Time Restricted Eating for Obesity in Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen byGeoffrey V Henderson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to test Time Restricted Eating (TRE) in Veterans with thoracic paraplegia and obesity. TRE involves eating all meals within a specific time window each day, which helps reduce calorie intake and promote weight loss. The study will assess how well these veterans can stick to this eating pattern over a period of time. The results will help design future trials to confirm TRE's effectiveness in this group. Time-restricted eating (TRE) is an emerging dietary intervention for weight loss that has shown positive effects on body weight and metabolic health in various populations.

Research Team

Geoffrey V Henderson, MD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Eligibility Criteria

This trial is for Veterans aged 18-75 with spinal cord injury (SCI) and obesity, who are part of the Syracuse VA's SCI/D registry. Participants must have a BMI indicating obesity specific to SCI, eat over a 12-hour window daily, and have thoracic paraplegia. Exclusions include diabetes type 1 or significant weight loss recently, among others.

Inclusion Criteria

My spinal cord injury is classified between A to D on the ASIA scale.

Qualifying diagnosis of SCI within the SCI/D registry

I have had a spinal cord injury for more than a year.

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Exclusion Criteria

I have been diagnosed with low blood pressure upon standing and am taking midodrine or fludrocortisone.

I do not have any current severe illnesses like sepsis or advanced liver failure.

I am currently taking corticosteroids.

See 12 more

Treatment Details

Interventions

Time Restricted Eating (Behavioral Intervention)

Trial OverviewThe study explores Time Restricted Eating (TRE), where participants consume all daily calories within a set time frame and fast outside it. This method aims to induce weight loss without calorie counting in Veterans with thoracic paraplegia due to SCI.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Time Restricted EatingExperimental Treatment1 Intervention

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).