UTSW NORC Pilot Spinal Cord Injury Dietary Program

Not Applicable

Recruiting

• Conditions: Obesity and Obesity-related Medical Conditions; Spinal Cord Injury, Chronic

• Registration Number: NCT06924177
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Study First Posted: 2025-04-11
• Study Start: 2025-05-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-03-15
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
body fat composition	from enrollment to 9 weeks after completion of the modified DPP-diet program	Whole body fat percentage from dual-energy X-ray absorptiometry scan. The unit will be %, with higher value indicating larger amount of body fat within an individual.
Homeostatic Model Assessment 2 for Insulin Resistance (HOMA2-IR)	from enrollment to 9 weeks after completion of the modified DPP-diet program	An insulin resistance index calculated from fasting glucose (mmol/l) and insulin (μU/ml) level from blood draw. The HOMA2-IR will be calculated using the formula: HOMA2-IR = (Fasting Insulin (μU/ml) \* Fasting Glucose (mmol/L)) / 22.5.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States