Contemporary clinical trials · 2025
Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Goldschmidt Andrea B, Ortega Adrian, Rooper Isabel R, Obleada Katrina T, Chapa Danielle A N, Silverberg Basia, Stalvey Erin, Camino Macarena Kruger, Levine Michele D, Yu Lan, Eichen Dawn M, Graham Andrea K
Аннотация
BACKGROUND: Pediatric overweight and obesity continue to be major public health issues. Loss of control (LOC) eating and overeating are two obesity-related phenotypes affecting approximately 30 % of adolescents with overweight/obesity that may undermine weight control treatment outcome. Cognitive-behavioral therapy (CBT) has promising effects on dysregulated eating, but effects on weight are modest, access is limited, and developmental changes in self-regulation (which may limit implementation of treatment skills) are often ignored.
METHODS: In the current proposal, we will apply human-centered design methods to design and test a novel CBT-based digital intervention, augmented with content and features to improve self-regulation, for weight gain prevention and dysregulated eating in adolescents. The first phase will involve design activities with adolescents (n = 25-30) who have body mass index (BMI; kg/m2) ≥ 75th percentile for age and sex and report dysregulated eating, to understand desired presentation, features, and barriers/facilitators to engagement. Research activities will include a needs assessment and iterative prototyping, usability testing, and refinement of the digital intervention. The second phase will be a multisite single arm open trial involving 50 adolescents who have or are at risk for overweight/obesity and report LOC and/or overeating to investigate intervention feasibility and preliminary efficacy, as well as putative treatment mechanisms and targets.
CONCLUSIONS: Results of the study will inform the design of an adequately powered randomized controlled trial. The project has clear potential to significantly impact public health via development of a relevant, accessible, and scalable intervention for adolescents at risk for adverse physical and mental health outcomes.
CLINICAL TRIAL REGISTRATION NUMBER: NCT06819813.
METHODS: In the current proposal, we will apply human-centered design methods to design and test a novel CBT-based digital intervention, augmented with content and features to improve self-regulation, for weight gain prevention and dysregulated eating in adolescents. The first phase will involve design activities with adolescents (n = 25-30) who have body mass index (BMI; kg/m2) ≥ 75th percentile for age and sex and report dysregulated eating, to understand desired presentation, features, and barriers/facilitators to engagement. Research activities will include a needs assessment and iterative prototyping, usability testing, and refinement of the digital intervention. The second phase will be a multisite single arm open trial involving 50 adolescents who have or are at risk for overweight/obesity and report LOC and/or overeating to investigate intervention feasibility and preliminary efficacy, as well as putative treatment mechanisms and targets.
CONCLUSIONS: Results of the study will inform the design of an adequately powered randomized controlled trial. The project has clear potential to significantly impact public health via development of a relevant, accessible, and scalable intervention for adolescents at risk for adverse physical and mental health outcomes.
CLINICAL TRIAL REGISTRATION NUMBER: NCT06819813.