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、监控和优化移动医疗解决方案

• 批准号: 10484739
• 负责人: Debra Geary Hook
• 金额: $ 87.03万
• 依托单位: BRIGHTOUTCOME INC.
• 依托单位国家: 美国
• 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/10484739
• 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 therapy; Dietary History; Dietary intake; Dietitian; Disease; Eating; Eating Behavior; Ensure; Enzymes; Fatty Acids; Fatty acid glycerol esters; Food; Food Packaging; General Population; Genetic; Goals; Hereditary Disease; Hour; Inborn Errors of Metabolism; Individual; Intake; Intellectual functioning disability; Interview; Lead; Macronutrients Nutrition; Manuals; Measures; Metabolic Diseases; 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; Surveys; Testing; Time; base; clinically significant; data integrity; design; diaries; dietary; dietary adherence; empowered; 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

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 天生的新陈代谢错误（IEM）是一组稀有的遗传（遗传）疾病，引起了障碍 代谢途径导致临床显着后果，导致发展和智力 残疾，癫痫发作，如果未经治疗，昏迷和死亡。大多数IEM疾病由 单独操纵和修改饮食以减少有毒代谢物，或者结合饮食 修改和药物。 IEM挑战常规饮食中使用的复杂饮食疗法 在这些条件下，建议和渲染饮食应用程序为Little Utility的公众设计。还， 没有专门为IEM社区开发的饮食应用程序，并满足研究的严格性， 特别是需要测量饮食中特定和多个氨基酸含量以促进更多研究 对脑神经化学的影响。在IEM领域，纸饮食日记用于监测食物摄入量。 这些日记经常在捕获由于召回错误和 其他因素。需要评估饮食摄入的新方法来减少饮食跟踪伯恩， 提高饮食调查的准确性，并提高饮食依从性。 我们建议开发和验证Myrarediet®（MRD），以满足IEM人群中未满足的需求 协助饮食管理旨在提高依从性和合规性，这可能会改善 结果，同时支持来自IEM的人的饮食数据收集，以进行研究。 MRD 包括患者门户网站，临床营养士门户和研究人员门户。病人门户将帮助IEM 患者追踪和监测自己的饮食，以便满足严格的饮食目标和限制。临床 Dietian门户网站是帮助临床营养师管理IEM患者的饮食修改。研究人员 门户将促进基于饮食的研究和研究结果的分析。 II阶段的目的是：1）通过添加功能来改进功能来增强和完善I期MRD原型 饮食报告准确性并降低用户伯恩（Burnen）； 2）进行标准有效性研究以测试协议 在MRD和广泛使用且基于访谈的24小时召回方法之间； 3）进行 随机对照试验评估使用MRD对参与者饮食跟踪和监测的影响 行为。我们的假设是与纸张饮食日记相比，MRD的使用将导致1）更高 对饮食摄入的自我报告的更大依从性满意； 2）蛋白质消耗更紧密 与蛋白质限制靶标保持一致。