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

延长夜间禁食作为减少肥胖和预防前体多发性骨髓瘤进展的行为干预措施

• 批准号: 10633083
• 负责人: Catherine Marinac
• 金额: $ 24.47万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-03 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10633083
• 关键词: Abate; Adipose tissue; Adopted; Adult; Animal Model; Area; Behavior; Behavior Therapy; Biological Markers; Body Composition; Body Weight; Body Weight decreased; Bone Marrow; Breast Cancer Risk Factor; Breast Cancer survivor; Carcinogenesis Mechanism; Cells; Clinical; Consumption; Control Groups; Data; Diagnosis; Disease Progression; Early Intervention; Eating; Education; Effectiveness; Energy Intake; Fasting; Foundations; Health; Hour; Human; Incidence; Individual; Inflammation; Intercept; Intervention; Laboratories; Link; Malignant - descriptor; Malignant Neoplasms; Metabolic; Monoclonal gammopathy of uncertain significance; Multiple Myeloma; Mus; Neoplasms; Obesity; Observational Study; Outcome; Overweight; Participant; Patient Care; Patients; Pattern; Phase; Plasma Cell Neoplasm; Plasma Cells; Population; Populations at Risk; Positioning Attribute; Postmenopause; Prevalence; Prevention; Proteins; Public Health; Publishing; Randomized; Recurrent Malignant Neoplasm; Reporting; Research; Risk Factors; Risk Reduction; Sampling; Serum; Sleep; Testing; Text Messaging; Time; Weight; Woman; Work; behavior change; cancer recurrence; cancer risk; clinical care; clinically relevant; design; disorder risk; energy balance; evidence base; glycemic control; healthy lifestyle; high risk population; improved; innovation; interest; intervention program; lifestyle intervention; lifetime risk; novel; novel strategies; obese person; obesity prevention; obesity treatment; prevent; randomized trial; telephone based; telephone coaching; weight loss program

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.

项目概要 多发性骨髓瘤 (MM) 是一种无法治愈且致命的浆细胞恶液质，总是由前体细胞演变而来 意义未明的单克隆丙种球蛋白病 (MGUS) 和冒烟型 MM (SMM)。 预防和阻止 MGUS/SMM 进展为明显 MM 的循证策略包括 缺乏，强调了这一领域重点研究的重要性。大量证据表明 肥胖是多发性骨髓瘤及其先兆病症的危险因素。因此，针对肥胖和/或 肥胖相关的致癌机制可作为预防和拦截多发性骨髓瘤的可能 针对超重或肥胖的 MGUS 和 SMM 患者的治疗策略。该研究将探索 前提是习惯性延长夜间禁食是促进减少和拦截肥胖的新策略 美国大部分超重和 SMM 患者的疾病进展 肥胖。我们专注于长时间的夜间禁食，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种简单的行为改变，大多数人都能理解并且 采纳。我们之前开发了基于电话咨询和短信的延长夜间服务 禁食（PROFAST）干预措施，并在肥胖绝经后女性样本中进行了一个月的测试 乳腺癌的风险，并发现在该女性样本中这是可以实现和可接受的。这 拟议的研究将建立在先前研究的基础上，通过测试 PROFAST 干预的改进版本 40 名被诊断患有 MGUS 和 SMM 的超重和肥胖个体的样本。参与者将是随机的 分配给 4 名同等数量的 PROFAST 干预组或健康生活方式教育对照组 几个月。该干预措施旨在促进每晚 14 小时禁食，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 初步结果数据表明 PROFAST 干预在 1) 改善身体方面的功效 成分，以及 2) 改变疾病进展为 MM 的临床体征。作为探索性目标，我们将 探讨 PROFAST 干预对骨髓脂肪组织 (BMAT) 的影响，这是一种 位于骨髓中 MM 细胞附近的代谢活跃的脂肪库。完成后，将 拟议的研究将为更大规模、更明确的试验提供初步证据基础。