Nutrition Education for Cardiovascular Disease Prevention in Spinal Cord Injury
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2020
CompletedAugust 30, 2022
February 1, 2022
5.2 years
February 10, 2015
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline at three months, and 12 months
Secondary Outcomes (6)
Body Mass Index
Baseline and 12 months
Waist Circumference
Baseline and 12 months
Laboratories - Fasting lipid panel
Baseline and 12 months
Laboratories - Fasting blood glucose
Baseline and 12 months
Laboratories - High Sensitivity C-reactive protein
Baseline and 12 months
- +1 more secondary outcomes
Study Arms (2)
Control
ACTIVE COMPARATORControl group will receive standard of care
Treatment
EXPERIMENTALParticipants 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"
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- American Spinal Injury Association classification A, B, C as long as they are not functional ambulators
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolinas Rehabilitation
Charlotte, North Carolina, 28203, United States
Related Publications (2)
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.
PMID: 32476140DERIVEDLieberman 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.
PMID: 29202852DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesse A Lieberman, MD, MSPH
Carolinas Rehabilitation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Study allocation was placed in concealed envelopes by research volunteer who was not otherwise involved in the study.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 23, 2015
Study Start
February 1, 2015
Primary Completion
April 1, 2020
Study Completion
June 26, 2020
Last Updated
August 30, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share