Background: Autism spectrum disorder (ASD) represents a significant public health challenge characterized by persistent social communication deficits and restricted, repetitive patterns of behavior. Current interventions show limited efficacy, particularly for core symptoms. Repetitive transcranial magnetic stimulation (rTMS) and auditory integration training (AIT) have independently demonstrated promise in addressing neurophysiological abnormalities associated with ASD.
Objective: This study aims to evaluate the clinical efficacy of a combined rTMS and AIT intervention compared to rTMS alone and sham stimulation in children with ASD.
Methods: This is a randomized, sham-controlled trial that will recruit 80 children aged 2 to 6 years with a confirmed ASD diagnosis. The randomization of the first 8 participants in this study used a 1:1:1 ratio. To more effectively test the core hypothesis (ie, the efficacy of the combined intervention), greater statistical power will be concentrated on the intervention group (rTMS+AIT), and the randomization ratio was ultimately adjusted to 2:1:1-specifically, (1) rTMS combined with AIT (n=40), (2) rTMS alone (n=20), or (3) sham rTMS (n=20). Primary outcome measures include the Autism Behavior Checklist and Childhood Autism Rating Scale. Secondary outcomes are the Strengths and Difficulties Questionnaire and Repetitive Behavior Scale-Revised. Assessments will be conducted at baseline, an interim time point, and immediately after the intervention. Data will be analyzed using SPSS (version 25.0; IBM Corp).
Results: This study has received funding, with data collection commencing in April 2024. Due to the small initial sample size of 8 participants (5 male and 3 female), no formal statistical comparisons of baseline characteristics between groups have been conducted at this time. It is anticipated that the rTMS combined with AIT intervention will exhibit superior efficacy compared to rTMS only.
Conclusions: This will be the first sham-controlled trial to systematically investigate the potential synergistic effects of a combined rTMS and AIT intervention in children with ASD. The results will provide valuable insights into the neurotherapeutic potential of this combined approach and contribute to the development of evidence-based interventions for ASD.
背景：自闭症谱系障碍（ASD）是一项重大的公共卫生挑战，其特征是持续的社会沟通缺陷和受限的、重复的行为模式。目前的干预措施效果有限，特别是对核心症状。重复经颅磁刺激（rTMS）和听觉整合训练（AIT）在解决与ASD相关的神经生理异常方面分别表现出了希望。目的：本研究旨在评价rTMS联合AIT干预与单独rTMS加假刺激治疗ASD儿童的临床疗效。方法：这是一项随机、假对照试验，将招募80名确诊为ASD的2至6岁儿童。本研究的前8名参与者采用1:1:1的比例随机分配。为了更有效地检验核心假设（即联合干预的有效性），将更大的统计能力集中在干预组（rTMS+AIT）上，并最终将随机化比例调整为2:1:1-具体而言，(1)rTMS联合AIT (n=40), (2) rTMS单独（n=20），或(3)假rTMS （n=20）。主要结果测量包括自闭症行为检查表和儿童自闭症评定量表。次要结果是优势与困难问卷和重复行为量表-修订版。评估将在基线、一个临时时间点和干预后立即进行。数据将使用SPSS （version 25.0; IBM Corp .）进行分析。结果：本研究已获得资助，数据收集将于2024年4月开始。由于8名参与者的初始样本量较小（5名男性和3名女性），目前尚未对组间基线特征进行正式的统计比较。预计rTMS联合AIT干预将比单独rTMS表现出更好的疗效。结论：这将是第一个系统地研究rTMS和AIT联合干预ASD儿童的潜在协同效应的假对照试验。该结果将为这种联合方法的神经治疗潜力提供有价值的见解，并有助于发展基于证据的ASD干预措施。
{"title":"Evaluating the Efficacy of Repetitive Transcranial Magnetic Stimulation Combined With Auditory Integration Training for Children With Autism Spectrum Disorder: Protocol for a Randomized Sham-Controlled Trial.","authors":"Qinghong Hao, Jinying Wang, Jindi Yang, Wei Li, Sufen Hu, Zhihai Lv","doi":"10.2196/80243","DOIUrl":"10.2196/80243","url":null,"abstract":"<p><strong>Background: </strong>Autism spectrum disorder (ASD) represents a significant public health challenge characterized by persistent social communication deficits and restricted, repetitive patterns of behavior. Current interventions show limited efficacy, particularly for core symptoms. Repetitive transcranial magnetic stimulation (rTMS) and auditory integration training (AIT) have independently demonstrated promise in addressing neurophysiological abnormalities associated with ASD.</p><p><strong>Objective: </strong>This study aims to evaluate the clinical efficacy of a combined rTMS and AIT intervention compared to rTMS alone and sham stimulation in children with ASD.</p><p><strong>Methods: </strong>This is a randomized, sham-controlled trial that will recruit 80 children aged 2 to 6 years with a confirmed ASD diagnosis. The randomization of the first 8 participants in this study used a 1:1:1 ratio. To more effectively test the core hypothesis (ie, the efficacy of the combined intervention), greater statistical power will be concentrated on the intervention group (rTMS+AIT), and the randomization ratio was ultimately adjusted to 2:1:1-specifically, (1) rTMS combined with AIT (n=40), (2) rTMS alone (n=20), or (3) sham rTMS (n=20). Primary outcome measures include the Autism Behavior Checklist and Childhood Autism Rating Scale. Secondary outcomes are the Strengths and Difficulties Questionnaire and Repetitive Behavior Scale-Revised. Assessments will be conducted at baseline, an interim time point, and immediately after the intervention. Data will be analyzed using SPSS (version 25.0; IBM Corp).</p><p><strong>Results: </strong>This study has received funding, with data collection commencing in April 2024. Due to the small initial sample size of 8 participants (5 male and 3 female), no formal statistical comparisons of baseline characteristics between groups have been conducted at this time. It is anticipated that the rTMS combined with AIT intervention will exhibit superior efficacy compared to rTMS only.</p><p><strong>Conclusions: </strong>This will be the first sham-controlled trial to systematically investigate the potential synergistic effects of a combined rTMS and AIT intervention in children with ASD. The results will provide valuable insights into the neurotherapeutic potential of this combined approach and contribute to the development of evidence-based interventions for ASD.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e80243"},"PeriodicalIF":1.5,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12893525/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146165414","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}
Tor A Strand, Maria Averina, Kjersti Sletten Bakken, Sudha Basnet, Yvonne Böttcher, Sandra Huber, Mari Hysing, Ingrid Kvestad, Torben Lüders, Adrian McCann, Dhiraj Pokhrel, Suman Ranjitkar, Arun K Sharma, Merina Shrestha, Manjeswori Ulak, Ram K Chandyo
