SALSA - Study of Active Lifestyle Activation

SALSA - 积极生活方式激活研究

• 批准号: 10910785
• 负责人: Eric Jessen Chow
• 金额: $ 19.95万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10910785
• 关键词: Acceleration; Aging; Biological Markers; Blood; Blood Pressure; Cancer Survivor; Cardiotoxicity; Cardiovascular Diseases; Collection; Control Groups; Data; Data Collection; Development; Diet; Funding; Future; Genomics; Goals; Inflammation; Inflammatory; Insulin Resistance; Intervention; Life Style; Lipids; Long-Term Survivors; Measurement; Methods; Nature; Parents; Participant; Phenotype; Physical Function; Physical activity; Physical assessment; Randomized, Controlled Trials; Recording of previous events; Risk; Sampling; Testing; Time; Weight; actigraphy; active lifestyle; adipokines; arm; cancer therapy; cardiovascular risk factor; childhood cancer survivor; design; frailty; functional outcomes; improved; insight; mHealth; premature; primary outcome; randomized trial; response; secondary outcome; sedentary; trial design

PROJECT SUMMARY The proposed supplemental funding request is in response to PA 20-272, and to support R01 CA263144 (SALSA: Study of Active LifeStyle Activation; NCT05075759; funding period 2021-2026). SALSA is a remotely conducted 12-month randomized controlled trial testing a multi-faceted approach at improving physical activity and diet quality in long-term survivors of childhood cancer at an increased risk of early cardiovascular (CV) disease. The primary outcomes of the trial are reductions in sedentary time and improvements in diet quality after 12 months. Secondary outcomes include other CV risk factors such as changes in blood pressure and weight, and the measurement of various blood biomarkers known to be associated with CV disease (e.g., lipid profile, insulin resistance, general inflammation, and adipokines). Collectively, many of these CV risk factors may contribute to the phenotype of accelerated aging and premature frailty, which is now increasingly recognized among cancer survivors, including survivors of childhood cancer. The proposed supplement seeks to enhance our understanding of the accelerated aging phenotype in survivors of childhood cancer. Specifically, we propose to approach SALSA participants who have completed the 12-month intervention with: 1) more in-depth phenotyping of physical function (via remote methods) beyond the actigraphy data collected by the parent trial, and 2) collect additional biomarkers known to be associated with accelerated aging in cancer survivors. Leveraging SALSA’s randomized trial design, we will also explore differences by study arms (i.e., control group; clinician-led goal-setting; mHealth-based goal setting), and among those participants (irrespective of study arm) who have better lifestyle profiles while adjusting for history of cardiotoxic cancer treatment exposures. While the limited nature of this supplement may preclude our ability to identify statistically significant differences between groups, it will provide important preliminary data demonstrating feasibility of assessing physical function using remote methods, and data on potentially detectable differences that may inform the design of future interventions that seek to target specific functional outcomes and other biomarkers of frailty and accelerated aging.

项目摘要 拟议的补充资金申请是对PA 20-272的回应，并支持R 01 CA 263144 （SALSA：积极生活方式激活研究; NCT 05075759;资助期2021-2026）。SALSA是一个远程 进行了一项为期12个月的随机对照试验，测试一种多方面的方法，以改善体力活动 早期心血管（CV）风险增加的儿童癌症长期幸存者的饮食质量 疾病试验的主要结果是减少久坐时间和改善饮食质量 12个月后。次要结局包括其他CV风险因素，如血压变化， 体重以及已知与CV疾病相关的各种血液生物标志物的测量（例如，脂质 谱、胰岛素抵抗、一般炎症和脂肪因子）。总的来说，许多CV风险因素 可能导致加速衰老和过早虚弱的表型，这是现在越来越多的 在癌症幸存者中得到认可，包括儿童癌症幸存者。拟议的补编旨在 以增强我们对儿童癌症幸存者加速衰老表型的理解。 具体来说，我们建议接触已完成12个月干预的SALSA参与者： 1)在收集的体动记录数据之外，对身体功能进行更深入的表型分析（通过远程方法） 2）收集已知与加速老化相关的其他生物标志物， 癌症幸存者利用SALSA的随机试验设计，我们还将探索研究组的差异 (i.e.,对照组;临床医生主导的目标设定;基于mHealth的目标设定），并且在这些参与者中 （不考虑研究组）在调整心脏毒性癌症病史时生活方式更好的患者 治疗暴露。虽然这种补充的有限性质可能会妨碍我们在统计上确定 组间差异显著，这将提供重要的初步数据，证明 使用远程方法评估身体功能，以及可能 为寻求针对特定功能结果和其他生物标志物的未来干预措施的设计提供信息 脆弱和加速衰老的迹象