JMIR Research Protocols最新文献

Background: One in 10 preschoolers (aged 3-4 y) meet the three 24-hour Movement Guidelines, that is, (1) physical activity, (2) sedentary screen time, and (3) sleep.

Objective: The overarching aim of this study is to evaluate the effectiveness and feasibility of a 12-week mobile health home-based intervention on 24-hour movement behaviors in preschoolers who meet few guidelines (zero or 1 guideline).

Methods: We will conduct a 12-week randomized controlled trial with a wait-list control in 80 families (40 per arm). Preliminary studies in this population informed intervention app content, features, and app development. Behavior change theories, including transfer theory and the multi-process action control framework, helped inform content presentation and topics. Primary outcomes include device-based and parent-report measures of 24-hour movement behaviors, and the secondary outcome is the feasibility and acceptability of the app. Exploratory outcomes include preschoolers' cognitive and motor skills, changes within the home environment, and behavioral control processes.

Results: This 2-phase study (K99/R00) received initial funding in March 2022, and preliminary studies were concluded in December 2023. The main grant received institutional review board approval in April 2024, and the grant funding began in May 2024. The study was registered in Clinical Trials in October 2024 and enrolled its first participant in January 2025. As of October 2025, the study has enrolled 39 families. We anticipate the trial will be completed in late 2026.

Conclusions: This research is designed to test a novel approach to improve all three 24-hour movement behaviors in preschoolers in home settings by using a mobile app. Results from this study will have implications for future 24-hour movement interventions, our understanding of improving all 3 behaviors, and ultimately, improvements in preschoolers' health.

Trial registration: Clinicaltrials.gov NCT06667661; https://clinicaltrials.gov/study/NCT06667661.

International registered report identifier (irrid): DERR1-10.2196/75621.

Background: California has the largest number of people living with HIV in the United States, and in 2022, there were 4882 new diagnoses. Veterans with histories of substance use, viral hepatitis, sexually transmitted infections, and homelessness carry substantial HIV burden. Testing is essential, yet approximately 12% of Californians with HIV were undiagnosed in 2020, and 50% of veterans in care had never been tested as of 2023. HIV self-tests (HIVSTs) can mitigate stigma, confidentiality, and access barriers, and vending machines (VMs) offer private, convenient distribution. However, the use of VM-dispensed HIVST has not been evaluated for veterans or within Veterans Affairs (VA) settings.

Objective: We describe a Reach, Evaluation, Adoption, Implementation, and Maintenance-guided pre-implementation protocol to evaluate VM-dispensed HIVSTs in Northern California VA clinics and supportive housing settings.

Methods: Fifteen VMs will stock oral-fluid HIVSTs (n=900). Program data (de-identified dispense logs), veteran electronic surveys (n=90), and qualitative interviews (n=15) will quantify reach (uptake), early effectiveness proxies (use, results, and next steps), adoption (machine/site dispensing), implementation (stockouts, restocking interval, and costs), and maintenance (dispensing trends).

Results: Ethics approval activities (study material development and Institutional Review Board submission) began 2 months prior to the receipt of award funding (January to February 2025). Following funding, the project is planned for over a total of 18 months (12 months original project period + 6 months no-cost extension; March 2025 to August 2026). Ethics approval was obtained in August 2025. Veteran feedback was incorporated into study materials, and HIVSTs were purchased and packaged in September to November 2025. HIVSTs were added to VMs, and data collection is projected to occur from December 2025 through June 2026. Results are anticipated to be available in August 2026.

Conclusions: This study will generate practice-ready evidence on the feasibility, acceptability, and early behavioral impacts of VM-dispensed HIVSTs for veterans. By pairing a stigma-responsive delivery channel with pragmatic measures, findings can inform equitable scale-up across VA and community settings, guide comparative evaluations of distribution channels (VMs, mail-to-home, or clinic pick-up), and support privacy-preserving linkage strategies to confirmatory testing, HIV pre-exposure prophylaxis, and treatment. Results will address a critical evidence gap for veteran-focused HIV prevention and provide parameters for multi-site evaluations.

