time points: T1, T2, and T3.ConclusionsUsing a video-based feedback training approach, a novel app is hypothesized to improve balance confidence, mobility, and knowledge of and confidence in walking aid fitting and use. This structured educational program for fitting and training of walking aids may improve balance confidence. Better walking aid fitting and use may improve mobility, especially for older adults, thereby increasing independence and social participation. Establishing efficacy is an important first step before exploring how the ICanWALK app may be used by walking aid users and clinicians in clinical and community settings.Trial RegistrationClinicalTrials.gov NCT05347875; https://clinicaltrials.gov/study/NCT05347875International Registered Report Identifier (IRRID)DERR1-10.2196/71060

BackgroundThe enhancement of primary care and the prevalence of chronic diseases are key issues worldwide, especially in Canada. The rising incidence of chronic illnesses, now the leading cause of mortality worldwide, creates complex challenges that can compromise the quality of care provided to patients. A lack of communication directly affects relational continuity. These challenges highlight the importance of establishing clear patient pathways within interprofessional teams, ensuring that information is shared efficiently and the continuity of care is coordinated effectively, especially in a telehealth context. Since 2019, telehealth has become an essential tool for patients with chronic disease, although often implemented with no specific infrastructure. Interprofessional collaboration (IPC) plays a critical role in the use of telehealth in managing chronic diseases.ObjectiveThis study aims to understand the IPC process as experienced by patients in a telehealth context within primary care, with a focus on patient engagement. More specifically, the study’s objectives are (1) to describe the IPC process in telehealth within primary care from the perspective of patients living with chronic conditions; (2) to identify, in collaboration with patients living with chronic disease, the barriers and facilitating factors in this process; and (3) to understand the engagement of these patients in relation to the IPC process in a telehealth context.MethodsThis qualitative research study is based on constructivist research methodology to describe the process of IPC in the telehealth context in primary care from the perspective of patients living with chronic disease. The research team will construct knowledge derived from the interpretation of information that was obtained during the interviews with participants. To meet the study’s objectives, we carried out qualitative journey mapping for data collection. Individual interviews were analyzed iteratively. This method is useful for this research as it visually and collaboratively captures patients’ lived experiences.ResultsData collection was completed in November 2024. A total of 22 interviews were conducted. The project was funded in March 2022. As of December 2025, all participants had been recruited, and the qualitative data analysis was currently underway. Multiple manuscripts are in development, and the first set of findings was submitted for publication in fall 2025.ConclusionsThe results of this study will support and improve the IPC process in the telehealth context by providing concrete insights into patients’ experiences, identifying gaps and strengths in current collaborative practices, and offering evidence-based recommendations. Journey mapping will help identify potential facilitating factors for improving primary care in the telehealth context according to the patient’s journey. The results will be used to build a practical guide (in phase 2) supporting IPC in the primary care telehealth context.

BackgroundThe relationship between cancer and central nervous system disorders has received increasing attention recently. Consequently, antipsychotics and antidepressants, commonly prescribed for conditions such as depression, bipolar disorder, and schizophrenia, have emerged as potential modulators of subsequent cancer risk. Previous studies have suggested that the use of these medications is associated with a decreased risk of cancer incidence and mortality, making them suitable candidates for drug repurposing. However, the potential therapeutic benefits do not extend to all cancer types, as some data suggest an increased risk for specific tumors.ObjectiveThis study aims to conduct a comprehensive review of systematic reviews and meta-analyses (review of reviews) that assess whether exposure to antidepressants or antipsychotics influences cancer incidence and mortality.MethodsTo provide a clear overview of this review, we have designed and registered the study protocol. Specifically, we will include systematic reviews and meta-analyses that examine the relationship between previous antipsychotic or antidepressant treatments and the subsequent cancer risk. The primary outcome will be the risk of cancer incidence and mortality (all malignant neoplasms) associated with exposure to psychopharmacological medications. Furthermore, secondary outcomes will include site-specific cancer incidence and mortality (eg, lung cancer). Literature searches will be conducted in multiple electronic databases (from their inception onwards), including PubMed/MEDLINE, Embase, and the Cochrane Database of Systematic Reviews. Three researchers will independently screen all citations, abstracts, and full-text articles. We will perform parallel search, selection, and extraction tasks using a large language model (GPT-4o; OpenAI). Data selection and extraction will involve both human reviewers and GPT-4o, whose performance will be validated through human evaluations. Thus, we will verify whether this type of tool can accelerate or even perform the tasks involved in a systematic review. The risk of bias and the quality of individual studies will be evaluated using appropriate tools. Subsequently, we will extract the summary association measures (eg, pooled relative risk, odds ratio, and hazard ratio) as reported in each included systematic review. Where available, we will summarize subgroup and sensitivity analyses as described by the authors.ResultsPlanned searches will be conducted in various electronic databases from their creation until September 2025. No results are available or included in this protocol. The expected results will be published in 2026.ConclusionsThis overview of systematic reviews and meta-analyses will provide an updated synthesis of the cancer risk associated with antipsychotic and antidepressant drugs. Furthermore, this study will examine factors that may explain potential study variations. Ultimately, these findings will be published in a peer-reviewed journal.Trial RegistrationOSF Registries 10.17605/OSF.IO/5ACWH; https://osf.io/5acwh/overviewInternational Registered Report Identifier (IRRID)DERR1-10.2196/78596

