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) 会导致瘫痪、肌肉萎缩、活动能力下降和代谢障碍 支出——导致体重增加和肥胖。肥胖直接导致功能障碍， 通过多种机制（包括慢性损伤）导致肌肉骨骼损伤和心脏代谢功能障碍 炎症、胰岛素抵抗和血脂异常。迫切需要减少日益增长的流行病 SCI 后的肥胖和心脏代谢疾病，从而改善退伍军人的功能和生活质量。 我在此应用程序中的总体目标是收集有关限时饮食的关键可行性数据 （TRE），一种新颖的间歇性禁食形式。该项目的基本原理是 SCI 肥胖管理 在功能和医学上都至关重要。体重减轻是由于持续的热量负平衡造成的。身体的 仅靠活动无法实现这一目标，因为 SCI 患者会失去瘦体重和肌肉收缩。 饮食干预可能有效，但单独限制热量会导致依从性差。相比之下，TRE 是一种无需计算卡路里即可诱导减肥的简单方法。 TRE 允许个人吃掉所有食物 他们在有限时间窗口内和在该时间窗口外禁食的每日卡路里摄入量。不断增长的文学作品 支持 TRE 的安全性和有效性。我们将首先在患有胸椎截瘫的退伍军人中测试这种干预措施， 由于在活动期间需要支撑体重，因此上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 小时的时间，称为进食窗口。进食窗口持续时间为 SCI 人群中未知，代表文献中的一个关键空白。测量和监控 吃窗口只是第一步。下一步是 TRE 的可行性试验，评估协议的遵守情况。 参与的障碍和促进因素将通过结构化问卷和访谈来确定。 目标 1：确定胸椎截瘫退伍军人的干预前饮食窗口 肥胖。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基线饮食窗口 两周内，通过食物日志对 50 名胸部 SCI 参与者进行研究，并使用带时间戳的数字数据进行验证。 我们假设平均进食时间至少为每天 14 小时。 目标 2：确定以下便利样本中 6 周内对 TRE 窗口的遵守情况 患有胸椎截瘫和肥胖的退伍军人。目标 1 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 12 小时窗口期在第 2 周结束时过渡到 10 小时窗口期，并一直维持到研究结束。 用餐开始时间将因人而异。每日坚持定义为在规定时间内消耗所有卡路里 TRE 窗口±15 分钟。我们假设会有很高的依从性（> 80%）。 目标 3：评估 SCI 退伍军人坚持 TRE 的障碍和促进因素。我们将评估 先前 TRE 研究中确定的因素，这些因素对坚持饮食起到障碍和促进作用 在可行性试验开始和结束时进行满意度调查。分析将辅以定性分析 在目标 1 和 2 之后进行退出访谈，以确定 SCI 特定的入学障碍和促进因素 参与。我们假设障碍的平均数量会随着时间的推移而减少。 将收集体重数据用于探索性分析，连续血糖监测数据也将作为 减肥的潜在中介。我们预计心脏代谢和功能结果会更加敏感 长期 TRE，并计划在 CDA-2 中测试这些结果。基于我们预期的良好结果 遵守性和可接受性，本研究将为 CDA-2 的设计提供信息，为 CDA-2 奠定基础。 随机对照试验测试 TRE 的功效。这项研究是 TRE 翻译的第一步 VA 的临床实践，用于治疗肥胖症并最大限度地提高患有 SCI 的退伍军人的功能。