NCT05953597RecruitingNot Applicable
Effectiveness of a Nutrition Education Program in Improving Nutrition Knowledge and Related Biomarkers in Individuals With Spinal Cord Injury
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Miami
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in Nutrition Knowledge
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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
- Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Potassium(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers -Triglycerides(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Chloride(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Glucose(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Total Cholesterol(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Hemoglobin a1c(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Insulin(Baseline, 12 months)
- Change in Cardiometabolic Biomarkers - Fasting Sodium(Baseline, 12 months)
Investigators
Elizabeth Felix
Research Professor
University of Miami
Study Sites (2)
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