Background: Dental fear and anxiety (DFA) affects approximately a quarter of children and adolescents. It significantly contributes to pediatric patients avoiding dental care later in adulthood. Lack of cooperation due to DFA can create a stressful environment, often forcing dentists to end appointments prematurely and consider alternative pharmacological treatments. The use of virtual reality (VR) during dental procedures, offering an immersive sensory experience, may serve as an additional nonpharmacologic tool to better manage DFA in children with special health care needs (SHCN) undergoing dental treatment.

Objective: This study aims to assess the effectiveness of VR immersion in reducing anxiety and pain among pediatric patients with SHCN undergoing dental procedures. The study also seeks to understand the satisfaction of parents and health care providers with the use of VR during dental appointments.

Methods: This randomized controlled trial follows a parallel design with two groups: a control group receiving standard care and an experimental group using VR. A sample size of 400 participants was calculated. Participants will be randomly assigned equally to each group. Recruitment will take place at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary- and quaternary-care center that primarily serves pediatric patients with SHCN. The two primary outcomes will include both observed and objective biomarker-based measures of anxiety. DFA will be evaluated using the Venham Anxiety Rating Scale as well as changes in mean levels of salivary alpha-amylase. Sociodemographic characteristics, parents' and health care professionals' satisfaction levels, participants' pain intensity and behavior during the procedure, changes in heart rate, occurrence of side effects, procedure duration, and any deviations from normal procedural length will also be collected. Descriptive and comparative statistics will be conducted for demographic and clinical comparisons and will be used to present sociodemographic and clinical data, parents' and health care professionals' satisfaction levels, child satisfaction with the game, and procedural time.

Results: This study will be conducted from November 2023 to December 2025. As of November 2025, 300 participants have been recruited. Results are expected to be available in June 2026.

Conclusions: We believe that the results of this study will confirm the efficacy of VR in reducing DFA in children with SHCN, providing an additional nonpharmacological alternative for better managing this condition in pediatric hospital settings.

Background: Despite advances in surgical resection, radiotherapy, and chemotherapy, the prognosis of recurrent malignant gliomas (rMG) remains poor, with limited efficacy of conventional treatments due to the blood-brain barrier (BBB) hindering drug delivery to the tumor site. Studies have demonstrated that albumin-bound paclitaxel (ABX), while potent in vitro, is restricted in its intravenous use due to BBB limitations. To overcome this, specific-mode electrical stimulation (SMES) has shown promise in transiently opening the BBB, enhancing the accumulation of ABX in glioma tumors. Therefore, this protocol designs a single-center, single-arm, prospective phase II clinical trial aiming to evaluate the safety and clinical efficacy of SMES combined with ABX (SMES+ABX) for treating rMG.

Objective: This study primarily evaluates the safety of SMES+ABX therapy in treating patients with rMG and assesses whether it can improve the 4-month progression-free survival (4m-PFS) rate, while providing data support for future large-scale clinical trials.

Methods: In this study, 20 eligible patients will receive intravenous ABX (135-175 mg/m²) per 21-day cycle for 6 cycles, combined with SMES for BBB modulation. A Simon 2-stage design will be employed, with the primary end point being the 4m-PFS. Secondary end points include adverse events, disease control rate, objective response rate, duration of disease control, duration of response, Neurological Assessment in Neuro-Oncology score, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, progression-free survival, and overall survival.

Results: The results will determine the 4m-PFS rate, overall safety profile, secondary efficacy outcomes, and patient-reported quality of life measures. The data will be analyzed upon trial completion. Patient enrollment is scheduled to begin in May 2025. The treatment and primary efficacy assessment phases are anticipated to be completed by January 2027 (allowing for staggered enrollment and a 4-month treatment period for the last enrolled patient). The final survival follow-up for all patients is anticipated to be completed by January 2028 (ie, 1 year after the last patient completes treatment). Data management is currently ongoing, and formal statistical analyses have not yet been performed.

Conclusions: This study aims to evaluate the efficacy and safety of SMES combined with ABX in the treatment of rMG. If successful, the combination could offer a promising therapeutic strategy for this challenging patient population.