Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-09 @ 8:02 AM
Study NCT ID:
NCT02368405
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Nutrition Education for Cardiovascular Disease Prevention in Individuals With Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled trial to study a nutrition education intervention in individuals with spinal cord injuries both in the acute rehabilitation setting (n = 100) and the community setting (n = 100). Participants in the treatment group will receive six interactive nutrition lectures based upon a successful program that has been used in older adults titled "Eat Smart, Stay Well". The goals of intervention are to improve whole-grain, fruit and vegetable, and low-fat dairy intake and reduce fat and saturated fat intake. Secondary outcomes will include improvements in waist circumference of body mass index and some biomarkers such as cholesterol and blood sugar.
Detailed Description:
The prevalence of SCI is significant. Obesity, diabetes, and CVD are more prevalent in the SCI population. Many individuals with SCI are unable or have a limited capacity to exercise. This reality makes good nutrition even more urgent. This study will be the first to test whether additional nutrition education can improve nutrition behavior and knowledge, diet quality, adiposity, and metabolic CVD risk factors in individuals with SCI and to determine the best setting to deliver nutrition education to individuals with SCI.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: