Camilla Göras, Ann-Sofie Ersson, Therese Hellman, Petronella Bjurling-Sjöberg, Gunnar Bergström, Robert Sarkadi Kristiansson, Malin Lohela-Karlsson
Background: Health care systems are increasingly challenged by demographic shifts, rising chronic illnesses, human resource constraints, and growing efficiency demands. Improving both occupational safety and health (OSH) and patient safety (PS) management has been identified as a pivotal strategy to address these challenges. However, there is a paucity of evidence-based methods that support systematic and integrated OSH and PS. In response, the Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems (SIOHPS) intervention was developed, guided by the Safer Culture Framework and the Medical Research Council (MRC) framework for complex interventions.
Objective: This paper outlines the study protocol for a process evaluation embedded in the SIOHPS trial.
Methods: The process evaluation will use a convergent parallel mixed methods design. The SIOHPS trial is conducted in 13 Swedish hospital settings. Guided by the Consolidated Framework for Implementation Research (CFIR), quantitative and qualitative data will be collected before, during, and after the trial through questionnaires, telephone interviews, focus group interviews (FGIs), observations, the SIOHPS digital tool, and other relevant documentation. In line with the convergent parallel mixed methods study design, the quantitative and qualitative data will be analyzed in a stepwise manner, initially independently from each other, followed by iterative triangulation.
Results: Funding began in January 2023. The development phase was completed in early 2024, and the evaluation phase started in June 2024, with completion planned in early February 2026. Quantitative data collection for two of three clusters (baseline, 4- and 8-month follow-up) is complete, and data cleaning is underway. All qualitative data collected to date have been transcribed. Final data collection for cluster III, including the 8-month survey and FGIs, is scheduled for the end of January and early February 2026. Data analysis will begin in early 2026, with results to be disseminated through publications and conference presentations later in 2026.
Conclusions: The process evaluation will integrate quantitative and qualitative data sources to elucidate the mechanisms through which the SIOHPS intervention influences safety culture, health care worker (HCW) health, PS, and quality of care. This comprehensive approach unpacks the "black box" of the implementation process, which will provide an in-depth nuanced picture of the intervention's effectiveness and valuable insights into scalability and transferability across diverse health care contexts.
{"title":"Process Evaluation of a Structured Method for Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems (SIOHPS): Protocol for a Convergent Parallel Mixed Methods Study.","authors":"Camilla Göras, Ann-Sofie Ersson, Therese Hellman, Petronella Bjurling-Sjöberg, Gunnar Bergström, Robert Sarkadi Kristiansson, Malin Lohela-Karlsson","doi":"10.2196/89185","DOIUrl":"10.2196/89185","url":null,"abstract":"<p><strong>Background: </strong>Health care systems are increasingly challenged by demographic shifts, rising chronic illnesses, human resource constraints, and growing efficiency demands. Improving both occupational safety and health (OSH) and patient safety (PS) management has been identified as a pivotal strategy to address these challenges. However, there is a paucity of evidence-based methods that support systematic and integrated OSH and PS. In response, the Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems (SIOHPS) intervention was developed, guided by the Safer Culture Framework and the Medical Research Council (MRC) framework for complex interventions.</p><p><strong>Objective: </strong>This paper outlines the study protocol for a process evaluation embedded in the SIOHPS trial.</p><p><strong>Methods: </strong>The process evaluation will use a convergent parallel mixed methods design. The SIOHPS trial is conducted in 13 Swedish hospital settings. Guided by the Consolidated Framework for Implementation Research (CFIR), quantitative and qualitative data will be collected before, during, and after the trial through questionnaires, telephone interviews, focus group interviews (FGIs), observations, the SIOHPS digital tool, and other relevant documentation. In line with the convergent parallel mixed methods study design, the quantitative and qualitative data will be analyzed in a stepwise manner, initially independently from each other, followed by iterative triangulation.</p><p><strong>Results: </strong>Funding began in January 2023. The development phase was completed in early 2024, and the evaluation phase started in June 2024, with completion planned in early February 2026. Quantitative data collection for two of three clusters (baseline, 4- and 8-month follow-up) is complete, and data cleaning is underway. All qualitative data collected to date have been transcribed. Final data collection for cluster III, including the 8-month survey and FGIs, is scheduled for the end of January and early February 2026. Data analysis will begin in early 2026, with results to be disseminated through publications and conference presentations later in 2026.</p><p><strong>Conclusions: </strong>The process evaluation will integrate quantitative and qualitative data sources to elucidate the mechanisms through which the SIOHPS intervention influences safety culture, health care worker (HCW) health, PS, and quality of care. This comprehensive approach unpacks the \"black box\" of the implementation process, which will provide an in-depth nuanced picture of the intervention's effectiveness and valuable insights into scalability and transferability across diverse health care contexts.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06398860; https://clinicaltrials.gov/study/NCT06398860.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/89185.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e89185"},"PeriodicalIF":1.5,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12892028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146063450","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}
Myra Muramoto, Allison Hopkins, Christopher McCarty, Alicia Allen, L Miriam Dickinson, Timothy Connolly, Janet Spradley, Jun Ying
<p><strong>Background: </strong>Despite major gains in smoking cessation treatment, over half of those who recently quit will relapse within one year. Two systematic reviews of relapse prevention studies reached differing conclusions on the effectiveness of behavioral interventions. Existing relapse prevention evidence is limited by study designs, methodology, and conceptual approaches to behavioral interventions. Personal networks exert powerful effects on initiating and maintaining smoking behavior and can facilitate maintaining abstinence or trigger relapse. To date, relapse prevention interventions have focused on those who are newly abstinent ("abstainers") and have not attempted to influence the abstainer's personal network. The Helpers Stay Quit (Helpers Stay Quit) online training is a conceptually novel "help others" intervention to increase abstainers' public identification as a nonsmoker and their ability to influence those in their personal network to also quit smoking-thereby creating a personal network social environment supportive of long-term abstinence.</p><p><strong>Objective: </strong>This study is a 2-arm, pragmatic randomized controlled trial (pRCT) testing the hypothesis that quitline abstainers receiving the Helpers Stay Quit intervention will have higher 30-day and 7-day point prevalence of abstinence than those receiving quitline follow-up usual care, and that outcomes may be mediated by characteristics of abstainers' personal networks. The embedded mixed methods study examines the effects of the Helpers Stay Quit intervention on the abstainers' personal network interactions related to smoking and smoking cessation.</p><p><strong>Methods: </strong>The study design is a 2-group pRCT (N=940) comparing the Helpers Stay Quit online training intervention with a quitline usual care condition. Baseline, 3-, 6-, and 12-month surveys collect data on cognitive and emotional factors potentially influencing relapse. Text messages survey tobacco use status and participants' use of the Helpers Stay Quit training content. The composition and structure of participants' personal networks are assessed at baseline and 12 months. We interviewed 60 participants (both relapsed and abstinent) at differing intervals in the last 6 months of study participation to qualitatively assess personal network influences on relapse or abstinence.</p><p><strong>Results: </strong>A total of 9 state quitlines are participating by referring potentially eligible clients for screening and potential enrollment. Recruitment began in December 2022. Enrollment of 940 participants was completed in September 2025. When the manuscript was submitted, as of August 31, 2025, 337 participants (65%) had completed the study with 12-month follow-up surveys.</p><p><strong>Conclusions: </strong>This pRCT tests whether exposure to the Helpers Stay Quit intervention decreases relapse rates of newly abstinent smokers enrolled in state quitline coaching treatment. The embedded perso
