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.

项目摘要/摘要