<p><strong>Background: </strong>Negative early-life exposures, particularly during the first 1000 days of life, may disrupt organ development and lead to lifelong negative health consequences.</p><p><strong>Objective: </strong>Using an exposome and deep phenotyping framework, this study aims to characterize established early-life risk factors, including environmental pollutants and nutritional status during pregnancy and infancy, and identify associated short- and long-term health and developmental outcomes.</p><p><strong>Methods: </strong>We leverage a pregnancy cohort of 800 mother-infant pairs in Bhaktapur, Nepal, nested within a randomized controlled trial (ClinicalTrials.gov: NCT03071666) that evaluated daily vitamin B12 supplementation from before 15 weeks of gestation until 6 months post partum. The primary outcomes of the original trial were linear growth and neurodevelopment at 12 months. In this follow-up, children will be evaluated up to school age to obtain more robust estimates of long-term health outcomes. Exposures include clinical, dietary, cognitive, demographic, and anthropometric variables during pregnancy and infancy, as well as analyses of environmental pollutants, inflammation, micronutrient status, and hormonal status. Outcomes comprise neurodevelopment, morbidity, mental health, vaccine responses, thyroid function, growth, body composition, lung function, and biomarkers of health and development. Our main research questions for this phase of the project are: (1) what are the most common environmental pollutants among Nepalese women and children? (2) Is there a social gradient in exposure to these pollutants? (3) To what extent are these exposures associated with nutritional status, growth, neurodevelopment, and clinical outcomes? Associations will be examined using cross-sectional, case-control, and cohort designs applying advanced statistical methods to address confounding and complex exposure patterns.</p><p><strong>Results: </strong>Enrollment began in March 2017, and the first child was born in August of the same year. More than 90% of the original cohort (734/800, 91.8%) have provided data up to the children's fourth birthday. By December 2025, the project will have funding until July 2027, and the papers addressing the main research questions will be submitted for publication before the end of 2026.</p><p><strong>Conclusions: </strong>This study draws on a well-characterized mother-child cohort in a South Asian setting with repeated biological samples from blood, breast milk, and urine and extensive high-quality longitudinal data on health, growth, and neurodevelopment. By integrating data on environmental exposures, nutrition, inflammation, and biological responses, the project aims to improve understanding of early-life determinants of health and inform policies and potential interventions to protect vulnerable women and children in marginalized settings. While the exploratory nature of exposome analyses entails a
{"title":"Early-Life Exposures, Neurodevelopment, and Health Outcomes: Protocol for a Birth Cohort Study.","authors":"Tor A Strand, Maria Averina, Kjersti Sletten Bakken, Sudha Basnet, Yvonne Böttcher, Sandra Huber, Mari Hysing, Ingrid Kvestad, Torben Lüders, Adrian McCann, Dhiraj Pokhrel, Suman Ranjitkar, Arun K Sharma, Merina Shrestha, Manjeswori Ulak, Ram K Chandyo","doi":"10.2196/78593","DOIUrl":"10.2196/78593","url":null,"abstract":"<p><strong>Background: </strong>Negative early-life exposures, particularly during the first 1000 days of life, may disrupt organ development and lead to lifelong negative health consequences.</p><p><strong>Objective: </strong>Using an exposome and deep phenotyping framework, this study aims to characterize established early-life risk factors, including environmental pollutants and nutritional status during pregnancy and infancy, and identify associated short- and long-term health and developmental outcomes.</p><p><strong>Methods: </strong>We leverage a pregnancy cohort of 800 mother-infant pairs in Bhaktapur, Nepal, nested within a randomized controlled trial (ClinicalTrials.gov: NCT03071666) that evaluated daily vitamin B12 supplementation from before 15 weeks of gestation until 6 months post partum. The primary outcomes of the original trial were linear growth and neurodevelopment at 12 months. In this follow-up, children will be evaluated up to school age to obtain more robust estimates of long-term health outcomes. Exposures include clinical, dietary, cognitive, demographic, and anthropometric variables during pregnancy and infancy, as well as analyses of environmental pollutants, inflammation, micronutrient status, and hormonal status. Outcomes comprise neurodevelopment, morbidity, mental health, vaccine responses, thyroid function, growth, body composition, lung function, and biomarkers of health and development. Our main research questions for this phase of the project are: (1) what are the most common environmental pollutants among Nepalese women and children? (2) Is there a social gradient in exposure to these pollutants? (3) To what extent are these exposures associated with nutritional status, growth, neurodevelopment, and clinical outcomes? Associations will be examined using cross-sectional, case-control, and cohort designs applying advanced statistical methods to address confounding and complex exposure patterns.</p><p><strong>Results: </strong>Enrollment began in March 2017, and the first child was born in August of the same year. More than 90% of the original cohort (734/800, 91.8%) have provided data up to the children's fourth birthday. By December 2025, the project will have funding until July 2027, and the papers addressing the main research questions will be submitted for publication before the end of 2026.</p><p><strong>Conclusions: </strong>This study draws on a well-characterized mother-child cohort in a South Asian setting with repeated biological samples from blood, breast milk, and urine and extensive high-quality longitudinal data on health, growth, and neurodevelopment. By integrating data on environmental exposures, nutrition, inflammation, and biological responses, the project aims to improve understanding of early-life determinants of health and inform policies and potential interventions to protect vulnerable women and children in marginalized settings. While the exploratory nature of exposome analyses entails a ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e78593"},"PeriodicalIF":1.5,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911638","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}
Felicia Iftene, Adriana Farcas, Simon O'Brien, Christopher Bowie, Michael Best, Oyedeji Ayonrinde, Terry Landry, Jennifer Carlson, Scott John Davidson, Ellie Rodgerson, Ashley Theis
<p><strong>Background: </strong>Transcranial alternating current stimulation (tACS) applies a low-intensity sinusoidal electrical current through electrodes placed on the scalp to boost the brain's own oscillation by way of entrainment. When a single frequency is applied, this exogenous oscillation synchronizes with the brain's endogenous frequency. Gamma frequency synchrony stands out as a binding mechanism for integrating disparate brain networks, mediating perception, cognition, and memory, typically disturbed in schizophrenia. The treatment of schizophrenia includes medication and cognitive behavioral therapy for psychosis (CBTp). We are adding tACS to these usual treatments, targeting gamma oscillation stimulation, to augment the CBTp efficacy in people living with schizophrenia.</p><p><strong>Objective: </strong>This study aims to elicit cognitive readiness and therapeutic engagement by adding tACS to each CBTp session in individuals with schizophrenia taking their usual medication, to evaluate the possible improvement of the level of functioning, and to determine if the response to intervention is gender specific.</p><p><strong>Methods: </strong>This is a pilot, prospective, randomized, repeated-measures, single-blind study design. We expect to enroll 28 participants randomly assigned to one of two treatment arms: arm 1 (tACS/CBTp, n=14) or arm 2 (sham tACS/CBTp, n=14; tACS is sham, but CBTp is active). The intervention with active or sham tACS/CBTp will take place weekly for 16 weeks. Primary outcome measures-electroencephalogram, Positive and Negative Syndrome Scale, 16-item Negative Symptom Assessment, and Cognitive Flexibility Scale-will evaluate the efficacy of treatment at the end of the intervention and at the two follow-ups. We will use SPSS (version 29, IBM Corp); the main tests will include repeated measures and mixed design ANOVA.</p><p><strong>Results: </strong>The timeline for recruitment, treatment, and follow-ups is 18 months, followed by 6 months for data analysis, writing manuscripts, and dissemination activities. By November 1, 2025, we have enrolled 15 participants: 12 are following the intervention protocol (8 active and 4 sham tACS). Two participants were screening failures, and one participant withdrew after intervention 2.</p><p><strong>Conclusions: </strong>Our expectations are as follows. CBTp will improve the scores of psychological and psychosocial tests at the end of therapy for both groups, but it will be superior for the group with tACS intervention. Considering that cognitive and emotional status is gender dependent (hormonal differences, brain structure, and sociocultural influences), we expect that the therapeutic response could be gender specific. CBTp will enhance electroencephalogram activity and the heart in clients with schizophrenia at the end of therapy for both groups, but it will be superior for the group with tACS preintervention. The baseline heart rate variability will predict symptom improvemen
{"title":"Therapeutic Improvement in People With Schizophrenia Undergoing tACS/CBTp (Transcranial Alternating Current Stimulation/Cognitive Behavioral Therapy for Psychosis) Associated With Usual Medication Regimen: Protocol for a Pilot, Randomized, Single-Blind Trial.","authors":"Felicia Iftene, Adriana Farcas, Simon O'Brien, Christopher Bowie, Michael Best, Oyedeji Ayonrinde, Terry Landry, Jennifer Carlson, Scott John Davidson, Ellie Rodgerson, Ashley Theis","doi":"10.2196/80593","DOIUrl":"10.2196/80593","url":null,"abstract":"<p><strong>Background: </strong>Transcranial alternating current stimulation (tACS) applies a low-intensity sinusoidal electrical current through electrodes placed on the scalp to boost the brain's own oscillation by way of entrainment. When a single frequency is applied, this exogenous oscillation synchronizes with the brain's endogenous frequency. Gamma frequency synchrony stands out as a binding mechanism for integrating disparate brain networks, mediating perception, cognition, and memory, typically disturbed in schizophrenia. The treatment of schizophrenia includes medication and cognitive behavioral therapy for psychosis (CBTp). We are adding tACS to these usual treatments, targeting gamma oscillation stimulation, to augment the CBTp efficacy in people living with schizophrenia.</p><p><strong>Objective: </strong>This study aims to elicit cognitive readiness and therapeutic engagement by adding tACS to each CBTp session in individuals with schizophrenia taking their usual medication, to evaluate the possible improvement of the level of functioning, and to determine if the response to intervention is gender specific.</p><p><strong>Methods: </strong>This is a pilot, prospective, randomized, repeated-measures, single-blind study design. We expect to enroll 28 participants randomly assigned to one of two treatment arms: arm 1 (tACS/CBTp, n=14) or arm 2 (sham tACS/CBTp, n=14; tACS is sham, but CBTp is active). The intervention with active or sham tACS/CBTp will take place weekly for 16 weeks. Primary outcome measures-electroencephalogram, Positive and Negative Syndrome Scale, 16-item Negative Symptom Assessment, and Cognitive Flexibility Scale-will evaluate the efficacy of treatment at the end of the intervention and at the two follow-ups. We will use SPSS (version 29, IBM Corp); the main tests will include repeated measures and mixed design ANOVA.</p><p><strong>Results: </strong>The timeline for recruitment, treatment, and follow-ups is 18 months, followed by 6 months for data analysis, writing manuscripts, and dissemination activities. By November 1, 2025, we have enrolled 15 participants: 12 are following the intervention protocol (8 active and 4 sham tACS). Two participants were screening failures, and one participant withdrew after intervention 2.</p><p><strong>Conclusions: </strong>Our expectations are as follows. CBTp will improve the scores of psychological and psychosocial tests at the end of therapy for both groups, but it will be superior for the group with tACS intervention. Considering that cognitive and emotional status is gender dependent (hormonal differences, brain structure, and sociocultural influences), we expect that the therapeutic response could be gender specific. CBTp will enhance electroencephalogram activity and the heart in clients with schizophrenia at the end of therapy for both groups, but it will be superior for the group with tACS preintervention. The baseline heart rate variability will predict symptom improvemen","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e80593"},"PeriodicalIF":1.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145582114","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}
Corinna Koebnick, Margo Sidell, Jessica D Vallejo, Xia Li, Emerson Delacroix, Deborah Young, Poornima Kunani, Ken Resnicow
Background: The increasing prevalence of severe obesity among youth and the early onset of comorbidities highlight the urgent need for effective solutions to support behavior and lifestyle changes. Motivational interviewing (MI), a client-centered counseling technique, has shown promise in improving obesity-related outcomes and is now recommended by the American Academy of Pediatrics as a key component of behavioral interventions for children with overweight and obesity.
Objective: This study aimed to describe the design and baseline characteristics of the Wellness Coaching for Kids and Families (WC4K) program, an MI-based behavioral health intervention integrated into pediatric primary care within a large integrated health care system. This trial aims to inform broader implementation strategies for other health care systems.
Methods: We are conducting a cluster randomized pragmatic trial across 50 pediatric clinics within Kaiser Permanente Southern California. Clinics were randomized to either the intervention arm (n=24, 48.00%) or the usual care arm (n=26, 52.00%), targeting children aged between 3 and 8 years with overweight or obesity. Pediatricians in intervention clinics received MI training and referred families to centralized health coaches for tailored telephone counseling. Key behavioral targets include increased fruit and vegetable intake, reduced consumption of sugar-sweetened beverages, increased physical activity, and reduced screen time. The primary outcome is a change in BMI-for-age, measured as relative distance from the median using electronic medical record data. Secondary outcomes include parent-reported behavior change indicators.
Results: The source population includes 150,482 children from clinics serving predominantly low-income and racial and ethnic minority populations. After randomization, intervention and control clinics were similar in demographics (standardized mean differences <0.2 for key variables), with 77,481 (51.49%) children in the WC4K intervention clinics and 73,001 (48.51%) children in the control clinics. In the total clinic population, 36.58% (55,052/150,482) of the children were overweight or with obesity. Enrollment started in fall 2022, study results are expected in spring 2027.
Conclusions: If the trial results indicate success in reducing BMI and improving health behaviors, WC4K may offer a scalable and sustainable model for integrating behavioral health coaching into pediatric primary care. By leveraging MI-trained pediatricians and centralized health coaching, WC4K has the potential to facilitate meaningful lifestyle changes in children with overweight or obesity.
{"title":"Evaluating the Effectiveness of the Motivational Interviewing-Based Wellness Coaching for Kids and Families (WC4K) Program in Pediatric Obesity Care: Protocol for a Cluster Randomized Pragmatic Trial.","authors":"Corinna Koebnick, Margo Sidell, Jessica D Vallejo, Xia Li, Emerson Delacroix, Deborah Young, Poornima Kunani, Ken Resnicow","doi":"10.2196/78792","DOIUrl":"https://doi.org/10.2196/78792","url":null,"abstract":"<p><strong>Background: </strong>The increasing prevalence of severe obesity among youth and the early onset of comorbidities highlight the urgent need for effective solutions to support behavior and lifestyle changes. Motivational interviewing (MI), a client-centered counseling technique, has shown promise in improving obesity-related outcomes and is now recommended by the American Academy of Pediatrics as a key component of behavioral interventions for children with overweight and obesity.</p><p><strong>Objective: </strong>This study aimed to describe the design and baseline characteristics of the Wellness Coaching for Kids and Families (WC4K) program, an MI-based behavioral health intervention integrated into pediatric primary care within a large integrated health care system. This trial aims to inform broader implementation strategies for other health care systems.</p><p><strong>Methods: </strong>We are conducting a cluster randomized pragmatic trial across 50 pediatric clinics within Kaiser Permanente Southern California. Clinics were randomized to either the intervention arm (n=24, 48.00%) or the usual care arm (n=26, 52.00%), targeting children aged between 3 and 8 years with overweight or obesity. Pediatricians in intervention clinics received MI training and referred families to centralized health coaches for tailored telephone counseling. Key behavioral targets include increased fruit and vegetable intake, reduced consumption of sugar-sweetened beverages, increased physical activity, and reduced screen time. The primary outcome is a change in BMI-for-age, measured as relative distance from the median using electronic medical record data. Secondary outcomes include parent-reported behavior change indicators.</p><p><strong>Results: </strong>The source population includes 150,482 children from clinics serving predominantly low-income and racial and ethnic minority populations. After randomization, intervention and control clinics were similar in demographics (standardized mean differences <0.2 for key variables), with 77,481 (51.49%) children in the WC4K intervention clinics and 73,001 (48.51%) children in the control clinics. In the total clinic population, 36.58% (55,052/150,482) of the children were overweight or with obesity. Enrollment started in fall 2022, study results are expected in spring 2027.</p><p><strong>Conclusions: </strong>If the trial results indicate success in reducing BMI and improving health behaviors, WC4K may offer a scalable and sustainable model for integrating behavioral health coaching into pediatric primary care. By leveraging MI-trained pediatricians and centralized health coaching, WC4K has the potential to facilitate meaningful lifestyle changes in children with overweight or obesity.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05143697; https://clinicaltrials.gov/study/NCT05143697.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/78792.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e78792"},"PeriodicalIF":1.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146157131","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}
<p><strong>Background: </strong>Intensive therapies based on motor skill learning have been widely used in stroke rehabilitation for improving upper extremity abilities, demonstrating significant improvements in arm function and daily life activities. Based on the same therapeutic principles of motor skill learning, hand and arm bimanual intensive therapy including lower extremities (HABIT-ILE) was developed focusing on bimanual coordination and constant concomitant stimulation of trunk control and lower extremities. However, the implementation of such high-dosage interventions in stroke rehabilitation might face barriers due to limited accessibility and high resource requirements. Delivering HABIT-ILE therapy at home (HABIT-ILE@home) via telerehabilitation may reduce logistical barriers while maintaining efficacy. In addition, the added value of a 9-week specific follow-up program will be tested after high dosage interventions.</p><p><strong>Objective: </strong>The first randomized controlled trial (RCT1) aims to evaluate the noninferiority of a high-dosage HABIT-ILE@home program compared to its on-site counterpart. The second randomized controlled trial (RCT2) aims to test the superiority of a 9-week specific HABIT-ILE@home follow-up vs a nonspecific home program.</p><p><strong>Methods: </strong>A total of 48 adults with chronic stroke will be randomized to either HABIT-ILE@home or HABIT-ILE on-site group (RCT1, 65 hours over 2 weeks). HABIT-ILE@home will follow the same principles as HABIT-ILE on-site but will be delivered by caregivers with remote supervision by trained therapists and the use of a dedicated telerehabilitation device to facilitate intervention delivery and remote monitoring (ie, REAtouch Lite; Axinesis). All participants will then participate in a HABIT-ILE@home follow-up program or nonspecific follow-up (RCT2, 45 hours over 9 weeks). Primary outcomes will be the change in Fugl-Meyer Assessment (FMA), while secondary outcomes include feasibility and adherence questionnaires, upper and lower extremity motor function assessments, daily activities, and quality of life questionnaires. Assessments will be performed before (T0) and after (T1) the 2 weeks of high dosage intervention, followed by an assessment after the 9-week follow-up (T2).</p><p><strong>Results: </strong>Recruitment for the trial started in March 2023 and ended in March 2025, and data collection has been completed for this study. Data analysis is planned to start early 2026; we expect to submit the results for publication in spring 2026.</p><p><strong>Conclusions: </strong>This study will provide evidence on the feasibility and efficacy of delivering HABIT-ILE through a home-based telerehabilitation model for adults with chronic stroke. Demonstrating noninferiority of HABIT-ILE@home compared to on-site therapy would support wider accessibility to intensive rehabilitation while reducing logistical and human resource constraints. Additionally, showing the added benef
{"title":"Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE@home) for Adults With Chronic Stroke: Protocol for a Randomized Controlled Trial.","authors":"Merlin Somville, Zélie Rosselli, Edouard Ducoffre, Carlyne Arnould, Yannick Bleyenheuft, Geoffroy Saussez","doi":"10.2196/87035","DOIUrl":"10.2196/87035","url":null,"abstract":"<p><strong>Background: </strong>Intensive therapies based on motor skill learning have been widely used in stroke rehabilitation for improving upper extremity abilities, demonstrating significant improvements in arm function and daily life activities. Based on the same therapeutic principles of motor skill learning, hand and arm bimanual intensive therapy including lower extremities (HABIT-ILE) was developed focusing on bimanual coordination and constant concomitant stimulation of trunk control and lower extremities. However, the implementation of such high-dosage interventions in stroke rehabilitation might face barriers due to limited accessibility and high resource requirements. Delivering HABIT-ILE therapy at home (HABIT-ILE@home) via telerehabilitation may reduce logistical barriers while maintaining efficacy. In addition, the added value of a 9-week specific follow-up program will be tested after high dosage interventions.</p><p><strong>Objective: </strong>The first randomized controlled trial (RCT1) aims to evaluate the noninferiority of a high-dosage HABIT-ILE@home program compared to its on-site counterpart. The second randomized controlled trial (RCT2) aims to test the superiority of a 9-week specific HABIT-ILE@home follow-up vs a nonspecific home program.</p><p><strong>Methods: </strong>A total of 48 adults with chronic stroke will be randomized to either HABIT-ILE@home or HABIT-ILE on-site group (RCT1, 65 hours over 2 weeks). HABIT-ILE@home will follow the same principles as HABIT-ILE on-site but will be delivered by caregivers with remote supervision by trained therapists and the use of a dedicated telerehabilitation device to facilitate intervention delivery and remote monitoring (ie, REAtouch Lite; Axinesis). All participants will then participate in a HABIT-ILE@home follow-up program or nonspecific follow-up (RCT2, 45 hours over 9 weeks). Primary outcomes will be the change in Fugl-Meyer Assessment (FMA), while secondary outcomes include feasibility and adherence questionnaires, upper and lower extremity motor function assessments, daily activities, and quality of life questionnaires. Assessments will be performed before (T0) and after (T1) the 2 weeks of high dosage intervention, followed by an assessment after the 9-week follow-up (T2).</p><p><strong>Results: </strong>Recruitment for the trial started in March 2023 and ended in March 2025, and data collection has been completed for this study. Data analysis is planned to start early 2026; we expect to submit the results for publication in spring 2026.</p><p><strong>Conclusions: </strong>This study will provide evidence on the feasibility and efficacy of delivering HABIT-ILE through a home-based telerehabilitation model for adults with chronic stroke. Demonstrating noninferiority of HABIT-ILE@home compared to on-site therapy would support wider accessibility to intensive rehabilitation while reducing logistical and human resource constraints. Additionally, showing the added benef","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e87035"},"PeriodicalIF":1.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12890077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146157150","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}
Suzhen Liu, Mengxia Qi, Hua-Fang Li, Ziqiu Ye, Yu Xu, Xiangying Yang
Background: Cognitive frailty (CF), characterized by the coexistence of mild cognitive impairment and physical frailty in the absence of dementia or other neurodegenerative diseases, is a significant risk factor for dementia and functional decline in older adults. Although Du-moxibustion has shown potential benefits in improving CF, the effect of spine-pinching therapy remains underexplored.
Objective: This study aims to evaluate, for the first time, the efficacy and safety of Du-moxibustion combined with spine-pinching therapy in older adults with prefrailty and CF.
Methods: This is a prospective, single-center, randomized, single-blind, 4-arm parallel controlled trial. A total of 156 older adults with prefrailty and CF will be recruited and randomly assigned to 1 of 4 groups: routine care group, Du-moxibustion group, spine-pinching group, or combined intervention group. The intervention will last for 8 weeks. The primary outcome is the change in Montreal Cognitive Assessment score. Secondary outcomes include the Fried frailty phenotype, Barthel Index (activities of daily living), 15-item Geriatric Depression Scale, 36-item Short Form Health Survey, global frailty status, and traditional Chinese medicine syndrome scores. Outcome assessments will be performed at baseline (wk 0), midintervention (wk 6), postintervention (wk 8), and follow-up (wk 12).
Results: Recruitment for this study is scheduled to commence in March 2026 and will end in June 2027 (recruitment and intervention). All follow-up and data collection activities will be finalized by October 2027. Results are anticipated to be completed in the first quarter of 2028.
Conclusions: This study is expected to provide high-quality evidence for the clinical efficacy of Du-moxibustion combined with spine-pinching therapy in managing CF and contribute to the integration of traditional Chinese medicine external therapies in the promotion of healthy aging. Although the single-blind design may introduce expectancy bias, strict randomization procedures and standardized interventions will enhance the reliability and scientific rigor of the results.
{"title":"Effect of Du-Moxibustion Combined With Spine-Pinching Therapy on Cognitive Frailty in Older Adults With Prefrailty: Protocol for a Randomized Controlled Trial.","authors":"Suzhen Liu, Mengxia Qi, Hua-Fang Li, Ziqiu Ye, Yu Xu, Xiangying Yang","doi":"10.2196/82683","DOIUrl":"10.2196/82683","url":null,"abstract":"<p><strong>Background: </strong>Cognitive frailty (CF), characterized by the coexistence of mild cognitive impairment and physical frailty in the absence of dementia or other neurodegenerative diseases, is a significant risk factor for dementia and functional decline in older adults. Although Du-moxibustion has shown potential benefits in improving CF, the effect of spine-pinching therapy remains underexplored.</p><p><strong>Objective: </strong>This study aims to evaluate, for the first time, the efficacy and safety of Du-moxibustion combined with spine-pinching therapy in older adults with prefrailty and CF.</p><p><strong>Methods: </strong>This is a prospective, single-center, randomized, single-blind, 4-arm parallel controlled trial. A total of 156 older adults with prefrailty and CF will be recruited and randomly assigned to 1 of 4 groups: routine care group, Du-moxibustion group, spine-pinching group, or combined intervention group. The intervention will last for 8 weeks. The primary outcome is the change in Montreal Cognitive Assessment score. Secondary outcomes include the Fried frailty phenotype, Barthel Index (activities of daily living), 15-item Geriatric Depression Scale, 36-item Short Form Health Survey, global frailty status, and traditional Chinese medicine syndrome scores. Outcome assessments will be performed at baseline (wk 0), midintervention (wk 6), postintervention (wk 8), and follow-up (wk 12).</p><p><strong>Results: </strong>Recruitment for this study is scheduled to commence in March 2026 and will end in June 2027 (recruitment and intervention). All follow-up and data collection activities will be finalized by October 2027. Results are anticipated to be completed in the first quarter of 2028.</p><p><strong>Conclusions: </strong>This study is expected to provide high-quality evidence for the clinical efficacy of Du-moxibustion combined with spine-pinching therapy in managing CF and contribute to the integration of traditional Chinese medicine external therapies in the promotion of healthy aging. Although the single-blind design may introduce expectancy bias, strict randomization procedures and standardized interventions will enhance the reliability and scientific rigor of the results.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e82683"},"PeriodicalIF":1.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12890076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146157161","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}
