- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03457558
Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries
Assessment of Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries Living in the Community
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- age <18 years old
- Chronic, nontobacco substance-abuse
- Community ambulator
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Food Security
Time Frame: Completed at time of enrollment
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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.
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Completed at time of enrollment
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Perception Barriers
Time Frame: Completed at time of enrollment
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Perceived personal, social, and environmental barriers will be measured using a questionnaire previously used among young women
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Completed at time of enrollment
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Collaborators and Investigators
Investigators
- Principal Investigator: Jesse Lieberman, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-17-21E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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