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

项目概要/摘要 1型糖尿病（T1D）是儿童最常见的慢性疾病之一。所涉及的治疗方案，包括每日胰岛素给药/泵管理、频繁的血糖检查和仔细跟踪食物摄入，给患者及其家属带来了高压力负担。考虑到治疗依从性和血糖控制的显著下降，青春期是T1D管理的特别风险时期。超过80%的T1D青少年血糖控制不良（A1c？7.5%），一个重要的风险因素是负性情感的增加，包括抑郁和焦虑症状，这是区分青少年T1D的因素。升高的抑郁和焦虑症状影响了40%的T1D青少年。我们的初步数据支持这样的观点，即消极情感有助于降低治疗依从性和血糖控制恶化，部分原因是消极情感对压力相关行为的影响，如适应不良的饮食行为（例如，饮食限制、不受控制的饮食模式和为了控制体重而遗漏胰岛素）。不幸的是，没有金标准的方法来解决T1D青少年中血糖控制不良的问题。需要针对T1D青少年的发展需求以及应对其慢性疾病的特殊负担，制定新的、有针对性的干预措施。对没有T1D的青少年进行基于正念的干预，包括我们自己在患有抑郁症和体重相关疾病的青少年中的初步工作，已经显示出治疗消极情感，适应不良饮食行为和健康结果的希望。基于正念的方法可能非常适合T1D青少年，但考虑到消极情感，压力相关行为和自我护理之间的关联机制是T1D个体所独有的，干预措施必须专门针对这一人群。因此，该提案的目标是调整现有的6周正念干预，学习呼吸，用于T1D青少年（呼吸-T1D）。拟议的研究的第一个具体目标是适应呼吸与T1D青少年和适应相关的和可信的6周健康教育比较课程（HealthEd-T1D）。第二个目的是进行一项3向试点随机对照试验，以评估BREATHE-T1D、通过远程医疗提供的BREATHE-T1D和通过远程医疗提供的HealthEd-T1D的可行性和可接受性。鉴于在专科诊所就诊的患者的地理多样性，应测试远程保健提供方式的可行性/可接受性。将在干预后立即和干预完成后3个月进行随访评估。目前的研究结果将是一个可行的和可接受的正念干预和com-personal课程，可以在疗效试验进行评估。多学科研究团队贡献了T1D青少年的专业知识，行为干预发展，消极情感和适应不良饮食行为，青少年正念干预，定性数据分析，以及通过远程健康提供行为健康干预的补充领域。我们的应用程序的创新方法将使我们能够建立一个可行的/可接受的干预与T1D青少年量身定制，导致未来的建议，一个全面的疗效试验。

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.