Lara Stone, Lili Ding, Meron Hirpa Kassa, Beakal Amsalu, Bruktawit Getnet, Hermella Eshete, Tesfaye Mersha, Lisa M Vaughn
<p><strong>Background: </strong>Immigrants experience significant health disparities, which are exacerbated by a heavy stress burden, which in turn affects the epigenetic profiles of the immune system, leading to chronic diseases. Cumulative stress burden for immigrants ranges from immigration-related stressors to unique psychosocial, environmental, and everyday challenges, all of which contribute to negative psychological and biological impacts on their health over the life-course. Although social and environmental conditions have been established as key factors driving disparities in health outcomes, the effects of stress and epigenetic change among immigrants remain poorly understood, impeding the development of novel and robust intervention approaches aimed at reducing health disparities. Epigenetic changes can act as surrogate markers for the stress effect. However, very few studies have examined epigenetic marks associated with stress among African immigrants. Ethiopians form one of the largest groups of African immigrants in the United States; yet, this is the first study of this kind among Ethiopian American immigrants.</p><p><strong>Objective: </strong>This protocol aims to quantify cumulative stress burden and determine DNA methylation (DNAm) associated with stress among Ethiopian American immigrants.</p><p><strong>Methods: </strong>Working with community partners, a community advisory board, and 3 community research coordinators, we will conduct a community-engaged research study of Ethiopian American immigrants. Data collection occurs at public events, church gatherings, and festivals. We use a multistation model composed of five stations through which participants rotate: (1) eligibility screening and consent, (2) stress-related questionnaires, (3) clinical measures, (4) health status and demographic questionnaires, and (5) saliva collection and incentive receipt. The measures used are: Stress of Immigration Survey, Boen's stress exposure measure, 10-item Perceived Stress Scale, Patient-Reported Outcomes Measurement Information System Global Health Scale (version 1.2), 8-item Patient Health Questionnaire, and 7-item Generalized Anxiety Disorder. Latent profile analysis, chi-square tests, and logistic regression will be used. Saliva samples will be tested using genome-wide DNAm. With a subset of the sample, we will also conduct and thematically analyze qualitative interviews to understand additional experiences of stress and buffers to stress among participants.</p><p><strong>Results: </strong>This study received National Institutes of Health R21 grant funding. Data collection began in October 2024 and will continue until November 2025 (currently at 89% completion). In November 2025, we will start data cleaning and analysis of questionnaires, clinical measures, and DNAm. We plan to complete data analyses and prepare scientific and community outputs by the Spring of 2026.</p><p><strong>Conclusions: </strong>The study will provide new i
{"title":"Cumulative Stress Burden and Association With DNA Methylation in Ethiopian American Immigrants: Protocol for a Community-Engaged, Biopsychosocial Study.","authors":"Lara Stone, Lili Ding, Meron Hirpa Kassa, Beakal Amsalu, Bruktawit Getnet, Hermella Eshete, Tesfaye Mersha, Lisa M Vaughn","doi":"10.2196/85971","DOIUrl":"https://doi.org/10.2196/85971","url":null,"abstract":"<p><strong>Background: </strong>Immigrants experience significant health disparities, which are exacerbated by a heavy stress burden, which in turn affects the epigenetic profiles of the immune system, leading to chronic diseases. Cumulative stress burden for immigrants ranges from immigration-related stressors to unique psychosocial, environmental, and everyday challenges, all of which contribute to negative psychological and biological impacts on their health over the life-course. Although social and environmental conditions have been established as key factors driving disparities in health outcomes, the effects of stress and epigenetic change among immigrants remain poorly understood, impeding the development of novel and robust intervention approaches aimed at reducing health disparities. Epigenetic changes can act as surrogate markers for the stress effect. However, very few studies have examined epigenetic marks associated with stress among African immigrants. Ethiopians form one of the largest groups of African immigrants in the United States; yet, this is the first study of this kind among Ethiopian American immigrants.</p><p><strong>Objective: </strong>This protocol aims to quantify cumulative stress burden and determine DNA methylation (DNAm) associated with stress among Ethiopian American immigrants.</p><p><strong>Methods: </strong>Working with community partners, a community advisory board, and 3 community research coordinators, we will conduct a community-engaged research study of Ethiopian American immigrants. Data collection occurs at public events, church gatherings, and festivals. We use a multistation model composed of five stations through which participants rotate: (1) eligibility screening and consent, (2) stress-related questionnaires, (3) clinical measures, (4) health status and demographic questionnaires, and (5) saliva collection and incentive receipt. The measures used are: Stress of Immigration Survey, Boen's stress exposure measure, 10-item Perceived Stress Scale, Patient-Reported Outcomes Measurement Information System Global Health Scale (version 1.2), 8-item Patient Health Questionnaire, and 7-item Generalized Anxiety Disorder. Latent profile analysis, chi-square tests, and logistic regression will be used. Saliva samples will be tested using genome-wide DNAm. With a subset of the sample, we will also conduct and thematically analyze qualitative interviews to understand additional experiences of stress and buffers to stress among participants.</p><p><strong>Results: </strong>This study received National Institutes of Health R21 grant funding. Data collection began in October 2024 and will continue until November 2025 (currently at 89% completion). In November 2025, we will start data cleaning and analysis of questionnaires, clinical measures, and DNAm. We plan to complete data analyses and prepare scientific and community outputs by the Spring of 2026.</p><p><strong>Conclusions: </strong>The study will provide new i","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e85971"},"PeriodicalIF":1.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146157176","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}
Jennifer Elizabeth Green, Heike Roth, Ben Harris-Roxas, Kathleen Baird, Caroline Guirgis, Zarin Gundevia, Amanda Henry
Background: Medical complications of pregnancy provide a window into a woman's future health risk. Hypertensive disorders of pregnancy (HDP) affect 1 in 10 pregnant women and elevate the risk for women of experiencing long-term health complications within 5 years of the affected pregnancy, continuing lifelong. These risks include a doubled to tripled risk of developing cardiovascular disease, a doubled risk of developing type 2 diabetes, and a 5- to 10-fold risk of developing chronic kidney disease. Early assessment and intervention following HDP are therefore crucial to improving women's life-course health trajectory, as well as outcomes for any subsequent pregnancies. However, previous research has shown that Australian women and their primary health care providers are largely unaware of ongoing health risks and the necessary follow-up screening and assessments. Primary care providers also receive inadequate hospital-to-community handover and support to promote preventive health measures to women following pregnancy complications. Consequently, post-HDP care remains insufficient for optimizing long-term health.
