Nutrition Education Program in Spinal Cord Injury (SCI)

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953597
• Other study ID #: 20230569
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Elizabeth R Felix, PhD
• Phone: 305-243-4497
• Email: efelix[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Nutrition Education
The intervention will consist of 12 monthly nutrition education sessions catered to people with spinal cord injuries. The curriculum is based on the 2020-2025 Dietary Guidelines for Americans such as consuming recommended amounts of fruits/vegetables, whole grains, etc. The sessions will be approximately 30-60 minutes and will be available in-person.

Locations

Country	Name	City	State
United States	Christine E. Lynn Rehabilitation Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sneij A, Farkas GJ, Carino Mason MR, Gater DR. Nutrition Education to Reduce Metabolic Dysfunction for Spinal Cord Injury: A Module-Based Nutrition Education Guide for Healthcare Providers and Consumers. J Pers Med. 2022 Dec 7;12(12):2029. doi: 10.3390/jpm12122029. — View Citation

Outcome

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