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：
10209783
负责人：
NEVILLE Hylton GOLDEN
金额：
$ 67.03万
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/10209783
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 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 Nutritional Outcome Overweight Parents Participant 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 base boys clinical practice clinical remission cognitive recovery cohort comparative efficacy cost cost effectiveness design 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.

项目概要背景：神经性厌食症（AN）是一种青春期和成年早期的疾病，预后不良。病情不稳定和营养不良的患者住院开始营养康复或“重新喂养”。尽管住院时间较长，但仍有约 45% 的患者再次入院，并且只有 18-55% 的患者在一年内康复。 AN 的死亡率是所有精神疾病中最高的（5.1%），与儿童癌症类似。使饮食失调成为“常见且昂贵”的儿科诊断 15. 我们研究计划的总体目标我们的早期工作表明，几十年来，我们的目标是通过新的重新喂养方法来改善这些结果。旧的低热量再喂养方法过于谨慎，导致体重增加不佳且时间延长我们在初步研究中开发并测试了高热量再喂食 (HCR) 方法。显示出改善的结果且风险没有明显增加，临床实践渴望采用 HCR，这是一种我们的母体试验 StRONG 是美国最大且唯一的关于重新喂养的随机对照试验。（R01HD082166；ClinicalTrials.gov NCT02488109）HCR 于 3.0 天前恢复了医疗稳定性，但没有出现任何症状。电解质异常增加，每个参与者节省约 20,000 美元的费用。拟议项目：自从我们开始这项研究以来，“非典型”AN（AAN）被认为是一种新的诊断描述正常体重的 AN，这一快速增长的患者群体占我们 StRONG 队列的 42%。基线时，他们与 AN 一样营养不良且身体状况不稳定，这是推动这一研究的主要发现。拟议的试验是，患有 AAN 的参与者体重增加速度减慢 40%，并且需要多于 2 天的时间与 AN 相比，在医院恢复 HCR 的医疗稳定性是由于这些喂养不足的迹象。我们开发了一种个体化热量再喂食 (ICR)，该剂量可调整为次优热量“剂量”。卡路里与体重的比值与其他儿科治疗（例如药物治疗）一致。目的、假设和设计：拟议试验（AIM 1 和 2）的主要目的是比较 ICR 对 AAN 住院患者新护理标准 (HCR) 的有效性和安全性。 ICR 会比 HCR 更快地恢复医疗稳定性，并且电解质异常不会增加。住院期间，对于 AAN 的临床缓解尚无共识，并且对于这些以前是否有争议超重的患者应该增加体重才能恢复。我们将检查代谢、荷尔蒙和心理。超过 12 个月的标记（AIM 3），以实现基于 AAN 的临床缓解定义的目标。我们发现体重抑制 (WS) 是入院时 AAN 疾病严重程度的重要预测因素，我们发现随访期间的 WS 代表 AAN 的不完全恢复设计：N=74 中的 RCT。患有 AAN 的患者，年龄 12-24 岁，入院时同意，随机分配至 ICR 或 HCR，并且每天在医院以及第 3、6、9 和 12 个月进行随访意义：AAN 是一位快速成长的多元化患者。迫切需要个体化治疗方法和康复目标的人群。