Randomized Trial of a Healthy Weight Intervention for Youth with Serious Emotional Disturbance

对患有严重情绪障碍的青少年进行健康体重干预的随机试验

• 批准号: 9177934
• 负责人: Gail L. Daumit
• 金额: $ 78.43万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-05 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9177934
• 关键词: Accelerometer; Address; Adolescent; Adult; Affect; Age; American Heart Association; Attention; Behavior; Behavioral trial; Blood Pressure; Body mass index; Cardiovascular Diseases; Cardiovascular system; Caring; Child; Child Care; Child Mental Health; Child health care; Communities; Community Services; Counseling; Diagnosis; Educational Materials; Employee; Enrollment; Epidemic; Equipment and supply inventories; Future; General Population; Glucose; Glucose Intolerance; Health; Health Personnel; High Prevalence; Hypertension; Impulsivity; Informal Social Control; Intervention; Life Style; Lipids; Maintenance; Maryland; Measures; Mediator of activation protein; Mental Health; Mental disorders; Modeling; Moods; Obesity; Outcome; Outpatients; Overweight; Parents; Participant; Patient Self-Report; Phase; Physical activity; Population; Premature Mortality; Prevalence; Provider; Quality of life; Questionnaires; Randomized; Recruitment Activity; Research; Risk; Risk Factors; Self Efficacy; Site; Social support; Subgroup; Symptoms; Techniques; Teenagers; Testing; Time; Training; Vulnerable Populations; Weight; Weight maintenance regimen; Youth; behavior change; behavioral outcome; cardiovascular disorder risk; cost; cost effectiveness; design; experience; fasting glucose; good diet; healthy lifestyle; healthy weight; high risk; innovation; interest; mental health organization; mood symptom; obesity in children; population based; premature; prevent; primary outcome; programs; psychiatric symptom; randomized trial; screening; secondary outcome; sedentary; serious emotional disturbance; severe mental illness; sex; study population; successful intervention; treatment as usual; two-arm trial; waist circumference

ABSTRACT The prevalence of overweight and obesity in youth with serious emotional disturbance (SED) exceeds the epidemic levels of overweight and obesity for children in the general population. Associated cardiovascular (CVD) risk factors such as glucose intolerance, hypertension and lipid abnormalities frequently already exist in obese children. Thus, focusing on overweight/obesity in youth with SED is critical to prevent their premature CVD. In 2015 the American Heart Association called attention to mental illnesses in youth as important risk conditions for early CVD and declared the need for transformational change in screening and management of overweight and obesity. Despite this, studies of healthy weight interventions in youth with SED are noticeably absent, and interventions will likely need to be tailored for this population who frequently have impulsivity, oppositional behavior and/or mood symptoms. In the general population, successful interventions targeting youth obesity often include active parental participation. Community mental health programs serving youth typically engage parents as part of routine treatment and therefore provide an unappreciated but potentially important opportunity to address overweight and obesity. The objective of this R01 application is to design and rigorously test an innovative, scalable healthy weight intervention in youth with SED that incorporates parental engagement and provider support. Our research team has extensive experience spanning child mental health, weight management and physical activity interventions in youth, and in adults with serious mental illness and in the general population. We propose the CHAMPION Trial, a two-arm trial partnering with community mental health organizations in Maryland. We will perform population-based screening to identify youth with overweight and obesity, and recruit and enroll 120 ages 8-18 years with SED with a BMI at or above the 85th%tile. We will stratify by sex and site and randomly assign participants to receive a) usual care plus educational materials on healthy weight, or b) the 12-month CHAMPION intervention with 1) a health coach, a trained mental health program employee, who provides healthy lifestyle counseling and support for weight management, a healthy diet and increased physical activity incorporating techniques to engage both the youth and parents; and 2) support from health providers who will provide basic weight management messages and encouragement for behavior change. The intervention's first 6 months will include frequent contacts, followed by a 6-month maintenance phase. The primary outcome will be decreased BMI z-score compared to control at 12 months; secondary outcomes include waist circumference, blood pressure, glucose, lipid levels, quality of life, and psychiatric symptoms at 6 and 12 mo. Antecedents of CVD begin early in youth, and those with SED are at particularly high risk. Breaking this cascade of risk factors leading to premature CVD will require capitalizing on the window of opportunity to intervene on overweight and obesity in youth with SED. The CHAMPION Trial will test an innovative, yet practical approach that could be readily incorporated into overall care of youth with SED.

摘要 严重情绪困扰（SED）的青少年超重和肥胖的患病率超过了 儿童超重和肥胖在一般人群中的流行程度。相关心血管 (CVD)危险因素，如葡萄糖耐受不良、高血压和血脂异常， 肥胖儿童因此，关注SED青少年的超重/肥胖对于防止他们过早死亡至关重要。 CVD。2015年，美国心脏协会呼吁关注年轻人的精神疾病， 早期CVD的条件，并宣布需要在筛查和管理方面进行转型变革， 超重和肥胖。尽管如此，对患有SED的青少年进行健康体重干预的研究仍然引人注目 缺乏，干预措施可能需要针对这一经常冲动的人群， 对立行为和/或情绪症状。在一般人群中，成功的干预措施， 青少年肥胖往往包括父母的积极参与。社区心理健康服务青年 通常让父母参与作为常规治疗的一部分，因此提供了一种不受重视但可能 解决超重和肥胖问题的重要机会。此R 01应用程序的目标是设计和 严格测试一种创新的，可扩展的健康体重干预与青年SED，结合父母 参与和提供商支持。我们的研究团队在儿童心理健康方面有着丰富的经验， 体重管理和身体活动干预，在青年，并在成年人患有严重精神疾病， 一般人。我们提出了CHAMPION试验，一个与社区精神病患者合作的双臂试验， 马里兰州的健康组织。我们会进行以人口为基础的筛选，以识别超重的青少年 和肥胖，招募并登记120名8-18岁的SED患者，其BMI ≥ 85%。我们将 按性别和地点分层，并随机分配参与者接受a）常规护理加教育材料， 健康的体重，或B）12个月的CHAMPION干预，1）健康教练，受过训练的心理健康 计划员工，谁提供健康的生活方式咨询和支持体重管理，健康的 饮食和增加体育活动，包括让青年和父母参与的技术;以及2） 健康提供者的支持，他们将提供基本的体重管理信息和鼓励， 行为改变干预的前6个月将包括经常接触，随后是6个月 维护阶段。主要结局将是12个月时与对照组相比BMI z评分降低; 次要结果包括腰围、血压、血糖、血脂水平、生活质量， 6个月和12个月时出现精神症状。心血管疾病的先兆开始在青年早期，那些与SED是在 尤其是高风险。打破这种级联的风险因素导致过早的心血管疾病将需要利用 干预SED青少年超重和肥胖的机会之窗。冠军审判将 测试一种创新且实用的方法，该方法可以很容易地纳入对患有SED的青少年的整体护理中。