UTSW NORC Pilot Spinal Cord Injury Dietary Program

NCT06924177 | Recruiting

• 1 other identifier: STU20250145
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

spinal cord injuries; obesity; insulin resistance

Outcome Measures

Primary Outcomes (2)

• body fat composition

  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.

  from enrollment to 9 weeks after completion of the modified DPP-diet program

• Homeostatic Model Assessment 2 for Insulin Resistance (HOMA2-IR)

  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.

  from enrollment to 9 weeks after completion of the modified DPP-diet program

Study Arms (1)

Experiment

EXPERIMENTAL

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

Other: Telehealth with dietician

Interventions

Telehealth with dietician OTHER

9 weeks of telehealth visit with dietician using the DPP diet modules

Experiment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years old
• have had SCI for more than one year
• not independently ambulatory
• primarily uses a wheelchair for mobility
• community-dwelling

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8878, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Spinal Cord Injuries; Bronchiolitis Obliterans Syndrome; Insulin Resistance

Interventions

Telemedicine; Nutritionists

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Personnel; Health Care Facilities Workforce and Services

Central Study Contacts

Yi-Ting Tzen

CONTACT

214-648-1786; Yi-Ting.Tzen@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: February 13, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12/31/2026-12/31/2030
• Access Criteria: Any researchers interested in the data could reach out to the PI directly with a proposal to request the data. Data will be shared de-identified.

Locations

US (1)