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Trial record 45 of 304 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

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

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ClinicalTrials.gov Identifier: NCT03457558
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jesse Lieberman, Carolinas Healthcare System

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.

Condition or disease
Spinal Cord Injuries

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 : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Assessment of Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries Living in the Community
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Food Security [ Time Frame: Completed at time of enrollment ]
    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.

  2. Perception Barriers [ Time Frame: Completed at time of enrollment ]
    Perceived personal, social, and environmental barriers will be measured using a questionnaire previously used among young women



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457558


Contacts
Contact: Jesse Lieberman, MD 704-355-0649 Jesse.Lieberman@Carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Rehabilitation Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jesse A Lieberman, MD, MSPH    704-355-0649    Jesse.Lieberman@Carolinashealthcare.org   
Contact: Sherri Stutts    704-355-4906    Sherri.R.Stutts@carolinashealthcare.org   
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Jesse Lieberman Carolinas Healthcare System

Responsible Party: Jesse Lieberman, Principal Investigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT03457558     History of Changes
Other Study ID Numbers: 05-17-21E
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System