Time Restricted Eating to Mitigate Obesity in Veterans with Spinal Cord Injury

限制时间饮食以减轻脊髓损伤退伍军人的肥胖

• 批准号: 10752306
• 负责人: Geoffrey V Henderson
• 金额: --
• 依托单位: SYRACUSE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-10-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10752306
• 关键词: Adherence; Affect; Body Weight; Body Weight decreased; Caloric Restriction; Calories; Cardiometabolic Disease; Chest; Chronic; Clinical; Collaborations; Consumption; Continuous Glucose Monitor; Data; Diet; Diet Modification; Dietary Intervention; Dyslipidemias; Eating; Effectiveness; Enrollment; Equilibrium; Exercise; Expenditure; Fasting; Food; Functional disorder; Goals; Grant; Health; Hour; Human Subject Research; Impairment; Individual; Inflammation; Injury; Insulin Resistance; Intermittent fasting; Intervention; Interview; Joints; Lead; Life Style; Link; Literature; Manual wheelchair; Measures; Mediator; Medical; Mentorship; Metabolic; Methods; Monitor; Muscle; Muscle Contraction; Muscular Atrophy; Obesity; Obesity Epidemic; Outcome; Paralysed; Paraplegia; Participant; Phase; Physical activity; Population; Prevalence; Protocols documentation; Quality of life; Questionnaires; Randomized, Controlled Trials; Research; Research Methodology; Risk; Safety; Sampling; Science; Spinal cord injury; Structure; Surveys; Testing; Thoracic spinal cord structure; Time; Time-restricted feeding; Training; Translations; Veterans; Weight; Weight Gain; Wheelchair propulsion; Work; Writing; cardiometabolism; career; clinical practice; design; dietary; digital; efficacy testing; feasibility trial; functional disability; functional improvement; functional outcomes; improved; lean body mass; loss of function; musculoskeletal injury; novel; obesity management; programs; recruit; satisfaction

Spinal cord injury (SCI) causes paralysis, muscle atrophy, decreased mobility, and metabolic expenditure – leading to weight gain and obesity. Obesity directly contributes to functional impairment, musculoskeletal injuries, and cardiometabolic dysfunction via multiple mechanisms including chronic inflammation, insulin resistance, and dyslipidemia. There is a critical need to reduce the growing prevalence of obesity and cardiometabolic disease after SCI, thereby improving Veterans’ function and quality of life. My overall objective in this application is to gather crucial feasibility data on time restricted eating (TRE), a novel form of intermittent fasting. The rationale for this project is that SCI obesity management is functionally and medically crucial. Weight loss results from a sustained negative caloric balance. Physical activity alone fails to achieve this goal, as individuals with SCI lose lean body mass and muscle contraction. Dietary interventions can be effective, but caloric restriction alone results in poor adherence. In contrast, TRE is a simple method to induce weight loss without the need for calorie counting. TRE allows individuals to eat all their daily calories in a time restricted window and fast outside that window. A growing body of literature supports the safety and efficacy of TRE. We will first test this intervention in Veterans with thoracic paraplegia, who are at greatest risk of muscle-joint upper body injury given the need to support body weight during activity. The critical variable in TRE studies is the eating window. In able-bodied individuals, food is typically consumed over a 14-15 hour period each day, known as the eating window. The eating window duration is unknown in the SCI population, representing a critical gap in the literature. Measuring and monitoring the eating window is only the first step. The next step is a feasibility trial of TRE, evaluating protocol adherence. Barriers and facilitators of participation will be determined via structured questionnaires and interviews. Aim 1: To determine the pre-intervention eating window of Veterans with thoracic paraplegia and obesity. The baseline eating window will be assessed by tracking start and stop times of food intake over a two week period in 50 participants with thoracic SCI via food logs and validated with time-stamped digital data. We hypothesize that the mean eating window is at least 14 hours/day. Aim 2: To determine adherence to a TRE window for 6-weeks duration in a convenience sample of Veterans with thoracic paraplegia and obesity. Fifteen participants from Aim 1 will be recruited to begin TRE. A step-wise reduction in eating window will be used to maximize adherence. Participants will start with a 12-hour window that transitions to a 10-hour window at the end of week 2, maintained through study’s end. Start times for eating will be individualized. Daily adherence will be defined as consuming all calories within the TRE window ±15 minutes. We hypothesize there will be a high degree of adherence (> 80%). Aim 3: To evaluate barriers and facilitators of adherence to TRE in Veterans with SCI. We will evaluate factors identified in prior TRE studies that act as barriers and facilitators of adherence by administering a Diet Satisfaction Survey at the beginning and end of the feasibility trial. Analysis will be supplemented by qualitative exit interviews after Aims 1 and 2 to identify SCI-specific barriers and facilitators of enrollment and participation. We hypothesize that the mean number of barriers will decrease over time. Weight data will be collected for exploratory analysis, as will continuous glucose monitor data as a potential mediator of weight loss. We expect cardiometabolic and functional outcomes to be more responsive to long-term TRE, and plan to test these outcomes in a CDA-2. Based on our expected outcomes of good adherence and acceptability, this study will lay the groundwork for a CDA-2 by informing the design of a randomized controlled trial to test the efficacy of TRE. This study is the first step toward the translation of TRE to clinical practice in the VA to treat obesity and maximize function in Veterans with SCI.

