NCT05953597

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

July 10, 2023

Last Update Submit

September 3, 2024

Conditions

Spinal Cord Injuries

Keywords

Metabolic dysfunctionNutrition education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Change in Cardiometabolic Biomarkers - Fasting Sodium

    Baseline, 12 months

  • Change in Cardiometabolic Biomarkers - Potassium

    Baseline, 12 months

  • Change in Cardiometabolic Biomarkers - Chloride

    Baseline, 12 months

  • Change in Cardiometabolic Biomarkers - Blood Urea Nitrogen

    Baseline, 12 months

  • Change in Cardiometabolic Biomarkers - Glucose

    Baseline, 12 months

  • +7 more secondary outcomes

Study Arms (1)

Nutrition Education Group

EXPERIMENTAL

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

Behavioral: Nutrition Education

Interventions

Nutrition EducationBEHAVIORAL

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.

Nutrition Education Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adults with SCI with complete and incomplete (American Spinal Injury Association Impairment Scale Score A-D) paraplegia or ventilator-independent tetraplegia.

You may not qualify if:

  • Adults unable to consent.
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women (self-report)
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christine E. Lynn Rehabilitation Center

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • 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.

    PMID: 36556250BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Elizabeth R Felix, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 20, 2023

Study Start

August 1, 2023

Primary Completion

July 3, 2024

Study Completion

July 3, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)