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

基于正念的干预措施减少 1 型糖尿病青少年适应不良饮食行为的可行性试验

• 批准号: 10380888
• 负责人: Eleanor Race Mackey
• 金额: $ 36.95万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380888
• 关键词: Address; Adherence; Adolescence; Adolescent; Adult; Affect; Anxiety; Area; Behavior; Behavior Therapy; Blood Glucose; Caring; Child; Childhood; Chronic Disease; Clinic; Control Groups; Cues; Data; Data Analyses; Development; Disease; Disease Management; Dropout; Eating; Eating Behavior; Educational Curriculum; Emotional; Enrollment; Esthesia; Exhibits; Family; Future; Geography; Goals; Gold; Health; Health education; Healthcare; Hunger; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Interview; Learning; Manuals; Measures; Mental Depression; Methods; Mindfulness Training; Modality; Modeling; National Center for Complementary and Integrative Health; Outcome; Participant; Patient Recruitments; Patients; Pattern; Persons; Physiological; Population; Process; Pump; Randomized; Randomized Controlled Trials; Risk; Risk Factors; Satiation; Self Care; Self Management; Series; Stress; Structure; Surveys; Teenagers; Testing; Time; Travel; Treatment Protocols; Weight; Weight maintenance regimen; Work; Youth; acceptability and feasibility; active control; adolescent health; anxiety symptoms; attentional control; base; behavioral health; behavioral health intervention; blood glucose regulation; comparison group; coping; critical period; depressive symptoms; diabetes management; dietary restriction; effective intervention; efficacy evaluation; efficacy testing; efficacy trial; evidence base; experience; feasibility testing; feasibility trial; follow up assessment; follow-up; glycemic control; improved; innovation; medical specialties; mindfulness; mindfulness intervention; multidisciplinary; negative affect; novel; post intervention; programs; recruit; satisfaction; stem; telehealth; therapy development; treatment adherence

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.

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、频繁的血糖检查以及仔细跟踪食物摄入量。由于治疗依从性和血糖控制显着下降，青春期对患者及其家人来说是一个特别危险的时期，超过 80% 的 T1D 青少年血糖控制 (A1c) 较差。 7.5%），其中一个显着的风险因素是负面情绪的增加，包括抑郁和焦虑症状，这是 1 型糖尿病青少年的显着特征。 40% 的 1 型糖尿病青少年患有抑郁和焦虑症状，我们的初步数据支持这一观点。情绪会导致治疗依从性降低和血糖控制时间延长，部分原因是负面情绪对压力相关行为的影响，例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胰岛素遗漏）不幸的是，没有金标准方法来解决 T1D 青少年血糖控制不佳的问题。针对 T1D 青少年的发展需求和应对其特殊负担而制定新颖的、有针对性的干预措施。需要向没有 T1D 的青少年提供基于正念的干预措施，包括我们在患有抑郁症和体重相关疾病的青少年中所做的初步工作，这些干预措施在治疗消极情感、适应不良饮食行为和健康方面已显示出希望。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护理之间的关联机制对于 T1D 患者来说是独特的，因此干预措施必须具有针对性。因此，该提案的目标是调整现有的为期 6 周的基于正念的干预措施“学习呼吸”，以用于患有 T1D 的青少年 (BREATHE-T1D)。是为患有 T1D 的青少年改编 BREATHE 并改编相关且可靠的 6 周健康教育比较课程（HealthEd-T1D）。第二个目标是进行三向试点随机对照试验，以评估可行性和有效性。 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 的可接受性 鉴于专科诊所就诊患者的地理多样性，可行性/可接受性。远程医疗提供方式应在干预后立即进行测试，并在干预完成后 3 个月进行。当前研究的结果将是一个可行且可接受的正念干预和比较课程，可以在其中进行评估。一项功效试验。多学科情感研究团队通过 T1D 青少年、行为干预发展、消极和适应不良饮食行为、青少年正念干预、定性数据分析以及行为健康干预措施的提供提供互补的专业知识。我们的应用程序的创新方法将使我们能够为患有 T1D 的青少年制定可行/可接受的干预措施，从而提出未来全面疗效试验的建议。

项目成果

Mindfulness-based Group Intervention for an Adolescent Girl at Risk for Type 2 Diabetes: A Case Report.

对有 2 型糖尿病风险的青春期女孩进行基于正念的团体干预：病例报告。

• DOI: 10.1037/13748-014
• 发表时间: 2024-09-14
• 期刊: Advances in mind-body medicine
• 作者: Stephanie L Dalager;Shelly K. Annameier;Stephanie M Bruggink;Bernadette Pivarunas;J. Coatsworth;A. Schmid;Christopher Bell;Patricia C. Broderick;K. Brown;Jordan T. Quaglia;L. Shomaker
• 通讯作者: L. Shomaker