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

Trial Summary

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 data supports the effectiveness of the treatment Modified DPP-diet for spinal cord injury?

Research suggests that dietary interventions, like a low-carbohydrate/high-protein diet, can improve body composition and lipid profiles in individuals with spinal cord injury. Additionally, dietary restriction has been shown to promote functional recovery and increase lifespan in animal models of spinal cord injury. ^{1 2 3 4 5}

Is the Telehealth Dietary Program for Spinal Cord Injury safe for humans?

Research on dietary restriction, like every-other-day fasting, suggests it is low-risk and may improve recovery and lifespan in spinal cord injury models. While specific safety data for humans is limited, similar dietary interventions have been beneficial in animal studies. ^{1 3 4 6 7}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Early versus late enteral feeding in patients with acute cervical spinal cord injury: a pilot study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of nutritional intake between individuals with acute and chronic spinal cord injury. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Energy expenditure and nutrient intake after spinal cord injury: a comprehensive review and practical recommendations. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Prophylactic dietary restriction may promote functional recovery and increase lifespan after spinal cord injury. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of a low-carbohydrate/high-protein diet on metabolic health in individuals with chronic spinal cord injury: An exploratory analysis of results from a randomized controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Energy balance following diets of varying fat content: metabolic dysregulation in a rodent model of spinal cord contusion. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The comparison of total energy and protein intake relative to estimated requirements in chronic spinal cord injury. [2023]