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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)
Must not have
Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
Medical instability (e.g., uncontrolled hypertension, pneumonia, severe pressure injury)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3 and 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can make my own decisions and understand the consent form.
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I use a wheelchair for most of my daily activities.
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I am 20 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with an eating disorder in the past or currently.
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I do not have any uncontrolled medical conditions like high blood pressure or severe infections.
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I follow a strict diet due to a medical condition like kidney failure or diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Healthy Eating Index (HEI) scores
Secondary study objectives
Bladder function
Blood lipid profile
Body Mass Index (BMI)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
2,593 Previous Clinical Trials
14,887,854 Total Patients Enrolled
Santa Clara Valley Health & Hospital SystemLead Sponsor
15 Previous Clinical Trials
4,370 Total Patients Enrolled
San Jose State UniversityOTHER
10 Previous Clinical Trials
1,845 Total Patients Enrolled
Kazuko Shem, MDPrincipal InvestigatorSanta Clara Valley Medical Center
2 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Telenutrition Clinical Trial Eligibility Overview. Trial Name: NCT05468437 — N/A
Spinal Cord Injury Research Study Groups: Immediate treatment, Delayed Treatment
Spinal Cord Injury Clinical Trial 2023: Telenutrition Highlights & Side Effects. Trial Name: NCT05468437 — N/A
Telenutrition 2023 Treatment Timeline for Medical Study. Trial Name: NCT05468437 — N/A
~27 spots leftby Jan 2026
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