9-week dietitian-led program for adults with spinal cord injury to reduce body fat and insulin resistance
Utilizing Dietician-guided Intervention to Combat Neurogenic Obesity in People With Spinal Cord Injury
This program will try a 9-week dietitian-led version of the Diabetes Prevention Program to see if it lowers body fat and insulin resistance in adults with chronic spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06924177 on ClinicalTrials.gov |
What this trial studies
This pilot uses a modified Diabetes Prevention Program (DPP) diet delivered via nine weekly telehealth visits with a certified dietitian to participants with chronic spinal cord injury (SCI). Twenty community-dwelling adults with SCI will undergo body composition testing and fasting blood draws before and after the intervention, with an additional follow-up visit nine weeks after completion. Ten participants start the program immediately and ten begin after a nine-week wait period, allowing within-subject comparisons and a waitlist control design. Qualitative semi-structured interviews at baseline, post-intervention, and follow-up will explore barriers and facilitators to adopting the diet.
Who should consider this trial
Good fit: Adults aged 18–65 who have had a spinal cord injury for more than one year, are primarily wheelchair users and not independently ambulatory, and live in the community without the specified exclusionary medical conditions are ideal candidates.
Not a fit: People with uncontrolled type 2 diabetes, current pregnancy, active systemic diseases listed in the exclusions, or who cannot travel to the site for required lab visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could offer a practical telehealth dietary approach to reduce body fat and improve insulin sensitivity for community-dwelling adults with chronic SCI.
How similar studies have performed: The original DPP has shown weight and metabolic benefits in other populations and some adapted DPPs have helped reduce weight and improve insulin sensitivity, but tailored applications specifically for SCI are limited and not well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18-65 years old * have had SCI for more than one year * not independently ambulatory * primarily uses a wheelchair for mobility * community-dwelling * without comorbidities listed in the exclusion criteria Exclusion Criteria: * uncontrolled type 2 diabetes mellitus * pregnancy * active systemic disease, e.g., heart disease, real failure/insufficiency, multiple myeloma, lupus with nephropathy, sickle cell disease, symptomatic myasthenia gravis, poorly controlled hypo- or hyperthyroidism.
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Yi-Ting Tzen
- Email: Yi-Ting.Tzen@UTSouthwestern.edu
- Phone: 214-648-1786
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.