| NCT ID | NCT05468437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Santa Clara Valley Health & Hospital System |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2022-06-13 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2022-06-13 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will provide nutrition counseling via FaceTime on an iPad to persons with traumatic spinal cord injury (SCI) who are overweight or obese and are at least one-year post-injury. Nutrition counseling may help participants to develop eating behaviors that match the participants' needs and help improve heart health. The purpose of this project is to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. This study will require 3 in person visits that are about 3 months apart. The total length of the study is about 6 months and includes 3 months of telenutrition counseling.
Eligibility Criteria
Inclusion Criteria: 1. Individuals with traumatic SCI 2. At least 1-year post-injury 3. Age 20 years of age or older 4. BMI \> 22 kg/m2 at enrollment 5. Proficiency in English or Spanish 6. Living at home or in a private home setting (i.e., not an extended care facility) in the state of California 7. Able / willing to come to SCVMC for in-person assessments 8. Primarily a wheelchair user (\>40 hours per week) 9. Able to use, or learn how to use, an iPad 10. Possess adequate decision-making capacity to provide independent informed consent Exclusion Criteria: 1. Medical instability (e.g., uncontrolled hypertension, pneumonia, severe pressure injury) 2. Current self-reported pregnancy 3. Other medical condition requiring a strict specialized diet (e.g., renal failure, diabetes) 4. Participation in another diet program (e.g., Jenny Craig, Weight Watchers, clinic-based program) and/or participated in another diet program within the past 6 months 5. Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder) 6. Receiving enteral nutrition 7. Individuals without a primary care physician 8. HbA1c \>7% (these individuals would need to be treated with metformin or other anti-diabetic medication and the intervention would have to be significantly altered for them) 9. Individuals who are in law enforcement custody
Contact & Investigator
Kazuko Shem, MD
PRINCIPAL INVESTIGATOR
Santa Clara Valley Medical Center
Frequently Asked Questions
Who can join the NCT05468437 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05468437 currently recruiting?
Yes, NCT05468437 is actively recruiting participants. Contact the research team at kazuko.shem@hhs.sccgov.org for enrollment information.
Where is the NCT05468437 trial being conducted?
This trial is being conducted at San Jose, United States.
Who is sponsoring the NCT05468437 clinical trial?
NCT05468437 is sponsored by Santa Clara Valley Health & Hospital System. The principal investigator is Kazuko Shem, MD at Santa Clara Valley Medical Center. The trial plans to enroll 96 participants.