Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury

August 24, 2022 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Control group will receive standard of care
Behavioral: Control
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)
Experimental: Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at three months, and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Jesse A Lieberman, MD, MSPH, Carolinas Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 26, 2020

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-14-06E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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