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Clinical Trials/NCT02368405
NCT02368405
Completed
Not Applicable

Nutrition Education for Cardiovascular Disease Prevention in Individuals With Spinal Cord Injury

Wake Forest University Health Sciences1 site in 1 country78 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
Wake Forest University Health Sciences
Enrollment
78
Locations
1
Primary Endpoint
Nutrition Behavior and Knowledge, measured by Likert scale
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
June 26, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • American Spinal Injury Association classification A, B, C as long as they are not functional ambulators

Exclusion Criteria

  • Stage III or IV pressure ulcers, pregnancy, end-stage renal disease, treatment for cancer except for nonmelanoma skin cancer within the past five years, and chronic, nontobacco substance-abuse, cognitive impairment with inability to learn

Outcomes

Primary Outcomes

Nutrition Behavior and Knowledge, measured by Likert scale

Time Frame: Change from baseline at three months, and 12 months

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.

Secondary Outcomes

  • Laboratories - Fasting blood glucose(Baseline and 12 months)
  • Diet quality as measured by Diet History Questionnaire (DHQ) II(Baseline and 12 months)
  • Body Mass Index(Baseline and 12 months)
  • Waist Circumference(Baseline and 12 months)
  • Laboratories - Fasting lipid panel(Baseline and 12 months)
  • Laboratories - High Sensitivity C-reactive protein(Baseline and 12 months)

Study Sites (1)

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