{"title":"Effect of Helpers Stay Quit Online Training on Preventing Smoking Relapse and Personal Networks: Protocol for a Pragmatic Randomized Controlled Trial and Embedded Mixed Methods Personal Network Study.","authors":"Myra Muramoto, Allison Hopkins, Christopher McCarty, Alicia Allen, L Miriam Dickinson, Timothy Connolly, Janet Spradley, Jun Ying","doi":"10.2196/82140","DOIUrl":"10.2196/82140","url":null,"abstract":"<p><strong>Background: </strong>Despite major gains in smoking cessation treatment, over half of those who recently quit will relapse within one year. Two systematic reviews of relapse prevention studies reached differing conclusions on the effectiveness of behavioral interventions. Existing relapse prevention evidence is limited by study designs, methodology, and conceptual approaches to behavioral interventions. Personal networks exert powerful effects on initiating and maintaining smoking behavior and can facilitate maintaining abstinence or trigger relapse. To date, relapse prevention interventions have focused on those who are newly abstinent (\"abstainers\") and have not attempted to influence the abstainer's personal network. The Helpers Stay Quit (Helpers Stay Quit) online training is a conceptually novel \"help others\" intervention to increase abstainers' public identification as a nonsmoker and their ability to influence those in their personal network to also quit smoking-thereby creating a personal network social environment supportive of long-term abstinence.</p><p><strong>Objective: </strong>This study is a 2-arm, pragmatic randomized controlled trial (pRCT) testing the hypothesis that quitline abstainers receiving the Helpers Stay Quit intervention will have higher 30-day and 7-day point prevalence of abstinence than those receiving quitline follow-up usual care, and that outcomes may be mediated by characteristics of abstainers' personal networks. The embedded mixed methods study examines the effects of the Helpers Stay Quit intervention on the abstainers' personal network interactions related to smoking and smoking cessation.</p><p><strong>Methods: </strong>The study design is a 2-group pRCT (N=940) comparing the Helpers Stay Quit online training intervention with a quitline usual care condition. Baseline, 3-, 6-, and 12-month surveys collect data on cognitive and emotional factors potentially influencing relapse. Text messages survey tobacco use status and participants' use of the Helpers Stay Quit training content. The composition and structure of participants' personal networks are assessed at baseline and 12 months. We interviewed 60 participants (both relapsed and abstinent) at differing intervals in the last 6 months of study participation to qualitatively assess personal network influences on relapse or abstinence.</p><p><strong>Results: </strong>A total of 9 state quitlines are participating by referring potentially eligible clients for screening and potential enrollment. Recruitment began in December 2022. Enrollment of 940 participants was completed in September 2025. When the manuscript was submitted, as of August 31, 2025, 337 participants (65%) had completed the study with 12-month follow-up surveys.</p><p><strong>Conclusions: </strong>This pRCT tests whether exposure to the Helpers Stay Quit intervention decreases relapse rates of newly abstinent smokers enrolled in state quitline coaching treatment. The embedded perso","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e82140"},"PeriodicalIF":1.5,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12840865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146063494","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}
Sarang K Yoon, German L Ellsworth, Steph Battan-Wraith, Andrew L Phillips, Rebecca V Fink, Joshua Griffin, Elizabeth A K Rowley, Jacob McKell, Ashley S Smith, Riley Campbell, Jesse Williams, Sarah W Ball, Hongwei Zhao, Brandy Warren, Matthew D Rousculp, Matthew S Thiese
<p><strong>Background: </strong>Surveillance of COVID-19 vaccine effectiveness (VE) was extensive upon vaccine introduction; however, it declined after the withdrawal of pandemic status in May 2023. Continued monitoring of updated vaccine formulations is needed to ensure the maintenance of VE in the face of evolving viral strains.</p><p><strong>Objective: </strong>The Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy (BEEHIVE) study (NCT06065176), a randomized trial with a hybrid design, was developed to assess the real-world VE of the 2023-2024 Pfizer-BioNTech and Novavax COVID-19 vaccine formulations targeting the XBB.1.5 SARS-CoV-2 variant.</p><p><strong>Methods: </strong>This study was designed to enroll approximately 1500 participants aged ≥18 years from the Salt Lake City, Utah, area who had previously received ≥2 doses of an authorized messenger RNA (mRNA)-based COVID-19 vaccine but had not received a dose of the 2023-2024 formulation. The study used a randomized, hybrid design comprising 2 blinded groups assigned to receive the 2023-2024 formula of either the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine and a nonrandomized, observational control group of volunteers who chose not to receive a 2023-2024 vaccine dose during the study. Follow-up lasted 24 weeks and included symptom surveys and self-administered COVID-19 antigen testing, both occurring weekly. The primary aim was to compare VE (defined as prevention of symptomatic SARS-CoV-2 infection) between study-vaccinated participants and the control group. The secondary aim was to determine the relative VE of the Pfizer-BioNTech mRNA and Novavax 2023-2024 COVID-19 vaccines. Secondary objectives included assessing how the number of previous COVID-19 vaccinations impacted VE of the 2023-2024 COVID-19 vaccines; identifying predictors and associated factors for asymptomatic versus symptomatic infection and/or prolonged or severe illness; examining factors associated with post-COVID-19 conditions; and evaluating participants' knowledge, attitudes, and practices related to COVID-19 vaccination. Participant engagement was maintained via online and text-based reminders and surveys, as well as researcher follow-up.</p><p><strong>Results: </strong>Participants were recruited from November 2023 through March 2024, with 452 and 457 participants randomized to the Novavax and Pfizer-BioNTech vaccine groups, respectively, and 279 participants enrolled in the control group. SARS-CoV-2 variants from the XBB, JN.1, KP.2, and KP.3 lineages were in circulation in the United States and the Utah region during data collection. The study ended on September 9, 2024, with results expected to be published in 2026.</p><p><strong>Conclusions: </strong>Data from this study will provide valuable real-world VE data for a dose of the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine after an mRNA-based COVID-19 primary series.</p><p><strong>Trial registration:
