NCT03457558

Brief Summary

Food security is one's ability to get food. Individuals with a Spinal Cord Injury (SCI) have many risk factors for low rates of food security. Some of these risk factors include lower levels of income and employment. Our long-term goal is to identify if food security is more prevalent in the SCI population, and to develop ways to improve food security in the SCI population. The purpose of this study is to determine the rates of food insecurity in a sample of people living with a SCI and to identify some perceptions of barriers to healthy eating in the SCI population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
Last Updated

April 27, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

March 1, 2018

Last Update Submit

April 20, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Food Security

    The US Adult Food Security Survey will be administered to all participants. They will each receive a score of 0-10. A score of zero represents high food security. A score of 1-2 represents marginal food security. A score of 3-5 represents low food security, and a score of 6-10 represents very low food security.

    Completed at time of enrollment

  • Perception Barriers

    Perceived personal, social, and environmental barriers will be measured using a questionnaire previously used among young women

    Completed at time of enrollment

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults, \>18 years of age, of any ethnicity and race, with history of a SCI without the diagnosis of multiple sclerosis or malignant cancer, at least one year prior to enrollment in the study. All participants will be community wheelchair users.

You may qualify if:

  • age \> 18 years old
  • Male or female, any ethnicity, with the history of a spinal cord injury at least one year prior (without a diagnosis of Multiple Sclerosis or malignant cancer)
  • Community wheelchair user
  • Voluntary, informed consent of participant and interest in participating in further research studies
  • Lives in the community, not a skilled nursing facility

You may not qualify if:

  • age \<18 years old
  • Chronic, nontobacco substance-abuse
  • Community ambulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jesse Lieberman

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 7, 2018

Study Start

October 1, 2017

Primary Completion

September 25, 2020

Study Completion

September 25, 2020

Last Updated

April 27, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations