NCI Administrative Supplement for the HALLO-P Planning Project

NCI 针对 HALLO-P 规划项目的行政补充

• 批准号: 10844298
• 负责人: STEPHEN B. KRITCHEVSKY
• 金额: $ 20.85万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10844298
• 关键词: Address; Adherence; Administrative Supplement; Adult; Age; Aging; Alabama; Authorization documentation; Award; Biological Markers; Blood; Blood specimen; California; Caloric Restriction; Cancer Center; Clinical; Clinical Trials; Collection; Colonoscopy; Colorectal; Companions; Consent Forms; Continuous Glucose Monitor; Control Groups; Data; Data Set; Databases; Disease; Dose; Eating; Elderly; Energy Intake; Enrollment; Epidemiology; Evaluation; Event; Exclusion Criteria; FHIT gene; Fecal occult blood; Focus Groups; Funding Mechanisms; Goals; Grant; Health; Health Benefit; Health Sciences; Hour; Image; Individual; Inflammatory; Intervention; Laboratories; Literature; Malignant Neoplasms; Mammography; Manuals; Measures; Minority; Modeling; Muscular Atrophy; Outcome; Output; Parents; Participant; Pattern; Personal Satisfaction; Persons; Physiological; Pilot Projects; Procedures; Protocols documentation; Randomized; Randomized, Controlled Trials; Recording of previous events; Regimen; Research Personnel; Risk; Risk Assessment; Screening for cancer; Shipping; Site; Structure; System; Time; Time-restricted feeding; Translating; Universities; Videoconferencing; Visit; Woman; attentional control; behavior change; bone; cancer risk; clinically relevant; design; dietary approach; disability; disability risk; disorder risk; doubly-labeled water; forest; functional decline; gut microbiome; health record; improved; inflammatory marker; innovation; intervention delivery; intervention refinement; mHealth; medical schools; member; microbiome analysis; multiple chronic conditions; operation; pilot test; randomized, clinical trials; recruit; remote delivery; repository; response; screening; stool sample; tool; trial comparing

The Health, Aging and Later-Life Outcomes Planning Grant (HALLO-P) is submitted in response to RFA-AG-21-016. Collectively, HALLO-P affiliated investigators have led 17 clinical trials of caloric restriction (CR; 3 ongoing), enrolling 2,773 adults (ages 55-91) with BMIs ≥ 27 kg/m2, showing multiple beneficial physiologic changes associated with lower disease and disability risk. Whether this translates to actual reductions in disease and disability is unclear. A large multi-year trial with definitive clinical outcomes is needed to fill this evidence gap. Time restricted feeding (TRF) could be an attractive alternative to CR if it produced similar health benefits, was more easily sustained, and mitigated CR’s undesirable loss of muscle and bone. The overall goal of this 3-year HALLO planning grant is to develop a protocol for a rigorous, multi-site, randomized clinical trial (RCT) comparing clinically-relevant health outcomes in older persons randomized to daily CR, a TRF regimen, or a non-dietary attention control group employing innovative mHealth tools to promote adherence. We will complete a 12-month pilot study enrolling 120 older adults (age ≥60 years; 50% women; ≥23% minority) to provide critical information on feasibility, intervention delivery, and data informing effect size determination. HALLO-P’s Objectives are to: 1. Establish a scientific advisory board and other structures to guide planning activities and the design of a full- scale RCT that engage a wide range of stakeholders and build a national constituency for the project. 2. Refine our mHealth behavior-change and adherence tracking platform—the HALLO-P Companion App—to optimize delivery of both the CR and TRF interventions. 3. Conduct focus groups and a 12-month pilot RCT of: 1) 20% CR delivered in-person; 2) 20% CR delivered remotely via video conferencing; and 3) TRF (8-10 hours) with ad libitum caloric intake. Pilot data will help refine recruitment criteria, estimate recruitment yields, and refine intervention approaches. We will use doubly- labeled water to measure achieved CR and continuous glucose monitoring to assess adherence to TRF. 4. Model aging biomarker changes for differing CR doses using WF OAIC repositories and the HALLO-P pilot. Existing epidemiological databases will be used to estimate the anticipated effect of these biomarker changes on clinical outcomes and to derive key design metrics related to inclusion/exclusion criteria, and event rates related to multi-morbidity, health deficit accumulation, and functional decline/disability; and 5. Integrate new data, the scientific literature .and expert advice to prepare a protocol, and develop informed consent forms, manuals of operation, study forms, and related systems to permit the rapid launch of the larger trial upon completion of the pilot activities in coordination with the other U01 project funded by this mechanism.

健康、老龄化和晚年生活成果规划补助金 (HALLO-P) 的提交是为了响应 RFA-AG-21-016。HALLO-P 附属研究人员总共领导了 17 项热量限制临床试验。 （CR；3 项正在进行中），招募了 2,773 名 BMI ≥ 27 kg/m2 的成年人（55-91 岁），显示出多种有益效果 与较低的疾病和残疾风险相关的生理变化是否转化为实际的。 疾病和残疾的减少尚不清楚，需要进行一项具有明确临床结果的大型多年试验。 为了填补这一证据空白，如果限时喂养（TRF）能够产生效果，它可能会成为 CR 的一个有吸引力的替代品。 类似的健康益处更容易持续，并减轻 CR 带来的不良肌肉和骨骼损失。 这项为期 3 年的 HALLO 规划拨款的总体目标是制定一项严格的、多站点、 随机临床试验 (RCT) 比较了随机分组的老年人的临床相关健康结果 每日 CR、TRF 方案或非饮食注意力对照组采用创新的移动医疗工具 我们将完成一项为期 12 个月的试点研究，招募 120 名老年人（年龄≥60 岁；50%） 女性；≥23% 少数族裔）提供有关可行性、干预实施和数据告知的关键信息 效应大小的确定。 HALLO-P 的目标是： 1. 建立科学顾问委员会和其他机构来指导规划活动和全面的设计 扩大随机对照试验的规模，让广泛的利益相关者参与进来，并为该项目建立一个全国选区。 2. 完善我们的移动医疗行为改变和依从性跟踪平台——HALLO-P 配套应用程序——以 优化 CR 和 TRF 干预措施的实施。 3. 开展焦点小组和为期 12 个月的试点随机对照试验：1) 亲自交付 20% CR；2) 交付 20% CR； 通过视频会议远程进行；3) TRF（8-10 小时）以及随意摄入的热量数据将有所帮助。 细化招聘标准、预估招聘收益率、细化干预方式。 标记水用于测量所达到的 CR，并进行连续血糖监测以评估对 TRF 的依从性。 4. 使用 WF OAIC 存储库和 HALLO-P 试点对不同 CR 剂量的衰老生物标志物变化进行建模。 现有的流行病学数据库将用于估计这些生物标志物变化的预期影响 临床结果并得出与纳入/排除标准和事件发生率相关的关键设计指标 与多种发病、健康缺陷积累和功能衰退/残疾有关；以及 5. 整合新数据、科学文献和专家建议来准备方案，并制定知情的方案 同意书、操作手册、研究表和相关系统，以允许快速启动更大规模的项目 与该机制资助的其他 U01 项目协调完成试点活动后进行试验。