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Nutrition Education Program in Spinal Cord Injury (SCI)

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition Education
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Metabolic dysfunction, Nutrition education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christine E. Lynn Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutrition Education Group

Arm Description

Participants in this study arm will receive nutrition education once a month for 12 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2023
Last Updated
September 16, 2023
Sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05953597
Brief Title
Nutrition Education Program in Spinal Cord Injury (SCI)
Official Title
Effectiveness of a Nutrition Education Program in Improving Nutrition Knowledge and Related Biomarkers in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Metabolic dysfunction, Nutrition education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Education Group
Arm Type
Experimental
Arm Description
Participants in this study arm will receive nutrition education once a month for 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
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 Outcome Measure Information:
Title
Change in Nutrition Knowledge
Description
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.
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in Cardiometabolic Biomarkers - Fasting Sodium
Description
Measured in millimoles/liter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Potassium
Description
Measured in millimoles/liter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Chloride
Description
Measured in millimoles/liter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen
Description
Measured in milligrams/deciliter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Glucose
Description
Measured in milligrams/deciliter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers -Triglycerides
Description
Measured in milligrams/deciliter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Total Cholesterol
Description
Measured in milligrams/deciliter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol
Description
Measured in milligrams/deciliter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein
Description
Measured in milligrams/deciliter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol
Description
Measured in milligrams/deciliter assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Hemoglobin a1c
Description
Measured as a percentage of hemoglobin a1c, assessed with blood analyses.
Time Frame
Baseline, 12 months
Title
Change in Cardiometabolic Biomarkers - Insulin
Description
Measured in units of insulin per millimeter (uU/ml) assessed with blood analyses.
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth R Felix, PhD
Phone
305-243-4497
Email
efelix@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia M Sneij, PhD, RDN
Phone
305-243-6078
Email
a.sneij@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth R Felix, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christine E. Lynn Rehabilitation Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia M Sneij, PhD
Phone
305-243-6078
Email
a.sneij@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth R Felix, PhD
First Name & Middle Initial & Last Name & Degree
Alicia M Sneij, PhD, RDN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36556250
Citation
Sneij A, Farkas GJ, Carino Mason MR, Gater DR. Nutrition Education to Reduce Metabolic Dysfunction for Spinal Cord Injury: A Module-Based Nutrition Education Guide for Healthcare Providers and Consumers. J Pers Med. 2022 Dec 7;12(12):2029. doi: 10.3390/jpm12122029.
Results Reference
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Nutrition Education Program in Spinal Cord Injury (SCI)

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