Health Aging & Later-Life Outcomes Planning (HALLO-P)
健康老龄化
基本信息
- 批准号:10282037
- 负责人:
- 金额:$ 110.77万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AddressAdherenceAdultAgeAgingAmericanAnimal ModelAttitudeBehavior TherapyBenefits and RisksBiological MarkersBiological ProcessBiometryBody Weight decreasedCaloric RestrictionCardiometabolic DiseaseClinicalClinical TrialsCompanionsComplexConsent FormsControl GroupsDataDatabasesDietary InterventionDiseaseDisease-Free SurvivalDoseEatingElderlyEnergy IntakeEnrollmentEpidemiologyEventExclusion CriteriaFocus GroupsFunding MechanismsGeroscienceGoalsGrantHealthHealth BenefitHourHumanImpairmentIndividualInterleukin-6Intermittent fastingInterventionIntervention TrialLiteratureLongevityMacronutrients NutritionManualsMeasuresMicronutrientsMild obesityMinorityModelingMuscleMuscle functionMuscular AtrophyObesityOutcomeOverweightParticipantPathway interactionsPatternPersonal SatisfactionPersonsPhysiologicalPilot ProjectsProcessProtocols documentationQuality ControlRandomizedRandomized Clinical TrialsRandomized Controlled Clinical TrialsRegimenReportingResearch PersonnelResourcesSiteStructureSystemTime-restricted feedingTranslatingVideoconferencingWeightWomanWorkage relatedattentional controlbehavior changeblood pressure reductionbonebone healthbone lossclinically relevantdata managementdesigndietarydisabilitydisability riskdisorder riskdoubly-labeled waterforestfracture riskfunctional declineglucose monitorhealthspanimprovedinnovationmHealthmultiple chronic conditionsmuscle metabolismobesity treatmentoperationrecruitremote deliveryrepositoryresponsetooltrial comparing
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(Hallo-P)是为了回应
RFA-AG-21-016。Hallo-P的附属研究人员总共领导了17项热量限制的临床试验
(CR;3正在进行),登记2,773名成年人(年龄55-91岁),体重指数≥为27公斤/平方米,显示出多重益处
与较低的疾病和残疾风险相关的生理变化。这是否转换为实际
疾病和残疾的减少还不清楚。需要一项具有明确临床结果的大型多年试验。
来填补这一证据空白。限时饲喂(TRF)如果能产生
类似的健康益处,更容易维持,并减轻了CR的肌肉和骨骼的不良损失。
这项为期3年的Hallo规划拨款的总体目标是为一个严格的、多地点、
随机临床试验(RCT)比较随机与临床相关的老年人的健康结果
每日CR、TRF方案或使用创新的mHealth工具的非饮食注意控制组
促进遵守。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%
妇女;≥23%的少数人)提供有关可行性、干预交付和数据通知的关键信息
效果大小确定。
Hallo-P的目标是:
1.设立一个科学咨询委员会和其他结构,以指导规划活动和设计一个完整的--
扩大有广泛利益相关者参与的区域工作队,并为该项目建立一个全国性的支持者群体。
2.改进我们的mHealth行为-更改和遵守跟踪平台-Hallo-P Companion App-以
优化CR和TRF干预措施的交付。
3.组织焦点小组和为期12个月的试点RCT:1)面对面交付20%的CR;2)交付20%的CR
远程通过视频会议;以及3)TRF(8-10小时),可随意摄入卡路里。试点数据将有所帮助
完善招聘标准,估计招聘收益,并完善干预方法。我们将加倍使用-
标记水的测量实现了CR和连续血糖监测,以评估对TRF的依从性。
4.使用WF OAIC资料库和Hallo-P Pilot模拟不同CR剂量下老化生物标记物的变化。
现有的流行病学数据库将被用来估计这些生物标志物变化的预期影响
关于临床结果,并得出与纳入/排除标准和事件发生率相关的关键设计指标
与多种疾病、健康缺陷累积和功能衰退/残疾有关;以及
5.整合新的数据、科学文献和专家意见,以制定一项议定书,并制定知情的
同意书、操作手册、研究表和相关系统,以允许快速发射较大的
在试点活动完成后,与该机制资助的另一个U01项目协调进行试验。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
STEPHEN B. KRITCHEVSKY其他文献
STEPHEN B. KRITCHEVSKY的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ 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:
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:
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:
相似海外基金
Structural Racism, Pharmacy Closures and Disparities in Medication Adherence Among Older Adult Medicare Part-D Beneficiaries
结构性种族主义、药房关闭以及老年人医疗保险 D 部分受益人的药物依从性差异
- 批准号:
10568717 - 财政年份:2023
- 资助金额:
$ 110.77万 - 项目类别:
Medication Adherence and Cardio-Metabolic Control Indicators among Adult American Indians Receiving Tribal Health Services
接受部落卫生服务的成年美洲印第安人的药物依从性和心脏代谢控制指标
- 批准号:
10419967 - 财政年份:2022
- 资助金额:
$ 110.77万 - 项目类别:
Medication Adherence and Cardio-Metabolic Control Indicators among Adult American Indians Receiving Tribal Health Services
接受部落卫生服务的成年美洲印第安人的药物依从性和心脏代谢控制指标
- 批准号:
10592441 - 财政年份:2022
- 资助金额:
$ 110.77万 - 项目类别:
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients
利用技术提高青少年和年轻肾移植或肝移植受者的药物依从性
- 批准号:
10369750 - 财政年份:2021
- 资助金额:
$ 110.77万 - 项目类别:
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients
利用技术提高青少年和年轻肾移植或肝移植受者的药物依从性
- 批准号:
10633248 - 财政年份:2021
- 资助金额:
$ 110.77万 - 项目类别:
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients
利用技术提高青少年和年轻肾移植或肝移植受者的药物依从性
- 批准号:
10487516 - 财政年份:2021
- 资助金额:
$ 110.77万 - 项目类别:
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
Mhealth 促进年轻 MSM 遵守暴露前预防
- 批准号:
10228564 - 财政年份:2018
- 资助金额:
$ 110.77万 - 项目类别:
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
Mhealth 促进年轻 MSM 遵守暴露前预防
- 批准号:
9347041 - 财政年份:2017
- 资助金额:
$ 110.77万 - 项目类别:
Mindfulness training with HIV-positive youth and adult family members to improve treatment adherence
对艾滋病毒呈阳性的青少年和成年家庭成员进行正念训练,以提高治疗依从性
- 批准号:
9480702 - 财政年份:2016
- 资助金额:
$ 110.77万 - 项目类别:
Mindfulness training with HIV-positive youth and adult family members to improve treatment adherence
对艾滋病毒呈阳性的青少年和成年家庭成员进行正念训练,以提高治疗依从性
- 批准号:
9906853 - 财政年份:2016
- 资助金额:
$ 110.77万 - 项目类别: