Clinical trial NCT02368405: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Nutrition Behavior and Knowledge, measured by Likert scale
timeFrame: Change from baseline at three months, and 12 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Baseline and 12 months
measure: Waist Circumference
timeFrame: Baseline and 12 months
measure: Laboratories - Fasting lipid panel
timeFrame: Baseline and 12 months
measure: Laboratories - Fasting blood glucose
timeFrame: Baseline and 12 months
measure: Laboratories - High Sensitivity C-reactive protein
timeFrame: Baseline and 12 months
measure: Diet quality as measured by Diet History Questionnaire (DHQ) II
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
Study officials:
affiliation: Carolinas Rehabilitation
name: Jesse A Lieberman, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.