UTSW NORC Pilot Spinal Cord Injury Dietary Program

July 14, 2026 updated by: Yi-Ting Tzen, University of Texas Southwestern Medical Center

Utilizing Dietician-guided Intervention to Combat Neurogenic Obesity in People With Spinal Cord Injury

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Telehealth with dietician
9 weeks of telehealth visit with dietician using the DPP diet modules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body fat composition
Time Frame: 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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU20250145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

age, gender, body mass index, whole body fat percentage, HOMA2-IR value

IPD Sharing Time Frame

12/31/2026-12/31/2030

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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