Nutrition Education Program in Spinal Cord Injury (SCI)

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: Nutrition Education

• Registration Number: NCT05953597
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-20
• Study Start: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-16
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutrition Education Group	Nutrition Education	Participants in this study arm will receive nutrition education once a month for 12 months.

Primary Outcome Measures

Name	Time	Method
Change in Nutrition Knowledge	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 Outcome Measures

Name	Time	Method
Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein	Baseline, 12 months	Measured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Potassium	Baseline, 12 months	Measured in millimoles/liter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen	Baseline, 12 months	Measured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers -Triglycerides	Baseline, 12 months	Measured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol	Baseline, 12 months	Measured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Chloride	Baseline, 12 months	Measured in millimoles/liter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Glucose	Baseline, 12 months	Measured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Total Cholesterol	Baseline, 12 months	Measured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol	Baseline, 12 months	Measured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Hemoglobin a1c	Baseline, 12 months	Measured as a percentage of hemoglobin a1c, assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Insulin	Baseline, 12 months	Measured in units of insulin per millimeter (uU/ml) assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Fasting Sodium	Baseline, 12 months	Measured in millimoles/liter assessed with blood analyses.

Trial Locations

Locations (1)

Christine E. Lynn Rehabilitation Center; 🇺🇸 Miami, Florida, United States