Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Adherence to prescribed macronutrient composition as measured by multiple pass 24 hour dietary recall
研究概览
简要总结
The purpose of this study is to examine the effectiveness of a low carbohydrate diet on increasing dietary adherence and improving cardiometabolic risk factors among adults with spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one of two groups: 1) a reduced carbohydrate diet or 2): a "standard" diet (STD). Participants will take part in a 6-month behavioral lifestyle intervention implemented through a novel eHealth platform specially designed for individuals with SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI ≥ 1 year post injury
- •able to use arms for exercise
- •BMI of 22-50 kg/m2
- •19-60 years old
- •reliable access to internet and smartphone
- •have the ability to converse in English
- •ability to prepare own food or have input into person responsible for food preparation
排除标准
- •heart disease
- •renal disease
- •active pressure sore
- •persons on medically restricted diets
结局指标
主要结局
Adherence to prescribed macronutrient composition as measured by multiple pass 24 hour dietary recall
时间窗: 6 months
Participants will record 3 days of food intake at each measurement time point. Calories and macronutrient values from the 3 days will be averaged. We will calculate an adherence score using methodology described by Alhassan et al. Adherence will be measured as the difference between recorded intake and prescribed intake of the macronutrient of interest for each group (i.e., carbohydrates for the low carbohydrate group, fat for the standard group). For example, if a participant in the low carbohydrate group is prescribed a limit of 50g of CHO/day, and recorded intake is 70g, the adherence score will be 20. A score of 0 indicates meeting recommended values, and higher scores indicate poorer adherence than lower scores.
次要结局
未报告次要终点
研究者
Brooks C. Wingo, PhD
Assistant Professor
University of Alabama at Birmingham