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CompletedNCT03457558Updated Apr 27, 2022

Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries

An observational study in Spinal Cord Injuries, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-27.

Sponsored by Wake Forest University Health Sciences · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
149
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Food security is one's ability to get food. Individuals with a SCI have many risk factors for low rates of food security. Some of these risk factors include lower levels of income and employment. This study consists of a one-time survey using the US Adult Food Security Survey and another previously validated survey about perceptions of barriers to healthy eating.

Our long-term goal is to develop a large SCI food security and perceived barriers to healthy eating multicenter study in order to determine if these factors are significant issues in the SCI population. We also aim to determine the causes of these issues in order to develop interventions to improve the health of all people living with a SCI and potentially reduce their health care costs. 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. This will also develop preliminary data to support a NIH R level grant application for a large, multicenter study to further explore SCI food security at the national level. Our central hypothesis is that there will be an increased rate of food insecurity in the SCI population compared to other groups in the literature, and that this will be associated with income and environmental barriers.

02

Conditions studied

  • Spinal Cord Injuries
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • age \<18 years old
  • Chronic, nontobacco substance-abuse
  • Community ambulator
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
149 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Completed at time of enrollment

  2. Perception Barriers

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

    Time frame: Completed at time of enrollment

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Study locations

1 site
  • Carolinas Rehabilitation
    Charlotte, North Carolina 28203, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03457558
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Oct 1, 2017
Primary completion
Sep 25, 2020
Completion
Sep 25, 2020
Last update
Apr 27, 2022

Study contacts

Jesse Lieberman
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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