Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03457558
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2018-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2018-03-01', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food Security', 'timeFrame': 'Completed at time of enrollment', 'description': '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.'}, {'measure': 'Perception Barriers', 'timeFrame': 'Completed at time of enrollment', 'description': 'Perceived personal, social, and environmental barriers will be measured using a questionnaire previously used among young women'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nOur 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years old\n* 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)\n* Community wheelchair user\n* Voluntary, informed consent of participant and interest in participating in further research studies\n* Lives in the community, not a skilled nursing facility\n\nExclusion Criteria:\n\n* age \\<18 years old\n* Chronic, nontobacco substance-abuse\n* Community ambulator'}, 'identificationModule': {'nctId': 'NCT03457558', 'briefTitle': 'Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Assessment of Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries Living in the Community', 'orgStudyIdInfo': {'id': '05-17-21E'}}, 'contactsLocationsModule': {'locations': [{'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Rehabilitation', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Jesse Lieberman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}