Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Behavioral: Eat Smart, Live Better; Behavioral: Control

• Registration Number: NCT02368405
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-23
• Primary Completion: 2020-04
• Study Completion: 2020-06-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Eat Smart, Live Better	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"
Control	Control	Control group will receive standard of care

Primary Outcome Measures

Name	Time	Method
Nutrition Behavior and Knowledge, measured by Likert scale	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 Outcome Measures

Name	Time	Method
Diet quality as measured by Diet History Questionnaire (DHQ) II	Baseline and 12 months	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.
Laboratories - Fasting blood glucose	Baseline and 12 months	Fasting blood glucose
Body Mass Index	Baseline and 12 months	participants will be weighed and measured and BMI calculated
Waist Circumference	Baseline and 12 months
Laboratories - Fasting lipid panel	Baseline and 12 months	Fasting lipid panel
Laboratories - High Sensitivity C-reactive protein	Baseline and 12 months	High Sensitivity C-reactive protein

Trial Locations

Locations (1)

Carolinas Rehabilitation; 🇺🇸 Charlotte, North Carolina, United States