{"title":"Real-World Effectiveness and Noninferiority Evaluation and Comparison of Messenger RNA-Based and Protein-Based COVID-19 Vaccines: Protocol for the BEEHIVE Randomized Study With a Hybrid Effectiveness Design.","authors":"Sarang K Yoon, German L Ellsworth, Steph Battan-Wraith, Andrew L Phillips, Rebecca V Fink, Joshua Griffin, Elizabeth A K Rowley, Jacob McKell, Ashley S Smith, Riley Campbell, Jesse Williams, Sarah W Ball, Hongwei Zhao, Brandy Warren, Matthew D Rousculp, Matthew S Thiese","doi":"10.2196/80858","DOIUrl":"10.2196/80858","url":null,"abstract":"<p><strong>Background: </strong>Surveillance of COVID-19 vaccine effectiveness (VE) was extensive upon vaccine introduction; however, it declined after the withdrawal of pandemic status in May 2023. Continued monitoring of updated vaccine formulations is needed to ensure the maintenance of VE in the face of evolving viral strains.</p><p><strong>Objective: </strong>The Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy (BEEHIVE) study (NCT06065176), a randomized trial with a hybrid design, was developed to assess the real-world VE of the 2023-2024 Pfizer-BioNTech and Novavax COVID-19 vaccine formulations targeting the XBB.1.5 SARS-CoV-2 variant.</p><p><strong>Methods: </strong>This study was designed to enroll approximately 1500 participants aged ≥18 years from the Salt Lake City, Utah, area who had previously received ≥2 doses of an authorized messenger RNA (mRNA)-based COVID-19 vaccine but had not received a dose of the 2023-2024 formulation. The study used a randomized, hybrid design comprising 2 blinded groups assigned to receive the 2023-2024 formula of either the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine and a nonrandomized, observational control group of volunteers who chose not to receive a 2023-2024 vaccine dose during the study. Follow-up lasted 24 weeks and included symptom surveys and self-administered COVID-19 antigen testing, both occurring weekly. The primary aim was to compare VE (defined as prevention of symptomatic SARS-CoV-2 infection) between study-vaccinated participants and the control group. The secondary aim was to determine the relative VE of the Pfizer-BioNTech mRNA and Novavax 2023-2024 COVID-19 vaccines. Secondary objectives included assessing how the number of previous COVID-19 vaccinations impacted VE of the 2023-2024 COVID-19 vaccines; identifying predictors and associated factors for asymptomatic versus symptomatic infection and/or prolonged or severe illness; examining factors associated with post-COVID-19 conditions; and evaluating participants' knowledge, attitudes, and practices related to COVID-19 vaccination. Participant engagement was maintained via online and text-based reminders and surveys, as well as researcher follow-up.</p><p><strong>Results: </strong>Participants were recruited from November 2023 through March 2024, with 452 and 457 participants randomized to the Novavax and Pfizer-BioNTech vaccine groups, respectively, and 279 participants enrolled in the control group. SARS-CoV-2 variants from the XBB, JN.1, KP.2, and KP.3 lineages were in circulation in the United States and the Utah region during data collection. The study ended on September 9, 2024, with results expected to be published in 2026.</p><p><strong>Conclusions: </strong>Data from this study will provide valuable real-world VE data for a dose of the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine after an mRNA-based COVID-19 primary series.</p><p><strong>Trial registration: ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e80858"},"PeriodicalIF":1.5,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12892025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146063446","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}
Rosa Maria Cabedo-Ferreiro, Liudmila Liutsko, Judit Cos-Busquets, Rosa García-Sierra, Margalida Colldeforns-Vidal, Azahara Reyes-Lacalle, Pere Torán-Monserrat, M Mercedes Vicente-Hernández, Miriam Gómez-Masvidal, Concepció Violán, Laura Montero-Pons, Gemma Falguera-Puig, Gemma Cazorla-Ortiz
<p><strong>Background: </strong>Exclusive breastfeeding is recommended as healthier and more sustainable than formula feeding. It produces less waste, requires fewer resources, and has a smaller environmental impact. Breastfeeding has some environmental impact related to increased maternal dietary needs and the use of feeding accessories. In light of the global climate emergency and suboptimal breastfeeding rates, targeted interventions are urgently needed to promote sustainable infant feeding practices. There are few studies that evaluate sustainability interventions in the postpartum period.</p><p><strong>Objective: </strong>The objective of this study is to evaluate the effectiveness of an educational and counseling intervention on breastfeeding and healthy maternal nutrition from an environmental perspective.</p><p><strong>Methods: </strong>A multicenter prospective intervention study is being conducted in 2 cohorts in primary care centers and hospitals in the north metropolitan area of Barcelona. The control group received standard obstetric care. The experimental group additionally received an educational intervention and health care support on breastfeeding and healthy and sustainable maternal nutrition. Pregnant women were monitored from 24 weeks of gestation to 6 months post partum. The rates of different types of breastfeeding, the women's diet, and the associated environmental impacts (climate change and water footprint) will be analyzed to assess the effectiveness of the intervention.</p><p><strong>Results: </strong>The development of the educational and counseling intervention has been completed, including the creation of the Guide to Good Practices in Breastfeeding, Nutrition, and Sustainability. Health care professionals received targeted training. Recruitment of pregnant women was conducted from December 2023 to December 2024. Prenatal education sessions and specialized care pathways were designed and implemented. Breastfeeding-friendly spaces were adapted to support the participating centers. Data collection for monitoring breastfeeding practices, maternal diet, and environmental impact indicators (carbon footprint and water footprint), with the follow-up period of 6 months post partum, was extended until September 2025, with a complementary missing data collection in October 2025. Data cleaning for final analysis is expected to conclude by January 2026. This study hypothesizes that mothers who receive higher levels of education and counseling support will (1) breastfeed for a longer duration, (2) adopt healthier and more sustainable dietary practices, and (3) reduce environmental impacts associated with both infant feeding accessories and dietary choices.</p><p><strong>Conclusions: </strong>We expect an increase in the incidence and prevalence rates of breastfeeding and a shift toward a healthy and sustainable diet with low environmental impact.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05729581; https://c
{"title":"Effectiveness of an Educational and Counseling Program (the Green Mother Project Phase 2) to Enhance Breastfeeding and Improve Mothers' Diets From an Environmental Perspective: Protocol for a Cluster Randomized Controlled Trial.","authors":"Rosa Maria Cabedo-Ferreiro, Liudmila Liutsko, Judit Cos-Busquets, Rosa García-Sierra, Margalida Colldeforns-Vidal, Azahara Reyes-Lacalle, Pere Torán-Monserrat, M Mercedes Vicente-Hernández, Miriam Gómez-Masvidal, Concepció Violán, Laura Montero-Pons, Gemma Falguera-Puig, Gemma Cazorla-Ortiz","doi":"10.2196/80358","DOIUrl":"10.2196/80358","url":null,"abstract":"<p><strong>Background: </strong>Exclusive breastfeeding is recommended as healthier and more sustainable than formula feeding. It produces less waste, requires fewer resources, and has a smaller environmental impact. Breastfeeding has some environmental impact related to increased maternal dietary needs and the use of feeding accessories. In light of the global climate emergency and suboptimal breastfeeding rates, targeted interventions are urgently needed to promote sustainable infant feeding practices. There are few studies that evaluate sustainability interventions in the postpartum period.</p><p><strong>Objective: </strong>The objective of this study is to evaluate the effectiveness of an educational and counseling intervention on breastfeeding and healthy maternal nutrition from an environmental perspective.