Telehealth Dietary Program for Spinal Cord Injury

Overseen By Yi-Ting Tzen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Uncontrolled diabetes, Pregnancy, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 9 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special 9-week diet program, the Modified DPP-diet, can help people with spinal cord injuries reduce body fat and improve insulin management. Participants will attend weekly online meetings with a dietician and provide feedback on factors that aid or hinder adherence to the diet in daily life. Individuals who have used a wheelchair for over a year due to a spinal cord injury and do not have uncontrolled diabetes are suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that may enhance dietary strategies for spinal cord injury patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this dietary program is safe for people with spinal cord injury?

Research has shown that the modified DPP-diet, based on the National Diabetes Prevention Program, has been studied for its effects on people with spinal cord injuries. These individuals often face a higher risk of health problems like heart disease and type 2 diabetes.

A study on lifestyle changes found that such programs can help manage these risks. Participants in similar programs reported better overall health without serious side effects, suggesting that the modified DPP-diet is generally easy to follow.

No major reports of negative effects have emerged from similar diet programs, indicating the safety of the modified DPP-diet. However, since this study is observational, it does not test the diet like a drug trial would. Nonetheless, the absence of negative reports and the focus on healthy eating habits suggest a low risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing spinal cord injury through a Telehealth Dietary Program. Unlike typical treatments that might focus on physical rehabilitation or medication, this program leverages telehealth technology to deliver a structured dietary intervention designed to prevent Type 2 Diabetes. The use of DPP (Diabetes Prevention Program) modules is unique, as it provides a comprehensive, remote dietary education with personalized support from a dietician, making it accessible and convenient for patients. This trial could offer a new, preventative dimension to spinal cord injury care by focusing on diet and lifestyle changes.

What evidence suggests that the modified DPP-diet is effective for reducing body fat and insulin resistance in people with spinal cord injury?

Research has shown that the modified Diabetes Prevention Program (DPP) diet, which participants in this trial will follow, can help reduce body fat and improve insulin use. Studies have found that this diet led to significant weight loss and lowered the risk of developing type-2 diabetes by 58% in participants. When adjusted for people with spinal cord injuries, the program also successfully reduced risks related to heart disease, diabetes, and stroke. These findings suggest that the modified DPP diet can be a promising way to manage body weight and insulin use in individuals with spinal cord injuries. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injury who are also dealing with obesity. Participants should be interested in a dietary program and willing to engage in telehealth visits with a dietician over 9 weeks. They must be able to visit the laboratory at specific times during the study.

Inclusion Criteria

* have had SCI for more than one year

* not independently ambulatory

* primarily uses a wheelchair for mobility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 9-week dietician-guided program modified from the National Diabetic Prevention Program via Telehealth

9 weeks

9 Telehealth visits with dietician

Follow-up

Participants visit the laboratory to assess body composition and insulin sensitivity before, immediately after, and 9 weeks post-treatment

9 weeks

3 laboratory visits

What Are the Treatments Tested in This Trial?

Interventions

• Modified DPP-diet

Trial Overview The trial is testing a modified diet from the National Diabetic Prevention Program, delivered via telehealth by a certified dietician, focusing on its impact on body composition and insulin sensitivity among those with spinal cord injuries.

How Is the Trial Designed?

Group I: Experiment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11414834/

Modification of the Diabetes Prevention Program Lifestyle ... This intervention study demonstrates effectiveness of a TLI adapted from the DPP on addressing cardiometabolic risks and improving overall health-related ...

2. nature.com nature.com/articles/scsandc20177

A lifestyle intervention program for successfully addressing ... Results showed both significant weight loss and a 58% decrease in the incidence of type-2 diabetes mellitus in the lifestyle intervention trial ...

3. news.med.miami.edu news.med.miami.edu/miami-project-researchers-introduce-a-lifestyle-intervention-diabetes-prevention-program-for-spinal-cord-injury/

Miami Project Researchers Introduce a Lifestyle Intervention ... When spinal cord injury (SCI) is added to the equation, the challenges of losing weight and the risk of developing heart disease and diabetes ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39309246/

Efficacy for Reducing Major Cardiometabolic Risks ... Modification of the Diabetes Prevention Program Lifestyle Intervention in Persons with Spinal Cord Injury: Efficacy for Reducing Major Cardiometabolic Risks ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379720303238

Group Lifestyle Balance Adapted for Individuals With ... Participants achieved significant 12-month weight loss of 3.31 (SD=10.13) kg (d=0.33) in mixed modeling analyses with groups combined yet did not significantly ...

6. clinicaltrials.gov clinicaltrials.gov/study/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 ( ...

7. mdpi.com mdpi.com/1660-4601/20/19/6819

A Study Protocol of a Multisite Randomized Controlled Trial Chronic spinal cord injury (SCI) is associated with increased risk for cardiometabolic disease (CMD), all-cause cardiovascular disease (CVD), and type 2 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723002555

Review Mapping of Dietary Interventions Beneficial in the ... To provide a catalogue of dietary interventions beneficial in prevention of SHC among individuals with SCI by conducting a systematic review of the literature ...