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Nutrition Education Program in Spinal Cord Injury (SCI)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05953597
Enrollment
10
Registered
2023-07-20
Start date
2023-08-01
Completion date
2024-07-03
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Metabolic dysfunction, Nutrition education

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).

Interventions

BEHAVIORALNutrition 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.

Sponsors

The Craig H. Neilsen Foundation
CollaboratorOTHER
University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Nutrition KnowledgeBaseline, 12 monthsThe 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

MeasureTime frameDescription
Change in Cardiometabolic Biomarkers - PotassiumBaseline, 12 monthsMeasured in millimoles/liter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - ChlorideBaseline, 12 monthsMeasured in millimoles/liter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Blood Urea NitrogenBaseline, 12 monthsMeasured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - GlucoseBaseline, 12 monthsMeasured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers -TriglyceridesBaseline, 12 monthsMeasured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Fasting SodiumBaseline, 12 monthsMeasured in millimoles/liter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Low Density Lipoprotein CholesterolBaseline, 12 monthsMeasured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Very-low-density lipoproteinBaseline, 12 monthsMeasured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterolBaseline, 12 monthsMeasured in milligrams/deciliter assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Hemoglobin a1cBaseline, 12 monthsMeasured as a percentage of hemoglobin a1c, assessed with blood analyses.
Change in Cardiometabolic Biomarkers - InsulinBaseline, 12 monthsMeasured in units of insulin per millimeter (uU/ml) assessed with blood analyses.
Change in Cardiometabolic Biomarkers - Total CholesterolBaseline, 12 monthsMeasured in milligrams/deciliter assessed with blood analyses.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026