Background Young adult caregivers of a family member with major depressive disorder (MDD) constitute a vulnerable population. They have substantial support needs because they often experience psychological distress and daily burdens during a developmental period in which education, partnership formation, and parenting frequently overlap with caregiving responsibilities. Consequently, the burden associated with caring for a family member with MDD may adversely affect young adult caregivers' mental health and life stability. Despite these needs, support programs and intervention studies specifically targeting young adult caregivers remain scarce. Videoconference-based family psychoeducation (vFPE) may help address this gap, improving access for individuals facing time and geographic barriers. However, the feasibility of conducting a randomized controlled trial (RCT) of vFPE in this population has not yet been established. Objective The objective of this study is to examine the feasibility of conducting a waitlist-controlled pilot RCT of vFPE and the acceptability of the vFPE intervention among young adult caregivers of a family member with MDD. Methods This study is a waitlist-controlled pilot RCT. Young adult caregivers (aged 18-39 y) will be randomly assigned in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in the intervention group will receive 4 weekly 40-minute vFPE sessions. The primary outcomes are feasibility and acceptability. Feasibility will be assessed by recruitment, randomization, intervention completion, dropout rates, and safety. Acceptability will be assessed using the Client Satisfaction Questionnaire-8 Japanese version. Exploratory outcomes, including anxiety and depressive symptoms, mental well-being, psychological distress, caregiver burden, self-efficacy, and health-related quality of life, will be assessed at baseline, postintervention, and 1-month follow-up via online self-administered questionnaires. Exploratory outcomes will be used to inform the design of a future definitive RCT rather than to draw conclusions about intervention effectiveness. Results This paper describes the study protocol. Ethical approval was obtained from the Research Ethics Committee, Faculty of Nursing, Toho University, on December 18, 2025. Recruitment commenced on January 10, 2026, with the first participant enrolled on February 20, 2026. As of May 2026, 8 participants had been enrolled. Intervention delivery and data collection are expected to continue until March 2028. Study findings will be disseminated through presentations at academic conferences and publication in peer-reviewed journals. Conclusions This study will clarify the feasibility of conducting an RCT of vFPE among young adult caregivers of a family member with MDD, providing foundational data to inform the design of a future definitive RCT.
Background Safe vacuum-assisted vaginal birth depends on appropriate case selection, accurate cup placement, controlled traction, recognition of technical difficulty, and timely abandonment of an unsuccessful attempt. Simulation-based education can improve procedural performance, but evidence that vacuum-specific simulation changes patient-level clinical practice remains limited. Objective This study aims to estimate the change in the occurrence of cup detachment (known as "pop off") following implementation of a standardized simulation-based training program for vacuum-assisted vaginal birth. Cup detachment was designated as the single primary outcome after evaluation of the preintervention cohort but before any postintervention versus preintervention comparative analysis. Methods This multicenter quasi-experimental before-and-after study is being conducted in 19 Spanish maternity hospitals participating in the Registro Español de Morbimortalidad Materna y Perinatal. The implemented preintervention observation period ran from November 28, 2024, through February 28, 2026. The training and washout phase was conducted during March and April 2026, followed by postintervention data collection from May through October 2026. Preintervention clinical variables are ascertained retrospectively from medical records, whereas postintervention data collection is prospective. The intervention combines preparatory theoretical material, a 1-hour face-to-face simulation workshop using a PROMPT FLEX obstetric simulator and vacuum devices, checklist-based assessment, supervised practice, feedback, and debriefing. The primary outcome will be analyzed using modified Poisson regression to estimate risk ratios and 95% CIs, accounting for hospital and protocol-defined calendar time trends. Sequential instrumentation and conversion to cesarean birth will be analyzed separately as key secondary clinical outcomes. Ethical approval was granted by the Clinical Research Ethics Committee of Girona (code 2024.070) on August 5, 2024. Results This study was funded in November 2024. During the preintervention phase, 1155 cases were recorded in 19 hospitals; 12 were excluded according to the selection criteria, leaving 1143 eligible cases. At the verified July 2026 project update, 144 postintervention cases had been collected. Postintervention data collection is scheduled to close in October 2026; the protocol-defined comparative analysis will be performed after database lock, with publication of the main results planned for summer 2027. Conclusions The current analysis plan was fixed before database lock and before any formal comparative postintervention versus preintervention effectiveness analysis. The protocol also defines assessment of contamination, intervention fidelity, secular trends, and the limitations inherent to a nonrandomized before-and-after evaluation.
