Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- adherence to dietary sodium targets as assessed from 3-day food recalls
研究概览
简要总结
With this study the investigators will test, in a randomised clinical trial (RCT), the efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a 4-month PDA-based dietary counseling intervention or to a 4-month attention control. Potential participants will be stratified by whether or not they have diabetes. Data on primary and secondary outcomes will be obtained at baseline and four months. Primary dependent variables are:
- adherence to dietary sodium targets as assessed from 3-day food recalls,
- average monthly interdialytic weight gain, and
- average pulse pressure. Secondary dependent variables are:
- adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and phosphorus levels determined on a monthly basis, and (6) nutritional status as determined from serum albumin. Laboratory data, interdialytic weight gain, and blood pressure data will be obtained per dialysis center routine and abstracted from the medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and analyzed using the Nutrient Data System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those individuals who are 21 years of age or older
- •Community-dwelling adults
- •Receiving maintenance HD for at least 3 months
排除标准
- •Individuals who cannot read or write
- •Those who do not speak English
- •Those who plan to move out of the area or change dialysis centers within the next 6 months
- •Those with a terminal illness and life expectancy of less than 12 months
- •Those who are scheduled for a living donor transplant
- •Individuals who cannot see the PDA screen or use the stylus to make selections from the PDA screen.
- •Those individuals with a score ≤ 26 on the Mini Mental Status Exam.
- •Also excluded will be individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake.
结局指标
主要结局
adherence to dietary sodium targets as assessed from 3-day food recalls
时间窗: baseline and 4 months
average daily interdialytic weight gain (IDWG)
时间窗: IDWG gathered with each dialysis treatment
average pulse pressure from pre-dialysis blood pressures
时间窗: with each dialysis treatment
次要结局
- adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls(collected at baseline and 4 months)
- serum potassium and phosphorus levels(baseline, and 1, 2, 3, and 4 months)
- nutritional status as determined from serum albumin(baseline, 1, 2, 3, and 4 months)