JMIR Research Protocols

IntroductionCompared to other high-income countries, the United States continues to have the highest rates of pregnancy-related and associated mortality and morbidity (PRAMM), particularly in rural areas and among non-Hispanic Black pregnancies. Over 80% of pregnancy- related deaths are preventable; however, the intensity of existing interventions has proven difficult to broadly disseminate. Technology offers the potential to address such barriers. This study will develop a multi-level digital intervention to reduce PRAMM and evaluate its effects using a site-randomized trial. Methods and analysisThe Michigan Healthy Mom (MI MOM) intervention will be developed using a community-partnered approach and will seek to address PRAMM risks at four distinct levels: individual, support system, provider, and community. Pregnant participants and up to three members of their personal support system will receive an initial brief interactive session through a mobile web app and will thereafter receive a series of text messages with links to extended content. Healthcare providers will receive biweekly text messages and/or flyers distributed in clinic staff areas, and community health workers (CHWs)-- who can facilitate access to local services--will be available via secure live chat text access. MI MOM effects will be evaluated using a cluster randomized trial in 10 antenatal care clinics throughout Michigan (N = 500 pregnant participants age 18+ receiving Medicaid). We will compare intervention and control arms on two co-primary outcomes: total PRAMM through 1 year postpartum as measured using a universally collected linked dataset of Medicaid claims and vital records and an index of PRAMM risk factors directly targeted by MI MOM. Ethics and disseminationThe Michigan State University (MSU) Institutional Review Board (IRB) has provided ethical approval (STUDY00011005). Results will be disseminated via presentations at academic conferences and community forums, as well as publications in peer-reviewed journals. Trial registration numberClinicalTrials.gov Registry (NCT07213284). STRENGTHS AND LIMITATIONS OF THIS STUDYO_LI* Community co-creation of the intervention content ensures MI MOM reflects the best available evidence-based practices while also being deeply rooted in the preferences and needs of the intended users. C_LIO_LI* The technology-driven approach provides a unique level of scalability for the developed intervention, enabling MI MOM to be readily implemented in practice with high fidelity and minimal training across contexts. C_LIO_LI* Integrating technology-delivered services with CHW live chat text access allows on-demand connection to helping professionals to facilitate warm handoffs to locally available services. C_LIO_LI* Digital approaches can elicit concerns around offering a minimally intensive approach to addressing the complexity of PRAMM; the ideal public health response would include person-delivered approaches used in concert with highly scalable, low-barrier technology- driven programs. C_LI

BackgroundLasers have wide applications in medicine and dermatology, but are associated with pain and anxiety, particularly in younger patients. Pain mitigation is often limited to topical anesthetics in the outpatient setting. Distraction techniques are limited by the need for ocular protection, which can include adhesive eye patches that can completely occlude vision. Virtual reality is effective at managing procedural pain and anxiety under other short medical procedures and is a promising tool for this population. ObjectiveThis trial aims to assess the safety, feasibility, and efficacy of Virtual Reality Pain Alleviation Therapeutic (VR-PAT) for pain management during outpatient laser procedures. Methods40 patients requiring outpatient laser therapy for at least two sessions will be recruited from a pediatric hospital in the midwestern United States for this crossover randomized, two-arm clinical trial with a 1:1 allocation ratio. During the first laser visit, the participant will be randomly assigned to either play the VR-PAT game during their procedure or wear the headset with a dark screen. Participants will answer questions about their pain (Numeric Rating Scale (NRS) 0-10), anxiety (State Trait Anxiety Inventory for Children, NRS 0-10, Modified Yale Preoperative Anxiety Scale (mYPAS)), and pain medication usage. Those playing the VR-PAT will additionally report simulator sickness symptoms and their experience playing the game. At their second laser visit, participants will crossover to the opposite intervention from their first visit. The primary outcomes are the difference in self-reported pain and anxiety between the two interventions. Feasibility outcomes include the proportion of screened patients who are eligible, consent, and complete both visits and adverse events reported. To evaluate the efficacy of pain reduction, composite scores of pain score, pain medication will be calculated for each laser visit. To evaluate the efficacy of anxiety reduction, the change of mYPAS scores will be compared between control and VR groups at each visit using Wilcoxon rank sum tests. All statistical analyses will follow the intention-to-treat principle in regard to intervention assignment at each visit. ResultsThe study was funded in January 2023 and began enrollment at that time. A total of n=44 participants were recruited and data collection was completed in November 2025, with n=40 subjects completing both visits. The sample was balanced with n=40 subjects using the intervention and participating in the control condition. The age range of the complete sample was 6 to 21 years at recruitment and was 55% female sex. Data analysis is in progress with final results planned for June 2026. ConclusionsFindings from this innovative randomized clinical trial will provide early evidence on the efficacy of the VR-PAT for reducing self-reported pain and anxiety during outpatient laser procedures. The results from this trial will inform a large-scale, multisite study. Trial RegistrationClinicalTrials.gov: NCT05645224 [https://clinicaltrials.gov/study/NCT05645224]

The everyday impacts of stressful experiences lead to an increased risk of heart disease, stroke, and mental illness. The Daily Inventory of Stressful Events (DISE) is a widely used measure of daily stressors. The DISEs popularity is based on its accepted validity and the detailed information it provides researchers. However, the DISE relies on interviews conducted one-on-one with participants over several days and, as such, presents a high burden to both participants and researchers. Thus, many researchers have opted to simplify the measure by substituting the interview with a battery of survey questions. For a feasibility study addressing dementia caregiver stress and self-care, this paper aims to examine the lessons learned from an adaptation delivered via phone text messages. While the adaptation was used to reduce participant and researcher burden, it still provides high-quality information about the variability in daily stressors experienced by participants. However, the quality of the data collected was hindered by several design choices made in the adaptions that limited the utility of the data. As such, this paper provides recommendations for enhancing the utility of mobile phone text-based delivery of both the DISE and other measures and highlights the need for further validity work on such adaptations.

IntroductionCondyloma acuminate (CA) is a chronic disease with a high rate of recurrence which has a detrimental impact on patients physical and mental health, as well as their quality of life and socioeconomic advancement. Photodynamic therapy is a less invasive and selective intervention for CA, but its safety and high price limit its utilization. Wei Ren Anti-Wart Formula (WRAWF), is a promising Chinese medicine for CA, however, the evidence of its effectiveness and safety is scarcely. This trial aimed to evaluate the clinical effectiveness, safety, and recurrence management of WRAWF combined with photodynamic in the CA patients. Methods and analysisA double-blind, randomized, parallel-group trial was designed. Participants will recruit in the Yue Yang Traditional Chinese Medicine Hospital, Shanghai University of Traditional Chinese Medicine from May 1, 2024, to December 31, 2025. The sample size is 148 CA patients (74 in each group), will randomly divide into the trial and control groups. followed up at weeks 6, 10, and 14 after the 2-week treatment period. The recurrence rate will be set as the primary outcome. The visual analogue scale (VAS) scores of pain, the rate of infection, superficial scarring, and the type, severity, and incidence of adverse events will be carefully documented at 0,1,2,6,10,14 weeks. Ethics and disseminationThis trial has approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine (No. 2023-023). Meanwhile, informed consent was provided by all patients conducted in accordance with the Declaration of Helsinki. Trial registration numberChiCTR2300071609; www.chictr.org.cn;Registered on April19, 2023(first version).

IntroductionWomen below the poverty threshold have lower representation and retention in breastfeeding studies. MethodsA secondary analysis of a longitudinal randomized controlled self-management for breast and nipple pain during breastfeeding study. Participants completed online surveys at discharge, weeks 1, 2, 3, 6, 9, 12, 18, and 24, with face-to-face interviews at 6 and 24 weeks. Text messages were sent to participants when modules and surveys were due. Retention was assessed in R with descriptive statistics, Mann-Whitney, Pearsons chi-square, and Cox Proportional Hazard Regression. ResultsTwo hundred and forty-four women (89 [≤]$50,000 and 155 >$50,000) were recruited. Retention rates at 1 (93%), 2 (87%), 6 (82%), 9 (77%) and 24 (72%) weeks. For women of low income compared to those of high income there was a hazard ratio (HR) of 2.5 (p=0.0001) for retention. For non-Hispanic Black and Hispanic women compared to the combined non-Hispanic White and Other group, HRs for retention were 3.3 and 2.6 respectively (p=0.0001). Adjustment for age in the final hazard regression model of income, age, race and ethnicity decreased the HR for women of low income to 1.6 and HRs for non-Hispanic Black and Hispanic women to 2.1 and 1.9, respectively (p=.0001). However, none of the individual factors in the model achieved statistical significance. DiscussionRetention in breastfeeding studies impacts breastfeeding duration, a key lifelong preventative health behavior. Despite accessible study design, retention of women desiring to breastfeed was adversely affected by the intersection of income, race and ethnicity, and age.

