JMIR Research Protocols最新文献

{"title":"Engagement With and Impact of an mHealth App for Childhood Obesity Prevention and Management: Protocol for a Mixed Methods Study.","authors":"Madison Milne-Ives, Ananya Ananthakrishnan, Sophie R Homer, Jackie Andrade, Edward Meinert","doi":"10.2196/71551","DOIUrl":"10.2196/71551","url":null,"abstract":"<p><strong>Background: </strong>Childhood obesity is a serious global health concern that affects approximately 20% of children worldwide. Digital health behavior change interventions have the potential to improve behaviors that can contribute to childhood obesity, such as diet and physical activity, but often lack sufficient user engagement to achieve significant impact.</p><p><strong>Objective: </strong>The aim of this project is to develop evidence to better understand how users engage with digital interventions and how behavior change techniques can be leveraged to support engagement. Specifically, the study will examine the impact of a family-focused app for childhood obesity prevention on health behaviors, health outcomes, and communication between families and health care professionals (HCPs).</p><p><strong>Methods: </strong>A pretest-posttest, mixed methods evaluation will examine the impact of the NoObesity app on families' physical activity and dietary behaviors and on HCPs' self-efficacy at communicating with families about childhood obesity. Secondary outcomes will include well-being, usability, and users' engagement with and perceptions of the intervention. An initial sample of 1000 families (children and young people of any weight and age under 18 years and their parents) and 180 HCPs will be recruited to participate in the study; a subset of these participants will be invited to take part in qualitative semistructured interviews. The study implementation and follow-up period will last for 6 months, with the outcomes measured at baseline and 3 and 6 months after baseline. Quantitative outcomes will be compared over time using repeated measures ANOVA, and qualitative data will be analyzed thematically and triangulated with app use data.</p><p><strong>Results: </strong>Ethics approval was granted by the Newcastle University Faculty of Medical Science Ethics Committee (2688/41816) on March 22, 2024. Recruitment has not yet started but will involve capturing informed consent (and assent from participants younger than 16 years).</p><p><strong>Conclusions: </strong>The project's key contributions will be to generate evidence of the potential for a family-based digital intervention to support families' health behavior change and HCPs' confidence in their ability to support them and to improve our understanding of how particular behavior change techniques can be used to support engagement with the intervention and its target behavior. Findings will be disseminated through peer-reviewed journals and shared with the general public, with support from patient and public involvement representatives.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71551"},"PeriodicalIF":1.5,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12490775/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying Optimal Testing Modalities to Increase COVID-19 Testing Access in Baltimore, Maryland: Protocol for a Household Randomized Controlled Trial.","authors":"Jessica Duchen, Alexandra K Mueller, Saifuddin Ahmed, Jamie Perin, Courtney Borsuk, Joshua Trowell, Kelly Lowensen, Steven Huettner, Andy Peytchev, Jason E Farley, Shruti H Mehta, Jacky M Jennings","doi":"10.2196/68600","DOIUrl":"https://doi.org/10.2196/68600","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic disproportionately affected low-income and racial and ethnic minority populations. Testing plays a critical role in disrupting disease transmission, but complex barriers prevent optimal testing access, particularly for Black and Latinx communities. There is limited evidence regarding the optimal testing modalities to increase testing access for these populations.</p><p><strong>Objective: </strong>This study aimed to define the optimal COVID-19 testing modalities for maximizing testing acceptance, uptake, and timeliness of receipt of results.</p><p><strong>Methods: </strong>The Community Collaboration to Combat COVID-19 (C-FORWARD) trial was a household randomized comparative effectiveness trial conducted in a representative sample of an urban population. Households across 653 census block groups were sampled using a probability proportional to size approach. The primary outcome was the completion of SARS-CoV-2 or COVID-19 testing within 30 days of randomization.</p><p><strong>Results: </strong>Between February 2021 and December 2022, a total of 1083 individuals were enrolled, including 881 (81.35%) index participants and 202 (18.65%) household members. The mean age of participants was 51 (SD 18) years.Of the total sample, 43% (n=460) of participants identified as Black or African American, 48.6% (n=526) as White, and 9% (n=91) as other, including Asian, American Indian, Native Hawaiian or Pacific Islander, and multiple races; 4.8% (n=48) of participants identified as Hispanic or Latino. At the time of enrollment, 51.1% (n=553) were currently working either full time or part time, and 32.9% (n=342) of participants had an advanced degree. In total, 80% (n=809) of participants had been tested for COVID-19 previously, with 22.3% (n=179) reporting a prior positive test for COVID-19, and 86.8% (n=890) reporting receiving at least one COVID-19 vaccination before enrollment.</p><p><strong>Conclusions: </strong>Data from the C-FORWARD trial will be used to address important questions regarding COVID-19 testing acceptance and uptake in an urban population.</p><p><strong>International registered report identifier (irrid): </strong>RR1-10.2196/68600.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68600"},"PeriodicalIF":1.5,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility, Safety, and Impact of the Probiotics Lactiplantibacillus plantarum and Bifidobacterium longum subspecies infantis in Papua New Guinean Infants: Protocol for a Randomized Controlled Trial.","authors":"Rebecca L Ford, Andrew R Greenhill, Joycelyn Sapura, Amelia Koata, Mary Dreyam, Tilda Orami, Joe Jude, Madeline Ong, Wendy Kirarock, Dorcas Joseph, Geraldine Masiria, Celestine Aho, William S Pomat, Anita H J van den Biggelaar, Peter C Richmond","doi":"10.2196/73926","DOIUrl":"https://doi.org/10.2196/73926","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Childhood mortality in low- or middle-income countries (LMICs) remains a major public health concern, with infections being a leading cause of infant death. Probiotics have shown promise in reducing infection-related morbidity and mortality in preterm infants, but their use in newborns born at or near term in LMICs requires further investigation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to assess the feasibility, safety, and initial outcomes of administering 1 of 2 synbiotic formulations or a placebo to newborns in the Eastern Highlands Province of Papua New Guinea.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Following ethics approvals in 2018 and 2019, and receipt of the synbiotic preparations in September 2020, healthy neonates (&lt;72 h old; n=244) were recruited between October 2020 and June 2023 and randomly assigned in a double-blind manner (1:1:1) to receive an oral preparation containing Lactiplantibacillus plantarum, Bifidobacterium longum subspecies infantis, or placebo for 7 consecutive days. Follow-up continued for 6 months, with rectal swabs, stool, blood, saliva, and nasopharyngeal swabs collected before the intervention; on day 7; at age 2 weeks; and at ages 1, 3, 4, and 6 months. Ongoing analyses will assess probiotic gut colonization, bacterial nasopharyngeal carriage, and antibody responses to routine childhood vaccines (Hemophilus influenzae type b; hepatitis B; 13-valent pneumococcal conjugate vaccine; and diphtheria, tetanus, and whole-cell pertussis) as well as hospitalization and infection rates among the intervention groups compared to the placebo group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment began in October 2020, with the target sample size expanded from 195 to 240 in March 2023 owing to higher-than-anticipated loss to follow-up during the COVID-19 pandemic. Of the 244 enrolled infants, 218 (89.3%) completed the full 7-day synbiotic or placebo course, and 169 (69.3%) completed the study. All follow-up visits concluded in December 2023. Disruptions due to the COVID-19 pandemic led to family relocations outside the study area, preventing some infants (75/244, 30.7%) from completing the study. High rates of sample collection were achieved, with rectal swabs (1452/1474, 98.1%), nasopharyngeal swabs (1255/1262, 99.44%), saliva samples (881/882, 99.9%), and blood samples (876/882, 99.3%) successfully obtained at multiple time points. Data analysis is ongoing and expected to be completed by the end of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study demonstrates that probiotic supplementation is feasible and safe in healthy infants in an LMIC such as Papua New Guinea. The findings from this study will inform the design of larger trials of probiotics and synbiotics to complement existing efforts to reduce infection-related infant mortality in LMICs, while also providing insights into their clinical, immunological, and microbiological impacts in infants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/stron","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73926"},"PeriodicalIF":1.5,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Use of Repetitive Transcranial Magnetic Stimulation to Improve Cognitive Impairment in Patients With Stroke Based on rs-fMRI Findings: Protocol for a Meta-Analysis.","authors":"Xin Xiang, Hao Li, Lin Lu, Yuting Cao, Chunzhen Li, Lubo Xiao, Furong Liu, Yi Ran, Hong Zhang, Ning Zhao","doi":"10.2196/77931","DOIUrl":"https://doi.org/10.2196/77931","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Poststroke cognitive impairment (PSCI) is a chronic form of poststroke cognitive dysfunction that affects approximately one-third of the survivors of stroke. PSCI significantly increases the rates of mortality and functional disabilities, such as limitations in motor function, speech, and activities of daily living. Therefore, effective treatments are needed for patients with PSCI. Repetitive transcranial magnetic stimulation (rTMS) has been shown to exert beneficial behavioral effects in patients with PSCI. More importantly, a limited number of neuroimaging studies with small sample sizes have reported the beneficial effects of rTMS on brain plasticity and its reciprocal influence on cognitive and behavioral performance. Resting-state functional magnetic resonance imaging (rs-fMRI) has been widely used to study changes in brain activity, but there is no consensus regarding which brain regions play pivotal roles in rTMS for patients with PSCI.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to explore the therapeutic effects of rTMS on changes in the brain activity of patients with PSCI, thereby providing robust evidence to elucidate its neuroimaging mechanisms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this meta-analysis, we will systematically search the PubMed, Embase, Cochrane Library, Web of Science, China Biology Medicine, and China National Knowledge Infrastructure databases, VIP Chinese Science and Technology Periodical Database, and the China WanFang Database up to December 2024 to identify randomized controlled trials comparing active rTMS with sham stimulation conditions or conventional control conditions in patients with PSCI. The primary outcomes will include the amplitude of low-frequency fluctuation, fractional amplitude of low-frequency fluctuation, regional homogeneity, and functional connectivity across the whole brain. The secondary outcomes will include the Montreal Cognitive Assessment and Mini-Mental State Examination scores. Statistical analyses will be conducted via Review Manager (version 5.4), Seed-based d Mapping with Permutation of Subject Images (version 6.23), and Stata (version 18.0) software to assess study quality, evaluate the risk of bias, and analyze the outcome measures.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study will offer a comprehensive analysis of the available evidence on the use of rTMS to improve cognitive impairment in patients with stroke based on rs-fMRI findings. The meta-analysis will be conducted from July 2024 to April 2026, following this predefined protocol. The process encompasses database searching and study screening (to be concluded by October 2025), data extraction and synthesis (to be completed by December 2025), and subsequent manuscript preparation and submission (anticipated by April 2026).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This meta-analysis will provide insights into the therapeutic potential of rTMS to improve cognitive impairment in patients with stroke.","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77931"},"PeriodicalIF":1.5,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Innovative Web-Based Future Planning and Well-Being for Caregivers of Individuals With Intellectual and Developmental Disabilities: Protocol of a Pragmatic Randomized Controlled Trial.","authors":"Caren Steinway, Charmaine Wright, Silvia Kwak, Olivia Teng, Abigail Seide, John Berens, Jason Woodward, Ilka Riddle, Thomas Davis, Adam Greenberg, Dava Szalda, Justine Shults, Jane Cerise, Sophia Jan","doi":"10.2196/77184","DOIUrl":"10.2196/77184","url":null,"abstract":"<p><strong>Background: </strong>Nearly three-quarters of the estimated 4.9 million people with intellectual and developmental disabilities (IDDs) in the United States live with family caregivers, 25% of whom are aged older than 60 years. People with IDDs experience disproportionately high rates of mortality, morbidity, and acute care use, often due to a lack of accessible, tailored resources to support them throughout the lifespan. Few caregivers engage in long-term care (LTC) planning, often due to a lack of information and support.</p><p><strong>Objective: </strong>This protocol describes the design and methods of the Future Planning and Well-Being for Individuals with Intellectual Disabilities and Family Caregivers study, a randomized controlled trial evaluating the effectiveness of the Map Our Life web-based LTC planning tool compared to an attention control website on caregiver-reported burden, caregiver-reported well-being, and progress in and communication of future plans for the individual with an IDD.