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NCT Number: NCT06924177

UTSW NORC Pilot Spinal Cord Injury Dietary Program

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telehealth with dietician

Other

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

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi-Ting Tzen

CONTACT

[email protected]

214-648-1786

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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