Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A 34-Week Single-Blind Trial of Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis

Conditions
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End-Stage Kidney Disease, Hyperphosphatemia

Intervention / Treatment
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* Behavioral: multimedia education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The research design explores the evaluation of intervention effectiveness through a parallel group and experimental research design. Intentionally select experimental and control groups. A single blinding design (participants). The experimental group used multi-media education, 20 minutes per session, total 8 courses. The control group received routine education. The Principal investigator explains the research purpose to eligible participant, and signs a consent form. The interviewer conducted data: basic information and nutritional status indicators (mini nutritional assessment scale, dietary knowledge, attitude, behavior scale, simple dietary intake frequency scale) of two groups of hemodialysis patients as the Baseline. After 8-week nutritional education by dialysis nursing staff. Post tests (dietary knowledge, attitude, behavior scale, mini nutritional assessment scale, simple dietary intake frequency scale) were conducted by interviewer at the 3rd, 4th, and 5th months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the theoretical model nutritional education<br>instruction with multimedia | Behavioral: multimedia education<br>* The experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses. The control group use routine education.<br>* Other names: instruction with traditional paper;|
| Placebo Comparator: control<br>instruction with traditional paper | Behavioral: multimedia education<br>* The experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses. The control group use routine education.<br>* Other names: instruction with traditional paper;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Biochemical value (Albumine) at the third month | Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition | Baseline and the third month | 
| Change from Baseline in Biochemical value (Albumine) at the fourth month | Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition | Baseline and the fourth month | 
| Change from Baseline in Biochemical value (Albumine) at the sixth month | Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition | Baseline and the sixth month | 
| Change from Baseline in Biochemical value( normalized protein catabolic rate) at 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 | Baseline and the third month | 
| Change from Baseline in Biochemical value( normalized protein catabolic rate) at 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 | Baseline and the fourth month | 
| Change from Baseline in Biochemical value( normalized protein catabolic rate) at the sixth 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 | Baseline and the sitxth month | 
| Change from Baseline in Biochemical value(cholesterol )at the third month | Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition | Baseline and the third month | 
| Change from Baseline in Biochemical value(cholesterol )at the fourth month | Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition | Baseline and the fourth month | 
| Change from Baseline in Biochemical value(cholesterol )at the sixth month | Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition | Baseline and and the sixth month | 
| Change from Baseline in Biochemical value(creatine)at 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 | Baseline and the third month | 
| Change from Baseline in Biochemical value(creatine) at 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 | Baseline and the fourth month | 
| Change from Baseline in Biochemical value(creatine) at 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 | Baseline and the sixth month | 
| Change from Baseline in Biochemical value( Phosphate) at 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 | Baseline and the third month | 
| Change from Baseline in Biochemical value( Phosphate) at 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 | Baseline and the fourth month | 
| Change from Baseline in Biochemical value( Phosphate) at 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 | Baseline and the sixth month | 
| Change from Baseline in body measurement ( Hand grip strength ) at 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 | Baseline and the third month | 
| Change from Baseline in body measurement ( Hand grip strength ) at 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 | Baseline and the fourth month | 
| Change from Baseline in body measurement ( Hand grip strength ) at 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 | Baseline and the sixth month | 
| Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at 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. | Baseline and the third month | 
| Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at 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. | Baseline and the fourth month | 
| Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the sixth 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. | Baseline and the six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the diet of knowledge form at the third month | The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge | Baseline and the third month | 
| Change from Baseline in the diet of knowledge form at the fourth month | The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge | Baseline and the fourth month | 
| Change from Baseline in the diet of knowledge form at the sixth month | The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge | Baseline and the sixth month | 
| Change from Baseline in the diet of attitude form at the third month | The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating | Baseline and the third month | 
| Change from Baseline in the diet of attitude form at the fourth month | The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating | Baseline and the fourth month | 
| Change from Baseline in the diet of attitude form at the sixth month | The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating | Baseline and the sixth month | 
| Change from Baseline in the diet of behavior form at the third month | The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior | Baseline and the third month | 
| Change from Baseline in the diet of behavior form at the fourth month | The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior | Baseline and the fourth month | 
| Change from Baseline in the diet of behavior form at the sixth month | The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior | Baseline and the sixth month | 
| Change from Baseline in the high phosphorus food frequency questionnaire at the third month | The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus. | Baseline and the third month | 
| Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month | The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus. | Baseline and the fourth month | 
| Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month | The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus. | Baseline and the sixth month | 
| Change from Baseline in the six major food frequency questionnaire at the third month | The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies | Baseline and the third month | 
| Change from Baseline in the six major food frequency questionnaire at the fourth month | The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies | Baseline and the fourth month | 
| Change from Baseline in the six major food frequency questionnaire at the sixth month | The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies | Baseline and the sixth month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis,nutrition education,The Transtheoretical Model