</p><p><strong>Methods: </strong>The Future Planning and Well-Being for Individuals with Intellectual Disabilities and Family Caregivers study is a national, multisite, randomized controlled clinical trial with a target enrollment of 1050 family caregivers of individuals with IDDs at 6 sites across the United States. Participants are randomly assigned (1:1) to either the Map Our Life web-based LTC planning tool plus enhanced usual care or an attention control group consisting of a Centers for Disease Control and Prevention-sponsored health promotion website for people with disabilities plus enhanced usual care. Primary outcomes, including caregiver-reported burden, caregiver-reported well-being, and LTC planning behaviors, are assessed at baseline and at 1, 6, and 18 months. Data will be analyzed using mixed-effects models to accommodate the repeated measures design.</p><p><strong>Results: </strong>This study was funded in July 2022, received initial Institutional Review Board approval in August 2023, and was registered on ClinicalTrials.gov in December 2023. Recruitment began in December 2023 and is scheduled to conclude in December 2025. Primary outcome analyses will commence immediately following the completion of final follow-up surveys.</p><p><strong>Conclusions: </strong>LTC planning is an important component of addressing health disparities among individuals with disabilities and their family caregivers. By focusing on using an innovative and accessible tool for LTC planning, the study addresses a critical gap in available resources with the potential to improve quality of life and reduce caregiver burden.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06065527; https://clinicaltrials.gov/study/NCT06065527.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/77184.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77184"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating Diversity in Open Photoplethysmography Datasets: Protocol for a Systematic Review.","authors":"Vedha Penmetcha, Lekaashree Rambabu, Brandon G Smith, Orla Mantle, Thomas Edmiston, Laura Hobbs, Shobhana Nagraj, Peter H Charlton, Tom Bashford","doi":"10.2196/73040","DOIUrl":"10.2196/73040","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Photoplethysmography (PPG) is an optical method for measuring blood volume changes in microcirculation through noninvasive photodetection. It has become a widespread and essential clinical tool, used in pulse oximeters and wearable devices. However, technical aspects of PPG make it susceptible to intrinsic bias, with the potential to adversely affect particular patient and consumer populations. Developments in PPG technology, increasingly driven by openly accessible datasets as opposed to de novo experimentation, have the potential to help monitor an array of physiological variables. However, some populations may be underrepresented in PPG datasets. We describe a protocol for a systematic review to assess the biases within open access PPG datasets.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This review aims to evaluate the underlying reporting patterns and structure of openly accessible PPG datasets. We will provide insight into the measured biosignals and demographic variables included in the datasets in the hope of shedding light on what PPG data parameters are being used to develop medical devices. Therefore, we can elucidate current gaps and areas for improvement to reduce bias in medical device development.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This review will be reported in accordance with the standard PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We will include primary studies that mention PPG and specifically reference openly accessible datasets since 2000. The datasets must contain physiological parameters such as heart rate, blood pressure, or respiratory rate, as well as the PPG waveform data, collected from humans. Searches will be conducted in literature databases and data repositories, including MedLine OVID, IEEE Xplore, Scopus, and PhysioNet. Studies will be evaluated in accordance with the Standing Together Initiative recommendations, which are urging for health care technologies supported by representative data. Biosignal and demographic variables will be extracted from the PPG datasets, with steps taken to harmonize and store this information. Statistical analysis will be performed, including descriptive statistics and the chi-square test for comparisons. Additional statistical analyses will be performed after data extraction is completed and the level of heterogeneity is characterized.