IntroductionCardiovascular diseases (CVDs) are the leading causes of death in the U.S. Having a healthy dietary pattern and engaging in regular physical activity (PA) reduces the risk of developing CVDs. The U.S. Preventative Services Task Force and the American College of Sports Medicines Exercise is Medicine (EIM) initiatives recommend patients at risk for CVDs receive behavioral counseling interventions (BCIs). However, few patients are screened for lifestyle behaviors and connected with evidence-based BCIs. PurposeTo describe (1) our approaches for identifying insufficiently active patients and connecting them to evidence-based BCIs and (2) the methods of our 12-week, theory-based BCI for insufficiently active patients. MethodsA novel clinical workflow was implemented in six Family Medicine clinics to screen and refer insufficiently active patients to a 12-week BCI. The BCI is theoretically grounded in the Multi-Process Action Control (M-PAC) framework and includes health education, health coaching, and self-monitoring. The implementation and preliminary efficacy of the workflow and BCI will be evaluated with the RE-AIM framework. Implementation outcomes include clinical workflow metrics and BCI acceptability and fidelity. Preliminary efficacy includes changes in psychosocial mechanisms of action, device-based and self-reported health behaviors, and health outcomes. Efficacy outcomes are assessed at baseline, post-intervention, with a subset of outcomes assessed after 12 weeks of post-intervention follow-up. ConclusionThis clinical workflow and BCI will inform the future implementation of primary care-based BCIs to reduce the risk of developing CVD in insufficiently active patients.

BackgroundAdolescent pregnancy constitutes a critical public health issue worldwide. Young mothers face substantial physical and psychological changes as they transition to motherhood, while limited knowledge, experience, and maturity may impair parenting and increase stress. The aim of the study was to evaluate the effects of the parental enhancing program with mobile application on parental stress and competence among adolescent postpartum women. MethodsA quasi-experimental study was conducted among sixty adolescent postpartum women, aged 15-19. They were randomly assigned to receive parental enhancing program with mobile application in intervention group (n = 30) and standard postpartum care in control group (n = 30). Adolescent postpartum women in intervention group were received two sessions in the parental enhancing program before discharge with weekly follow-up through the Line Official Account Parent Paplearn. Data was collected using questionnaires, including the Edinburgh Postnatal Depression Scale (EPDS), Parenting Stress Index (PSI-4-SF), and Parenting Sense of Competence Scale (PSOC). Evaluations were conducted during 6-weeks postpartum. Independent t-test was used to compare post-intervention mean scores of parental stress and competence between groups. ResultsAll enrolled participants completed the study (Intervention: 30; Control: 30). At 6-weeks postpartum, adolescent postpartum women in the intervention group who participated in the parental enhancing program with mobile application through Line Official Account Parent Paplearn demonstrated significantly lower parental stress (t = 4.50, p < .001) and higher parental competence (t = -4.16, p < .001) compared to the control group. ConclusionProviding knowledge, skill training, and ongoing support in parenting for adolescent postpartum women through the mobile application significantly reduced parental stress and improved parental competence. Healthcare providers, particularly nurses, are encouraged to integrate such accessible and convenient tools into postpartum care routines. Continuous follow-up post-discharge is recommended to provide ongoing counselling, reduce parental stress, and enhance parental competence in adolescent postpartum women.

BackgroundSexual health education interventions should provide adolescents with the knowledge and skills to assist them to navigate and develop safe and healthy relationships allowing them to positively transition from adolescence to adulthood. However, many sexual health education interventions omit addressing sexual violence and sexual safety. Of the interventions that do address sexual violence and sexual safety many are poorly or not at all evaluated. This paper details a protocol for a mixed-methods systematic review to critically appraise the evidence on the effectiveness of sexual health interventions that address sexual violence and sexual safety for adolescents. MethodsA systematic review of the literature following the Preferred Reporting Guidelines for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines will be undertaken. A search of the following databases will be conducted: CINAHL, PSYCHINFO, ERIC, EMBASE, PubMed, JSTOR, Scopus, PyscArticles, Soc Index with Full Text, Humanities Full Text (H. W. Wilson) and the British Education Index. Citations will be evaluated against predefined eligibility criteria using a two-stage screening process which will be conducted independently in pairs. Data will be extracted from eligible papers using pilot-tested data extraction forms focusing on measurements of effectiveness of the intervention and the impact of the intervention. Quality of evidence will be assessed using the Mixed Methods Appraisal Tool (MMAT). The Template for intervention and description (TIDieR)) framework will be utilised to describe the included interventions. DiscussionThis study will describe sexual health education interventions that address sexual violence and sexual safety for adolescents and their efficacy. The evidence will help inform future planning for sexual health education interventions which address sexual violence and/or safety. OSF Registration: https://doi.org/10.17605/OSF.IO/YP2XQ