Abstract Background The integration of wearable device–based telemonitoring into hospital systems presents a transformative opportunity for chronic disease management, particularly in settings such as Indonesia facing a high burden of noncommunicable diseases. However, widespread adoption is hindered by multifaceted operational barriers, including workflow integration, data management, and unclear adoption pathways, highlighting a critical need for structured, evidence-based guidance. Objective This study protocol aims to develop a role-specific adoption guideline for integrating wearable telemonitoring systems into routine workflow in Indonesian hospitals for chronic disease management. Methods An exploratory sequential mixed methods design is employed across 3 phases. Phase 1 involves a critical interpretive synthesis of the literature to synthesize evidence on wearable technology adoption to populate the Domain-by-Actor matrix. Phase 2 comprises qualitative semistructured interviews with 32 to 44 key stakeholders (administrators, IT staff, and clinicians) from 4 purposively selected hospitals in Yogyakarta, Indonesia, to explore contextual barriers and facilitators. Phase 3 uses a modified nominal group technique with a panel of 12 experts to build consensus and finalize the guideline. Results As of December 13, 2025, this study is in progress. Ethical approval has been obtained. The critical interpretive synthesis (phase 1) is completed, yielding preliminary thematic data on adoption factors. Data collection for the qualitative interviews (phase 2) has commenced, with interviews conducted at 1 hospital and administrative permissions secured for 2 sites. Recruitment and data collection are ongoing. Conclusions This protocol offers a systematic methodology to bridge the gap between digital health pilot studies and routine use in clinical operations. By mapping complex adoption factors onto an anticipated Domain-by-Actor matrix, the proposed study has the potential to guide sustainable, role-specific wearable telemonitoring integration across diverse hospital structures.
Abstract Background The rising prevalence of obesity among preschool children has become a critical public health concern in Suzhou, China. Nevertheless, evidence-based, personalized, and multicomponent intervention strategies tailored to children with overweight or obesity remain inadequately established in current practice. Objective This study aims to investigate the prevalence and pathogenic factors of obesity among preschool children in Suzhou and to develop a comprehensive and multifaceted integrated intervention program. Through systematic assessment of its short-term effectiveness and long-term sustainability in improving obesity-related indicators and preventing overweight, it provides a scientific basis for obesity prevention and control. Methods This cluster randomized controlled trial is being conducted among children aged 3 to 6 years in Suzhou City, Jiangsu Province. Children from 3 kindergartens were randomly assigned to the intervention group and children from 3 other kindergartens were assigned to the control group. The 1-year intervention includes health education, dietary guidance, and increased physical activity, adopting a multilevel approach that engages children, families, schools, communities, and society. Children participate in health education and physical activity courses in the kindergarten, while parents receive educational materials online. Parental education and regular assessment of knowledge, attitudes, and practices are key components of the family-based intervention. Body measurements will be taken at baseline, 6 months, 12 months, and thereafter, alongside questionnaires for both parents and children to evaluate their own health behaviors. The primary outcome will be the difference in BMI, BMI z scores, and body fat percentage between the 2 groups of children at the end of the intervention. Results The study received ethical approval in March 2025. Baseline assessments were conducted from March to June 2025, followed by the initiation of the intervention, which will be completed by June 2026. Participants will then enter a noninterventional long-term follow-up until June 2032, with annual surveys conducted during this period. Conclusions This program will test the effectiveness of comprehensive multifaceted interventions on children. The results of this study will provide scientific evidence for formulating effective intervention strategies for childhood overweight and obesity and are also expected to offer crucial practical references for the formulation and improvement of treatment guidelines for childhood obesity in China.
