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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK1RX004538-01A1 | U.S. NIH Grant/Contract | View source |
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Spinal cord injury (SCI) causes paralysis and muscle atrophy and leads to weight gain and obesity. Obesity directly contributes to functional impairment and cardiometabolic dysfunction. There is a critical need to reduce the growing prevalence of obesity and cardiometabolic disease after SCI. My overall objective in this project is to gather crucial feasibility data on time restricted eating (TRE), a novel form of intermittent fasting. TRE is a straightforward 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. Given the feasibility, high adherence, and substantial benefits of TRE in able-bodied individuals, it is important to test TRE to determine its feasibility in Veterans with SCI. The investigators will first test this intervention in Veterans with paraplegia, who are at greatest risk of muscle-joint upper body injury given the need to support body weight during activity. The investigators will determine adherence to a TRE window for 6-weeks duration in a convenience sample of Veterans with paraplegia and obesity. Based on the expected outcomes of good adherence, this study will lay the groundwork for future work by informing the design of a randomized controlled trial to test the efficacy of TRE to facilitate weight loss and improve function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Restricted Eating | Experimental | This is a single-arm study in a convenience sample of Veterans with paraplegia and obesity. The intervention will test adherence of participants to a TRE window with a self-selected start time. The duration of the eating window will be 10 hours, maintained through study's end (end of week 6). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Eating | Behavioral | Time Restricted Eating Protocol: Subjects will be instructed to limit caloric consumption to a 10-hour TRE window. The window start-time will be self-selected (individualized). During the eating window, subjects will not be restricted on types or quantities of food consumed, and will be advised to continue their usual diets. Subjects will not be required to monitor their caloric intake. During the fasting period, subjects will be encouraged to stay hydrated and drink ample water. Outside the designated eating window, subjects are only permitted to consume medication, water, or zero-calorie herbal drinks such as unsweetened tea or black coffee. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the daily eating window | Measured by questionnaire (assesses the time the participant started and stopped eating each day) | Measured weekly from baseline to week 6 |
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Inclusion Criteria:
Exclusion Criteria:
Females who are pregnant (tested via urinary hCG), planning to become pregnant in the next 6 months, or breast-feeding
A member of the SCI/D registry through the Syracuse VA, with a qualifying diagnosis of MS or ALS
Diagnosis of heart failure
Diagnosis of diabetes mellitus, type 1
Diagnosis of diabetes mellitus, type 2, and on insulin or other antidiabetic agent with high incidence of hypoglycemia
o Of note, antidiabetic agents with low incidence of hypoglycemia are: metformin, GLP-1 receptor agonists, SGLT2 inhibitors, DPP4 inhibitors, alpha glucosidase inhibitors, thiazolidinediones (as discussed with VA pharmacist)
Diagnosis of End Stage Renal Disease
Diagnosis of dementia
Diagnosis of orthostatic hypotension and prescribed midodrine or fludrocortisone
History of syncopal episode in the month prior to the study
History of significant weight loss (> 10% body weight) in the month prior to the study
History of eating disorders (e.g., anorexia or bulimia) within the last five years, or clearance from a mental health provider
History of active suicidal ideation in the last six months, or clearance from a mental health provider
Currently prescribed weight loss medication (e.g., liraglutide)
Currently prescribed corticosteroids
Current acute medical issues including cancer, sepsis, advanced liver failure, porphyria, or uncontrolled hyperthyroidism
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey V Henderson, MD | Syracuse VA Medical Center, Syracuse, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York | 13210-2716 | United States |
A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
The dataset will be available following publication of the primary manuscript for this project.
The dataset will be released upon written request for scientific purposes including re-analysis and validation of results.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Intervention: This is a single-arm study in a convenience sample of Veterans with paraplegia and obesity.
Research Design: Those with mean eating windows of at least 10 hours per day will be eligible to participate in the TRE intervention. Tests for adherence (food log) will be collected.
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| D014947 | Wounds and Injuries |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |