JMIR Research Protocols最新文献

{"title":"An In-Person and Online Intervention for Parkinson Disease (UPGRADE-PD): Protocol for a Patient-Centered and Culturally Tailored 3-Arm Crossover Trial.","authors":"Michail Elpidoforou, Irene Grimani, Marianna Papadopoulou, Nikolaos Papagiannakis, Anastasia Bougea, Athina-Maria Simitsi, Evangelos Sfikas, Ioanna Alexandratou, Ioanna Alefanti, Roubina Antonelou, Christos Koros, Ioanna Mavroyianni, Chrysa Chrysovitsanou, Leonidas Stefanis, Daphne Bakalidou","doi":"10.2196/65490","DOIUrl":"10.2196/65490","url":null,"abstract":"<p><strong>Background: </strong>Dance for Parkinson's Disease (DfPD) is a dance program for individuals with Parkinson disease (PD). There is a lack of knowledge about the effect of this program on frailty and sarcopenia experienced by patients with PD. In addition, no randomized controlled trial to date has investigated either the possible differential effects of in-person versus online DfPD or the possible effects of DfPD on clinical parameters in Greek patients with PD.</p><p><strong>Objective: </strong>We aimed to assess the efficacy, safety, and feasibility of a culturally tailored and patient-centered DfPD program offered both in-person and online to Greek patients with early- to midstage PD.</p><p><strong>Methods: </strong>This is a 3-arm crossover randomized controlled trial (in-person DfPD vs online DfPD vs control) of UPGRADE-PD (Upbeating Greek Application of Dance in Parkinson's Disease). The experimental period will be 10 months, including three 2-month interventional periods of two 60-minute dance classes per week for each group (in-person DfPD vs online DfPD) versus a control group (nonintervention group), and two 2-month washout periods between each group for 40 Greek patients with early- to midstage PD. Assessments will be performed face-to-face at baseline and at the end of each study period and will include quality of life, fatigue, depressive symptoms, stress, anxiety, sarcopenia, frailty, balance, cognitive functions, movement and nonmovement PD symptoms, and BMI. Safety, feasibility, and patient satisfaction for each dance intervention (in-person DfPD vs online DfPD) will be assessed as well.</p><p><strong>Results: </strong>The study protocol was approved by the Medical Ethics Committee of the Eginition University Hospital in September 2022 and the Research and Ethics Committee of the University of West Attica in October 2023 and funded in September 2023. The first participant was enrolled in April 2023, and the trial is currently ongoing and will conclude in September 2024.</p><p><strong>Conclusions: </strong>The results of this study are expected to show the possible differential effect of a patient-centered and culturally tailored in-person vs online DfPD intervention on several movement and nonmovement symptoms, as well as on quality of life, sarcopenia, and frailty in people living with PD in Greece.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06220084; https://clinicaltrials.gov/study/NCT06220084.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/65490.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65490"},"PeriodicalIF":1.4,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084774/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing a Digital Tool to Screen and Educate Survivors of Domestic Violence on Affordable Housing Programs in New York City: Protocol for a Mixed Methods Feasibility Study.","authors":"Jennifer K Tan, Michelle R Kaufman","doi":"10.2196/63162","DOIUrl":"10.2196/63162","url":null,"abstract":"<p><strong>Background: </strong>Extant research has long documented the association between domestic violence and homelessness. Yet, there appear to be few interventions to address the housing needs of survivors of domestic violence, and none on a digital platform.</p><p><strong>Objective: </strong>Our primary objective is to determine the feasibility of a full-scale intervention trial of a web-based tool that screens and educates survivors of domestic violence on affordable housing programs in New York City. Our secondary objectives are to assess the perceived usability and acceptability of the tool.</p><p><strong>Methods: </strong>The study will take place in a community-based domestic violence center in New York City. Treatment will consist of study participants not using (SC) or using (SC+) the tool, in or outside of private meetings with a case manager to discuss housing and other benefits. The frequency of the meetings will vary depending on the participant's needs. The study will measure changes in housing knowledge, housing self-efficacy, and staff trust through two electronic surveys, administered at times 0 and 2 weeks. Following a historical cohort control group design, we will sequentially recruit participants, starting with SC and followed by SC+. After data collection for SC+ ends, we will invite staff from the partner site to individual, web-based interviews to share their experiences of and recommendations for implementing the tool.</p><p><strong>Results: </strong>Recruitment for the SC arm commenced in March 2022 and was completed in April 2023. After a year, 23 participants completed the study: 75 were screened, 44 were deemed eligible, 35 enrolled, and in the end, 23 participants completed baseline and follow-up surveys. Given the length of time it took to recruit for SC and the limited time overall that we had for the study, the study team decided to follow an expedited recruitment timeline for SC+. Recruitment for SC+ commenced in January 2024 and is anticipated to end by May 2024. Recruitment for the staff interviews will take place in June 2024. We expect to complete the study and be ready to compile the results by the end of June 2024.