A 34-Week Single-Blind Trial of Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month
研究概览
简要总结
The purpose of this study is to assess the improvement degree of nutritional care program on the nutritional status and eating habits of hemodialysis patients
详细描述
After being informed about the study and potential risks, all patients giving written Informed consent will undergo a 1-week screening period to determine eligibility For study entry. At week 0, eligible patients will be assigned to the intervention group and the control group by single-blind manner(participant) with convenience sampling. In the intervention group, the patients were trained in The Transtheoretical Model on nutritional education for 8 weeks. In the control group, the patients were trained in roution nutrition education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The participant does not know who the intervention group is versus the control group
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the biochemical value ≥ 5.5 mg/dl or albumin value<3.8g/dL
- •BMI<23kg/m2
- •Unexpected weight loss.
- •Must be able to swallow tablets
排除标准
- •Clinical diagnosis of Alzheimer's Disease
- •Malignant tumors, gastrointestinal cachexia, and catheterization
结局指标
主要结局
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month
时间窗: Baseline and the third month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Change from Baseline in Biochemical value(cholesterol )at the fourth month
时间窗: Baseline and the fourth month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Change from Baseline in Biochemical value( Phosphate) at the fourth month
时间窗: Baseline and the fourth month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the fourth month
时间窗: Baseline and the fourth month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
Change from Baseline in Biochemical value (Albumine) at the fourth month
时间窗: Baseline and the fourth month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Change from Baseline in Biochemical value (Albumine) at the sixth month
时间窗: Baseline and the sixth month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the fourth month
时间窗: Baseline and the fourth month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Change from Baseline in Biochemical value(cholesterol )at the third month
时间窗: Baseline and the third month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Change from Baseline in Biochemical value(cholesterol )at the sixth month
时间窗: Baseline and and the sixth month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Change from Baseline in Biochemical value (Albumine) at the third month
时间窗: Baseline and the third month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the sixth month
时间窗: Baseline and the sitxth month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Change from Baseline in body measurement ( Hand grip strength ) at the fourth month
时间窗: Baseline and the fourth month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the third month
时间窗: Baseline and the third month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
Change from Baseline in Biochemical value(creatine)at the third month
时间窗: Baseline and the third month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Change from Baseline in Biochemical value(creatine) at the fourth month
时间窗: Baseline and the fourth month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Change from Baseline in body measurement ( Hand grip strength ) at the sixth month
时间窗: Baseline and the sixth month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Change from Baseline in Biochemical value(creatine) at the sixth month
时间窗: Baseline and the sixth month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Change from Baseline in Biochemical value( Phosphate) at the third month
时间窗: Baseline and the third month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Change from Baseline in Biochemical value( Phosphate) at the sixth month
时间窗: Baseline and the sixth month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Change from Baseline in body measurement ( Hand grip strength ) at the third month
时间窗: Baseline and the third month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the sixth month
时间窗: Baseline and the six month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
次要结局
- Change from Baseline in the diet of knowledge form at the fourth month(Baseline and the fourth month)
- Change from Baseline in the diet of knowledge form at the third month(Baseline and the third month)
- Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month(Baseline and the fourth month)
- Change from Baseline in the diet of attitude form at the third month(Baseline and the third month)
- Change from Baseline in the diet of attitude form at the sixth month(Baseline and the sixth month)
- Change from Baseline in the high phosphorus food frequency questionnaire at the third month(Baseline and the third month)
- Change from Baseline in the diet of knowledge form at the sixth month(Baseline and the sixth month)
- Change from Baseline in the diet of behavior form at the sixth month(Baseline and the sixth month)
- Change from Baseline in the six major food frequency questionnaire at the third month(Baseline and the third month)
- Change from Baseline in the six major food frequency questionnaire at the sixth month(Baseline and the sixth month)
- Change from Baseline in the diet of attitude form at the fourth month(Baseline and the fourth month)
- Change from Baseline in the diet of behavior form at the third month(Baseline and the third month)
- Change from Baseline in the diet of behavior form at the fourth month(Baseline and the fourth month)
- Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month(Baseline and the sixth month)
- Change from Baseline in the six major food frequency questionnaire at the fourth month(Baseline and the fourth month)
研究者
Liu, Liu-Yin
Nurse
E-DA Hospital