</p><p><strong>Methods: </strong>A multicenter prospective intervention study is being conducted in 2 cohorts in primary care centers and hospitals in the north metropolitan area of Barcelona. The control group received standard obstetric care. The experimental group additionally received an educational intervention and health care support on breastfeeding and healthy and sustainable maternal nutrition. Pregnant women were monitored from 24 weeks of gestation to 6 months post partum. The rates of different types of breastfeeding, the women's diet, and the associated environmental impacts (climate change and water footprint) will be analyzed to assess the effectiveness of the intervention.</p><p><strong>Results: </strong>The development of the educational and counseling intervention has been completed, including the creation of the Guide to Good Practices in Breastfeeding, Nutrition, and Sustainability. Health care professionals received targeted training. Recruitment of pregnant women was conducted from December 2023 to December 2024. Prenatal education sessions and specialized care pathways were designed and implemented. Breastfeeding-friendly spaces were adapted to support the participating centers. Data collection for monitoring breastfeeding practices, maternal diet, and environmental impact indicators (carbon footprint and water footprint), with the follow-up period of 6 months post partum, was extended until September 2025, with a complementary missing data collection in October 2025. Data cleaning for final analysis is expected to conclude by January 2026. This study hypothesizes that mothers who receive higher levels of education and counseling support will (1) breastfeed for a longer duration, (2) adopt healthier and more sustainable dietary practices, and (3) reduce environmental impacts associated with both infant feeding accessories and dietary choices.</p><p><strong>Conclusions: </strong>We expect an increase in the incidence and prevalence rates of breastfeeding and a shift toward a healthy and sustainable diet with low environmental impact.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05729581; https://c","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e80358"},"PeriodicalIF":1.5,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12887563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052313","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}
Frederique Dupuis, Yannick Tousignant-Laflamme, Pascale Marier Deschênes, Philippe Fournier, Ildephonse Nduwimana, Orlane Ballot, Loris Loisel, Anne Marie Pinard, Luc Lacombe, Pierre Langevin, Alain Gaumond, Jean-Sébastien Roy, Hugo Massé-Alarie
<p><strong>Background: </strong>Low back pain (LBP) is the most common chronic pain condition in veterans, but the effectiveness of standard management approaches is modest. Addressing the psychological risk factors of chronic pain that are often observed in this population (eg, anxiety, depression, stress and mood disorders) may be important to enhance outcomes. Psychologically informed physiotherapy (PiP) identifies and mitigates the negative impacts of emotional and cognitive factors alongside the biomedical aspects of chronic LBP to improve physical functioning and has shown promising results in this population. However, residual pain and disability often persist in veterans. The combination of PiP with repetitive transcranial magnetic stimulation (rTMS) to the prefrontal cortex may enhance its effectiveness by modulating cognition, emotion, and pain perception.</p><p><strong>Objective: </strong>The aim of this study is to compare the effects of (1) combining active rTMS with PiP, (2) combining sham rTMS with PiP, and (3) usual physiotherapy (UP) on physical functioning in veterans with chronic LBP and comorbid psychological risk factors. Secondary objectives include comparing their effect on pain intensity, quality of life, depression symptoms, pain catastrophizing, movement pain-related fear, self-efficacy, medication use, and posttraumatic stress disorder symptoms.</p><p><strong>Methods: </strong>Ninety-six veterans with chronic LBP and comorbid psychological risks factors of pain will be enrolled in this 3-arm parallel randomized controlled trial. Individuals will be allocated to receive an 8-week intervention of (1) active rTMS + PiP, (2) sham rTMS + PiP, or (3) UP. Online self-administered questionnaires will be completed at baseline, 2, 8, and 26 weeks after the first treatment session. A linear mixed model will be used to assess the treatment effects by using intention-to-treat analyses. We hypothesize that active rTMS + PiP will be more effective than sham rTMS + PiP and that active PiP + rTMS or sham rTMS will be more effective than UP.</p><p><strong>Results: </strong>Ethics approval was obtained in January 2025, and participating physiotherapists completed the 2-day PiP training in May 2025. Participants have been recruited since June 2025. As of December 2025, 28 participants have been included, and recruitment is expected to continue up to June 2027, targeting the inclusion of approximately 4 new participants per month. Follow-up should be completed by December 2027, and results will be analyzed. The results of this randomized controlled trial should be published and available in June 2028.</p><p><strong>Conclusions: </strong>It is paramount to identify innovative and effective interventions for the management of chronic LBP in veterans. This study will provide new evidence on the effectiveness of two innovative interventions targeting cognitive and emotional factors of pain (ie, PiP and rTMS). If our hypothesis is confirmed, it
{"title":"Combining Noninvasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans: Protocol for a Multi-Arm Randomized Controlled Trial.","authors":"Frederique Dupuis, Yannick Tousignant-Laflamme, Pascale Marier Deschênes, Philippe Fournier, Ildephonse Nduwimana, Orlane Ballot, Loris Loisel, Anne Marie Pinard, Luc Lacombe, Pierre Langevin, Alain Gaumond, Jean-Sébastien Roy, Hugo Massé-Alarie","doi":"10.2196/78952","DOIUrl":"10.2196/78952","url":null,"abstract":"<p><strong>Background: </strong>Low back pain (LBP) is the most common chronic pain condition in veterans, but the effectiveness of standard management approaches is modest. Addressing the psychological risk factors of chronic pain that are often observed in this population (eg, anxiety, depression, stress and mood disorders) may be important to enhance outcomes. Psychologically informed physiotherapy (PiP) identifies and mitigates the negative impacts of emotional and cognitive factors alongside the biomedical aspects of chronic LBP to improve physical functioning and has shown promising results in this population. However, residual pain and disability often persist in veterans. The combination of PiP with repetitive transcranial magnetic stimulation (rTMS) to the prefrontal cortex may enhance its effectiveness by modulating cognition, emotion, and pain perception.</p><p><strong>Objective: </strong>The aim of this study is to compare the effects of (1) combining active rTMS with PiP, (2) combining sham rTMS with PiP, and (3) usual physiotherapy (UP) on physical functioning in veterans with chronic LBP and comorbid psychological risk factors. Secondary objectives include comparing their effect on pain intensity, quality of life, depression symptoms, pain catastrophizing, movement pain-related fear, self-efficacy, medication use, and posttraumatic stress disorder symptoms.</p><p><strong>Methods: </strong>Ninety-six veterans with chronic LBP and comorbid psychological risks factors of pain will be enrolled in this 3-arm parallel randomized controlled trial. Individuals will be allocated to receive an 8-week intervention of (1) active rTMS + PiP, (2) sham rTMS + PiP, or (3) UP. Online self-administered questionnaires will be completed at baseline, 2, 8, and 26 weeks after the first treatment session. A linear mixed model will be used to assess the treatment effects by using intention-to-treat analyses. We hypothesize that active rTMS + PiP will be more effective than sham rTMS + PiP and that active PiP + rTMS or sham rTMS will be more effective than UP.</p><p><strong>Results: </strong>Ethics approval was obtained in January 2025, and participating physiotherapists completed the 2-day PiP training in May 2025. Participants have been recruited since June 2025. As of December 2025, 28 participants have been included, and recruitment is expected to continue up to June 2027, targeting the inclusion of approximately 4 new participants per month. Follow-up should be completed by December 2027, and results will be analyzed. The results of this randomized controlled trial should be published and available in June 2028.</p><p><strong>Conclusions: </strong>It is paramount to identify innovative and effective interventions for the management of chronic LBP in veterans. This study will provide new evidence on the effectiveness of two innovative interventions targeting cognitive and emotional factors of pain (ie, PiP and rTMS). If our hypothesis is confirmed, it ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e78952"},"PeriodicalIF":1.5,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12887568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146046690","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}
Josephine Pui-Hing Wong, Alan Tai-Wai Li, Carla T Hilario, Mandana Vahabi, Egbe Etowa, Isaac Luginaah, Aniela M Dela Cruz, Miya Narushima, Kenneth Po-Lun Fung
<p><strong>Background: </strong>Racialized immigrants are disproportionately impacted by HIV in Canada. In 2022, 69.5% of first-time HIV cases, where race and/or ethnicity was reported, were among racialized individuals: Indigenous (22.6%), Black (18.0%), Asian and Arab (16.3%), and Latinx (10.1%). HIV vulnerability in racialized communities is reinforced by HIV stigma intersecting with prejudice and discrimination associated with racism, gendered oppression, homophobia, and economic marginalization. Stigma and discrimination impede public health efforts in HIV prevention, testing, treatment, and care.</p><p><strong>Objective: </strong>The goal of the study is to reduce HIV-related stigma in racialized immigrant communities in 6 Canadian cities in Alberta (Calgary, Edmonton) and Ontario (London, Niagara, Ottawa, Toronto). We will implement an evidence-based 6-session online intervention, Acceptance and Commitment to Empowerment (ACE), to promote skills for psychological flexibility (mindfulness, acceptance, cognitive defusion, values clarification, and committed action) and collective empowerment (critical reflection, dialogue, interconnectedness, and collective action). The objectives are to (1) assess community contexts and needs to inform the refinement of ACE; (2) build community capacity in stigma reduction; (3) evaluate the facilitators and barriers of implementing stigma reduction programs; and (4) disseminate knowledge to advance research, policy, and practice.</p><p><strong>Methods: </strong>Guided by the principles of social justice and health equity, we will apply the context-based PRISM (Practical Robust Implementation and Sustainability Model) and outcome-based RE-AIM (reach, effectiveness, adoption, implementation, maintenance) frameworks to inform the contextual adaptation, implementation, and evaluation of the ACE intervention. In phase 1 (year 1), we aim to survey 12 local organizations on their existing stigma reduction programs; engage 30 service providers and 60 community members to explore the local contexts and needs of stigma reduction. In phase 2 (year 2), phase 1 results will be used to refine the ACE intervention and apply a train-the-trainer (TTT) approach to engage 48 service providers or community leaders in the ACE training. ACE TTT graduates will be mentored to become ACE Community Facilitators. In phase 3 (years 3-4), project staff and ACE Community Facilitators will work in small 3-member teams to deliver the online ACE intervention to qualified participants (n=288) in 6 cities. Mixed methods will be used to examine the contextual factors on implementation processes and intervention effectiveness. Data analyses will include reflexive thematic analysis of qualitative data, inferential statistics, and analyses of variance to determine the effectiveness of the intervention over time.</p><p><strong>Results: </strong>The implementation of project ACE was delayed by 2 years due to the COVID-19 pandemic. The requirement
{"title":"Acceptance and Commitment to Empowerment Intervention to Reduce HIV Stigma and Promote Community Resilience: Protocol for an Implementation Study.","authors":"Josephine Pui-Hing Wong, Alan Tai-Wai Li, Carla T Hilario, Mandana Vahabi, Egbe Etowa, Isaac Luginaah, Aniela M Dela Cruz, Miya Narushima, Kenneth Po-Lun Fung","doi":"10.2196/80669","DOIUrl":"10.2196/80669","url":null,"abstract":"<p><strong>Background: </strong>Racialized immigrants are disproportionately impacted by HIV in Canada. In 2022, 69.5% of first-time HIV cases, where race and/or ethnicity was reported, were among racialized individuals: Indigenous (22.6%), Black (18.0%), Asian and Arab (16.3%), and Latinx (10.1%). HIV vulnerability in racialized communities is reinforced by HIV stigma intersecting with prejudice and discrimination associated with racism, gendered oppression, homophobia, and economic marginalization. Stigma and discrimination impede public health efforts in HIV prevention, testing, treatment, and care.</p><p><strong>Objective: </strong>The goal of the study is to reduce HIV-related stigma in racialized immigrant communities in 6 Canadian cities in Alberta (Calgary, Edmonton) and Ontario (London, Niagara, Ottawa, Toronto). We will implement an evidence-based 6-session online intervention, Acceptance and Commitment to Empowerment (ACE), to promote skills for psychological flexibility (mindfulness, acceptance, cognitive defusion, values clarification, and committed action) and collective empowerment (critical reflection, dialogue, interconnectedness, and collective action). The objectives are to (1) assess community contexts and needs to inform the refinement of ACE; (2) build community capacity in stigma reduction; (3) evaluate the facilitators and barriers of implementing stigma reduction programs; and (4) disseminate knowledge to advance research, policy, and practice.</p><p><strong>Methods: </strong>Guided by the principles of social justice and health equity, we will apply the context-based PRISM (Practical Robust Implementation and Sustainability Model) and outcome-based RE-AIM (reach, effectiveness, adoption, implementation, maintenance) frameworks to inform the contextual adaptation, implementation, and evaluation of the ACE intervention. In phase 1 (year 1), we aim to survey 12 local organizations on their existing stigma reduction programs; engage 30 service providers and 60 community members to explore the local contexts and needs of stigma reduction. In phase 2 (year 2), phase 1 results will be used to refine the ACE intervention and apply a train-the-trainer (TTT) approach to engage 48 service providers or community leaders in the ACE training. ACE TTT graduates will be mentored to become ACE Community Facilitators. In phase 3 (years 3-4), project staff and ACE Community Facilitators will work in small 3-member teams to deliver the online ACE intervention to qualified participants (n=288) in 6 cities. Mixed methods will be used to examine the contextual factors on implementation processes and intervention effectiveness. Data analyses will include reflexive thematic analysis of qualitative data, inferential statistics, and analyses of variance to determine the effectiveness of the intervention over time.</p><p><strong>Results: </strong>The implementation of project ACE was delayed by 2 years due to the COVID-19 pandemic. The requirement ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e80669"},"PeriodicalIF":1.5,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12834450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052279","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}
Background: For root canal procedures to be successful, adequate bond strength between endodontic sealer and post material is necessary. For postendodontic restorations, glass fiber posts and carbon fiber posts are frequently used. Depending on the type of root canal sealer used, such posts may work differently. The chemical composition and characteristics of calcium hydroxide-based, resin-based, and bioceramic-based sealers vary, which may have an impact on the posts' binding strength. Therefore, optimizing rehabilitative results requires an understanding of these connections.
Objective: This study aims to evaluate and compare the push-out bond strength of glass fiber posts and carbon fiber posts in root canals treated with calcium hydroxide-based, resin-based, and bioceramic-based endodontic sealers.
Methods: A total of 60 extracted human premolars will be used in this in vitro investigation. After canal preparation, specimens will be separated into 3 groups according to the type of sealer used (bioceramic-based, resin-based, and calcium hydroxide-based). The type of post (carbon fiber or glass fiber) will be used to further split each group into 2 subgroups. A universal testing machine will be used to exert a compressive force on each post to test its push-out bond strength. Bond strength data will be recorded in megapascals and analyzed using ANOVA and post hoc tests.
Results: The results are expected to demonstrate significant differences in push-out bond strength among different post and sealer combinations. Glass fiber posts are expected to have higher bond strength values than carbon fiber posts across all sealer groups, with the highest bond strength anticipated in the bioceramic-based sealer group. Resin-based sealers are expected to exhibit intermediate bond strength values, whereas calcium hydroxide-based sealers are expected to show the lowest bond strength values across both types of post.
Conclusions: Glass fiber posts are expected to offer superior push-out bond strength in comparison to carbon fiber posts, especially when used with bioceramic-based sealers. The type of root canal sealer significantly affects bond strength, with bioceramic-based sealers providing the most reliable bond. Findings are expected that will suggest that careful selection of both post material and sealer type is necessary to enhance the long-term success of root canal restorations.
International registered report identifier (irrid): DERR1-10.2196/76621.
{"title":"Comparative Evaluation of Push-Out Bond Strength of Glass Fiber Posts and Carbon Fiber Posts in Root Canals Treated With Calcium Hydroxide-Based, Resin-Based, and Bioceramic-Based Root Canal Sealers: Protocol for an In Vitro Study.","authors":"Vinus Shivlani, Manoj Chandak, Sanika Damle","doi":"10.2196/76621","DOIUrl":"10.2196/76621","url":null,"abstract":"<p><strong>Background: </strong>For root canal procedures to be successful, adequate bond strength between endodontic sealer and post material is necessary. For postendodontic restorations, glass fiber posts and carbon fiber posts are frequently used. Depending on the type of root canal sealer used, such posts may work differently. The chemical composition and characteristics of calcium hydroxide-based, resin-based, and bioceramic-based sealers vary, which may have an impact on the posts' binding strength. Therefore, optimizing rehabilitative results requires an understanding of these connections.</p><p><strong>Objective: </strong>This study aims to evaluate and compare the push-out bond strength of glass fiber posts and carbon fiber posts in root canals treated with calcium hydroxide-based, resin-based, and bioceramic-based endodontic sealers.</p><p><strong>Methods: </strong>A total of 60 extracted human premolars will be used in this in vitro investigation. After canal preparation, specimens will be separated into 3 groups according to the type of sealer used (bioceramic-based, resin-based, and calcium hydroxide-based). The type of post (carbon fiber or glass fiber) will be used to further split each group into 2 subgroups. A universal testing machine will be used to exert a compressive force on each post to test its push-out bond strength. Bond strength data will be recorded in megapascals and analyzed using ANOVA and post hoc tests.</p><p><strong>Results: </strong>The results are expected to demonstrate significant differences in push-out bond strength among different post and sealer combinations. Glass fiber posts are expected to have higher bond strength values than carbon fiber posts across all sealer groups, with the highest bond strength anticipated in the bioceramic-based sealer group. Resin-based sealers are expected to exhibit intermediate bond strength values, whereas calcium hydroxide-based sealers are expected to show the lowest bond strength values across both types of post.</p><p><strong>Conclusions: </strong>Glass fiber posts are expected to offer superior push-out bond strength in comparison to carbon fiber posts, especially when used with bioceramic-based sealers. The type of root canal sealer significantly affects bond strength, with bioceramic-based sealers providing the most reliable bond. Findings are expected that will suggest that careful selection of both post material and sealer type is necessary to enhance the long-term success of root canal restorations.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/76621.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e76621"},"PeriodicalIF":1.5,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12887557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052322","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}
Duanchun Zhang, Dan Zhang, Xiaoxiao Qu, Huihong Cao, Yanming He
<p><strong>Background: </strong>Hashimoto thyroiditis (HT) is a chronic inflammation of the thyroid gland mediated by autoimmune disorders, often leading to hypothyroidism and a significant reduction in a patient's quality of life. At the time of this writing, there is a lack of effective clinical treatments for early-stage HT. Kangjia decoction granules (KDGs) were developed based on clinical experience and results analysis, showing promising outcomes in improving antibody levels and quality of life in patients with HT. However, there is a lack of further evaluation of the efficacy and safety of KDGs.</p><p><strong>Objective: </strong>This pilot study aims to further understand and validate the efficacy and safety of KDGs for treating HT through clinical research and comprehensively assess the benefits of this intervention for patients.</p><p><strong>Methods: </strong>This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Participants meeting the HT diagnostic criteria will be randomly allocated to the intervention and control groups (n1=n2=70). The intervention group will receive KDG treatment, whereas the control group will receive a placebo treatment. All participants will undergo treatment for 3 months. Changes in antithyroid peroxidase antibody (TPOAb) levels will be the primary outcome. Secondary outcomes include antithyroglobulin antibodies (TGAb), thyrotropin, also known as thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroid hormone (T4), serum free triiodothyronine (FT3), serum free thyroxine (FT4), thyroid ultrasonography, IL17 mRNA and FOXP3 mRNA, traditional Chinese medicine (TCM) syndrome efficacy scores, and quality of life scale scores. Throughout the treatment and follow-up periods, safety indicators, such as routine blood and urine tests, hepatic and renal function, electrocardiography, and major adverse reactions, will be monitored.</p><p><strong>Results: </strong>The research protocol and informed consent form received approval from the Clinical Research Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, on December 14, 2022 (Approval No. 2022-123). Participant recruitment commenced in June 2023. All intervention and concurrent data collection activities were scheduled for completion by October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed.</p><p><strong>Conclusions: </strong>This study's findings will offer initial clinical evidence regarding the efficacy of the TCM compound KDGs in modulating peripheral immunity in patients with HT, decreasing autoimmune antibody levels, ameliorating TCM syndromes, and enhancing quality of life. These results will serve as a basis for future large-scale trial designs.</p><p><strong>Trial registration: </strong>China Clinical Trials Registry ChiCTR2300070184; https://www.chictr.org.cn/showp
