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

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

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

Study Overview

• Status: Recruiting
• Conditions: End-Stage Kidney Disease; Hyperphosphatemia
• Intervention / Treatment: Behavioral: multimedia education

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: liu-yin Liu; Phone Number: 5121 07-6150011; Email: ed113442@edah.org.tw
• Study Contact Backup: Name: Hsin-Lan Wen; Phone Number: 5121 07-6150011; Email: ed100844@edah.org.tw

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 84402
    • Recruiting
    • Liu liu.yin
    • Contact: Liu liu.yin, postgraduate; Phone Number: 5121 07-6150011; Email: ed113442@edah.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Liu, Liu-Yin
• Investigators: Principal Investigator: liu-yin Liu, The Nursing department of EDAHospital

Publications and helpful links

General Publications

• Karavetian M, Elzein H, Rizk R, Jibai R, de Vries N. Nutritional education for management of osteodystrophy: Impact on serum phosphorus, quality of life, and malnutrition. Hemodial Int. 2016 Jul;20(3):432-40. doi: 10.1111/hdi.12405. Epub 2016 Feb 3.

Helpful Links

• I will refer to the food composition analysis in the materials, and the part about phosphorus and protein will be the basis of the research.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Actual): July 11, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: hemodialysis,nutrition education,The Transtheoretical Model
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Phosphorus Metabolism Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic; Hyperphosphatemia
• Other Study ID Numbers: EMRP-112-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Based on the privacy and confidentiality factors of the subjects' personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No