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Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02368405
Recruitment Status : Recruiting
First Posted : February 23, 2015
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jesse Lieberman, Carolinas Healthcare System

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Behavioral: Control Behavioral: Eat Smart, Live Better Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutrition Education for Cardiovascular Disease Prevention in Individuals With Spinal Cord Injury
Actual Study Start Date : February 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Body Mass Index [ Time Frame: Baseline and 12 months ]
    participants will be weighed and measured and BMI calculated

  2. Waist Circumference [ Time Frame: Baseline and 12 months ]
  3. Laboratories - Fasting lipid panel [ Time Frame: Baseline and 12 months ]
    Fasting lipid panel

  4. Laboratories - Fasting blood glucose [ Time Frame: Baseline and 12 months ]
    Fasting blood glucose

  5. Laboratories - High Sensitivity C-reactive protein [ Time Frame: Baseline and 12 months ]
    High Sensitivity C-reactive protein

  6. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368405


Contacts
Contact: Sherri Stutts 704-355-4906 Sherri.R.Stutts@carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Rehabilitation Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jesse A Lieberman, MD, MSPH    704-355-0649    Jesse.Lieberman@Carolinashealthcare.org   
Contact: Sherri Stutts    704-355-4906    Sherri.R.Stutts@carolinashealthcare.org   
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Jesse A Lieberman, MD, MSPH Carolinas Rehabilitation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesse Lieberman, Assistant Professor, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT02368405     History of Changes
Other Study ID Numbers: 09-14-06E
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Wounds and Injuries
Cardiovascular Diseases
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System