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。 支出--导致体重增加和肥胖。肥胖直接导致功能障碍， 肌肉骨骼损伤和心脏代谢功能障碍通过多种机制，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 脊髓损伤后肥胖和心脏代谢性疾病，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有关限时进食的关键可行性数据 间歇禁食的一种新形式(Tre)。这个项目的基本原理是SCI肥胖管理是 在功能和医学上都是至关重要的。体重减轻的原因是持续的负热量平衡。物理 单靠运动无法实现这一目标，因为患有脊髓损伤的人失去了瘦的身体质量和肌肉收缩。 饮食干预可能是有效的，但单靠限制卡路里会导致依从性差。相比之下，Tre 是一种简单的减肥方法，不需要计算卡路里。Tre允许个人吃掉所有 他们每天的卡路里在一个有时间限制的窗口内，在这个窗口外快速。越来越多的文学作品 支持Tre的安全性和有效性。我们将首先在患有胸截瘫的退伍军人身上测试这种干预措施， 由于在活动期间需要支撑体重，这些人上半身肌肉关节受伤的风险最大。 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个小时，被称为进食窗口。进食窗口持续时间为 在SCI人群中未知的，代表着文献中的一个关键差距。测量和监控 就餐窗口只是第一步。下一步是TRE的可行性试验，评估协议的遵从性。 将通过结构化问卷和访谈确定参与的障碍和促进者。 目的1：确定退伍军人胸截瘫患者的干预前进食时间窗。 肥胖。基线进食窗口将通过跟踪食物摄取的开始和停止时间在一年内进行评估 通过食物记录和带有时间戳的数字数据对50名胸部脊髓损伤患者进行为期两周的研究。 我们假设平均进食时间至少为14小时/天。 目标2：在一个方便的样本中，确定6周内对TRE窗口的依从性 患有胸部截瘫和肥胖的退伍军人。将从Aim 1招募15名参与者开始 Tre.逐步减少进食窗口将被用来最大限度地遵守。参与者将从一个 12小时窗口，在第二周结束时过渡到10小时窗口，一直保持到研究结束。 就餐开始时间将个性化。每日依从性将被定义为摄取 时间窗口±15分钟。我们假设将有高度的遵守(&gt；80%)。 目的3：评估患有脊髓损伤的退伍军人坚持tre的障碍和促进者。我们将评估 在先前的TRE研究中确定的因素，通过实施饮食来作为坚持的障碍和促进者 可行性试验开始和结束时的满意度调查。分析将由定性补充 在目标1和目标2之后进行退出面谈，以确定SCI特有的障碍和招生和促进者 参与。我们假设，障碍的平均数量将随着时间的推移而减少。 体重数据将被收集用于探索性分析，连续血糖监测数据将作为 减肥的潜在调停者。我们预计心脏代谢和功能结果会更灵敏。 长期的TRE，并计划在CDA-2上测试这些结果。基于我们对好的预期结果 依从性和可接受性，这项研究将为CDA-2奠定基础，为 随机对照试验，以检验特雷帕米的疗效。这项研究是通向翻译的第一步。 在退伍军人脊髓损伤中治疗肥胖和最大化功能的临床实践。