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Completed

NCT Number: NCT05953597

Nutrition Education Program in Spinal Cord Injury (SCI)

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).

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christine E. Lynn Rehabilitation Center

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Education

Behavioral

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.

Primary outcomes

  1. 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

  1. Change in Cardiometabolic Biomarkers - Fasting Sodium

    Time frame: Baseline, 12 months

    Measured in millimoles/liter assessed with blood analyses.

  2. Change in Cardiometabolic Biomarkers - Potassium

    Time frame: Baseline, 12 months

    Measured in millimoles/liter assessed with blood analyses.

  3. Change in Cardiometabolic Biomarkers - Chloride

    Time frame: Baseline, 12 months

    Measured in millimoles/liter assessed with blood analyses.

  4. Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen

    Time frame: Baseline, 12 months

    Measured in milligrams/deciliter assessed with blood analyses.

  5. Change in Cardiometabolic Biomarkers - Glucose

    Time frame: Baseline, 12 months

    Measured in milligrams/deciliter assessed with blood analyses.

  6. Change in Cardiometabolic Biomarkers -Triglycerides

    Time frame: Baseline, 12 months

    Measured in milligrams/deciliter assessed with blood analyses.

  7. Change in Cardiometabolic Biomarkers - Total Cholesterol

    Time frame: Baseline, 12 months

    Measured in milligrams/deciliter assessed with blood analyses.

  8. Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol

    Time frame: Baseline, 12 months

    Measured in milligrams/deciliter assessed with blood analyses.

  9. Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein

    Time frame: Baseline, 12 months

    Measured in milligrams/deciliter assessed with blood analyses.

  10. Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol

    Time frame: Baseline, 12 months

    Measured in milligrams/deciliter assessed with blood analyses.

  11. Change in Cardiometabolic Biomarkers - Hemoglobin a1c

    Time frame: Baseline, 12 months

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

  12. Change in Cardiometabolic Biomarkers - Insulin

    Time frame: Baseline, 12 months

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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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