Nutrition Education for Cardiovascular Disease Prevention in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Nutrition Behavior and Knowledge, measured by Likert scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study allocation was placed in concealed envelopes by research volunteer who was not otherwise involved in the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Spinal Injury Association classification A, B, C as long as they are not functional ambulators
排除标准
- •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
结局指标
主要结局
Nutrition Behavior and Knowledge, measured by Likert scale
时间窗: 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.
次要结局
- Laboratories - Fasting blood glucose(Baseline and 12 months)
- Diet quality as measured by Diet History Questionnaire (DHQ) II(Baseline and 12 months)
- Body Mass Index(Baseline and 12 months)
- Waist Circumference(Baseline and 12 months)
- Laboratories - Fasting lipid panel(Baseline and 12 months)
- Laboratories - High Sensitivity C-reactive protein(Baseline and 12 months)