Health Aging & Later-Life Outcomes Planning (HALLO-P)

健康老龄化

• 批准号: 10906442
• 负责人: STEPHEN B. KRITCHEVSKY
• 金额: $ 30.81万
• 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/10906442
• 关键词: Address; Adherence; Adult; Age; Aging; American; Animal Model; Attitude; Behavior Therapy; Benefits and Risks; Biological Markers; Biological Process; Biometry; Body Weight decreased; Caloric Restriction; Cardiometabolic Disease; Clinical; Clinical Trials; Companions; Complex; Consent Forms; Continuous Glucose Monitor; Control Groups; Data; Databases; Dietary Intervention; Disease; Disease-Free Survival; Dose; Eating; Elderly; Energy Intake; Enrollment; Epidemiology; Event; Exclusion Criteria; Focus Groups; Funding Mechanisms; Geroscience; Goals; Grant; Health; Health Benefit; Hour; Human; Impairment; Individual; Interleukin-6; Intermittent fasting; Intervention; Intervention Trial; Literature; Longevity; Macronutrients Nutrition; Manuals; Measures; Micronutrients; Mild obesity; Minority; Modeling; Muscle; Muscle function; Muscular Atrophy; Obesity; Outcome; Overweight; Participant; Pathway interactions; Pattern; Personal Satisfaction; Persons; Physiological; Pilot Projects; Process; Protocols documentation; Quality Control; Randomized; Randomized Controlled Clinical Trials; Regimen; Reporting; Research Personnel; Resources; Site; Structure; System; Time-restricted feeding; Translating; Videoconferencing; Weight; Woman; Work; age related; attentional control; behavior change; blood pressure reduction; bone; bone health; bone loss; clinically relevant; data management; design; dietary; disability; disability risk; disorder risk; doubly-labeled water; forest; fracture risk; functional decline; healthspan; improved; innovation; intervention delivery; intervention refinement; mHealth; multiple chronic conditions; muscle metabolism; obesity treatment; operation; randomized, clinical trials; recruit; remote delivery; repository; response; 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.

提交健康，老化和后期的成果计划补助金（Hallo-P）是为了回应 RFA-AG-21-016。总体而言，Hallo-P会员研究人员领导了17次热量限制临床试验 （CR; 3正在进行），招募2,773名成年人（55-91岁），BMIS≥27kg/m2，显示出多种有益的 生理变化与较低的疾病和残疾风险有关。这是否转化为实际 疾病和残疾的减少尚不清楚。需要进行大型多年试验，具有确切的临床结果 填补这一证据差距。如果产生时间，时间限制的喂养（TRF）可能是CR的有吸引力的替代品 类似的健康益处，更容易维持，并且减轻了CR的肌肉和骨骼的不良丧失。 这项为期三年的Hallo计划赠款的总体目标是为严格的多站点制定协议 比较随机的老年人的临床健康结果的随机临床试验（RCT） 每日CR，TRF治疗方案或使用创新的MHealth工具的非注视控制组 促进依从性。我们将完成一项为期120个老年人（年龄≥60岁的老年人； 50％）的12个月试点研究 女性; ≥23％的少数民族）提供有关可行性，干预交付和数据通知的关键信息 效应大小确定。 Hallo-P的目标是： 1。建立一个科学咨询委员会和其他结构，以指导计划活动以及设计的设计 与广泛的利益相关者相关并为该项目建立国家一致性的规模RCT。 2。完善我们的MHealth行为改变和依从性跟踪平台（Hallo-P Companion App） 优化CR和TRF干预措施的交付。 3。进行焦点小组和12个月的飞行员RCT：1）面对面交付的20％CR； 2）交付20％CR 通过视频会议进行远程； 3）trf（8-10小时），并随意热量摄入。飞行员数据将有所帮助 完善的招聘标准，估计招聘收益率和完善的干预方法。我们将使用double- 标记水以测量已达到的CR和连续的葡萄糖监测，以评估对TRF的依从性。 4。使用WF OAIC存储库和Hallo-P Pilot区分CR剂量的模型老化生物标志物变化。 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 关于临床结果并得出与包含/排除标准和事件速率有关的关键设计指标 与多物种，健康不足的积累和功能下降/残疾有关；和 5。整合新数据，科学文献和准备协议的专家建议，并开发了知情 同意表格，操作手册，研究表格和相关系统，以允许较大的迅速推出 试点活动完成后与该机制资助的其他U01项目协调后的审判。