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.

项目摘要 多发性骨髓瘤（mm）是一种无法治愈的致命浆细胞性障碍，总是从前体演变 不确定意义（MGU）和闷烧的MM（SMM）的单克隆性伽马病的条件。 防止和拦截MGU/SMM向明显MM的循证策略是 缺乏该领域的重点研究的重要性。大量证据表明 肥胖是MM及其前体状况的危险因素。因此，针对肥胖症和/或针对的干预措施 癌变的肥胖相关机制可能是预防和拦截的MM 超重或肥胖的患有MGU和SMM的人的策略。该研究将探索 习惯性延长的夜间禁食的前提是一种促进肥胖和拦截的新型策略 在美国超重和超重的MGU和SMM患者中，疾病进展 肥胖。我们专注于长时间的夜间禁食，而不是传统的多方面减肥计划 因为长时间的夜间禁食涉及大多数人可以理解和 采纳。我们以前已经开发了电话咨询和基于文本消息的延长晚上 禁食（滥用）干预并在肥胖的绝经后妇女样本中对其进行了一个月的测试 乳腺癌的风险，发现在那个女性样本中既可以实现又可以接受。这 拟议的研究将在这项先前的研究基础上通过测试A中的精致版本 样本的40个超重和肥胖个体被诊断为MGU和SMM。参与者将随机 分配给有滥用的干预措施或四个健康的生活方式教育控制 月份。干预措施旨在促进每晚14小时的快速促进，并将以 基于电话的健康教练和文字传理。该研究的总体目的是获取 初步结果数据表明，在1）改善身体的效率 组成和2）改变疾病进展到MM的临床迹象。作为探索目标，我们将 探索滥用干预对骨髓脂肪组织（BMAT）的影响，这是一个 代谢活性脂肪仓库位于骨髓中的MM细胞附近。完成后， 拟议的研究将为更大，更明确的试验提供证据的初步基础。