Objective: This study aims to (1) explore whether a post-HDP education and follow-up service package can be designed, developed, and implemented among targeted general practitioners (GPs) and maternity hospitals across Sydney, Australia, and (2) evaluate whether the post-HDP education and follow-up package can address knowledge gaps among health care providers regarding the long-term health risks after HDP and build capacity among GPs to implement evidence-based care.
Methods: This pilot study will design, develop, and implement a post-HDP education and follow-up package ("the package") adopting a collaborative and implementation methodological approach. The package, designed by expert health care providers and informed by prior evidence-based research, will include educational materials, improved hospital-to-community handover, and a funded 6-month postpartum visit.
Results: Data collection occurred over an 18-month implementation and follow-up period between April 2024 and October 2025. Sixteen GPs across the Central and Eastern Primary Health Network (CESPHN) were recruited, along with their antenatal shared care (ANSC) affiliated tertiary referral hospitals in Sydney. Postimplementation data collection and analysis is planned for completion throughout 2026.
Conclusions: Mixed methods evaluation will assess the efficacy, acceptability, and utility of the post-HDP package among health care providers and inform its suitability for deployment at scale.
{"title":"Pilot Implementation of a Post-Hypertensive Disorders of Pregnancy Education and Follow-Up Package for Health Care Providers: Protocol for a Mixed Methods Pilot Study.","authors":"Jennifer Elizabeth Green, Heike Roth, Ben Harris-Roxas, Kathleen Baird, Caroline Guirgis, Zarin Gundevia, Amanda Henry","doi":"10.2196/81069","DOIUrl":"10.2196/81069","url":null,"abstract":"<p><strong>Background: </strong>Medical complications of pregnancy provide a window into a woman's future health risk. Hypertensive disorders of pregnancy (HDP) affect 1 in 10 pregnant women and elevate the risk for women of experiencing long-term health complications within 5 years of the affected pregnancy, continuing lifelong. These risks include a doubled to tripled risk of developing cardiovascular disease, a doubled risk of developing type 2 diabetes, and a 5- to 10-fold risk of developing chronic kidney disease. Early assessment and intervention following HDP are therefore crucial to improving women's life-course health trajectory, as well as outcomes for any subsequent pregnancies. However, previous research has shown that Australian women and their primary health care providers are largely unaware of ongoing health risks and the necessary follow-up screening and assessments. Primary care providers also receive inadequate hospital-to-community handover and support to promote preventive health measures to women following pregnancy complications. Consequently, post-HDP care remains insufficient for optimizing long-term health.</p><p><strong>Objective: </strong>This study aims to (1) explore whether a post-HDP education and follow-up service package can be designed, developed, and implemented among targeted general practitioners (GPs) and maternity hospitals across Sydney, Australia, and (2) evaluate whether the post-HDP education and follow-up package can address knowledge gaps among health care providers regarding the long-term health risks after HDP and build capacity among GPs to implement evidence-based care.</p><p><strong>Methods: </strong>This pilot study will design, develop, and implement a post-HDP education and follow-up package (\"the package\") adopting a collaborative and implementation methodological approach. The package, designed by expert health care providers and informed by prior evidence-based research, will include educational materials, improved hospital-to-community handover, and a funded 6-month postpartum visit.</p><p><strong>Results: </strong>Data collection occurred over an 18-month implementation and follow-up period between April 2024 and October 2025. Sixteen GPs across the Central and Eastern Primary Health Network (CESPHN) were recruited, along with their antenatal shared care (ANSC) affiliated tertiary referral hospitals in Sydney. Postimplementation data collection and analysis is planned for completion throughout 2026.</p><p><strong>Conclusions: </strong>Mixed methods evaluation will assess the efficacy, acceptability, and utility of the post-HDP package among health care providers and inform its suitability for deployment at scale.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e81069"},"PeriodicalIF":1.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12894576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146165392","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}
Ahmed Mohamed Dirie, Nor Afiah Mohd Zulkefli, Salmiah Md Said, Ahmed Zaid Fatah Azman, Kassim Abdi Jimale, Osman Abubakar Fiidow
Background: Tuberculosis (TB) in children is one of the most significant public health crises in Somalia. This issue is aggravated by the fact that only 36.7% of children aged 12 to 23 months receive the Bacillus Calmette-Guérin (BCG) vaccine in Somalia, which helps prevent TB-disseminated diseases. Among the major factors that contribute to poor BCG uptake and TB prevention practices are the lack of maternal knowledge, negative attitude, and poor self-efficacy toward the BCG vaccine and TB prevention practices. As such, pregnant women play a vital role in ensuring timely, routine BCG vaccination for their newborns and adherence to TB prevention practices.
Objective: This study aims to develop, implement, and evaluate the impact of health education intervention using the information-motivation-behavioral (IMB) skills model to improve knowledge, attitudes, and self-efficacy regarding BCG uptake and TB prevention among pregnant women in Banadir Hospital.
Methods: This single-blind randomized controlled trial enrolled a sample of 370 pregnant women recruited at Banadir Hospital in Mogadishu, Somalia. Eligible participants will be randomized to an intervention group receiving an IMB-based health education and to a waiting list control group, in a 1:1 ratio. Outcome assessments will be conducted at baseline, 2-month follow-up, and 4-month follow-up. The primary outcomes are BCG vaccine uptake and TB prevention practices. Secondary outcomes include knowledge, attitudes, and self-efficacy related to the BCG vaccine and TB prevention practices. The IMB-based health education intervention program consists of 6 sessions, with 1 group per session, and with each session containing 30 participants. The effects of the intervention will be assessed by handing out the same self-administered questionnaires at baseline, 2-month postintervention, and 4-month postintervention.
Results: A total of 370 pregnant women were recruited at baseline in November 2021, with 185 assigned to the intervention group and 185 assigned to the control group. In January 2022, the 185 pregnant women enrolled in the intervention program and completed the sessions by February 2022. Data collection for the 2-month and 4-month postintervention assessments was completed in June 2022. The findings of this study will be reported by the beginning of 2026.
Conclusions: The developed health education intervention module in this study has the potential to be adopted and included as part of routine antenatal care services. Its implementation could effectively raise awareness among pregnant women in Somalia regarding the importance of BCG vaccination and TB prevention practices, ultimately mitigating childhood mortality rates associated with TB-disseminated diseases in the country.
