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

Not Applicable

Completed

• Conditions: End-Stage Kidney Disease; Hyperphosphatemia
• Interventions: Behavioral: multimedia education

• Registration Number: NCT05897502
• Lead Sponsor: Liu, Liu-Yin

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.

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-09
• Study Start: 2023-07-04
• Primary Completion: 2023-07-17
• Status Verified: 2024-02
• Study Completion: 2024-02-29
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. the biochemical value ≥ 5.5 mg/dl or albumin value<3.8g/dL
2. BMI<23kg/m2
3. Unexpected weight loss.
4. Must be able to swallow tablets

Exclusion Criteria

1. Clinical diagnosis of Alzheimer's Disease
2. Malignant tumors, gastrointestinal cachexia, and catheterization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the theoretical model nutritional education	multimedia education	instruction with multimedia
control	multimedia education	instruction with traditional paper

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Change from Baseline in the diet of knowledge form at the fourth month	Baseline and 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
Change from Baseline in the diet of knowledge form at the third month	Baseline and 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
Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month	Baseline and 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.
Change from Baseline in the diet of attitude form at the third month	Baseline and 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
Change from Baseline in the diet of attitude form at the sixth month	Baseline and 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
Change from Baseline in the high phosphorus food frequency questionnaire at the third month	Baseline and 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.
Change from Baseline in the diet of knowledge form at the sixth month	Baseline and 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
Change from Baseline in the diet of behavior form at the sixth month	Baseline and 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
Change from Baseline in the six major food frequency questionnaire at the third month	Baseline and 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
Change from Baseline in the six major food frequency questionnaire at the sixth month	Baseline and 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
Change from Baseline in the diet of attitude form at the fourth month	Baseline and 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
Change from Baseline in the diet of behavior form at the third month	Baseline and 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
Change from Baseline in the diet of behavior form at the fourth month	Baseline and 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
Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month	Baseline and 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.
Change from Baseline in the six major food frequency questionnaire at the fourth month	Baseline and 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

Trial Locations

Locations (1)

Liu liu.yin; 🇨🇳 Kaohsiung, Taiwan