Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06924177

Conditions

Obesity and Obesity-related Medical Conditions

Spinal Cord Injury, Chronic

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Telehealth with dietician

Study Details

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

Study ID

NCT06924177

Start date

Feb 13, 2026

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

Telehealth with dietician

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

Primary outcome measure

  • body fat composition [ Time Frame: from enrollment to 9 weeks after completion of the modified DPP-diet program ]
  • Homeostatic Model Assessment 2 for Insulin Resistance (HOMA2-IR) [ Time Frame: from enrollment to 9 weeks after completion of the modified DPP-diet program ]

Central Contacts and Locations

Central contacts

Yi-Ting Tzen

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

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-8878

Contacts

Yi-Ting Tzen

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

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • spinal cord injuries
  • obesity
  • insulin resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-15.