Spinal Cord InjuriesNCT05953597
Nutrition Education Program in Spinal Cord Injury (SCI)
A study testing Nutrition Education in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 3 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with SCI with complete and incomplete (American Spinal Injury Association Impairment Scale Score A-D) paraplegia or ventilator-independent tetraplegia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Christine E. Lynn Rehabilitation Center
Miami, Florida, 33136
About this study
Official title: Effectiveness of a Nutrition Education Program in Improving Nutrition Knowledge and Related Biomarkers in Individuals with Spinal Cord Injury
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).
- Conditions
- Spinal Cord Injuries
- Being tested
- Nutrition Education
- Keywords
- Metabolic dysfunction, Nutrition education
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education Group | Experimental | Participants in this study arm will receive nutrition education once a month for 12 months. Receives: Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 months
Secondary outcomes (12)
Change in Cardiometabolic Biomarkers - Fasting Sodium
Measured in millimoles/liter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Potassium
Measured in millimoles/liter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Chloride
Measured in millimoles/liter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen
Measured in milligrams/deciliter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Glucose
Measured in milligrams/deciliter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers -Triglycerides
Measured in milligrams/deciliter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Total Cholesterol
Measured in milligrams/deciliter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol
Measured in milligrams/deciliter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein
Measured in milligrams/deciliter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol
Measured in milligrams/deciliter assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Hemoglobin a1c
Measured as a percentage of hemoglobin a1c, assessed with blood analyses.
Measured: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Insulin
Measured in units of insulin per millimeter (uU/ml) assessed with blood analyses.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Aug 2023
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Elizabeth Felix, University of Miami
- Investigators
- Elizabeth R Felix, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953597
- Sponsor's protocol ID
- 20230569
- Status last verified
- Sep 2024
- First submitted
- 10 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36556250
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nutrition Education Program in Improving Nutrition Knowledge and Related Biomarkers in Individuals with Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05953597
- Acronym / sponsor ID
- 20230569
- Conditions
- Spinal Cord Injuries
- Keywords
- Metabolic dysfunction, Nutrition education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education Group | Experimental | Behavioral: Nutrition EducationParticipants in this study arm will receive nutrition education once a month for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with SCI with complete and incomplete (American Spinal Injury Association Impairment Scale Score A-D) paraplegia or ventilator-independent tetraplegia.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition EducationThe 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. | Behavioural | Nutrition Education Group |
Primary outcome
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.
12 secondary outcomes
Change in Cardiometabolic Biomarkers - Fasting Sodium
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Potassium
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Chloride
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Glucose
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers -Triglycerides
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Total Cholesterol
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Low Density Lipoprotein Cholesterol
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Very-low-density lipoprotein
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers -High-density lipoprotein cholesterol
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Hemoglobin a1c
Time frame: Baseline, 12 months
Change in Cardiometabolic Biomarkers - Insulin
Time frame: Baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 36556250Sneij 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth R Felix, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nutrition Knowledge (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.