Adapting an Adolescent Weight Management Program for a Type 1 Diabetes Population

项目摘要 在患有1型糖尿病的年轻人中，超重/肥胖(BMI和GT；性别和年龄的第85百分位数)并存的情况很少见 1990年代以前的糖尿病(T1 DM)，但现在的患病率超过了一般人口中的青年。 行为体重管理干预是针对儿童肥胖的循证一线治疗。 然而，T1 DM有一些独特的挑战，需要对这些干预措施进行深思熟虑的适应。示例 包括运动减少和低血糖导致的过量卡路里消耗。患有T1 DM的青少年和 超重/肥胖并存的人也有发生饮食失调行为的高风险。有一个关键的问题 需要采取行为体重管理干预措施，解决T1 DM特有的障碍，并将 注意在这一高危人群中预防饮食失调。这个K23项目的目标是适应 初级导师(Elissa Jelian博士)建立了为期16周的青少年体重管理干预措施 T1 DM人群。使用肥胖相关行为干预试验(Orbit)模型，框架 干预开发，该项目将设计、改进和测试适应的行为体重管理 使用两项相关但不同的研究对患有T1糖尿病和超重/肥胖的青少年进行干预。 研究1将通过以下方式确保干预材料的可行性(即参与者出席)和可接受性 同时患有T1糖尿病和超重/肥胖的青少年，采用2-3个小组(n=5)的开放试验设计 青少年/群体)。参与者将在每周会议结束后完成经过验证的可接受性测量 以及干预后的离职调查。候选人将根据研究1反复改进干预措施 结果。研究2将比较适应后的体重管理干预和常规护理控制组 一项先导性随机对照试验设计(n=50名青少年)，以验证适应性干预 降低参与者的体重指数，增加在目标血糖范围(70-180 mg/dL； 主要结果)。研究2的参与者将在以下时间完成生态瞬时评估(EMA) 基线和16周以确定随时间推移的不良饮食和体重控制行为事件 (次要结果)。探索性分析将评估这些不适应饮食和体重的相关性。 控制真实世界设置中的行为。这个K23项目建立在候选人以前在儿科的工作基础上 肥胖和T1 DM。高素质的专家指导团队将提供支持和监督， 允许候选人获得必要的技能，以开始独立的研究生涯，旨在 改善患有T1糖尿病和超重/肥胖的青少年的体重管理。结果将 为后续应用提供数据，以进行完全有效的随机对照试验，以测试 改良式体重管理干预的效果。拟议的项目与NIDDK的项目一致 减轻糖尿病相关心血管事件的使命，并有可能成为重要的公众 健康干预以改善患有T1糖尿病和超重/肥胖的青少年的健康。

PROJECT ABSTRACT Comorbid overweight/obesity (BMI>85th percentile for sex and age) was rare in youth with type 1 diabetes mellitus (T1DM) prior to the 1990s, but the prevalence now exceeds that of youth in the general population. Behavioral weight management interventions are evidence-based, first-line treatments for pediatric obesity. Yet, there are unique challenges of T1DM that require thoughtful adaptations to these interventions. Examples include reduced exercise and excess calorie consumption due to hypoglycemia. Adolescents with T1DM and comorbid overweight/obesity are also at high risk of developing disordered eating behaviors. There is a critical need for behavioral weight management interventions that address barriers specific to T1DM and incorporate attention to eating disorder prevention in this at-risk population. The objective of this K23 project is to adapt the primary mentor’s (Dr. Elissa Jelalian) established 16-week adolescent weight management intervention for a T1DM population. Using the Obesity-Related Behavioral Intervention Trials (ORBIT) model, a framework for intervention development, this project will design, refine, and test an adapted behavioral weight management intervention for adolescents with comorbid T1DM and overweight/obesity using two related yet distinct studies. Study 1 will ensure feasibility (i.e., participant attendance) and acceptability of intervention materials by adolescents with comorbid T1DM and overweight/obesity using an open-trial design with 2-3 small groups (n=5 adolescents/group). Participants will complete validated measures of acceptability after each weekly session and an exit survey post-intervention. The Candidate will iteratively refine the intervention based upon Study 1 results. Study 2 will compare the adapted weight management intervention to a usual care control group using a pilot randomized controlled trial design (n=50 total adolescents) to verify that the adapted intervention reduces participant BMI and increases the percent time spent in the target blood glucose range (70-180mg/dL; primary outcomes). Participants in Study 2 will complete ecological momentary assessments (EMA) at baseline and 16-weeks to determine events of maladaptive eating and weight control behaviors over time (secondary outcomes). Exploratory analyses will evaluate correlates of these maladaptive eating and weight control behaviors in real-world settings. This K23 project builds upon the Candidate’s prior work in pediatric obesity and T1DM. The highly qualified and expert mentorship team will provide support and oversight, allowing the Candidate to acquire the necessary skills to launch an independent research career aimed at improving weight management for adolescents with comorbid T1DM and overweight/obesity. Results will provide data for a subsequent application to conduct a fully powered randomized controlled trial to test the efficacy of the adapted weight management intervention. The proposed project aligns with the NIDDK’s mission to mitigate diabetes-related cardiovascular events and has the potential to be an important public health intervention to improve the health of adolescents with T1DM and overweight/obesity.