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

健康老龄化

• 批准号: 10282037
• 负责人: STEPHEN B. KRITCHEVSKY
• 金额: $ 110.77万
• 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/10282037
• 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; 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 Clinical Trials; 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; glucose monitor; healthspan; improved; innovation; mHealth; multiple chronic conditions; muscle metabolism; obesity treatment; operation; 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.

健康、老龄化和晚年生活成果规划补助金（halo - p）是根据以下情况提交的