MyRareDiet: A Diet Tracking, Monitoring and Optimization mHealth Solution for Patients with Inborn Errors of Metabolism

MyRareDiet：针对先天性代谢缺陷患者的饮食跟踪、监控和优化 mHealth 解决方案

基本信息

批准号：
10703418
负责人：
Debra Geary Hook
金额：
$ 79.57万
依托单位：
BRIGHTOUTCOME INC.
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：
2022-09-12 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10703418
关键词：
Address Adherence Agreement Amino Acids Bar Codes Behavior assessment Behavior monitoring Brain Carbohydrates Caregivers Cessation of life Clinical Clinical Management Clinical Trials Collection Coma Communities Complex Consumption Data Databases Developmental Disabilities Diet Diet Modification Diet Monitoring Diet Surveys Diet therapy Dietary Assessment Dietary History Dietary intake Dietitian Disease Disease Management Eating Eating Behavior Ensure Enzymes Fatty Acids Fatty acid glycerol esters Food Food Packaging General Population Genetic Goals Hour Inborn Errors of Metabolism Individual Inherited Intake Intellectual functioning disability Interview Macronutrients Nutrition Manuals Measures Metabolic Pathway Methods Monitor Nutrient Nutrition Assessment Organ Paper Participant Patient Self-Report Patients Pharmaceutical Preparations Phase Poison Population Process Production Proteins Protocol Compliance Protocols documentation Randomized Randomized, Controlled Trials Recommendation Reducing diet Reporting Research Research Personnel Resort Role Scanning Security Seizures Single-Gene Defect Site Specific qualifier value Testing Time clinically significant data integrity design diaries dietary dietary adherence empowerment food surveillance improved improved outcome innovation mHealth medical food neurochemistry novel patient engagement patient portal product development prototype rare genetic disorder recruit satisfaction tool treatment guidelines

项目摘要

Project Abstract Inborn errors of metabolism (IEM) are a group of rare genetic (inherited) disorders that cause a block in a metabolic pathway leading to clinically significant consequences, causing developmental and intellectual disabilities, seizures, and, if untreated, coma and death. The majority of the IEM disorders are managed by manipulation and modification of diet alone to reduce toxic metabolites, or with a combination of dietary modification and medications. The complex dietary therapies used in IEM challenge routine dietary recommendations and render diet apps designed for the general public of little utility in these conditions. Also, no diet app is developed specifically for the IEM community and meets the rigor required for research, particularly the need to measure specific and multiple amino acid content in the diet to facilitate more study on impact on brain neurochemistry. Within the field of IEM, paper diet diaries are utilized to monitor food intake. These diaries are frequently inadequate in capturing what is actually being consumed due to recall errors and other factors. Novel methods of assessing dietary intake are required to reduce the diet tracking burden, improve accuracy in dietary surveys, and improve diet adherence. We propose to develop and validate MyRareDiet® (MRD) to address an unmet need in the IEM population to assist with dietary management designed to increase adherence and compliance that could lead to improved outcomes, while facilitating the collection of dietary data from individuals with IEM for research purposes. MRD includes a Patient Portal, a Clinical Dietician Portal, and a Researcher Portal. The Patient Portal is to help IEM patients track and monitor their own diet so they can meet their strict diet targets and restrictions. The Clinical Dietician Portal is to help clinical dieticians manage diet modifications for individuals with IEM. The Researcher Portal is to facilitate the conduct of diet-based studies and the analysis of study results. The aims for Phase II are: 1) enhance and refine the Phase I MRD prototype by adding features to improve diet reporting accuracy and reduce user burden; 2) conduct a criterion validity study to test the agreement between MRD and a widely used and validated interview-based 24-hour recall method; and 3) conduct a randomized controlled trial to assess the effects of using MRD on participants’ diet tracking and monitoring behaviors. Our hypotheses are that compared to paper diet diaries, the use of MRD will result in 1) higher satisfaction with greater adherence to self-reporting of dietary intake; and 2) protein consumption more closely aligned to protein restriction target.

项目摘要先天性代谢错误 (IEM) 是一组罕见的遗传（遗传）疾病，会导致代谢障碍代谢途径导致临床上显着的后果，导致发育和智力障碍残疾、癫痫发作，如果不治疗，还会导致昏迷和死亡。大多数 IEM 疾病都是通过以下方法治疗的。单独控制和改变饮食以减少有毒代谢物，或结合饮食 IEM 中使用的复杂饮食疗法挑战常规饮食。在这些情况下，建议和渲染为公众设计的饮食应用程序几乎没有用处。没有专门为 IEM 社区开发的饮食应用程序，也没有满足研究所需的严格要求，特别是需要测量饮食中特定和多种氨基酸的含量，以促进更多研究在 IEM 领域，纸质饮食日记被用来监测食物摄入量。由于回忆错误和错误，这些日记常常不足以记录实际消费的内容需要评估饮食摄入量的新方法来减少饮食跟踪负担，提高饮食调查的准确性，并提高饮食依从性。我们建议开发并验证 MyRareDiet® (MRD)，以解决 IEM 人群中未满足的需求协助饮食管理，旨在提高依从性和依从性，从而改善结果，同时促进从 IEM 个体收集饮食数据以用于研究目的。包括患者门户、临床营养师门户和研究人员门户。患者门户旨在帮助 IEM。患者跟踪和监控自己的饮食，以便满足严格的饮食目标和限制。营养师门户网站旨在帮助临床营养师管理 IEM 患者的饮食调整。门户网站旨在促进基于饮食的研究的进行和研究结果的分析。第二阶段的目标是：1）通过添加功能来增强和完善第一阶段 MRD 原型以改进饮食报告准确性并减轻用户负担；2）进行标准有效性研究以测试一致性； MRD 与广泛使用且经过验证的基于访谈的 24 小时回忆方法之间的比较；3) 进行评估使用 MRD 对参与者饮食跟踪和监测的影响的随机对照试验我们的假设是，与纸质饮食日记相比，使用 MRD 会导致：1) 更高。对更严格地自我报告饮食摄入量感到满意；2) 更密切地关注蛋白质摄入量；与蛋白质限制目标对齐。