The number of patients who suffer from pelvic floor disorders increases with age and can have a significant impact on quality of life. The first-line treatment for these different disorders includes pelvic floor rehabilitation. However, there are high rates of non-compliance with completing the recommended duration of treatment due to delays in appointments and time constraints. Thus, the primary goal of this study is to evaluate the feasibility and acceptability of an online 8-week video-based pelvic floor muscle therapy program. A secondary goal is determining whether the treatment can improve quality of life and symptoms. This study is a registry-based pilot single-arm prospective trial (NCT06689891: Video-Based Pelvic Floor Muscle Therapy). Eligible participants will be offered the online program as an alternative to in-person pelvic floor rehabilitation. Primary timepoints include a pre-intervention in-person visit with a licensed pelvic floor therapist and the 8-week video-based pelvic floor muscle therapy program. There will be a midpoint evaluation followed by a post-intervention visit with the same pelvic floor therapist, where participants will be graded on their ability to complete the various exercises to assess efficacy. A survey assessing the online-based programs usability will be conducted post-intervention. Patient-reported outcome measures, including quality-of-life and symptom changes, will be collected pre-, mid-, and post-intervention. As this is a pilot trial, the goal is to establish the acceptability and feasibility of a video-based pelvic floor muscle therapy program as an alternative to in-person treatment.

BackgroundCancer survivors experience challenges, that may affect their psychological well-being. Technology-based, mindfulness-based interventions have been offered to cancer survivors; however, contents do not sufficiently cover issues related to cancer and its treatments. This study protocol presents a three-arm randomized controlled trial (RCT) that aims to examine the effectiveness of a digital mindfulness psychoeducation programme (Digital-MindCAN programme) on psychological symptoms among cancer survivors. This program contains knowledge linking to cancer-related matters, mindfulness principles and mindfulness practice, which will be delivered real-time using a videotelephony software. MethodsEligible cancer survivors will include adults who completed curative treatments from two weeks to two years. They will be randomly assigned to one of the three groups: Digital-MindCAN programme with standard care, Palouse Mindfulness programme with standard care, and a wait-list control group. A convenience sample will be recruited from a tertiary hospital in Singapore. A target sample size will be 150 participants, with 50 participants in each group. Primary outcomes encompass objective stress and subjective stress. Secondary outcomes comprise psychological well-being, perceived relaxation, mindfulness, resilience, depression, and anxiety. Self-administered questionnaires and physiological measures will be used to collect participants responses. Focus group interviews will be conducted for intervention groups after the end of the eighth session. Quantitative data will be analyzed by descriptive statistics, analysis of covariance and repeated measures analysis of variance. Qualitative findings will be analyzed using a realist evaluation method. DiscussionThis RCT will be the first to test the effectiveness of the technology-based, mindfulness-based intervention on cancer survivors in Singapore. Positive findings will add knowledge and inform clinical practice. Specifically, the Digital-MindCAN intervention may be offered as part of standard care for cancer survivors. Future research can be implemented and further tested the program in other healthcare institutions. Trial registrationThis study has been registered with ISCTN Clinical Trial Registry (Trial NO. ISRCTN10756933).

Background: Documentation burden significantly impacts nursing workload and well-being, with nurses spending an estimated 20-40% of their time on documentation. Ambient AI technologies offer potential to reduce documentation time by mapping real-time nurse-patient conversations to structured EHR data entries with human-in-the-loop verification. Methods: This protocol describes a pragmatic, EHR-embedded randomized controlled trial evaluating the effectiveness of an Ambient AI tool in reducing nursing documentation time across three inpatient medical/surgical units. The study employs a closed-cohort, stepped-wedge, unit-randomized design, integrating the intervention into routine clinical workflows. The primary outcome is documentation time per shift hour, derived from EHR audit logs. Secondary outcomes include documentation burden, professional well-being, and perceived usability. Results: The trial is being implemented within a shared governance model that integrates executive oversight, operational feasibility, and research rigor. Multidisciplinary workgroups coordinate technical integration, user experience, and analytics, ensuring alignment between operational priorities and pragmatic trial objectives. Early implementation has highlighted the importance of adapting training and analytic strategies to address differential intervention exposure, as well as the need for rapid operational responses to late-emerging technical issues. Discussion: This protocol demonstrates the feasibility of embedding a randomized pragmatic trial within a health system-led operational deployment of Ambient AI for inpatient nursing documentation. The approach highlights the necessity of adapting existing outpatient provider-focused AI implementation strategies for inpatient nursing, emphasizing the unique nature of different nursing care environments. Recruitment challenges and the integration of research with operational workflows are discussed as key considerations for future pragmatic AI trials in nursing. Keywords: Artificial Intelligence; Ambient AI; Nursing Documentation; Documentation Burden; Large Language Models; Speech Recognition Software; Stepped-Wedge Design ClinicalTrials.gov Identifier NCT07456241V4: 2026-05-27 https://clinicaltrials.gov/study/NCT07456241

