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

健康老龄化

基本信息

项目摘要

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

项目成果

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STEPHEN B. KRITCHEVSKY其他文献

STEPHEN B. KRITCHEVSKY的其他文献

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{{ truncateString('STEPHEN B. KRITCHEVSKY', 18)}}的其他基金

Health Aging & Later-Life Outcomes Planning (HALLO-P)
健康老龄化
  • 批准号:
    10477330
  • 财政年份:
    2021
  • 资助金额:
    $ 110.77万
  • 项目类别:
The Mobile Devices for Meal Timing (MD4MT) Study: A supplement to HALLO-P using multiple wearable devise to improve accuracy in meal timing for older adults2
进餐时间移动设备 (MD4MT) 研究:HALLO-P 的补充,使用多个可穿戴设备提高老年人进餐时间的准确性2
  • 批准号:
    10709387
  • 财政年份:
    2021
  • 资助金额:
    $ 110.77万
  • 项目类别:
Health Aging & Later-Life Outcomes Planning (HALLO-P)
健康老龄化
  • 批准号:
    10906442
  • 财政年份:
    2021
  • 资助金额:
    $ 110.77万
  • 项目类别:
Health Aging & Later-Life Outcomes Planning (HALLO-P)
健康老龄化
  • 批准号:
    10674850
  • 财政年份:
    2021
  • 资助金额:
    $ 110.77万
  • 项目类别:
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
  • 财政年份:
    2021
  • 资助金额:
    $ 110.77万
  • 项目类别:
Research Centers Collaborative Network Renewal
研究中心协作网络更新
  • 批准号:
    10175328
  • 财政年份:
    2018
  • 资助金额:
    $ 110.77万
  • 项目类别:
Developing an NIA Research Centers Collaborative Network (RCCN)
开发 NIA 研究中心协作网络 (RCCN)
  • 批准号:
    9904387
  • 财政年份:
    2018
  • 资助金额:
    $ 110.77万
  • 项目类别:
Research Centers Collaborative Network Renewal
研究中心协作网络更新
  • 批准号:
    10407599
  • 财政年份:
    2018
  • 资助金额:
    $ 110.77万
  • 项目类别:
B-NET Administrative Supplement
B-NET行政补充
  • 批准号:
    10631298
  • 财政年份:
    2017
  • 资助金额:
    $ 110.77万
  • 项目类别:
Brain Networks and Mobility Function: B-NET
大脑网络和移动功能:B-NET
  • 批准号:
    10189465
  • 财政年份:
    2017
  • 资助金额:
    $ 110.77万
  • 项目类别:

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