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UTSW NORC Pilot Spinal Cord Injury Dietary Program
NCT06924177 · University of Texas Southwestern Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Utilizing Dietician-guided Intervention to Combat Neurogenic Obesity in People With Spinal Cord Injury
About this study
A mixed study design will be conducted to test the effectiveness of modified DPP-diet for SCI on body composition and insulin sensitivity before and after the intervention, and the sustained changes in both outcomes at a follow up visit 9 weeks after completion of the program. Qualitative design will be conducted to obtain participants input on the barriers and facilitators in initiating and implementing a sustainable modified DPP-diet for future clinical application on community dwelling individuals with SCI.
20 adults who have had diagnosis of SCI will be recruited for the study. All of them will undergo the modified DPP-diet as an intervention, and outcome measures collected before and after the intervention will be compared within subjects. Of the 20 participants, 10 of them will undergo modified DPP-diet upon enrollment, and the other 10 will wait for nine weeks before undergoing modified DPP-diet. Fasting blood draw and body composition measurements will be collected at three time points for the 10 participants starting modified DPP-diet upon enrollment: tpre, tpost, and tfollow-up. The same set of data will be collected at four time points for the 10 participants with a 9-week waiting period before starting the modified DPP-diet: t0, tpre, tpost, and tfollow-up. Qualitative study comprised of open-ended, semi-structured interviews will be provided for all 20 participants at the three time points: tpre, tpost, and tfollow-up.
Eligibility 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.
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-13
Estimated completion: 2026-05-31
Last updated: 2026-03-31
Interventions
Other: Telehealth with dietician
Primary outcomes
- • body fat composition (from enrollment to 9 weeks after completion of the modified DPP-diet program)
- • Homeostatic Model Assessment 2 for Insulin Resistance (HOMA2-IR) (from enrollment to 9 weeks after completion of the modified DPP-diet program)
Sponsor
University of Texas Southwestern Medical Center · other
Contacts & investigators
ContactYi-Ting Tzen · contact · Yi-Ting.Tzen@UTSouthwestern.edu · 214-648-1786
All locations (1)
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States