Multi-center Randomized Controlled Trial of Refeeding an Anorexia Nervosa

神经性厌食症重新进食的多中心随机对照试验

基本信息

批准号：
10618160
负责人：
NEVILLE Hylton GOLDEN
金额：
$ 64.79万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-07-13 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10618160
关键词：
Admission activity Adolescence Adolescent and Young Adult Adopted Age Anorexia Nervosa Appearance Attitude Behavior Blood Pressure Body Image Body Weight decreased Body mass index Caloric Restriction Calories Charge Childhood Communities Consensus Consent Data Diagnosis Disease Disparity Dose Eating Disorders Electrolytes Energy Metabolism Enrollment Estradiol Follicle Stimulating Hormone Goals Heart Rate Hormonal Hospitalization Hospitals Hydrocortisone Hypokalemia Hypophosphatemia Incidence Inpatients Length of Stay Leptin Luteinizing Hormone Malignant Childhood Neoplasm Malnutrition Medical Menstruation Mental disorders Metabolic Newly Diagnosed Nutritional Outcome Overweight Parents Participant Patient Readmission Patients Pharmaceutical Preparations Population Prognosis Questionnaires Randomized Randomized, Controlled Trials Recovery Rehabilitation therapy Research Rest Risk Safety Savings Severity of illness Specific qualifier value Starvation Syndrome Temperature Testing Testosterone Treatment outcome Weight Weight Gain Work boys clinical practice clinical remission cognitive recovery cohort comparative efficacy cost cost effectiveness design feeding follow-up girls hospital readmission improved improved outcome individualized medicine mortality novel strategies patient population programs psychologic psychological symptom rapid weight gain risk minimization social culture standard of care young adult

项目摘要

Project Summary Background: Anorexia nervosa (AN) is a disorder of adolescence and young adulthood with a poor prognosis. Patients with medical instability and malnutrition are hospitalized to begin nutritional rehabilitation, or “refeeding”. Despite long hospitalizations, ~45% of patients are readmitted and only 18-55% recover in one year. Further, AN has the highest mortality of all psychiatric disorders (5.1%), similar to childhood cancers. These challenges make eating disorders a “common and costly” pediatric diagnosis 15. The overall goal of our research program is to improve these outcomes through novel approaches to refeeding. Our early work showed that the decades- old lower calorie refeeding approach was overly cautious and contributed to poor weight gain and protracted hospital stay. We developed and tested a Higher Calorie Refeeding (HCR) approach in preliminary studies showing improved outcomes with no apparent increase in risk. Clinical practice was eager to adopt HCR, an RCT was imperative. Our parent trial, StRONG, was the largest and only RCT of refeeding in the U.S. (R01HD082166; ClinicalTrials.gov NCT02488109). HCR restored medical stability 3.0 days earlier, with no increase in electrolyte abnormalities, and saved ~$20,000 in charges/participant. Proposed project: Since we began this research, “atypical” AN (AAN) was recognized as a new diagnosis describing AN at normal weight. This rapidly growing patient population comprised 42% our StRONG cohort. At baseline, they were equally malnourished and medically unstable as AN. The major finding motivating the proposed trial is that participants with AAN gained weight 40% slower and required >2 additional days in hospital to restore medical stability on HCR, as compared to AN. These signs of underfeeding were due to a suboptimal caloric “dose”. We have developed an Individualized Caloric Refeeding (ICR), which doses calories to weight consistent with other pediatric treatments (e.g. medication). Purpose, hypotheses and design: The primary purpose of the proposed trial (AIMs 1&2) is to compare the efficacy and safety of ICR to the new standard of care (HCR) in hospitalized patients with AAN. We hypothesize that ICR will restore medical stability faster than HCR with no increase in electrolyte abnormalities. After hospitalization, there is no consensus on clinical remission in AAN and controversy over whether these formerly overweight patients should gain weight to recover. We will examine metabolic, hormonal and psychological markers over 12 mo. (AIM 3), toward the goal of developing a definition of clinical remission in AAN. Based on our finding that Weight Suppression (WS) was a significant predictor of illness severity in AAN at admission, we hypothesize that WS during follow-up represents incomplete recovery from AAN. Design: RCT in N=74 patients with AAN, age 12-24 years, consented upon hospital admission, randomly assigned to ICR or HCR, and followed daily in hospital and at 3,6,9 and 12 mo. Significance: AAN is a rapidly growing diverse patient population in urgent need of individualized treatment approaches and recovery goals.

项目摘要背景：厌食症（AN）是一种青春期和成年年轻人的疾病，预后不良。医疗不稳定和营养不良的患者已住院，开始营养康复或“补充”。尽管住院时间很长，但约有45％的患者被重新入院，一年中只有18-55％的康复。更远， AN在所有精神疾病中的死亡率最高（5.1％），类似于儿童癌症。这些挑战使饮食失调成为“常见且昂贵的”小儿诊断15。我们的研究计划的总体目标是通过新颖的补充方法来改善这些结果。我们的早期工作表明，数十年 - 旧的低卡路里补充方法过于谨慎，导致体重增加不良并持久住院。在初步研究中显示出改善的预后，风险没有明显增加。临床实践渴望采用HCR RCT是必须的。我们的母公司审判是美国的最大和唯一的参考RCT （R01HD082166; ClinicalTrials.gov NCT02488109）。 HCR恢复了3.0天前的医疗稳定性，没有电解质异常增加，并节省了约20,000美元的费用/参与者。拟议项目：自从我们开始这项研究以来，“非典型” AN（AAN）被公认为是新的诊断描述正常体重。这个快速增长的患者人群使我们的强大队列完成了42％。基线，它们同样营养不良，并且在医学上不稳定。激励的主要发现拟议的试验是，AAN的参与者体重增加了40％，需要> 2个额外的天数与An相比，在医院恢复了HCR的医疗稳定性。这些喂养不足的迹象应得进行次优的热量“剂量”。我们已经开发了一个个性化的热量重新审进（ICR），该热量剂量与其他儿科治疗（例如药物）一致的加权卡路里。目的，假设和设计：拟议试验的主要目的（目标1和2）是比较 ICR对住院的AAN患者的新护理标准（HCR）的功效和安全性。我们假设 ICR将比HCR更快地恢复医疗稳定性，而电解质异常没有增加。后住院，AAN尚无关于临床缓解的共识，也没有关于这些以前的争议超重患者应增加体重以康复。我们将检查代谢，骑马和心理超过12个月的标记。（AIM 3），目的是制定AAN临床缓解的定义。基于我们的发现，抑制体重（WS）是AAN入院时疾病严重程度的重要预测指标，我们假设随访期间的WS表示从AAN恢复的不完全恢复。设计：n = 74中的RCT AAN患者，年龄在12-24岁之间，同意住院后，随机分配给ICR或HCR，以及每天在医院，3,6,9和12个月。意义：AAN是一个快速增长的潜水员患者迫切需要个性化治疗方法和恢复目标的人口。