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

针对 1 型糖尿病人群调整青少年体重管理计划

• 批准号: 10689195
• 负责人: Jennifer Lynn Warnick
• 金额: $ 18.76万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10689195
• 关键词: Address; Adolescent; Age; Attention; Award; Behavior; Behavior Control; Behavior Therapy; Behavioral; Behavioral trial; Blood Glucose; Body Weight decreased; Body mass index; Calories; Cardiovascular system; Caregivers; Childhood; Clinical Investigator; Clinical Research; Consumption; Dangerous Behavior; Data; Data Analyses; Development; Diabetes Mellitus; Diet; Disease Management; Eating; Eating Behavior; Eating Disorders; Ecological momentary assessment; Endocrinologist; Ensure; Event; Evidence based intervention; Exercise; Fright; General Population; Glycosylated hemoglobin A; Goals; Grain; Guidelines; Health; Hunger; Hypoglycemia; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Intervention Trial; Interview; Longevity; Measures; Mentors; Mentorship; Mission; Modeling; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Obesity; Outcome; Overweight; Participant; Patient Self-Report; Patients; Phase; Phase Ib Trial; Population; Populations at Risk; Prevalence; Qualifying; Randomized, Controlled Trials; Regulation; Research; Review Literature; Risk; Surveys; Testing; Thinking; Time; Training; Weight; Weight Gain; Weight maintenance regimen; Work; Youth; acceptability and feasibility; adolescent health; age group; behavior test; behavioral health; cardiometabolic risk; cardiovascular health; cardiovascular risk factor; career; comorbidity; comparative; comparison control; design; disorder prevention; efficacy testing; efficacy trial; evidence base; experience; high risk; improved; interest; intervention refinement; medical appointment; mortality risk; novel; obesity in children; pilot test; post intervention; prevent; primary outcome; programs; public health intervention; purge; secondary outcome; sex; skills; therapy development; trial design; usual care arm

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.

项目摘要 在1型糖尿病青年患者中，合并超重/肥胖（BMI>性别和年龄的第85百分位数）是罕见的 糖尿病（T1 DM）的发病率在20世纪90年代之前就已经上升，但现在的患病率已经超过了一般人群中的青年人。 行为体重管理干预是以证据为基础的儿童肥胖的一线治疗方法。 然而，T1 DM存在独特的挑战，需要对这些干预措施进行深思熟虑的调整。示例 包括由于低血糖而减少运动和过量卡路里消耗。T1 DM青少年和 超重/肥胖共病者也有发生饮食行为紊乱的高风险。存在一个临界 需要行为体重管理干预措施，解决T1 DM特有的障碍， 注意在这一高危人群中预防饮食失调。该K23项目的目标是适应 主要导师（Elissa Jelalian博士）建立了为期16周的青少年体重管理干预， T1 DM人群。使用肥胖相关行为干预试验（ORBIT）模型， 干预发展，该项目将设计，完善和测试一个适应行为体重管理 使用两项相关但不同的研究对患有T1 DM和超重/肥胖共病的青少年进行干预。 研究1将确保可行性（即，参与者出席）和干预材料的可接受性 采用开放性试验设计，2-3个小组（n=5），在患有T1 DM和超重/肥胖共病的青少年中进行 青少年/组）。每周课程结束后，参与者将完成经过验证的可接受性测量 和一个离职后调查候选人将根据研究1反复完善干预措施 结果研究2将比较适应体重管理干预与常规护理对照组， 一项初步随机对照试验设计（n=50例青少年），以验证适应性干预 降低参与者的BMI，并增加在目标血糖范围（70- 180 mg/dL; 主要成果）。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适应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适应不良的饮食和体重的相关性 控制现实世界中的行为。该K23项目建立在候选人先前在儿科领域的工作基础上 肥胖和T1 DM。高素质的专家辅导小组将提供支持和监督， 允许候选人获得必要的技能，以开展独立的研究生涯， 改善合并T1 DM和超重/肥胖的青少年的体重管理。结果将 为后续申请提供数据，以进行完全有效的随机对照试验来测试 适应性体重管理干预的有效性。拟议项目符合NIDDK的 使命是减轻糖尿病相关心血管事件，并有可能成为重要的公众 健康干预，以改善T1 DM和超重/肥胖青少年的健康。