Obesity and Obesity-related Medical ConditionsNCT06924177
UTSW NORC Pilot Spinal Cord Injury Dietary Program
A study testing Telehealth with dietician in people with Obesity and Obesity-related Medical Conditions and Spinal Cord Injury, Chronic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Spinal Cord Injury, Chronic
- What is being tested?
- Telehealth with dietician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8878
Yi-Ting Tzen, 214-648-1786, Yi-Ting.Tzen@UTSouthwestern.edu
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Telehealth with dietician
- Keywords
- spinal cord injuries, obesity, insulin resistance
- Medical subject headings
- Obesity, Spinal Cord Injuries, Bronchiolitis Obliterans Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth with dieticianOther
9 weeks of telehealth visit with dietician using the DPP diet modules
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Telehealth with dietician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from enrollment to 9 weeks after completion of the modified DPP-diet program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start13 Feb 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ting Tzen, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924177
- Sponsor's protocol ID
- STU20250145
- Status last verified
- Jul 2026
- First submitted
- 4 Apr 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age, gender, body mass index, whole body fat percentage, HOMA2-IR value
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Dietician-guided Intervention to Combat Neurogenic Obesity in People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06924177
- Acronym / sponsor ID
- STU20250145
- Keywords
- spinal cord injuries, obesity, insulin resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: Telehealth with dietician9 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18-65 years old
- have had SCI for more than one year
- not independently ambulatory
- primarily uses a wheelchair for mobility
- community-dwelling
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth with dietician9 weeks of telehealth visit with dietician using the DPP diet modules | Other | Experiment |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. age, gender, body mass index, whole body fat percentage, HOMA2-IR value
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth with dietician in people with Obesity and Obesity-related Medical Conditions and Spinal Cord Injury, Chronic, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Ting Tzen (214-648-1786, Yi-Ting.Tzen@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body fat composition (time frame: from enrollment to 9 weeks after completion of the modified DPP-diet program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.