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

Syracuse Va Medical Center, Syracuse NY

Investigators

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Abstract

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.