{"title":"Effectiveness and Safety of Kangjia Decoction Granules for the Treatment of Hashimoto Thyroiditis: Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Clinical Trial.","authors":"Duanchun Zhang, Dan Zhang, Xiaoxiao Qu, Huihong Cao, Yanming He","doi":"10.2196/80993","DOIUrl":"10.2196/80993","url":null,"abstract":"<p><strong>Background: </strong>Hashimoto thyroiditis (HT) is a chronic inflammation of the thyroid gland mediated by autoimmune disorders, often leading to hypothyroidism and a significant reduction in a patient's quality of life. At the time of this writing, there is a lack of effective clinical treatments for early-stage HT. Kangjia decoction granules (KDGs) were developed based on clinical experience and results analysis, showing promising outcomes in improving antibody levels and quality of life in patients with HT. However, there is a lack of further evaluation of the efficacy and safety of KDGs.</p><p><strong>Objective: </strong>This pilot study aims to further understand and validate the efficacy and safety of KDGs for treating HT through clinical research and comprehensively assess the benefits of this intervention for patients.</p><p><strong>Methods: </strong>This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Participants meeting the HT diagnostic criteria will be randomly allocated to the intervention and control groups (n1=n2=70). The intervention group will receive KDG treatment, whereas the control group will receive a placebo treatment. All participants will undergo treatment for 3 months. Changes in antithyroid peroxidase antibody (TPOAb) levels will be the primary outcome. Secondary outcomes include antithyroglobulin antibodies (TGAb), thyrotropin, also known as thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroid hormone (T4), serum free triiodothyronine (FT3), serum free thyroxine (FT4), thyroid ultrasonography, IL17 mRNA and FOXP3 mRNA, traditional Chinese medicine (TCM) syndrome efficacy scores, and quality of life scale scores. Throughout the treatment and follow-up periods, safety indicators, such as routine blood and urine tests, hepatic and renal function, electrocardiography, and major adverse reactions, will be monitored.</p><p><strong>Results: </strong>The research protocol and informed consent form received approval from the Clinical Research Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, on December 14, 2022 (Approval No. 2022-123). Participant recruitment commenced in June 2023. All intervention and concurrent data collection activities were scheduled for completion by October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed.</p><p><strong>Conclusions: </strong>This study's findings will offer initial clinical evidence regarding the efficacy of the TCM compound KDGs in modulating peripheral immunity in patients with HT, decreasing autoimmune antibody levels, ameliorating TCM syndromes, and enhancing quality of life. These results will serve as a basis for future large-scale trial designs.</p><p><strong>Trial registration: </strong>China Clinical Trials Registry ChiCTR2300070184; https://www.chictr.org.cn/showp","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e80993"},"PeriodicalIF":1.5,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12887561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052361","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}
Mas Norehan Merican Aljunid Merican, Zaleha Md Isa, Rozita Hod, Roszita Ibrahim, Zamtira Seman, Rusdi Abd Rashid
<p><strong>Background: </strong>Leptospirosis is the most common zoonotic cause of mortality, with most of its burden occurring in tropical regions and low-income countries. It is endemic in Southeast and South Asian nations. Leptospirosis outbreaks occur after natural disasters. In Malaysia, the e-notification system of the Communicable Diseases Control Information System recorded 5217 leptospirosis cases in 2019 with 32 fatalities. The incidence rate was 15.61 per 100,000 people. Male individuals comprised 67% of leptospirosis cases, while people aged 25 to 55 years accounted for 45% of the cases. Information and perception are crucial in influencing positive behavior. Nonetheless, information on urban and rural people's knowledge, attitude, and practice (KAP) regarding the incidence of leptospirosis is limited.</p><p><strong>Objective: </strong>We aimed to develop a mobile app with information on leptospirosis and measure its effectiveness in improving KAP regarding leptospirosis among wet market workers in Selangor, Malaysia.</p><p><strong>Methods: </strong>A 3-phase study will be conducted and includes development of a mobile app containing information about leptospirosis, analysis of its acceptability, and application of the intervention. Participants will be recruited based on specific inclusion criteria by using purposive sampling. Four wet markets in Hulu Langat district, Selangor, will be selected according to a list provided by local municipal councils. The respondents from each selected wet market will be workers aged 18 years and older. Mobile app development will begin with an idea description, storyboard creation, and content approval through the nominal group technique. The mobile app content will be constructed using the Health Belief Model theory. Subsequently, the usability of the mobile app prototype will be evaluated using the validated Malay version of the System Usability Scale questionnaire for the evaluation of mobile apps. This protocol entails a 12-week intervention stage, in which the baseline assessment is regarded as a pretest evaluation and the follow-up assessment as a posttest evaluation. Participant selection will be based on the inclusion and exclusion criteria. This study will incorporate a set of validated questionnaires created by a group of leptospirosis experts. The validated questionnaire will comprise 9 sections with open-ended questions on sociodemographic data, KAP, and mobile app requirements.</p><p><strong>Results: </strong>Mobile app development and usability testing were completed between January 2024 and March 2025. Participant recruitment is scheduled in April to May 2025 after submission of this manuscript, with the 12-week intervention and data collection running from May to July 2025. As of manuscript submission, recruitment, data collection, and data analysis have not yet begun. Data analysis is expected to be completed by September 2025, and results are anticipated for publication in late 202
{"title":"Development of a Mobile App (MyLepto App) to Improve Knowledge, Attitude, and Practice Regarding Leptospirosis Among Wet Market Workers in Selangor, Malaysia: Protocol for a Quasi-Experimental Study.","authors":"Mas Norehan Merican Aljunid Merican, Zaleha Md Isa, Rozita Hod, Roszita Ibrahim, Zamtira Seman, Rusdi Abd Rashid","doi":"10.2196/75809","DOIUrl":"10.2196/75809","url":null,"abstract":"<p><strong>Background: </strong>Leptospirosis is the most common zoonotic cause of mortality, with most of its burden occurring in tropical regions and low-income countries. It is endemic in Southeast and South Asian nations. Leptospirosis outbreaks occur after natural disasters. In Malaysia, the e-notification system of the Communicable Diseases Control Information System recorded 5217 leptospirosis cases in 2019 with 32 fatalities. The incidence rate was 15.61 per 100,000 people. Male individuals comprised 67% of leptospirosis cases, while people aged 25 to 55 years accounted for 45% of the cases. Information and perception are crucial in influencing positive behavior. Nonetheless, information on urban and rural people's knowledge, attitude, and practice (KAP) regarding the incidence of leptospirosis is limited.</p><p><strong>Objective: </strong>We aimed to develop a mobile app with information on leptospirosis and measure its effectiveness in improving KAP regarding leptospirosis among wet market workers in Selangor, Malaysia.