Prolonged Nightly Fasting as a Behavioral Intervention for Obesity Reduction and the Prevention of Progression in Precursor Multiple Myeloma

项目总结 多发性骨髓瘤(MM)是一种不治之症和致命性浆细胞营养不良，它总是从前体演变而来 未确定意义的单克隆性伽马病(MGUS)和阴燃MM(SMM)的情况。 预防和拦截MGUS/SMM进展为显性MM的循证策略包括 缺乏，强调了在这一领域进行重点研究的重要性。确凿的证据表明 肥胖是多发性骨髓瘤及其前驱疾病的危险因素。因此，针对肥胖和/或 肥胖相关的致癌机制可能是多发性骨髓瘤的预防和拦截 超重或肥胖的MGUS和SMM患者的策略。这项研究将探索 假设习惯性的夜间长时间禁食是一种促进减肥和拦截肥胖的新策略 在美国，很大比例的MGUS和SMM患者超重和 太胖了。我们专注于延长夜间禁食时间，而不是更传统的多方面减肥计划 因为长时间的夜间禁食涉及一个大多数人都能理解的简单的行为改变， 领养。我们之前已经开发了一种基于电话咨询和短信的延长每晚 禁食(PROFAST)干预，并对肥胖的绝经后妇女样本进行为期一个月的测试 对乳腺癌风险的研究发现，在该样本的女性中，这是可以实现的，也是可以接受的。这个 拟议的研究将建立在这一先前研究的基础上，通过在 40名超重和肥胖者的样本，诊断为MGUS和SMM。参赛者将随机 等额分配给PROFAST干预组或健康生活方式教育控制组，共四人 月份。这项干预旨在促进14小时的夜间禁食，并将以 基于电话的健康指导和短信。研究的总体目标是获得 初步结果数据显示PROFAST干预在1)改善身体方面的有效性 成分，以及2)改变疾病进展到MM的临床体征。作为一个探索性目标，我们将 探讨PROFAST干预对骨髓脂肪组织(BMAT)的影响 位于骨髓中MM细胞附近的代谢活跃的脂肪储存库。完成后， 拟议的研究将为更大规模、更明确的审判提供初步的证据基础。

PROJECT SUMMARY Multiple Myeloma (MM) is an incurable and fatal plasma cell dyscrasia that always evolves from the precursor conditions of monoclonal gammopathy of undetermined significance (MGUS) and smoldering MM (SMM). Evidence-based strategies for preventing and intercepting the progression of MGUS/SMM to overt MM are lacking, underscoring the importance of focused research in this area. Substantial evidence indicates that obesity is a risk factor for MM and its precursor conditions. Therefore, interventions that target obesity and/or obesity-related mechanisms of carcinogenesis may serve as possible MM prevention and interception strategies in individuals with MGUS and SMM who are overweight or obese. The research will explore the premise that habitual prolonged nightly fasting is a novel strategy to promote obesity reduction and intercept disease progression in the large proportion of MGUS and SMM patients in the US who are overweight and obese. We focus on prolonged nightly fasting over more traditional multifaceted weight-loss programs because prolonged nightly fasting involves a simple behavior change that most individuals can understand and adopt. We have previously developed a telephone counseling and text messaging-based prolonged nightly fasting (PROFAST) intervention and tested it for one-month in a sample of obese, postmenopausal women at risk for breast cancer and found it to be both achievable and acceptable in that sample of women. The proposed study will build on this prior research by testing a refined version of the PROFAST intervention in a sample of 40 overweight and obese individuals diagnosed with MGUS and SMM. Participants will be randomly assigned, in equal numbers, to the PROFAST intervention or a healthy lifestyle education control for four months. The intervention is designed to promote a 14 hour nightly fast and will be delivered in the form of telephone-based health coaching and text-messaging. The overall objective of the research is to acquire preliminary outcome data suggesting the efficacy of the PROFAST intervention in in 1) improving body composition, and 2) altering clinical signs of disease progression to MM. As an exploratory objective, we will explore the impact of the PROFAST intervention on bone marrow adipose tissue (BMAT), which is a metabolically active adipose depot that resides near MM cells in the bone marrow. Upon completion, the proposed study will provide the preliminary foundation of evidence for a larger, more definitive trial.