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

基本信息

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
项目类别：
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

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

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项目摘要

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型糖尿病的青年中，合并性超重/肥胖（BMI>性别和年龄的第85个百分点）很少见 1990年代之前的Mellitus（T1DM），但现在的患病率超过了普通人群的年轻人。行为体重管理干预措施是基于证据的小儿肥胖症的一线治疗方法。然而，T1DM的独特挑战需要对这些干预措施进行周到的适应。例子包括减少运动并超过由于低血糖引起的卡路里消耗。具有T1DM的青少年合并的超重/肥胖症也有发展无序饮食行为的高风险。有关键需要进行行为体重管理干预措施，以解决特定于T1DM的障碍并合并注意这种高危人群中预防饮食失调。这个K23项目的目的是适应小学导师（Elissa Jellalian博士）为A建立了16周的青少年体重管理干预措施 T1DM人口。使用与肥胖相关的行为干预试验（Orbit）模型，这是一个框架干预开发，该项目将设计，完善和测试适应的行为体重管理使用两项相关但独特的研究对合并症T1DM和超重/肥胖的青少年进行干预。研究1将确保可行性（即参与的出勤率）和干预材料可接受性使用2-3个小组的开放式试验设计（n = 5）青少年/组）。参与者将在每个每周一次之后完全验证可接受性的措施干预后的出口调查。候选人将根据研究1迭代地完善干预措施结果。研究2将使用改编的体重管理干预与通常的护理控制组进行比较飞行员随机对照试验设计（n = 50个总青少年），以验证适应的干预措施是否减少参与者BMI，并增加在目标血糖范围（70-180mg/dl）中所花费的时间百分比；主要结果）。研究2的参与者将完成生态瞬时评估（EMA）基线和16周，以确定适应不良的饮食和体重控制行为的事件（次要结果）。探索性分析将评估这些不良适应性饮食和体重的相关性在现实世界中控制行为。这个K23项目建立在候选人先前在儿科工作肥胖和T1DM。高素质和专业的精力团队将提供支持和监督，允许候选人获得必要的技能，以启动针对的独立研究职业改善合并症T1DM和超重/肥胖的青少年体重管理。结果将提供随后应用的数据，以进行完全动力的随机对照试验以测试适应体重管理干预的功效。拟议的项目与Niddk的项目保持一致减轻与糖尿病相关的心血管事件的使命，并有可能成为重要的公众健康干预措施以改善T1DM和超重/肥胖症的青少年的健康。