脊髓损伤（SCI）导致瘫痪、肌肉萎缩、活动性降低和代谢紊乱。 支出-导致体重增加和肥胖。肥胖直接导致功能障碍， 肌肉骨骼损伤，以及通过多种机制（包括慢性 炎症、胰岛素抵抗和血脂异常。迫切需要减少日益普遍的 肥胖和心脏代谢疾病的SCI后，从而改善退伍军人的功能和生活质量。 我在这个应用程序中的总体目标是收集时间限制饮食的关键可行性数据 (TRE)这是一种新型的间歇性禁食。该项目的基本原理是，SCI肥胖管理是 功能和医学上至关重要。体重减轻是由于持续的负热量平衡。物理 单靠活动无法达到这个目标，因为SCI患者会失去瘦体重和肌肉收缩。 饮食干预可能是有效的，但单独的热量限制会导致依从性差。相反，TRE 是一个简单的方法，以诱导减肥，而不需要计算卡路里。TRE允许个人吃所有 他们的每日卡路里在一个时间限制的窗口和快速窗口之外。越来越多的文献 支持TRE的安全性和有效性。我们将首先在胸截瘫的退伍军人中测试这种干预， 由于在活动期间需要支撑体重，这些人的上半身肌肉关节损伤的风险最大。 TRE研究中的关键变量是进食窗口。对于身体健全的人来说，食物通常是 每天消耗14-15小时，称为进食窗口。进食窗口持续时间为 在SCI人群中未知，代表了文献中的关键空白。衡量和监测 吃窗只是第一步下一步是TRE的可行性试验，评估方案依从性。 将通过结构化问卷和访谈确定参与的障碍和促进因素。 目的1：确定胸截瘫退伍军人的干预前进食窗口， 肥胖基线进食时间窗将通过跟踪一段时间内食物摄入的开始和停止时间来评估。 通过食物日志在50名胸部SCI参与者中进行为期两周的研究，并使用时间戳数字数据进行验证。 我们假设平均进食窗口至少为14小时/天。 目的2：在以下便利样本中确定6周TRE窗口的依从性： 胸截瘫和肥胖的退伍军人。目标1中的15名参与者将被招募开始 TRE。将逐步减少进食窗口，以最大限度地提高依从性。参与者将从一个 12-小时窗口，在第2周结束时过渡到10小时窗口，并维持至研究结束。 开始吃饭的时间将个性化。每日坚持将被定义为消耗所有的卡路里内， TRE窗口±15分钟。我们假设会有很高的依从性（> 80%）。 目的3：评估SCI退伍军人坚持TRE的障碍和促进因素。我们将评估 在之前的TRE研究中确定的因素，这些因素通过管理饮食作为坚持的障碍和促进因素 可行性试验开始和结束时的满意度调查。定性分析将作为补充 在目标1和2之后进行离职面谈，以确定SCI特定的入学障碍和促进因素， 参与的我们假设屏障的平均数量将随着时间的推移而减少。 将收集体重数据进行探索性分析，并将连续血糖监测数据作为 潜在的减肥中介。我们希望心脏代谢和功能结果更敏感 长期TRE，并计划在CDA-2中测试这些结果。根据我们的预期结果， 遵守和可接受性，这项研究将奠定基础的CDA-2的设计， 随机对照试验，以测试TRE的疗效。本文的研究是对汉语翻译理论的初步探索 到退伍军人管理局的临床实践，以治疗肥胖和最大限度地发挥功能的退伍军人与SCI。