Effectiveness of a Nutrition Education Program in Improving Nutrition Knowledge and Related Biomarkers in Individuals With Spinal Cord Injury

University of Miami1 site in 1 country20 target enrollmentAugust 1, 2023

ConditionsSpinal Cord Injuries

Overview

Phase: N/A
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: University of Miami
Enrollment: 20
Locations: 1
Primary Endpoint: Change in Nutrition Knowledge
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to assess the effectiveness of a nutrition education program in increasing nutrition knowledge and improving health-related biomarkers in individuals with spinal cord injury (SCI).

Registry

clinicaltrials.gov

Start Date

August 1, 2023

End Date

January 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Elizabeth Felix

Research Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

•Adults with SCI with complete and incomplete (American Spinal Injury Association Impairment Scale Score A-D) paraplegia or ventilator-independent tetraplegia.

Exclusion Criteria

•Participants who do not meet inclusion criteria.
•Adults unable to consent.
•Individuals who are not yet adults (infants, children, teenagers)
•Pregnant women (self-report)
•Prisoners

Outcomes

Primary Outcomes

Change in Nutrition Knowledge

Time Frame: Baseline, 12 months

The General Nutrition Knowledge Questionnaire is an 88-item scale that has a scoring range of 0 to 88 with a high score indicating more knowledge of nutrition.

Secondary Outcomes

Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Potassium(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen(Baseline, 12 months)
Change in Cardiometabolic Biomarkers -Triglycerides(Baseline, 12 months)
Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Chloride(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Glucose(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Total Cholesterol(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Hemoglobin a1c(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Insulin(Baseline, 12 months)
Change in Cardiometabolic Biomarkers - Fasting Sodium(Baseline, 12 months)