Nutrition counseling for individuals with spinal cord injuries
Telenutrition to Improve Cardiometabolic Health and Quality of Life Among Individuals With Spinal Cord Injury
This study is testing if nutrition counseling through FaceTime can help people with spinal cord injuries who are overweight improve their eating habits and health over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Santa Clara Valley Health & Hospital System Academic / other |
| Locations | 1 site (San Jose, California) |
| Trial ID | NCT05468437 on ClinicalTrials.gov |
What this trial studies
This study provides nutrition counseling via FaceTime on an iPad to individuals with traumatic spinal cord injuries who are overweight or obese and at least one year post-injury. Participants will undergo an initial screening and then be enrolled in a 6-month program where they will receive individualized nutrition education and counseling. The study includes two groups: one receiving immediate counseling and another receiving it after a delay, allowing for comparisons in outcomes related to obesity and cardiometabolic health. The goal is to improve eating behaviors and reduce the risk of complications such as high cholesterol and diabetes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 and older with traumatic spinal cord injuries, a BMI greater than 22, and proficiency in English or Spanish.
Not a fit: Patients with medical instability or those requiring a strict specialized diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve heart health and reduce obesity-related complications in individuals with spinal cord injuries.
How similar studies have performed: Other studies have shown success with similar nutrition counseling approaches, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Jose, California
- Santa Clara Valley Medical Center — San Jose, California, United States (Recruiting)
Study contacts
- Principal investigator: Kazuko Shem, MD — Santa Clara Valley Medical Center
- Study coordinator: Kazuko Shem, MD
- Email: kazuko.shem@hhs.sccgov.org
- Phone: 800-352-1956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.