BackgroundMounting evidence from randomized controlled trials have shown that antibiotics can be a safe and effective treatment for appendicitis. Patients and surgeons must work together to choose the optimal treatment approach for each patient based on their own preferences and values. We developed a novel decision support tool (DST) to facilitate shared decision making for appendicitis. The effect of this DST on decisional outcomes remains unknown. MethodsWe conducted an online randomized field test in at-risk individuals comparing the DST to a standard infographic as a control. Individuals were randomized 3:1 to the DST (intervention) or infographic (control). The primary outcome was the total decisional conflict scale (DCS) score measured before and after exposure to the DST. Secondary outcomes included between-group DCS scores, and between group comparisons of the acceptability of DST or infographic. Results180 individuals were included in the study after quality control checks. Total DCS scores decreased significantly after viewing the DST (59.0 to 14.6, p<0.001) representing movement from a state of high to low decisional conflict. Individuals exposed to the DST reported higher acceptability ratings (3.7 vs. 3.3, p<0.001) and had more individuals who would completely agreed that they would be willing to try antibiotics (45% vs. 21%, p=0.008). ConclusionsThe novel appendicitis DST significantly decreased decisional conflict in this online randomized field test. Users rated the tool as highly acceptable and expressed increased willingness to consider antibiotics as a treatment approach after viewing it. Study FundingThis work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases [grant number T32DK070555]; and a generous gift from Marty and Linda Ellison. The development of aspects of the decision support tool was funded by the Patient Centered Outcomes Research Institute. The funding sources had no role in the study design, collection, analysis, or interpretation of data, in the writing of the manuscript or in the decision to submit for publication.

IntroductionPrimary care is facing multiple crises, including an increase in health misinformation. Digital health messaging by primary care providers has been shown to reach a diverse patient population. With the uptake of Generative Artificial Intelligence (GenAI) usage in healthcare, there is an important opportunity to rapidly create messages that are tailored to different populations and conditions. However, thoroughly assessing AI-generated content is essential, as GenAI raises concerns regarding its accuracy, understandability, actionability, and bias perpetuation. We aim to investigate whether digital health messages created by GenAI are evaluated as noninferior compared to those created by human experts. Methods and analysisThe AI-CARE (AI to Create Accessible and Reliable patient Education materials) study is a double-blind, crossover, non-inferiority randomized controlled trial. Data collection began on May 30, 2025, and is expected to be completed at the end of April 2026. Over 12 months, 192 messages on 48 topics will be written: half by primary care and public health experts and half by a GenAI tool (OpenAIs ChatGPT). Review Panels composed of 24 primary care providers and 24 patients will evaluate these messages using an Evaluation Grid developed to assess the messages quality of information, adaptation to the target audience, relevance and usefulness, and readiness to be shared with patients. Evaluations will be completed via online REDCap surveys and the order in which the 192 messages appear will be randomized and will vary between individuals. Participants and analysts will be blinded to the generation source. The primary outcome will be the Clarity and Understandability score. Ethics and disseminationThe Research Ethics Boards of the Hopital Montfort (24-25-11-038) and the University of Ottawa (S-12-24-11153) formally approved this study in December 2024. Reported data will be grouped and anonymized for dissemination in peer-reviewed scientific journals and conferences. Trial registration numberNCT06997107 ARTICLE SUMMARYO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LIThe AI-CARE study allows for within-participant comparison between human- and AI-generated digital health messages, minimizing variability due to individual differences. C_LIO_LIThe Review Panels are diverse and composed of primary care providers and patients currently practicing in or using the healthcare system in five Canadian provinces. C_LIO_LIThe developed Evaluation Grid allows for the assessment of multiple aspects related to digital health messages: quality of information, adaptability to the target audience, relevance and usefulness, and readiness to be shared with patients. C_LIO_LIOne limitation is that messages generated by AI are created using only one LLM (Open AIs ChatGPT). C_LIO_LIDue to the nature and location of recruitment, we may introduce selection bias (participants already engaged in research and interested in digital communication and AI) and the racial diversity of our study population may be limited. C_LI

