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: 10370660
• 负责人: Catherine Marinac
• 金额: $ 20.8万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10370660
• 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; 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; Public Health; Publishing; Randomized; Reporting; Research; Risk Factors; Risk Reduction; Sampling; Serum; Sleep; Testing; Text Messaging; Time; Weight; Woman; Work; base; behavior change; cancer recurrence; cancer risk; clinical care; clinically relevant; design; disorder risk; energy balance; evidence base; glycemic control; healthy lifestyle; high risk; human data; improved; innovation; interest; intervention program; lifestyle intervention; lifetime risk; multiple myeloma M Protein; novel; novel strategies; obese person; obesity prevention; obesity treatment; prevent; randomized trial; telephone coaching; telephone-based; 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）是一种无法治愈和致命的浆细胞恶液质，总是从前体演变而来， 未确定意义的单克隆丙种球蛋白病（MGUS）和阴燃型MM（SMM）。 预防和阻断MGUS/SMM进展为明显MM的循证策略包括 缺乏，强调了在这一领域集中研究的重要性。大量证据表明， 肥胖是MM及其前驱病症的危险因素。因此，针对肥胖症和/或 肥胖相关的致癌机制可能作为预防和拦截MM的可能途径 超重或肥胖的MGUS和SMM患者的治疗策略。该研究将探讨 前提是习惯性长期夜间禁食是一种新的策略，以促进肥胖减少和拦截 在美国，超重的MGUS和SMM患者中有很大比例的疾病进展， 肥胖我们专注于延长夜间禁食，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大多数人都能理解的简单行为改变， 领养我们以前开发了一个电话咨询和短信为基础的延长夜间 空腹（PROFAST）干预，并在肥胖，绝经后妇女的样本中进行了一个月的测试， 并发现它在妇女样本中既可以实现又可以接受。的 拟议的研究将建立在这一先前的研究，通过测试一个改进版本的PROFAST干预， 40名被诊断患有MGUS和SMM的超重和肥胖个体的样本。参与者将随机 以相等的数量分配到PROFAST干预组或健康生活方式教育对照组， 个月该干预措施旨在促进每晚14小时的禁食，并将以 电话健康指导和短信。研究的总体目标是获得 初步结果数据表明PROFAST干预在以下方面的疗效：1）改善身体 组成，和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，BMAT是一种 在骨髓中，代谢活性脂肪库位于MM细胞附近。建成后 拟议的研究将为更大规模、更明确的试验提供初步的证据基础。