{"title":"Effectiveness of a Theory-Based Intervention in Improving Bacillus Calmette-Guérin Uptake and Preventive Practices of Childhood Tuberculosis Among Pregnant Women: Protocol for a Randomized Control Trial.","authors":"Ahmed Mohamed Dirie, Nor Afiah Mohd Zulkefli, Salmiah Md Said, Ahmed Zaid Fatah Azman, Kassim Abdi Jimale, Osman Abubakar Fiidow","doi":"10.2196/68088","DOIUrl":"10.2196/68088","url":null,"abstract":"<p><strong>Background: </strong>Tuberculosis (TB) in children is one of the most significant public health crises in Somalia. This issue is aggravated by the fact that only 36.7% of children aged 12 to 23 months receive the Bacillus Calmette-Guérin (BCG) vaccine in Somalia, which helps prevent TB-disseminated diseases. Among the major factors that contribute to poor BCG uptake and TB prevention practices are the lack of maternal knowledge, negative attitude, and poor self-efficacy toward the BCG vaccine and TB prevention practices. As such, pregnant women play a vital role in ensuring timely, routine BCG vaccination for their newborns and adherence to TB prevention practices.</p><p><strong>Objective: </strong>This study aims to develop, implement, and evaluate the impact of health education intervention using the information-motivation-behavioral (IMB) skills model to improve knowledge, attitudes, and self-efficacy regarding BCG uptake and TB prevention among pregnant women in Banadir Hospital.</p><p><strong>Methods: </strong>This single-blind randomized controlled trial enrolled a sample of 370 pregnant women recruited at Banadir Hospital in Mogadishu, Somalia. Eligible participants will be randomized to an intervention group receiving an IMB-based health education and to a waiting list control group, in a 1:1 ratio. Outcome assessments will be conducted at baseline, 2-month follow-up, and 4-month follow-up. The primary outcomes are BCG vaccine uptake and TB prevention practices. Secondary outcomes include knowledge, attitudes, and self-efficacy related to the BCG vaccine and TB prevention practices. The IMB-based health education intervention program consists of 6 sessions, with 1 group per session, and with each session containing 30 participants. The effects of the intervention will be assessed by handing out the same self-administered questionnaires at baseline, 2-month postintervention, and 4-month postintervention.</p><p><strong>Results: </strong>A total of 370 pregnant women were recruited at baseline in November 2021, with 185 assigned to the intervention group and 185 assigned to the control group. In January 2022, the 185 pregnant women enrolled in the intervention program and completed the sessions by February 2022. Data collection for the 2-month and 4-month postintervention assessments was completed in June 2022. The findings of this study will be reported by the beginning of 2026.</p><p><strong>Conclusions: </strong>The developed health education intervention module in this study has the potential to be adopted and included as part of routine antenatal care services. Its implementation could effectively raise awareness among pregnant women in Somalia regarding the importance of BCG vaccination and TB prevention practices, ultimately mitigating childhood mortality rates associated with TB-disseminated diseases in the country.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e68088"},"PeriodicalIF":1.5,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12887941/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146149844","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}
Edgar Ross, Jason Ross, Patricia Beschler, David Guydan, Robert Jamison
Background: Noncommunicable diseases (NCDs) have become the leading cause of mortality worldwide. NCDs account for 89% of all deaths in the United States and cost the US economy more than US $47 trillion in direct and indirect expenses. NCDs also account for the main cause of disability worldwide, and the incidence is increasing. The leading NCDs include diabetes, cancer, cardiovascular disease, chronic respiratory disease, and mental health conditions. Outside of aging, NCDs are caused by modifiable behavioral risk factors that include smoking, drug and alcohol abuse, unhealthy diet, obesity, and inadequate physical activity, and treatment must be directed to all of these domains. We hypothesize that a digital twin concept can be used to personalize treatment regimens through analysis of data that allows for artificial intelligence-based decision making.
Objective: This study aims to present a methodology to validate this concept, which would provide a new clinical approach toward addressing the leading cause of disability and mortality worldwide today.
Methods: This study will use delta scores between treatment arms to ascertain whether that distribution was normal for each of the study variables. Parametric (eg, analysis of covariance) or nonparametric analyses will be used to examine the variables to determine the impact of digital twin efficacy over normal treatment paradigms.
Results: Recruitment of participants is expected to begin 6 months after study funding has been awarded and the needed approvals have been obtained. The expected results will show that digital twin modeling using the biopsychosocial characteristics of each participant will be statistically significant, supporting using this approach for personalized medical care.
Conclusions: This study can help to identify significant clinical characteristics to help mitigate the impact of NCDs through biopsychosocial treatment paradigms. This paper proposes a statistical framework to evaluate the validity of the platform's modeling in support of clinical decision making.
{"title":"Designing a Digital Twin for the Management of Noncommunicable Diseases: Protocol for a Pilot Study and Methodology Validation.","authors":"Edgar Ross, Jason Ross, Patricia Beschler, David Guydan, Robert Jamison","doi":"10.2196/75934","DOIUrl":"10.2196/75934","url":null,"abstract":"<p><strong>Background: </strong>Noncommunicable diseases (NCDs) have become the leading cause of mortality worldwide. NCDs account for 89% of all deaths in the United States and cost the US economy more than US $47 trillion in direct and indirect expenses. NCDs also account for the main cause of disability worldwide, and the incidence is increasing. The leading NCDs include diabetes, cancer, cardiovascular disease, chronic respiratory disease, and mental health conditions. Outside of aging, NCDs are caused by modifiable behavioral risk factors that include smoking, drug and alcohol abuse, unhealthy diet, obesity, and inadequate physical activity, and treatment must be directed to all of these domains. We hypothesize that a digital twin concept can be used to personalize treatment regimens through analysis of data that allows for artificial intelligence-based decision making.</p><p><strong>Objective: </strong>This study aims to present a methodology to validate this concept, which would provide a new clinical approach toward addressing the leading cause of disability and mortality worldwide today.</p><p><strong>Methods: </strong>This study will use delta scores between treatment arms to ascertain whether that distribution was normal for each of the study variables. Parametric (eg, analysis of covariance) or nonparametric analyses will be used to examine the variables to determine the impact of digital twin efficacy over normal treatment paradigms.</p><p><strong>Results: </strong>Recruitment of participants is expected to begin 6 months after study funding has been awarded and the needed approvals have been obtained. The expected results will show that digital twin modeling using the biopsychosocial characteristics of each participant will be statistically significant, supporting using this approach for personalized medical care.</p><p><strong>Conclusions: </strong>This study can help to identify significant clinical characteristics to help mitigate the impact of NCDs through biopsychosocial treatment paradigms. This paper proposes a statistical framework to evaluate the validity of the platform's modeling in support of clinical decision making.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e75934"},"PeriodicalIF":1.5,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12890778/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146157156","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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