Nutrition Education Program in Spinal Cord Injury (SCI)

September 16, 2023 updated by: Elizabeth Felix, University of Miami

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elizabeth R Felix, PhD
  • Phone Number: 305-243-4497
  • Email: efelix@miami.edu

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Christine E. Lynn Rehabilitation Center
        • Principal Investigator:
          • Elizabeth R Felix, PhD
        • Contact:
        • Sub-Investigator:
          • Alicia M Sneij, PhD, RDN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

The Craig H. Neilsen Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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