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
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Behavioral: Control Behavioral: Eat Smart, Live Better||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Active Comparator: Control
Control group will receive standard of care
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)
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.
- 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.
- Body Mass Index [ Time Frame: Baseline and 12 months ]participants will be weighed and measured and BMI calculated
- Waist Circumference [ Time Frame: Baseline and 12 months ]
- Laboratories - Fasting lipid panel [ Time Frame: Baseline and 12 months ]Fasting lipid panel
- Laboratories - Fasting blood glucose [ Time Frame: Baseline and 12 months ]Fasting blood glucose
- Laboratories - High Sensitivity C-reactive protein [ Time Frame: Baseline and 12 months ]High Sensitivity C-reactive protein
- 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.
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
|Contact: Sherri Stutts||704-355-4906||Sherri.R.Stutts@carolinashealthcare.org|
|United States, North Carolina|
|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|
|Principal Investigator:||Jesse A Lieberman, MD, MSPH||Carolinas Rehabilitation|