Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Eat Smart, Live Better
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility 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
Sites / Locations
- Carolinas Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Treatment
Arm Description
Control group will receive standard of care
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"
Outcomes
Primary Outcome Measures
Nutrition Behavior and Knowledge, measured by Likert scale
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
Body Mass Index
participants will be weighed and measured and BMI calculated
Waist Circumference
Laboratories - Fasting lipid panel
Fasting lipid panel
Laboratories - Fasting blood glucose
Fasting blood glucose
Laboratories - High Sensitivity C-reactive protein
High Sensitivity C-reactive protein
Diet quality as measured by Diet History Questionnaire (DHQ) II
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.
Full Information
NCT ID
NCT02368405
First Posted
February 10, 2015
Last Updated
August 24, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02368405
Brief Title
Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury
Official Title
Nutrition Education for Cardiovascular Disease Prevention in Individuals With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
Study allocation was placed in concealed envelopes by research volunteer who was not otherwise involved in the study.
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group will receive standard of care
Arm Title
Treatment
Arm Type
Experimental
Arm 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"
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Eat Smart, Live Better
Intervention Description
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 Measure Information:
Title
Nutrition Behavior and Knowledge, measured by Likert scale
Description
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.
Time Frame
Change from baseline at three months, and 12 months
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
participants will be weighed and measured and BMI calculated
Time Frame
Baseline and 12 months
Title
Waist Circumference
Time Frame
Baseline and 12 months
Title
Laboratories - Fasting lipid panel
Description
Fasting lipid panel
Time Frame
Baseline and 12 months
Title
Laboratories - Fasting blood glucose
Description
Fasting blood glucose
Time Frame
Baseline and 12 months
Title
Laboratories - High Sensitivity C-reactive protein
Description
High Sensitivity C-reactive protein
Time Frame
Baseline and 12 months
Title
Diet quality as measured by Diet History Questionnaire (DHQ) II
Description
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.
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse A Lieberman, MD, MSPH
Organizational Affiliation
Carolinas Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32476140
Citation
Hooper L, Abdelhamid AS, Jimoh OF, Bunn D, Skeaff CM. Effects of total fat intake on body fatness in adults. Cochrane Database Syst Rev. 2020 Jun 1;6(6):CD013636. doi: 10.1002/14651858.CD013636.
Results Reference
derived
PubMed Identifier
29202852
Citation
Lieberman JA, McClelland JW, Goff DC Jr, Racine E, Dulin MF, Bauman WA, Niemeier J, Hirsch MA, Norton HJ, Moore CG. Nutrition education for cardiovascular disease prevention in individuals with spinal cord injuries: study protocol for a randomized controlled trial. Trials. 2017 Dec 4;18(1):584. doi: 10.1186/s13063-017-2263-2.
Results Reference
derived
Learn more about this trial
Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury
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