</p><p><strong>Conclusions: </strong>The protocol describes a feasibility study that can inform future research on housing or digital tools for a similar study population. Data from the study will also be used to inform revisions to the tool.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/63162.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63162"},"PeriodicalIF":1.4,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health Education Campaign to Improve Malaria Knowledge, Prevention, and Treatment Behaviors in Rural East Nusa Tenggara Province, Indonesia: Protocol for a Cluster-Assigned Quasi-Experimental Study.","authors":"Robertus Dole Guntur, Maria Lobo, Dony Martinus Sihotang, Yulianti Paula Bria, Damai Kusumaningrum","doi":"10.2196/66982","DOIUrl":"10.2196/66982","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Malaria is a major health issue that is distributed across 85 countries globally including Indonesia. Indonesia is in the process of achieving malaria elimination. Currently, a high burden of malaria exists in the rural eastern part of the nation, including East Nusa Tenggara Province where the number of malaria cases increased significantly during COVID-19. To achieve malaria elimination, malaria awareness must be measurable and integrated into malaria policy. Currently, malaria awareness among rural communities in the region is low, and interventional studies aiming at improving malaria awareness in rural areas in Indonesia are poorly documented.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to investigate the impact of a local wisdom-based health education campaign combining local music, the voice of subdistrict leaders, and loudspeaker announcements on malaria-related behaviors in rural communities. Specifically, we aim to assess the effect of this intervention on (1) improvement in the malaria awareness index among rural communities and their associated factors, (2) changes in appropriate malaria treatment-seeking behavior (AMTSB) and its associated factors, (3) enhancements in knowledge and practice of malaria prevention measures and their associated factors, and (4) increased use of long-lasting insecticide-treated nets and their associated factors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study used a cluster-assigned quasi-experimental design with pretest and posttest assessments in control and intervention groups. The control group, consisting of 12 villages, received malaria education integrated into routine health services provided by local health centers. The intervention group, comprising 13 villages, received the same education as the control group, in addition to a malaria campaign conducted once a week for 20 weeks. Before and after the campaign, a household survey was conducted to assess behavioral aspects of malaria, including general knowledge of malaria, AMTSB, and malaria prevention measures knowledge and practice. Improvement in the malaria awareness index, AMTSB, good level of malaria prevention measure knowledge, and good level of malaria prevention measure practice will be determined based on the difference scores for each index before and after the intervention in both groups. The chi-square test will be used to assess score differences. Binary logistic regression analysis will be conducted to identify key risk factors associated with changes in each index.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The intervention was conducted from the last week of August 2024 to the second week of January 2025. A total of 894 respondents participated before and after the intervention. The project is currently in progress, with multiple papers being drafted for publication in peer-reviewed journals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study is expected to provide significant findings to comprehensively inves","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66982"},"PeriodicalIF":1.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12082057/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143971423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Accessibility for Work Opportunities for Adults With Autism in an End-to-End Supported Workplace Program: Protocol for a Mixed Methods Cohort Study.","authors":"Adam J Guastella, Lorna Hankin, Elizabeth Stratton, Nick Glozier, Elizabeth Pellicano, Vicki Gibbs","doi":"10.2196/60806","DOIUrl":"10.2196/60806","url":null,"abstract":"<p><strong>Background: </strong>Adults with autism have a strong desire and need for employment that matches their strengths, skills, and interests. Yet, they are more likely to be un- or underemployed than their neurotypical peers. Facilitators to successful employment include positive attitudes toward and awareness of autism in the workplace, and provision of adequate support and accommodations, including mental health support. Despite previous workplace programs identifying the need for adapted recruitment and interviewing processes, awareness training, and ongoing employee support, there are no programs that specifically provide these supports and adaptations for employees with autism.</p><p><strong>Objective: </strong>In this study protocol, we describe a framework for a new end-to-end supported workplace program for adults with autism that encompasses 8 key areas to promote inclusive workplaces and improve recruitment and retention of employees with autism.