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Telenutrition for Obesity in Spinal Cord Injury
N/A
Recruiting
Led By Kazuko Shem, MD
Research Sponsored by Santa Clara Valley Health & Hospital System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Possess adequate decision-making capacity to provide independent informed consent
Primarily a wheelchair user (>40 hours per week)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3 and 6 months
Awards & highlights
Study Summary
This trial will provide nutrition counseling to obese people with spinal cord injuries via FaceTime, in order to improve their eating habits and heart health. There will be 3 in-person visits required, spaced 3 months apart, for a total trial length of 6 months.
Who is the study for?
This trial is for adults over 20 with traumatic spinal cord injury who are overweight, primarily use a wheelchair, and are at least one year post-injury. Participants must live in California, be able to use an iPad, attend three in-person visits at SCVMC, and speak English or Spanish. Those on specialized diets for medical conditions or involved in other diet programs recently cannot join.Check my eligibility
What is being tested?
The study tests telenutrition counseling via FaceTime to help individuals with SCI improve their eating habits and heart health. It aims to reduce obesity-related risks like high cholesterol or diabetes and examine the relationship between nutrition and bowel/bladder function.See study design
What are the potential side effects?
Since this trial involves nutrition counseling rather than medication, there may not be direct side effects like those seen with drugs. However, changes in diet can sometimes lead to digestive adjustments such as changes in bowel habits or discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can make my own decisions and understand the consent form.
Select...
I use a wheelchair for most of my daily activities.
Select...
I am 20 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Healthy Eating Index (HEI) scores
Secondary outcome measures
Bladder function
Blood lipid profile
Body Mass Index (BMI)
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Immediate treatmentExperimental Treatment1 Intervention
Three months of treatment followed by a 3 month durability phase
Group II: Delayed TreatmentExperimental Treatment1 Intervention
A 3 month waitlist period followed by 3 months of treatment
Find a Location
Who is running the clinical trial?
University of California, San FranciscoOTHER
2,505 Previous Clinical Trials
15,237,459 Total Patients Enrolled
Santa Clara Valley Health & Hospital SystemLead Sponsor
15 Previous Clinical Trials
4,455 Total Patients Enrolled
San Jose State UniversityOTHER
10 Previous Clinical Trials
1,845 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can make my own decisions and understand the consent form.Your HbA1c level is higher than 7%.I have been diagnosed with an eating disorder in the past or currently.I do not have any uncontrolled medical conditions like high blood pressure or severe infections.You do not have a regular doctor.I use a wheelchair for most of my daily activities.I am 20 years old or older.It has been over a year since my injury.I follow a strict diet due to a medical condition like kidney failure or diabetes.You are currently receiving nutrition through a feeding tube.People who are in police custody.You have a spinal cord injury from an accident.Your body mass index (BMI) is higher than 22.I am proficient in English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate treatment
- Group 2: Delayed Treatment
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.
Are any more participants being sought for this clinical investigation?
"Affirmative. Clinicaltrials.gov confirms this medical study is presently looking for participants, having been posted on June 13th 2022 and updated most recently July 19th 2022, with 96 patients sought from a single trial site."
Answered by AI
What is the current participation rate in this experiment?
"Affirmative. According to the clinicaltrials.gov website, this trial is currently accepting participants and has been since June 13th 2022 when it was first posted. As of July 19th 2022, a total of 96 patients are needed across one medical centre."
Answered by AI
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