Clinical Trials Directory

Trials / Completed

CompletedNCT02368405

Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
78 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALControlParticipants 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)
BEHAVIORALEat Smart, Live BetterIntervention 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.

Timeline

Start date
2015-02-01
Primary completion
2020-04-01
Completion
2020-06-26
First posted
2015-02-23
Last updated
2022-08-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02368405. Inclusion in this directory is not an endorsement.