A 34-Week Single-Blind Trial of Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End-Stage Kidney Disease
- Sponsor
- Liu, Liu-Yin
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Liu, Liu-Yin
Nurse
E-DA Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Clinical diagnosis of Alzheimer's Disease
- •Malignant tumors, gastrointestinal cachexia, and catheterization
Outcomes
Primary Outcomes
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)