Nutrition Education Program in Spinal Cord Injury (SCI)

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05953597
• Collaborator: The Craig H. Neilsen Foundation (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Behavioral: Nutrition Education	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effectiveness of a Nutrition Education Program in Improving Nutrition Knowledge and Related Biomarkers in Individuals With Spinal Cord Injury
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nutrition Education Group Participants in this study arm will receive nutrition education once a month for 12 months.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in Cardiometabolic Biomarkers - Fasting Sodium [Baseline, 12 months]

   Measured in millimoles/liter assessed with blood analyses.

2. Change in Cardiometabolic Biomarkers - Potassium [Baseline, 12 months]

   Measured in millimoles/liter assessed with blood analyses.

3. Change in Cardiometabolic Biomarkers - Chloride [Baseline, 12 months]

   Measured in millimoles/liter assessed with blood analyses.

4. Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen [Baseline, 12 months]

   Measured in milligrams/deciliter assessed with blood analyses.

5. Change in Cardiometabolic Biomarkers - Glucose [Baseline, 12 months]

   Measured in milligrams/deciliter assessed with blood analyses.

6. Change in Cardiometabolic Biomarkers -Triglycerides [Baseline, 12 months]

   Measured in milligrams/deciliter assessed with blood analyses.

7. Change in Cardiometabolic Biomarkers - Total Cholesterol [Baseline, 12 months]

   Measured in milligrams/deciliter assessed with blood analyses.

8. Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol [Baseline, 12 months]

   Measured in milligrams/deciliter assessed with blood analyses.

9. Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein [Baseline, 12 months]

   Measured in milligrams/deciliter assessed with blood analyses.

10. Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol [Baseline, 12 months]

    Measured in milligrams/deciliter assessed with blood analyses.

11. Change in Cardiometabolic Biomarkers - Hemoglobin a1c [Baseline, 12 months]

    Measured as a percentage of hemoglobin a1c, assessed with blood analyses.

12. Change in Cardiometabolic Biomarkers - Insulin [Baseline, 12 months]

    Measured in units of insulin per millimeter (uU/ml) assessed with blood analyses.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christine E. Lynn Rehabilitation Center	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• The Craig H. Neilsen Foundation

Investigators

• Principal Investigator: Elizabeth R Felix, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Elizabeth Felix, Research Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT05953597
• Other Study ID Numbers: 20230569
• First Posted: Jul 20, 2023
• Last Update Posted: Jul 20, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elizabeth Felix, Research Professor, University of Miami: Metabolic dysfunction; Nutrition education
• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Jul 20, 2023