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Behavioral Intervention
Time Restricted Eating for Obesity in Spinal Cord Injury
N/A
Waitlist Available
Led By Geoffrey V Henderson, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured weekly from baseline to week 6
Awards & highlights
Study Summary
This trial will study whether a form of intermittent fasting called time restricted eating can help reduce obesity and improve function for veterans with spinal cord injury.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of TRE may include hunger pangs, fatigue during fasting periods, irritability or mood changes initially as the body adapts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured weekly from baseline to week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured weekly from baseline to week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the daily eating window
Trial Design
1Treatment groups
Experimental Treatment
Group I: Time Restricted EatingExperimental Treatment1 Intervention
This is a single-arm study in a convenience sample of Veterans with thoracic 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 initially be 12 hours, then transition to 10 hours at the end of week 2, maintained through study's end (end of week 6).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time Restricted Eating
2018
N/A
~50
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,438 Total Patients Enrolled
40 Trials studying Obesity
10,072 Patients Enrolled for Obesity
Geoffrey V Henderson, MDPrincipal InvestigatorSyracuse VA Medical Center, Syracuse, NY
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My spinal cord injury is classified between A to D on the ASIA scale.I am currently taking corticosteroids.I have been diagnosed with heart failure.I have been diagnosed with type 1 diabetes.I am not pregnant, planning a pregnancy soon, or breastfeeding.I have had a spinal cord injury for more than a year.I have lost more than 10% of my body weight in the last month.I am registered with the Syracuse VA SCI/D and diagnosed with MS or ALS.I have type 2 diabetes and take insulin or medication that often causes low blood sugar.I am currently taking medication for weight loss.My kidneys are in the final stage of chronic kidney disease.I have been diagnosed with dementia.I have fainted in the last month.I am a veteran aged between 18 and 75.My spinal cord injury is between the T1 and T12 levels.
Research Study Groups:
This trial has the following groups:- Group 1: Time Restricted Eating
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a way for me to be part of this research endeavor?
"In order to be eligible for this medical experiment, individuals must have obesity and fall between 18 -75 years old. A maximum of 15 participants will be accepted into the clinical trial."
Answered by AI
Is the cutoff age for entry to this research study above thirty years of age?
"Patients hoping to enroll in this medical trial must be between the ages of 18 and 75. For individuals below age 18, there are 337 trials available while 1393 options exist for those above 65 years old."
Answered by AI
Are any patient enrollments being accepted for this trial currently?
"The clinicaltrials.gov website indicates that this investigation is no longer seeking applicants; the trial was first posted on September 1st 2023 and concluded its recruitment process by June 16th of the same year. Nevertheless, there remain 1934 other medical trials actively recruiting participants at present."
Answered by AI
Who else is applying?
What site did they apply to?
Syracuse VA Medical Center, Syracuse, NY
What portion of applicants met pre-screening criteria?
Met criteria
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