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We will analyze the dataset diversity and the structural basis of PPG datasets. This includes statistically analyzing the demographic and biosignal variables in the datasets. By using statistical test fit for nominal variable comparisons, we will evaluate the frequencies of characteristics like the devices used, biosignals collected, clinical parameters, demographic characteristics, and geographic information. This systematic review is expected to be completed by September 2025. The screening and review of the articles is currently being conducted.&lt;/p&gt;&lt;p","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73040"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12488168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145206443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Culturally Tailored Diabetes Self-Management Education and Support Programs in Black African and Caribbean Adults With Type 2 Diabetes (HEAL-D): Protocol for a Multicenter, Pragmatic Randomized Controlled Trial.","authors":"Louise M Goff, Drusus A Johnson, Vicky Bell, Susan Blyden, Peter Bower, Jeremy Dale, Tess Harris, Andrew Healey, Eleanor Hoverd, Huajie Jin, Tony Kelly, Carol Rivas, Clare Robinson, Jayne Thorpe, Sandra Tomlinson, Michael Ussher, Charlotte Wahlich, Barbara McGowan","doi":"10.2196/71861","DOIUrl":"https://doi.org/10.2196/71861","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;People of Black African and Black Caribbean ethnicity experience higher rates and poorer outcomes of type 2 diabetes (T2D) than people of White European ethnicity; these inequalities are compounded by poor healthcare access. Cultural tailoring of diabetes self-management education and support (DSMES) programs has the potential to improve healthcare engagement and clinical outcomes for ethnic minority groups. Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) is a co-designed, culturally tailored group-based DSMES program for adults of Black African and Black Caribbean ethnicity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This trial aims to evaluate the clinical and cost effectiveness of the HEAL-D intervention, compared to standard DSMES programs, in Black African and Black Caribbean adults living with T2D.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A 24-month, multicenter, pragmatic, open-label, 2-arm, parallel-group, individually randomized group treatment trial will be conducted, with primary end point (glycated hemoglobin [HbA&lt;sub&gt;1c&lt;/sub&gt;]) assessment at 12 months. Black African and Black Caribbean adults with T2D (n=300), recruited from 3 to 5 centers in the United Kingdom (including London, West Midlands, and Greater Manchester), will be randomized in a 1:1 ratio to HEAL-D (intervention) or a standard DSMES program (control). HbA&lt;sub&gt;1c&lt;/sub&gt;, blood lipids, anthropometric outcomes, blood pressure, physical activity, and patient-reported outcome measures relating to psychological well-being and self-management support, lifestyle behaviors, and health economics will be collected at baseline and follow-up visits (6, 12, and 24 months). Cost-effectiveness will be assessed through a cost-utility analysis conducted from a health and social care perspective. A mixed methods process evaluation will provide a formative evaluation of delivery, intervention fidelity, and implementation of HEAL-D, and an embedded study within a project will assess the impact of multiple long-term conditions on uptake of, and engagement with HEAL-D, and the impact of HEAL-D on multiple long-term conditions. The trial received Research Authority and Research Ethics Council approval on April 22, 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Funding began in August 2023. Site \"green light\" was received on August 15, 2024, for London; November 29, 2024, for Manchester; and January 31, 2025, for the West Midlands. Recruitment commenced in August 2024 and is due to run for 11 months. As of March 26, 2025, a total of 76 participants have consented. Last patient, last visit is expected in June 2027; primary data analysis is expected to begin in July 2027. Final results are anticipated to be available in September 2027, and publication is expected by the end of 2027.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The HEAL-D trial will address whether a culturally tailored DSMES program, provided in-person or via videoconferencing, is clinically and cost-effective compared to sta","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71861"},"PeriodicalIF":1.5,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Stage of Change Theory-Based, Stage-Matched Intervention for Healthy Dietary Intake Among Office Workers in a Low- to Middle-Income Country: Protocol for a Cluster Randomized Trial.","authors":"Janaka Godevithana, Champa Jayalakshmie Wijesinghe, Millawage Supun Dilara Wijesinghe","doi":"10.2196/70293","DOIUrl":"https://doi.org/10.2196/70293","url":null,"abstract":"<p><strong>Background: </strong>An unhealthy diet is a well-established risk factor for the development of noncommunicable diseases, and office workers are at a higher risk of noncommunicable diseases due to their sedentary work style. Stage of change (SOC) theory-based and stage-matched interventions effectively influence dietary and behavior changes. The effectiveness of such interventions in the context of low- and middle-income countries is yet to be assessed.</p><p><strong>Objective: </strong>This protocol describes a cluster randomized trial planned to evaluate the effectiveness of an intervention for changing dietary behavior among government office workers in the Galle district in Sri Lanka.</p><p><strong>Methods: </strong>A cluster randomized trial was conducted in 20 clusters divided into intervention and control arms. A cluster was an office with 30 clerical-type workers who were sedentary at work. A stage-matched intervention based on behavior change processes was implemented in the intervention clusters for 3 months. Participants were provided with an intervention matched to their SOC at baseline. Precontemplators and contemplators received awareness-raising and emotional arousal interventions. Others received goal setting and self-monitoring interventions. The SOC and dietary intake were assessed at baseline and the postintervention stage through a staging algorithm, and 24-hour dietary recall was supplemented with a picture guide and computer software. Adherence to the intervention was assessed monthly. We hypothesized that participants would achieve a progressive change in the SOC and healthy dietary intake in the intervention clusters compared to the control clusters.</p><p><strong>Results: </strong>By December 2024, the planned intervention was completed. Data analysis on the effectiveness of the intervention is to be completed and published in 2025.</p><p><strong>Conclusions: </strong>This protocol reports a stage-matched intervention based on SOC theory, enriching the current knowledge base with new evidence from office workers in a low- to middle-income country.</p><p><strong>Trial registration: </strong>Sri Lanka Clinical Trials Registry SLCTR/2020/025; https://slctr.lk/trials/slctr-2020-025.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/70293.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70293"},"PeriodicalIF":1.5,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vascular and Cardiovascular Outcomes of Smoking Cessation and Switching to Electronic Cigarette Use: Protocol for a Systematic Review of Prospective Studies.","authors":"Giusy Rita Maria La Rosa, Jacqueline Yu, Giulio Geraci, Davide Capodanno, Takao Ohki, Jacob George, Riccardo Polosa","doi":"10.2196/74949","DOIUrl":"10.2196/74949","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Despite the well-documented adverse health effects of tobacco smoking, it remains prevalent worldwide. Chronic tobacco smoking is associated with significant cardiovascular effects, including an increased risk of cardiovascular disease and vascular dysfunction. In recent years, the use of electronic cigarettes (ECs) has increased, with many former tobacco cigarette smokers switching to ECs to aid in smoking cessation. To date, no systematic review has synthesized prospective evidence on key vascular and cardiovascular outcomes among adult smokers who quit or switch to ECs, with the specific aim of identifying early and clinically meaningful indicators of vascular recovery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This systematic review aims to summarize the current prospective studies on the vascular effects of switching to exclusive EC use and the overall effects of smoking cessation on regular tobacco cigarette smokers. The review will focus, in particular, on early indicators of vascular improvement, such as measures of vascular function, including arterial stiffness and endothelial function, as well as on heart rate, blood pressure, nonfatal myocardial infarction, nonfatal stroke, sudden cardiovascular death, and acute heart failure.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The review will be reported following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A comprehensive search was performed in PubMed and Scopus on January 12, 2025, without restrictions on the publication date. Studies will be included if they focus on cardiovascular outcomes, with study designs, including clinical trials (randomized controlled trials, observational studies), prospective cohort studies, and case-control studies. Studies involving regular smokers, aged 18 years and older, and those reporting on smoking cessation or switching to ECs will be considered. Data will be extracted using a standardized form and synthesized qualitatively. Risk of bias will be assessed using Joanna Briggs Institute's critical appraisal tools, with results informing sensitivity analyses and interpretation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of January 2025, the preliminary search retrieved 1479 records across PubMed and Scopus. At the time of this protocol's publication, the first manuscript on vascular function outcomes was completed in July 2025 and is currently under peer review. Each subsequent review will include an updated search before completion.