</p><p><strong>Methods: </strong>A 3-phase study will be conducted and includes development of a mobile app containing information about leptospirosis, analysis of its acceptability, and application of the intervention. Participants will be recruited based on specific inclusion criteria by using purposive sampling. Four wet markets in Hulu Langat district, Selangor, will be selected according to a list provided by local municipal councils. The respondents from each selected wet market will be workers aged 18 years and older. Mobile app development will begin with an idea description, storyboard creation, and content approval through the nominal group technique. The mobile app content will be constructed using the Health Belief Model theory. Subsequently, the usability of the mobile app prototype will be evaluated using the validated Malay version of the System Usability Scale questionnaire for the evaluation of mobile apps. This protocol entails a 12-week intervention stage, in which the baseline assessment is regarded as a pretest evaluation and the follow-up assessment as a posttest evaluation. Participant selection will be based on the inclusion and exclusion criteria. This study will incorporate a set of validated questionnaires created by a group of leptospirosis experts. The validated questionnaire will comprise 9 sections with open-ended questions on sociodemographic data, KAP, and mobile app requirements.</p><p><strong>Results: </strong>Mobile app development and usability testing were completed between January 2024 and March 2025. Participant recruitment is scheduled in April to May 2025 after submission of this manuscript, with the 12-week intervention and data collection running from May to July 2025. As of manuscript submission, recruitment, data collection, and data analysis have not yet begun. Data analysis is expected to be completed by September 2025, and results are anticipated for publication in late 202","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e75809"},"PeriodicalIF":1.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12881893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146029689","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}
Jialing Zhang, Hoi Ki Wong, Zhilin Lin, Shuyan Zhong, Minxia Ma, Xuejiao Wang
Background: The global burden of type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) continues to rise, with these conditions significantly increasing risks of cardiovascular disease, disability, and mortality. Traditional Chinese Medicine (TCM) syndrome differentiation, a cornerstone of TCM practice, guides diagnosis and treatment by identifying patterns of disharmony. However, large-scale studies investigating TCM syndrome patterns in T2DM comorbid with MetS remain scarce.
Objective: This cross-sectional study aims to characterize TCM syndrome profiles in a population diagnosed with T2DM and MetS and evaluate their diagnostic relevance.
Methods: This cross-sectional study will enroll a cohort of 470 participants diagnosed with T2DM and MetS. All participants will undergo comprehensive assessments, including the Syndrome Differentiation Questionnaire for T2DM and MetS, demographic and anthropometric measurements, biochemical profiling (eg, fasting glucose, glycosylated hemoglobin, and lipid panel), dietary measurement (Food Frequency Questionnaire), physical activity measurement (International Physical Activity Questionnaire Short Form), sleep quality evaluation (Pittsburgh Sleep Quality Index), quality-of-life assessment (Audit of Diabetes-Dependent Quality of Life), stroke risk estimation (Framingham Stroke Risk Score), and retinal imaging. Latent class analysis will be used to identify the TCM syndrome patterns. Factor analysis will be employed to identify core TCM syndrome factors. Hierarchical cluster analysis will be performed to classify TCM syndrome elements, and logistic regression will examine associations between syndrome differentiation, metabolic parameters, lifestyle factors, and disease progression.
Results: This trial was registered on November 17, 2024. Participant recruitment for this study was initiated in November 2024. As of October 2025, more than 450 eligible participants have been enrolled and have completed data collection. Recruitment is scheduled to conclude on December 31, 2025.
Conclusions: As the first large-scale clinical study to systematically characterize TCM syndrome differentiation in T2DM-MetS comorbidity, this research will establish syndrome profiles associated with metabolic parameters, lifestyle factors, and disease progression. The findings are expected to provide a framework for integrating TCM syndrome differentiation into chronic disease management, ultimately contributing to personalized treatment strategies and improved patient outcomes in integrative medicine.
{"title":"Traditional Chinese Medicine Syndrome Differentiation of Adult Patients With Type 2 Diabetes and Metabolic Syndrome: Protocol for a Cross-Sectional Study.","authors":"Jialing Zhang, Hoi Ki Wong, Zhilin Lin, Shuyan Zhong, Minxia Ma, Xuejiao Wang","doi":"10.2196/86217","DOIUrl":"10.2196/86217","url":null,"abstract":"<p><strong>Background: </strong>The global burden of type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) continues to rise, with these conditions significantly increasing risks of cardiovascular disease, disability, and mortality. Traditional Chinese Medicine (TCM) syndrome differentiation, a cornerstone of TCM practice, guides diagnosis and treatment by identifying patterns of disharmony. However, large-scale studies investigating TCM syndrome patterns in T2DM comorbid with MetS remain scarce.</p><p><strong>Objective: </strong>This cross-sectional study aims to characterize TCM syndrome profiles in a population diagnosed with T2DM and MetS and evaluate their diagnostic relevance.</p><p><strong>Methods: </strong>This cross-sectional study will enroll a cohort of 470 participants diagnosed with T2DM and MetS. All participants will undergo comprehensive assessments, including the Syndrome Differentiation Questionnaire for T2DM and MetS, demographic and anthropometric measurements, biochemical profiling (eg, fasting glucose, glycosylated hemoglobin, and lipid panel), dietary measurement (Food Frequency Questionnaire), physical activity measurement (International Physical Activity Questionnaire Short Form), sleep quality evaluation (Pittsburgh Sleep Quality Index), quality-of-life assessment (Audit of Diabetes-Dependent Quality of Life), stroke risk estimation (Framingham Stroke Risk Score), and retinal imaging. Latent class analysis will be used to identify the TCM syndrome patterns. Factor analysis will be employed to identify core TCM syndrome factors. Hierarchical cluster analysis will be performed to classify TCM syndrome elements, and logistic regression will examine associations between syndrome differentiation, metabolic parameters, lifestyle factors, and disease progression.</p><p><strong>Results: </strong>This trial was registered on November 17, 2024. Participant recruitment for this study was initiated in November 2024. As of October 2025, more than 450 eligible participants have been enrolled and have completed data collection. Recruitment is scheduled to conclude on December 31, 2025.</p><p><strong>Conclusions: </strong>As the first large-scale clinical study to systematically characterize TCM syndrome differentiation in T2DM-MetS comorbidity, this research will establish syndrome profiles associated with metabolic parameters, lifestyle factors, and disease progression. The findings are expected to provide a framework for integrating TCM syndrome differentiation into chronic disease management, ultimately contributing to personalized treatment strategies and improved patient outcomes in integrative medicine.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06703684; https://clinicaltrials.gov/study/NCT06703684.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/86217.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e86217"},"PeriodicalIF":1.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12881900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146040802","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}
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