Feasibility Trial of a Mindfulness Based Intervention to Reduce Maladaptive Eating Behaviors in Youth with Type 1 Diabetes

项目摘要/摘要 1型糖尿病(T1D)是儿童时期最常见的慢性病之一。所涉及的治疗规则，包括每日胰岛素注射/泵管理，频繁的血糖检查，以及仔细跟踪食物摄入量，给患者及其家人带来了高度的压力负担。考虑到治疗依从性和血糖控制的显着下降，青春期是T1D管理的一个特别危险的时期。超过80%的患有T1D的青少年血糖控制较差(A1c？7.5%)，一个重要的危险因素是包括抑郁和焦虑症状在内的负性情感增加，这些症状是区分T1D的青少年。抑郁和焦虑症状的增加影响了40%的T1D青少年。我们的初步数据支持这一观点，即负面情感导致治疗依从性降低和血糖控制恶化，部分是通过负面情感对与压力相关的行为的影响，如不适应饮食行为(例如，饮食限制、不受控制的饮食模式和为控制体重而省略胰岛素)。不幸的是，没有黄金标准的方法来解决T1D青少年血糖控制不良的问题。需要为患有T1D的青少年的发育需求和应对其慢性病的特殊障碍而制定有针对性的干预措施。为没有T1D的青少年提供的基于正念的干预，包括我们自己在患有抑郁症和体重相关障碍的青少年中所做的前期工作，在治疗负面情感、不适应饮食行为和健康结果方面显示出了希望。基于正念的方法可能非常适合患有T1D的青少年，但鉴于负面情感、压力相关行为和自我照顾之间的关联机制对于T1D患者来说是独一无二的，干预必须针对这一人群进行专门的定制。因此，这项建议的目标是调整现有的基于正念的6周干预措施，学习呼吸，用于患有T1D(呼吸-T1D)的青少年。这项拟议研究的第一个具体目标是适应患有T1D的青少年的呼吸，并调整一个相关的和可信的6周健康教育比较课程(Healed-T1D)。第二个目标是开展一项3向先导随机对照试验，以评估通过远程医疗提供的呼吸-T1D、呼吸-T1D和通过远程医疗提供的健康-T1D的可行性和可接受性。考虑到专科诊所患者的地域差异，应测试远程医疗提供方式的可行性/可接受性。后续评估将在干预后立即进行，并在干预完成后3个月进行。目前的研究结果将是一个可行的和可接受的正念干预和比较课程，可以在有效性试验中进行评估。多学科研究团队提供了以下方面的专业知识：青少年T1D、行为干预发展、消极情感和不适应饮食行为、基于青少年正念的干预、定性数据分析，以及通过远程健康提供行为健康干预。我们的应用程序的创新方法将使我们能够为患有T1D的青少年量身定做可行/可接受的干预措施，从而导致未来提出全面疗效试验的建议。

PROJECT SUMMARY / ABSTRACT Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regi-men, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and glycemic control. Over 80% of adolescents with T1D have poor glycemic control (A1c ?7.5%), and one significant risk factor is the increase in negative affectivity, including depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Our preliminary data support the notion that negative affectivity contributes to diminished treatment adherence and worsening of glycemic control, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). Unfortunately, there is no gold-standard approach to address the poor glycemic control seen in adolescents with T1D. The creation of nov-el, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular bur-dens of coping with their chronic illness, are needed. Mindfulness-based interventions delivered to adolescents without T1D, including our own preliminary work in teens with depression and weight-related disorders, have shown promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A mindfulness-based approach may be well-suited for adolescents with T1D, but given that the mechanisms of association among negative affectivity, stress-related behavior, and self-care are unique to individuals with T1D, interven-tions must be specifically tailored for this population. The goal of this proposal is to, therefore, adapt an existing 6-week mindfulness-based intervention, Learning to BREATHE, for use with adolescents with T1D (BREATHE-T1D). The first specific aim of the proposed study is to adapt BREATHE for adolescents with T1D and to adapt a relevant and credible 6-week health education comparison curriculum (HealthEd-T1D). The second aim is to car-ry out a 3-way pilot randomized controlled trial to evaluate the feasibility and acceptability of BREATHE-T1D, BREATHE-T1D delivered via telehealth, and HealthEd-T1D delivered via telehealth. Given the geographic diver-sity of patients seen in specialty clinics, feasibility/acceptability of a telehealth delivery modality should be tested. Follow-up assessments will be conducted immediately after the intervention and at 3 months post intervention completion. The result of the current study will be a feasible and acceptable mindfulness intervention and com-parison curriculum that can be evaluated in an efficacy trial. The multidisciplinary study team contributes com-plementary areas of expertise in adolescents with T1D, behavioral intervention development, negative affectivity and maladaptive eating behavior, adolescent mindfulness-based intervention, qualitative data analysis, and de-livery of behavioral health interventions via telehealth. Our application’s innovative approach will enable us to es-tablish a feasible/acceptable intervention tailored for adolescents with T1D, leading to a future proposal for a full-scale efficacy trial.