</p><p><strong>Methods: </strong>Candidates with autism (n=15) will complete 2 workplace skills training sessions at the University of Sydney's Brain and Mind Centre, before attending a tailored interview, onboarding session, and paid 12-week placement at consulting firm Ernst and Young (EY). EY managers and colleagues (n=30) will complete a half-day awareness and inclusion training program before supporting the adults with autism through their 12-week placements. Tailored mental health support will also be provided. This mixed methods cohort study will assess the change in the daily functioning and well-being of employees with autism, as well as the change in the managers' and colleagues' knowledge, attitude, and confidence in working with adults with autism following the training programs. These changes will be analyzed using repeated measures of ANOVAs.</p><p><strong>Results: </strong>Data collection for this study was completed in February 2022. As of November 2024, data analysis was in progress. This study is expected to be submitted for publication in June 2025.</p><p><strong>Conclusions: </strong>This study holds the potential to enhance the recruitment and retention of adults with autism, as well as their overall experience in the workplace.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/60806.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60806"},"PeriodicalIF":1.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12082053/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144001891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neuromuscular Electrical Stimulation to Maximize Hip Abductor Strength and Reduce Fall Risk in Older Veterans: Protocol for a Randomized Controlled Trial.","authors":"Ben Friedman, Brock A Beamer, Jeffrey Beans, Vicki Gray, Gad Alon, Alice Ryan, Leslie I Katzel, John D Sorkin, Odessa Addison","doi":"10.2196/68082","DOIUrl":"10.2196/68082","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Nearly half of all veterans are 65 years and older, and they have a higher prevalence of functional disabilities compared to the nonveteran population. Balance impairments resulting in injurious falls are a leading cause of morbidity and mortality in older adults. Instability or fear of falling can significantly reduce physical activity and social participation, even in the absence of falls. Dysmobility is a leading factor in long-care admissions, and therefore, maintenance of mobility throughout aging is crucial. Recent evidence indicates lower extremity muscle weakness as a key risk factor for falls, with lower limb muscle strength and quality being critical for balance recovery. The primary hip abductors, the gluteus maximus, medius, and minimus, are particularly essential for balance recovery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to test the hypothesis that adding neuromuscular electrical stimulation (NMES) to a multimodality balance intervention (MMBI) will yield greater reductions in fall risk and improvements in muscle and mobility function compared with MMBI alone.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This randomized controlled trial will enroll 80 veterans aged 55 years and older at risk for falls (defined by a four-square step test [FSST] time &gt;12 seconds, history of falls, or fear of falling). Participants will be randomized to receive either NMES + MMBI or MMBI alone. The 12-week outpatient center-based intervention will include 3 sessions per week, focusing on hip abductor strength, balance, and mobility. Assessments will occur at baseline, postintervention, and at 6- and 12-month follow-ups. Primary outcomes include fall risk and dynamic balance, measured by FSST and hip abductor strength using a Biodex dynamometer. Secondary outcomes will examine muscle composition through computed tomography (CT) scans and assess gait variability parameters.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded on January 1, 2022, with a data collection period from April 1, 2022, to December 31, 2026. As of March 2025, we have screened 100 potential participants and excluded 38. Out of the 61 participants enrolled to date, 21 have completed the 12-month follow-up, 32 have completed the 6-month follow-up, and 41 have completed the posttesting. A total of 4 participants are currently in the intervention phase; 1 has just completed the baseline testing, while 15 have been dropped from the study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This trial will be the first large, randomized controlled trial to evaluate NMES as an adjunct to an MMBI for fall prevention in older veterans. If successful, NMES combined with hip abductor strengthening and balance training could provide a low-cost, scalable solution to reduce falls, improve balance and mobility, and decrease health care costs related to falls in older adults. This study will address a critical gap in knowledge about the effectiveness of NMES in enhancing rehabilit","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68082"},"PeriodicalIF":1.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12082051/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Heterosexual-Identified Men Who Have Sex With Men and Men of Diverse Sexual Identities: Protocol for an International, Multilingual, Online, Comparative Sexuality Study.","authors":"Andrew D Eaton, Travis R Scheadler, Megan Rowe, Salem Rao, Sandra Kwan, Oliver W J Beer, Paul A Shuper, Tyrone J Curtis, Adam Busch, Daniel Vandervoort, Lauren B McInroy","doi":"10.2196/66897","DOIUrl":"10.2196/66897","url":null,"abstract":"<p><strong>Background: </strong>Sexuality is multidimensional and complex, and involves identity development, attraction, and behavior. Heterosexual-identified men who have sex with men (H-MSM) experience sexual identity and behavior discordance, yet it is unknown how H-MSM compare to concordant heterosexual men and gay, bisexual, and queer (GBQ+) men in terms of sexuality constructs.</p><p><strong>Objective: </strong>This study aims to survey adult cisgender men in Canada, the United States, and the United Kingdom to gain greater insights into how demographics, identity development, attraction, behavior, technology use, relationship negotiation and communication skills, and pre-exposure prophylaxis and life satisfaction relate to each other, and then to interview H-MSM for an in-depth follow-up on survey concepts.</p><p><strong>Methods: </strong>Purposive sampling will be used to recruit men via online and offline venues. Data collection will be multifaceted and include an online questionnaire for adult cisgender men and a subsequent interview for H-MSM. The survey will be available in English, French, and Spanish. Structural equation modeling, underpinned by hegemonic masculinity and sexual script theories, will be performed to test the relationships among survey variables. Interpretive phenomenology will be employed on the qualitative data to consider how unique sociocultural factors influence the sexuality and experiences of H-MSM, allowing for similarities and differences across participants to be identified and explored.</p><p><strong>Results: </strong>Data collection began on November 26, 2024, and as of February 2025, data collection remains ongoing. We expect to conclude data collection and data cleaning by mid-summer 2025. Data analysis will begin in fall 2025. Our findings will provide a more nuanced understanding of the identity development, attraction, behavior, relationship negotiation, and technology use of H-MSM in comparison with GBQ+ men and concordant heterosexual men.</p><p><strong>Conclusions: </strong>This research aims to broaden the scope of existing literature and support advancements in interventions and knowledge to support the overall health and well-being of H-MSM. An examination of potential differences among H-MSM, concordant heterosexual men, and GBQ+ men aims to improve the understanding of H-MSM as a distinct population, without dismissing them as closeted GBQ+ men. This study aims to provide key insights into avenues for research and practice with men whose sexuality and sexual behaviors may be outside of commonly accepted norms.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/66897.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66897"},"PeriodicalIF":1.4,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079075/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144001807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Short- and Long-Term Effectiveness of Brief Intensive Trauma Treatment for Adolescents With Posttraumatic Stress Disorder and Their Caregivers: Protocol for a Multicenter Randomized Controlled Trial.","authors":"Myrna M Westerveld, Malindi van der Mheen, Rik Knipschild, Kim Maijer, Marieke E de Keizer-Altink, Nina Albisser, Marielle J E Hoekstra, Anne Timmermans-Jansen, Rosa Zijp, Anne A Krabbendam, Francisca J A Bonny van Steensel, Kees-Jan Kan, Chaim Huyser, Wouter G Staal, Elisabeth M W J Utens, Ramón J L Lindauer","doi":"10.2196/66115","DOIUrl":"10.2196/66115","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Childhood trauma is pervasive, with approximately 50% of adolescents experiencing at least one potentially traumatic event before adulthood. Eight percent to 33% of potentially traumatic event-exposed adolescents develop posttraumatic stress disorder (PTSD), which can cause extreme suffering and coincides with numerous comorbid illnesses and high-risk behaviors. PTSD can be effectively treated in adolescents through weekly sessions of eye movement desensitization and reprocessing or trauma-focused cognitive behavioral therapy. Despite the availability of these treatments, numerous severely traumatized adolescents do not receive available treatment options due to high treatment avoidance. In adolescents who receive care, a large group of youth does not experience a sufficient symptom decrease after regular treatment. In addition, dropout rates during prolonged treatment are substantial, varying between 10% and 30%. This underscores the need for innovative and brief trauma treatment. Pilot studies indicate that Brief Intensive Trauma Treatment (BITT) can be a safe and effective treatment for adolescents with PTSD. However, randomized controlled trials on its effectiveness are crucial and urgently needed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This is the first study to test the effectiveness of a 1-week BITT in adolescents with PTSD and comorbid symptoms and their caregivers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This multicenter, single-blinded randomized controlled trial will be conducted in 4 youth care centers in the European and Caribbean Netherlands: Levvel, Karakter, Fornhese-GGz Centraal, and Mental Health Caribbean (Bonaire). We will randomize adolescents (12-18 years old) with PTSD to a BITT (n=50) or waitlist control group (WLCG; n=50). BITT comprises 1-week (ie, 5 consecutive workdays) intensive trauma treatment, encompassing daily 90-minute manualized sessions of trauma-focused cognitive behavioral therapy and eye movement desensitization and reprocessing. The day begins and ends with psychomotor therapy. Caregivers receive daily parental counseling sessions consisting of psychoeducation and social support skill training. We will conduct measurements at similar intervals for both groups: at baseline; directly after BITT or WLCG; and at 3, 6, and 9 months' follow-up. The WLCG will receive BITT after the 3-month follow-up assessment. We will assess all study parameters using digital or face-to-face questionnaires and semistructured interviews. We will assess the primary outcome PTSD symptoms using the Child and Adolescent Trauma Screen 2 (CATS-2) and the Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition])-Child/Adolescent Version (CAPS-CA-5).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of September 2022, we enrolled 104 participants. Data will be collected until December 2025. Results are expected to be published in the summer of 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66115"},"PeriodicalIF":1.4,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079078/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144010431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Diet Quality of People Living With Obesity by Building Effective Dietetic Service Delivery Using Technology in a Primary Health Care Setting: Protocol for a Randomized Controlled Trial.","authors":"Deborah A Kerr, Clare E Collins, Andrea Begley, Barbara Mullan, Satvinder S Dhaliwal, Claire E Pulker, Fengqing Zhu, Marie Fialkowski, Richard L Prince, Richard Norman, Anthony P James, Paul Aveyard, Helen Mitchell, Jacquie Garton-Smith, Megan E Rollo, Chloe Maxwell-Smith, Amira Hassan, Hayley Breare, Lucy M Butcher, Christina M Pollard","doi":"10.2196/64735","DOIUrl":"10.2196/64735","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Almost a third of Australian adults are living with obesity, yet most cannot access medical nutrition therapy from dietitians, that is, the health professionals trained in dietary weight management services. Across the health system, primary care doctors readily identify people who may benefit from weight management services, but there are limited referral options in the community. Dietitians are trained to provide evidence-informed dietary treatment of overweight and obesity but are underutilized and underresourced. The chat2 (Connecting Health and Technology 2) trial will test combining new technologies for dietary assessment with behavior change techniques to improve outcomes for people living with obesity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to compare the effectiveness of a 1-year digital dietary intervention, with standard care on body weight reduction and improved diet quality, in adults living with obesity delivered by dietitians in a primary care setting.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This randomized controlled trial will compare a 1-year, digitally tailored, feedback dietary intervention with a control group in 430 adults living with obesity (BMI≥30 to ≤45 kg/m&lt;sup&gt;2&lt;/sup&gt;). Participants will be recruited by letters sent to individuals randomly selected from the electoral roll and supplemented by hospital site posters, newsletters, and unaddressed mailbox delivery postcards sent to residential street points. The primary outcome is change in body weight, measured face-to-face at a baseline, 6 months, and 12 months. A 4-day, image-based dietary assessment tool (mobile Food Record) will be used to measure diet quality score. Secondary outcomes include diet quality score; dual-energy absorptiometry body composition; and total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein, glycated hemoglobin, and fasting glucose levels. The intervention group will receive 8 video counseling sessions with a trained dietitian delivered over 12 months to support dietary behavior change and relapse prevention. The trial is unblinded. Both groups will receive feedback on their clinical chemistry and dual-energy absorptiometry scans at each time point.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Participant recruitment commenced in July 2023 and ended in August 2024. Data analysis will commence in 2025, with the anticipated publication of results in 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;If found to be effective, the results of this randomized controlled trial will support the delivery of effective, evidence-based weight management advice using new technologies. Improving community access to high-quality dietetic services will ensure more effective use of the dietetic workforce to improve outcomes for people living with obesity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Australian New Zealand Clinical Trials Registry ACTRN12622000803796; https://anzctr.org.au/Trial/Registration/TrialReview.as","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64735"},"PeriodicalIF":1.4,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079054/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exposure to and Engagement With Digital Psychoeducational Content and Community Related to Maternal Mental Health by Perinatal Persons and Mothers: Protocol for a Web-Based Survey With Optional Follow-Up.","authors":"Molly E Waring, Katherine E McManus-Shipp, Christiana M Field, Sandesh Bhusal, Asley Perez, Olivia Shapiro, Sophia A Gaspard, Cindy-Lee Dennis","doi":"10.2196/64075","DOIUrl":"10.2196/64075","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Leveraging digital platforms may be an effective strategy for connecting perinatal persons and mothers with evidence-based information and support related to maternal mental health and peers. Momwell is a mom-centered model of care that provides psychoeducational content through several digital platforms, including social media, a podcast, and a blog. The aims of this project were to describe how perinatal persons and mothers engage with Momwell's psychoeducational content and community; describe the perceived benefits of exposure to and engagement with content and community; examine associations between engagement with digital psychoeducational content and maternal mental health, parenting attitudes, and interparental relationships; and examine changes in mental health and parenting attitudes and concurrent engagement with Momwell's digital psychoeducational content and community over 2 to 3 months.