In India, 20%-30% of pregnancies are high-risk, contributing to 75% of perinatal mortality and morbidity. An effective approach to reduce this mortality and morbidity is early identification, effective management, and timely referral of high-risk pregnancies (HRPs). The Integrated High-Risk Pregnancy Tracking and Management program aims to enhance the capacity of auxiliary nurse midwives (ANMs), medical officers (MOs), and specialist gynecologists by (1) providing algorithmic, color-coded, detailed yet simple HRP protocols, customized for each role; (2) offering live training; (3) delivering digital training and handholding; and (4) tracking management details for HRPs. Equipping health workers (HWs) with these interventions supports early identification, effective management, and timely referral of HRPs, ultimately improving primary care and enhancing satisfaction of mothers with HRPs. These interventions are implemented in the intervention arm for over 18 months. During this time, HWs of intervention and control arms will continue to receive routine training through state and national programs, and pregnant women of both arms have access to standard maternity services. At the system level, the program evaluates the impact on the knowledge and skills of HWs in diagnosing and managing HRPs. At the community level, it assesses translation of this knowledge into practice in terms of early diagnosis and protocol-based management of women with HRPs. The program will be implemented in 2 intervention (Sambhal and Shravasti) and 2 matched control districts (Budaun and Gonda) of Uttar Pradesh, on 6 HRPs. The study uses a "quasi-experimental, before-and-after design" with intervention and control arms. However, the impact of the program will be assessed only on 3 HRPs: moderate or severe anemia, pregnancy-induced hypertension, and antepartum hemorrhage. System-level impacts will be assessed through qualitative data from district officials, specialist gynecologists, MOs, and ANMs at baseline and end line. The community-level impacts will be assessed by comparing quantitative data from recently delivered women at baseline and end line. Community-level impact assessed using the difference-in-difference (DiD) technique. The study received ethical approval. By November 2024, all the ANMs, MOs, specialist gynecologists, staff nurses, and community health officers in 2 intervention districts were trained on 6 HRP protocols, after the protocols were vetted by the Government of Uttar Pradesh. A digital learning tool and WhatsApp-based support system were introduced to facilitate continued learning and handholding of ANMs in managing HRPs and to address queries. Baseline data were collected from 2 arms during June-October 2024. This trial will provide valuable insights into the feasibility and effectiveness of the program at system and community levels in an emerging state like Uttar Pradesh. These insights can feed into capacitating HWs across all the districts and support expansion of the program to include additional HRPs, with significant potential for improving maternal and neonatal outcomes.

Low back pain (LBP) is a common and disabling condition that is costly for health systems and society. Interprofessional primary care models may improve care quality and reduce this burden. This protocol and analysis plan communicates the methods for a cluster randomized trial with the following objectives: (1) evaluate the effectiveness of a physiotherapist-led (PT-led) primary care model for LBP at improving disability (primary outcome), pain intensity, quality of life, global rating of change, patient satisfaction, and adverse events compared with usual physician-led primary care; and (2) determine the impact of the PT-led primary care model for LBP on the health care system and society (health care access, health care use, missed work, cost-effectiveness). Both objectives are evaluated over a 1-year period. A multimethod process evaluation is embedded to assess model implementation, mechanisms, perspectives of patients and providers, and contextual influences. This study is a cluster randomized controlled trial with 20 primary care practices (clusters) in Canada, randomized 1:1 to a PT-led or usual physician-led primary care model for LBP. Adults seeking care from their primary care team for LBP are recruited over 1 year. Data collection occurs at baseline, 6 weeks, and 3, 6, 9, and 12 months. Effectiveness will be analyzed using linear mixed regression. The process evaluation analysis will include: descriptive and comparative analyses to assess implementation; descriptive and mediation analyses to assess potential mechanisms; qualitative interpretive description to understand experiences and perspectives of patients, PTs, and other health professionals; and mixed methods to determine contextual influences on implementation. Recruitment of primary care sites (clusters) was completed in June 2023, following delays related to the COVID-19 pandemic. Cluster randomization occurred in July 2023. Recruitment of patient participants began in October 2023 and concluded in November 2024 (n=739). The final self-reported patient data was collected on November 25, 2025. Extraction of electronic health record data is scheduled for completion on December 19, 2025. Data analysis will be conducted in accordance with the study protocol and analysis plan and will begin once all data collection activities are complete. No interim analyses have been performed. The results of this trial will provide evidence for knowledge users to determine whether a PT-led primary care model for LBP is effective and should be adopted more widely. Knowledge users have identified the impact of the new model of care on disability, quality of life, and cost-effectiveness as key evidence needed to inform key decision-making. The multimethod process evaluation will provide critical evidence to interpret trial results and inform future scale and spread of this model of care if effective. ClinicalTrials.gov NCT04287413; https://clinicaltrials.gov/study/NCT04287413. DERR1-10.2196/89004.