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This review will provide a comprehensive landscape of current literature on the long-term vascular effects of smoking cessation and switching to exclusive EC use. The findings will help identify early indicators of vascular damage reversal, gaps in the current evidence base, and inform future research directions. By disseminating the results through peer-reviewed journals, conferences, and digital platforms, the review aims to enhance the u","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e74949"},"PeriodicalIF":1.5,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrating a Combination HIV Prevention Intervention Into a Widely Used Geosocial App for Chinese Men Who Have Sex With Men: Protocol for a Single-Arm Pilot and Repeated Cross-Sectional Study.","authors":"Wenting Huang, Kunru Ning, Shi Hao Ernest Koh, Guodong Mi, Fei Yu, Yufen Liu, Daniel Stegmueller, Kimberly A Powers, Stefan Baral, Patrick S Sullivan, Aaron J Siegler","doi":"10.2196/69536","DOIUrl":"https://doi.org/10.2196/69536","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;HIV disproportionately affects men who have sex with men in China. However, HIV prevention services use among this population remains limited, in part due to concerns of privacy and sexual identity disclosure. These concerns might be addressed through telehealth services.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study was designed to assess the feasibility and acceptability of Blued+, which integrates an HIV prevention services package into a geosocial networking app commonly used by Chinese men who have sex with men.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study design was a single-arm pilot of the Blued+ intervention among men who have sex with men, using repeated cross-sectional surveys of an external population for comparison. For the pilot study, men were recruited from Beijing and Chengdu. A 3-month standard-of-care period with measurement at enrollment and month 0 (baseline) was followed by a 12-month intervention period with measurement at months 3, 6, 9, and 12. During the intervention period, participants received the enhanced version of the Blued app (Blued+) with HIV testing, linkage to care as needed, choice of condoms and condom-compatible lubricants, and pre-exposure prophylaxis (PrEP) services. PrEP was provided through in-app counseling and prescription, followed by lab tests at local clinics and mailed medication. Three cross-sectional surveys in months 0, 6, and 12 were administered to men in Beijing and Chengdu who were not enrolled in another HIV prevention study. These participants had access to the standard Blued geosocial networking app and local health services. The primary outcome of feasibility was the uptake of home HIV testing and PrEP. The coprimary outcome of intervention acceptability was measured with the System Usability Scale.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The run-in period was launched on July 15, 2022, with recruitment completed on August 24, 2022. The baseline period concluded in November 2022, and all follow-up assessments were completed by December 2023. At baseline, the pilot study enrolled 423 participants, and the cross-sectional comparison enrolled 1314 participants. Participants in the pilot were young (mean age 30, SD 7 years) and educated (324/423, 76.6% reported a college degree or higher), and most (302/423, 71.4%) reported HIV testing in the prior 3 months. Most participants (404/423, 95.5%) had heard of PrEP, and over a quarter had used PrEP (114/423, 27%). Participants in the comparison population had comparable sociodemographic characteristics, reporting HIV testing (501/857, 58.5%) in the prior 3 months, PrEP awareness (723/857, 84.4%), and PrEP use in the last 3 months (182/857, 15.4%).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This pilot study will provide preliminary evidence regarding the feasibility and acceptability of the Blued+ intervention. The study findings will provide evidence setting the foundation for future research that involves embedding prevention platf","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69536"},"PeriodicalIF":1.5,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}