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This paper aims to describe the design of a study of perinatal persons and mothers who are exposed to or engage with Momwell's psychoeducational content and community and describe sample characteristics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Adults who engaged with Momwell on any of their digital platforms were recruited to complete a web-based survey in July 2023 to September 2023. Participants completed either a longer or shorter survey. Participants who provided permission to be recontacted were invited to complete a second survey 2 to 3 months later. The surveys included validated psychological measures, study-specific quantitative questions, and open-ended questions that assessed participant demographics, exposure to and engagement with Momwell's psychoeducational content and community, maternal mental health, parenting relationships, parenting self-efficacy, and additional psychosocial and health measures. We outline planned analyses to achieve the aims of the project.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Data collection occurred from July 2023 to September 2023 (N=584). A subset of participants completed the optional second survey in October 2023 to December 2023 (N=246). Participants were &gt;99% mothers (582/584, 99.7%); 45.5% (266/584) perinatal (59/584, 10.1% pregnant; 210/584, 36% post partum); and, on average, aged 32.4 (SD 3.9) years. In total, 59.1% (345/584) were from the United States, 35.6% (208/584) were from Canada, and 5.3% (31/584) were from other countries. The vast majority (552/584, 94.5%) followed Momwell on Instagram, 44.2% (258/584) listened to the Momwell podcast, and 41.1% (240/584) received their newsletter. Most participants had been exposed to Momwell's psychoeducational content for at least 6 months across the different platforms (range 16/36, 44% on TikTok to 480/552, 87% on Instagram).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Data from this study will provide insights into how pregnant persons and mothers use digital psychoeducational content and peer communities to su","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64075"},"PeriodicalIF":1.4,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diabetic Retinopathy Screening Among at Risk Populations: Protocol for Distributional Cost-Effectiveness Analysis.","authors":"Aleksandra Stanimirovic, Troy Francis, Sonia Meerai, Suja Mathew, Sarah Ibrahim, James M Bowen, Aleksandra PIkula, Valeria Rac","doi":"10.2196/60488","DOIUrl":"10.2196/60488","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Diabetic retinopathy (DR) remains the primary vision complication of diabetes and the leading cause of blindness among adults, with up to 30% prevalence among low-income populations. Tele-retina is a cost-effective screening alternative to vision loss prevention, yet there is an adverse association between screening and income. Intersectionality theory notes that barriers to achieving health equity result from the intersection of personal and social characteristics. Experiences at this intersection are influenced by interpersonal and structural systems of oppression. Studies have found that tele-retina is the preferred strategy over standard of care screening for at-risk populations. No study has assessed the economic equity impact of DR screening using a theoretical foundation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to address shortcomings related to the utilization of intersectionality theory in the economic evaluation of DR screening. We propose conducting a distributional cost-effectiveness analysis (DCEA) of the tele-retina program.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study will be undertaken using a deductive theoretical drive sequential multimethod approach, consisting of two studies: (1) a modified Delphi study and (2) DCEA. The Delphi panel (patient partners, field experts, and decision makers; N=35-50) will select the social constructs (eg, age, gender) for at-risk populations and potential trade-offs between health maximization and equity. The research will be guided by a social theory framework (intersectionality theory) to understand the impact of social constructs on economic outcomes. Social constructs that are selected by the Delphi panel will be integrated into the validated tele-retina cost-effectiveness analysis model, which will serve as a case study for DCEA.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We have submitted the research ethics board application to the University Health Network Research Ethics Board and are expecting to begin recruitment for the Delphi study in Spring 2025. We anticipate beginning work on the model in the summer of 2025 and completing it by early 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The Delphi study will provide an understanding of which social factors are deemed necessary by the stakeholders for guiding the inequity in care access. Study results will offer information related to the net health benefit of the intervention and the health equity impact of the tele-retina program, hence providing a more comprehensive valuation of the tele-retina program, which is informative to policy makers and governments whose goal is to mitigate the drivers of health inequities. We anticipate that each of these drivers will raise important questions regarding the implications for decision-making that may have not yet been addressed by Canadian health technology assessment bodies, such as the Canada Drug Agency. This is the first Canadian study to (1) have social constructs for ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60488"},"PeriodicalIF":1.4,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143971419","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}