UTSW NORC Pilot Spinal Cord Injury Dietary Program

NCT ID: NCT06924177

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Telehealth with dietician

Intervention Type OTHER

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

Interventions

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Telehealth with dietician

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

Intervention Type OTHER

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yi-Ting Tzen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yi-Ting Tzen

Role: CONTACT

214-648-1786

Facility Contacts

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Yi-Ting Tzen

Role: primary

214-648-1786

Other Identifiers

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STU20250145

Identifier Type: -

Identifier Source: org_study_id

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