An interventional study of Control and Eat Smart, Live Better in Spinal Cord Injury, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 78 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
Control group will receive standard of care
Behavioral: Control
Participants in the treatment group will receive six interactive nutrition lectures over the course of three weeks. The treatment program is titled "Eat Smart, Live Better"
Behavioral: Eat Smart, Live Better
Participants in the control group will receive the standard nutrition lecture currently given at Carolinas Rehabilitation to all inpatients with spinal cord injuries. This one lecture is what is required by Commission on Accreditation for Rehabilitation Facilities (CARF)
Intervention participants will participate in a series of six, 60-minute small group sessions of interactive nutrition education discussions led by a Registered Dietitian delivered over 3 weeks. They will also have one follow-up comprehensive nutrition education session approximately 3 months after receipt of the Eat Smart, Live Better curriculum. In order to help us assess the effectiveness of the nutrition education program, we will assess nutrition behavior and knowledge at this time as well. Community participants in the treatment group will attend the sessions at Carolinas Rehabilitation (CR). The control participants from the community will come to CR for the one standard nutrition lecture. Caregivers and spouses of all of the participants will be encouraged to attend the sessions.
Nutrition Behavior and Knowledge, measured by Likert scale
Nutrition behavior will be recorded from two five point Likert scale questions ranging from 1 = not practicing the behavior to 5 = practicing it regularly. Questions are related to eating fruits and vegetables and to decreasing fat intake. The recorded scores for these questions will be pooled for nutrition behavior and range from 2 = very low to 10 = very high.
Time frame: Change from baseline at three months, and 12 months
Body Mass Index
participants will be weighed and measured and BMI calculated
Time frame: Baseline and 12 months
Waist Circumference
Time frame: Baseline and 12 months
Laboratories - Fasting lipid panel
Fasting lipid panel
Time frame: Baseline and 12 months
Laboratories - Fasting blood glucose
Fasting blood glucose
Time frame: Baseline and 12 months
Laboratories - High Sensitivity C-reactive protein
High Sensitivity C-reactive protein
Time frame: Baseline and 12 months
Diet quality as measured by Diet History Questionnaire (DHQ) II
The Diet History Questionnaire (DHQ) II will be administered. Each participant will be assessed for fruit, vegetable, dairy, whole-grain, lean protein, fat, and saturated fat intake. Intake for each food group will also be checked for compliance with the 2010 Dietary Guidelines for Americans.
Time frame: Baseline and 12 months
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Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences