UTSW NORC Pilot Spinal Cord Injury Dietary Program
Purpose
The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity. The main question it aims to answer is: Does 9 week modified DPP-diet reduce body fat percentage and insulin resistance? Participants will: Have 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet. Share with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.
Conditions
- Obesity and Obesity-related Medical Conditions
- Spinal Cord Injury, Chronic
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experiment |
9 weeks of Telehealth with dietician using DPP modules diet portion. The nine modules are: 1. Eat well to prevent T2DM 2. Track your food 3. Shop and cook to prevent T2DM 4. Eat well away from home 5. Stay motivated to prevent T2DM 6. More about carbs 7. Have health food you enjoy 8. Get back on track 9. Prevent T2DM for life |
|
Recruiting Locations
Dallas, Texas 75390-8878
More Details
- Status
- Recruiting
- Sponsor
- University of Texas Southwestern Medical Center
Detailed Description
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.