BackgroundSkin conditions are extremely common worldwide, and are an important cause of both anxiety and morbidity. Since the advent of the internet, individuals have used text-based search (eg, "red rash on arm") to learn more about concerns on their skin, but this process is often hindered by the inability to accurately describe the lesions morphology. In the study, we surveyed respondents experiences with an image-based search, compared to the traditional text-based search experience. MethodsAn internet-based survey was conducted to evaluate the experience of text-based vs image-based search for skin conditions. We recruited respondents from an existing cohort of volunteers in a commercial survey panel; survey respondents that met inclusion/exclusion criteria, including willingness to take photos of a visible concern on their body, were enrolled. Respondents were asked to use the Google mobile app to conduct both regular text-based search (Google Search) and image-based search (Google Lens) for their concern, with the order of text vs. image search randomized. Satisfaction for each search experience along six different dimensions were recorded and compared, and respondents preferences for the different search types along these same six dimensions were recorded. Results372 respondents were enrolled in the study, with 44% self-identifying as women, 86% as White and 41% over age 45. The rate of respondents who were at least moderately familiar with searching for skin conditions using text-based search versus image-based search were 81.5% and 63.5%, respectively. After using both search modalities, respondents were highly satisfied with both image-based and text-based search, with >90% at least somewhat satisfied in each dimension and no significant differences seen between text-based and image-based search when examining the responses on an absolute scale per search modality. When asked to directly rate their preferences in a comparative way, survey respondents preferred image-based search over text-based search in 5 out of 6 dimensions, with an absolute 9.9% more preferring image-based search over text-based search overall (p=0.004). 82.5% (95% CI 78.2 - 86.3) reported a preference to leverage image-based search (alone or in combination with text-based search) in future searches. Of those who would prefer to use a combination of both, 64% indicated they would like to start with image-based search, indicating that image-based search may be the preferred entry point for skin-related searches. ConclusionDespite being less familiar with image-based search upon study inception, survey respondents generally preferred image-based search to text-based search and overwhelmingly wanted to include this in future searches. These results suggest the potential for image-based search to play a key role in people searching for information regarding skin concerns.

Low literacy is on the rise in the USA and is one of the independent predictors of poor health outcomes. While much written health information is now adapted to lower reading levels, more needs to be done to address the gap between material content and target consumers comprehension ability which often is more complex than simple reading level adjustments. This paper describes the process of developing a culturally, context and literacy-aligned intervention that promotes and supports preventive lifestyle behaviors among low-income Latino women (Latinas). Focus group discussions and key-informant interviews were conducted to identify needs, barriers and beliefs of low-income Latinas regarding obesity, healthy eating and physical activity. A simple literacy-aligned, culturally-appropriate and socio-economically acceptable (LACASA) framework and intervention were then created through an academic-community partnership: medical professionals and students, community health workers and researchers. The curriculum - which included minimal and easy-to-read written material and power point presentations - was piloted and revised before being launched. The resulting lifestyle curriculum for high-risk low-income Latinas was well-received and was a good fit for the priority population. Creating a program using the LACASA approach requires an interdisciplinary team to invest time working with key members of the priority population and a commitment to adjusting materials to the groups literacy level and its cultural and economic realities. Programs created to serve low-income individuals with limited literacy cannot rely on pre-created curricula. Instead, these must be re-evaluated and adjusted to address both content core principles and specific contexts of the priority population.

BackgroundThe acquisition of laparoscopic skills is a key component of modern pediatric surgical training, yet structured hands-on exposure remains limited. Conventional box training is widely used but may be constrained by suboptimal visualization and ergonomics. Virtual reality (VR)-based approaches offer immersive visual perspectives and may enhance skill acquisition, motivation, and ergonomic performance. However, robust comparative data on VR-assisted versus conventional laparoscopic training remain limited. MethodsThis randomized controlled study evaluates the effectiveness of VR-assisted laparoscopic training compared with conventional training. 40-60 participants, including students, physicians and laypersons without prior laparoscopic experience, will be randomized to either a conventional training group or a VR-assisted training group. Both groups will complete a structured three-week training curriculum using pediatric laparoscopic box trainers and standardized tasks, including PEG transfer, laparoscopic suturing, cyst dissection and a validated esophageal atresia model. The intervention group will use 360 training videos and a VR headset, while the control group will train using standard 2D video material. Pre- and post-training assessments will be video-recorded and evaluated in a blinded manner using validated objective performance metrics (GOALS and OSATS), task-specific error definitions and time to task completion. Secondary outcomes include participant satisfaction, motivation, mental workload and musculoskeletal strain assessed with standardized questionnaires. All data will be pseudonymized and stored securely. ConclusionThis study aims to provide evidence on the role of VR-assisted training in laparoscopic skill acquisition and ergonomics. The findings may inform future training curricula in pediatric and minimally invasive surgery.

BackgroundLifestyle interventions incorporating medically-tailored meal delivery may support rapid behavior change among pregnant individuals with gestational diabetes (GDM). PurposeTo examine the feasibility and acceptability of a multicomponent lifestyle intervention for pregnant individuals with GDM. Primary outcomes included recruitment, retention, intervention receipt, and acceptability. MethodsWe conducted a pilot randomized feasibility trial among pregnant individuals with GDM recruited from maternal fetal medicine clinics in the Hartford, Connecticut area. Participants were randomized to usual GDM care or the Meals4Moms intervention plus usual care. The intervention included medically-tailored meal delivery, personalized physical activity support, and multimodal education with digital tools. Participants completed a survey and three 24-hour dietary recalls at baseline and post-intervention. Meals4Moms participants also completed a semi-structured interview at follow-up. Intervention receipt was tracked by study staff. ResultsOf 30 individuals approached, we screened 80% (n=24), of whom 75% (n=18/24) were eligible; we randomized 8 participants. Seventy-five percent (n=6/8) completed at least one component of the follow-up assessment (100%, n=4/4 Meals4Moms, 50%, n=2/4 Usual Care). One participant spent [&ge;]80% of her total food budget (n=1/4, 25%), and no participants completed [&ge;]80% of prescribed exercise sessions (range: 0-50%). All (n=4) Meals4Moms participants reported they would be very likely to participate in the program if they had GDM again, and 100% (n=4) would be very likely to recommend the program to a friend with GDM. ConclusionsWhile the Meals4Moms intervention was highly acceptable to participants, procedural refinements are needed prior to conducting a full-scale efficacy trial.

IntroductionSchool-aged autistic children commonly experience social communication and interaction challenges in their everyday lives. While international evidence suggests that social skills group training (SSGT) programmes can support autistic children, improving their psycho-social functioning, to date there is no standardised evidence-based SSGT tailored towards the needs of autistic children aged 8 to 12 years living in the Chinese Mainland. Therefore, the primary objective is to evaluate the feasibility and acceptability of a culturally adapted 16-session version of the social skills programme KONTAKT in Chinese autistic children. Additionally, preliminary efficacy and cost-effectiveness will be assessed to inform a future definitive trial. Methods and analysisThis study will employ a randomised, single-blinded, wait-list controlled feasibility design with 36 Chinese autistic children aged 8 to 12 years with Intelligence Quotient over 70 referred to the Child Development Behaviour Centre, in Guangzhou, China. Participants will be randomly assigned to either the immediate training group or the delayed training group stratified by sex. Feasibility will be assessed using quantitative and qualitative data obtained from the KONTAKT CHILD participants, their parents, and facilitators of the programme. Preliminary efficacy and cost-effectiveness are assessed via quantitative data obtained at five time points. The primary efficacy outcome is participants improvement in social skills as measured by the Contextual Assessment of Social Skills (CASS). Other outcomes include parents and teachers reports of participants autistic traits and adaptive functioning, participants self-report and projective tests for self-assertiveness and psycho-social functioning, and parent reports on parental reflective functioning and perceived school support. Common process factors and their effects on outcomes will also be explored. Cost-effectiveness will consider both societal and healthcare perspectives. Ethics and disseminationThe current study protocol has been reviewed and ethics approval has been obtained from the Ethical Board Committee at the Third Affiliated Hospital of Sun Yat-sen University (II2023-119-01). The trial was pre-registered in Chinese Clinical Trials (ChiCTR2300072136) on 2023 June 05. The results of this trial will be actively disseminated through peer-reviewed publications and conference presentations. Any identifiable personal information will be anonymised to protect confidentiality. Protocol version2.0, 2024 July 31 Strengths and limitations of this studyO_LIComprehensive assessment of diverse outcomes via multiple informants. C_LIO_LISystematic cultural adaptation using the Integrative Cultural Adaptation Framework (ICAF) C_LIO_LIensuring the appropriateness of the Chinese version of KONTAKT. C_LIO_LICollect data on readiness for change, providing insights into "help-seeker" effects. C_LIO_LILimited generalisability due to a single study site, location-specific inclusion, and absence of an active comparator. C_LIO_LIGiven the absence of previous research examining the efficacy of SSGT programs in autistic children in the Chinese Mainland, this study is appropriately a feasibility study. As such, only the preliminary efficacy of KONTAKT with this population in a small sample will be examined. The small sample size will limit the power of the study in examining the effect of moderators on the study outcomes. C_LI

Background: Pre-exposure prophylaxis (PrEP) has demonstrated a significant reduction in HIV infections among men who have sex with men (MSM), however, low medication adherence hinders its preventative effectiveness. Traditional approaches, such as health education and face-to-face inquiry (HEF), have demonstrated certain efficacy in improving PrEP adherence. However, these methods are resource-intensive and often plagued by delays, rendering timely and precise interventions challenging. This randomized controlled trial aims to assess the effectiveness of an intervention comprising AI-chatbot for PrEP (PrEP-bot) and Smart pillbox (SPB) (PrEP-bot-SPB) strategy to improve PrEP adherence among MSM compared to HEF.Methods and analysis: A three-arm, multicenter, open-lable RCT will be conducted with Chinese MSM [&ge;]18 years. A total of 300 participants will be recruited through three sources, including hospitals, community-based organizations (CBOs) and peer referral in five cities: Shenzhen, Beijing, Qingdao, Hangzhou and Zhengzhou. After completing baseline survey, participants will be randomized evenly into interventions or control groups: the PrEP-bot group, the PrEP-bot-SPB group, and the HEF control group. Participants in the PrEP-bot group will be granted access to an AI-chatbot agent through WeChat. This agent will: 1) generate personalized PrEP medication plans; 2) provide medication reminders and PrEP-related health check-ups notifications; 3) inquire about missed doses to deliver tailored interventions; 4) answer participant questions about PrEP using guideline-based knowledge. Participants in the PrEP-bot-SPB group will receive both the SPB and the PrEP-bot interventions. SPB could delivers medication reminders. Participants in HEF group will receive a health education pamphlet introducing PrEP and knowledge related to PrEP medication adherence at baseline and face-to-face inquiry every three months. Outcomes will be assessed for both short-term and medium-to-long-term effects. The primary objective is the effectiveness in improving PrEP adherence measured by self-report, Eight-Item Morisky medication adherence scale (MMAS-8) and concentration of Tenofovir in dried blood spots (DBS) (PrEP adherence [&ge;]90%) at 3 months follow-up. Secondary outcomes include: 1) effectiveness in preventing HIV infection measured by HIV-self test (HIVST); 2) effectiveness of PrEP-related health check-ups; 3) the effectiveness, feasibility, acceptability, and user satisfaction with the PrEP-bot; 4) effectiveness in improving PrEP adherence at 6-month, 9-month and 12-month follow-up periods. All participants will receive quarterly follow-up visits during the 12-month study period. Intention-to-treat analysis and per protocol set (PPS) analysis will be used.Results: Recruitment and enrollment of participants began in January 2026 and is currently ongoing.Discussion: This study is expected to establish a novel AI-based intervention model for PrEP, providing innovative strategies for HIV control among MSM populations. If the PrEP-bot is proven non-inferior to HEF, it could offer users real-time, precise, and personalized interventions while simultaneously addressing PrEP-related inquiries and health check-ups reminders. Importantly, this approach would achieve significant reductions in resource requirements for implementation and maintenance and be more cost-effective. With the ongoing advancement of AI technologies, PrEP-bot holds substantial promise for widespread implementation in PrEP adherence, potentially revolutionizing HIV prevention for MSM in China through this innovative intervention modality.Trial registration: ChiCTR2500111280 (Chinese Clinical Trial Registry). Date of registration: 29 October 2025.

IntroductionThe COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public, including adults, parents, and youth, to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the publics (youth, parents, and adult populations) understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (herein referred to as the RecMap). Methods and AnalysisThis is a protocol for a multi-method study. We will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCT) in three populations to test alternative formats of presenting health recommendations: adults (21 years of age or older), parents (18 years or above and are a parent or legal guardian of a child under 18 years old), and youth (15 to 24 years old), with at least 240 participants in each population. The research will consist of a randomized online survey and an optional one-on-one interview. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. In each population group, the intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (herein referred to as Standard Language Version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the two recommendation formats. Each populations results will be analyzed separately. However, we are planning a meta-analysis of the results across populations, and will also explore potential interaction and subgroup effects within each population. At the end of each survey, participants will be invited to participate in a one-on-one, virtual semi-structured interview to explore their user experience and their learning preferences and future research. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach. Iterative member checking, triangulation, interpretation, and saturation of themes will be sought to enhance reliability. Ethics and DisseminationThrough Clinical Trials Ontario (CTO), the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). All potential participants will be required to provide informed consent. The findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media. Strengths and limitations of this studyO_LIWe are following a multi-method approach: randomized controlled trials and qualitative interviews. The qualitative results will supplement and help explain our quantitative findings. C_LIO_LIThis protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), which enhances transparency and completeness. The trials use previously validated outcomes from similar trials. This will strengthen the credibility of our results. C_LIO_LIOur study is testing an optimized plain language recommendation format, which makes our intervention relevant to our stakeholder groups, and is recruiting internationally, which ensures the inclusion of a diverse population. Recruitment will take place online using social media, and data will be collected using an online survey. This allows for self-selection and limits accessibility to those who have no or limited digital access, which in turn limits generalizability. C_LIO_LIWhile the recommendations are offered in multiple languages through the RecMap, the study is only testing English plain language recommendation summaries. C_LI