Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury

Wake Forest University (WFU)

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Behavioral: Control; Behavioral: Eat Smart, Live Better

Study type: Interventional

Funder types: Other

Identifiers

NCT02368405

09-14-06E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

78 participants in 2 patient groups

Control

Active Comparator group

Description:

Control group will receive standard of care

Treatment:

Behavioral: Control

Treatment

Experimental group

Description:

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"

Treatment:

Behavioral: Eat Smart, Live Better