Nutrition Education Program in Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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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).

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Nutrition Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition Education Group<br>Participants in this study arm will receive nutrition education once a month for 12 months. | Behavioral: Nutrition Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic dysfunction, Nutrition education