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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03457558
Other study ID # 05-17-21E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date September 25, 2020

Study information

Verified date February 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date September 25, 2020
Est. primary completion date September 25, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Carolinas Rehabilitation Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Perception Barriers Perceived personal, social, and environmental barriers will be measured using a questionnaire previously used among young women Completed at time of enrollment
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