Back to results

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

Primary Purpose

End-Stage Kidney Disease, Hyperphosphatemia

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

multimedia education

About this trial

This is an interventional prevention trial for End-Stage Kidney Disease focused on measuring hemodialysis,nutrition education,The Transtheoretical Model

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Liu liu.yinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

the theoretical model nutritional education

control

Arm Description

instruction with multimedia

instruction with traditional paper

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the fourth month

Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the sixth month

Secondary Outcome Measures

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

Change from Baseline in the diet of knowledge form at the fourth month

Change from Baseline in the diet of knowledge form at 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

Change from Baseline in the diet of attitude form at the fourth month

Change from Baseline in the diet of attitude form at 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

Change from Baseline in the diet of behavior form at the fourth month

Change from Baseline in the diet of behavior form at 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.

Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month

Change from Baseline in the high phosphorus food frequency questionnaire at 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

Change from Baseline in the six major food frequency questionnaire at the fourth month

Change from Baseline in the six major food frequency questionnaire at the sixth month

Full Information

NCT ID

NCT05897502

First Posted

May 18, 2023

Last Updated

July 10, 2023

Sponsor

Liu, Liu-Yin

1. Study Identification

Unique Protocol Identification Number

NCT05897502

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 6, 2023 (Actual)

Primary Completion Date

July 11, 2023 (Actual)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Liu, Liu-Yin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-Stage Kidney Disease, Hyperphosphatemia

Keywords

hemodialysis,nutrition education,The Transtheoretical Model

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Participant

Masking Description

The participant does not know who the intervention group is versus the control group

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

the theoretical model nutritional education

Arm Type

Experimental

Arm Description

instruction with multimedia

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

instruction with traditional paper

Intervention Type

Behavioral

Intervention Name(s)

multimedia education

Other Intervention Name(s)

instruction with traditional paper

Intervention Description

The experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses. The control group use routine education.

Primary Outcome Measure Information:

Title

Change from Baseline in Biochemical value (Albumine) at the third month

Description

Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition

Time Frame

Baseline and the third month

Title

Change from Baseline in Biochemical value (Albumine) at the fourth month

Description

Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition

Time Frame

Baseline and the fourth month

Title

Change from Baseline in Biochemical value (Albumine) at the sixth month

Description

Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition

Time Frame

Baseline and the sixth month

Title

Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month

Description

Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k

Time Frame

Baseline and the third month

Title

Change from Baseline in Biochemical value( normalized protein catabolic rate) at the fourth month

Description

Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k

Time Frame

Baseline and the fourth month

Title

Change from Baseline in Biochemical value( normalized protein catabolic rate) at the sixth month

Description

Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k

Time Frame

Baseline and the sitxth month

Title

Change from Baseline in Biochemical value(cholesterol )at the third month

Description

Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition

Time Frame

Baseline and the third month

Title

Change from Baseline in Biochemical value(cholesterol )at the fourth month

Description

Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition

Time Frame

Baseline and the fourth month

Title

Change from Baseline in Biochemical value(cholesterol )at the sixth month

Description

Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition

Time Frame

Baseline and and the sixth month

Title

Change from Baseline in Biochemical value(creatine)at the third month

Description

Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition

Time Frame

Baseline and the third month

Title

Change from Baseline in Biochemical value(creatine) at the fourth month

Description

Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition

Time Frame

Baseline and the fourth month

Title

Change from Baseline in Biochemical value(creatine) at the sixth month

Description

Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition

Time Frame

Baseline and the sixth month

Title

Change from Baseline in Biochemical value( Phosphate) at the third month

Description

Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL

Time Frame

Baseline and the third month

Title

Change from Baseline in Biochemical value( Phosphate) at the fourth month

Description

Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL

Time Frame

Baseline and the fourth month

Title

Change from Baseline in Biochemical value( Phosphate) at the sixth month

Description

Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL

Time Frame

Baseline and the sixth month

Title

Change from Baseline in body measurement ( Hand grip strength ) at the third month

Description

Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty

Time Frame

Baseline and the third month

Title

Change from Baseline in body measurement ( Hand grip strength ) at the fourth month

Description

Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty

Time Frame

Baseline and the fourth month

Title

Change from Baseline in body measurement ( Hand grip strength ) at the sixth month

Description

Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty

Time Frame

Baseline and the sixth month

Title

Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the third month

Description

Time Frame

Baseline and the third month

Title

Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the fourth month

Description

Time Frame

Baseline and the fourth month

Title

Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the sixth month

Description

Time Frame

Baseline and the six month

Secondary Outcome Measure Information:

Title

Change from Baseline in the diet of knowledge form at the third month

Description

Time Frame

Baseline and the third month

Title

Change from Baseline in the diet of knowledge form at the fourth month

Description

Time Frame

Baseline and the fourth month

Title

Change from Baseline in the diet of knowledge form at the sixth month

Description

Time Frame

Baseline and the sixth month

Title

Change from Baseline in the diet of attitude form at the third month

Description

Time Frame

Baseline and the third month

Title

Change from Baseline in the diet of attitude form at the fourth month

Description

Time Frame

Baseline and the fourth month

Title

Change from Baseline in the diet of attitude form at the sixth month

Description

Time Frame

Baseline and the sixth month

Title

Change from Baseline in the diet of behavior form at the third month

Description

Time Frame

Baseline and the third month

Title

Change from Baseline in the diet of behavior form at the fourth month

Description

Time Frame

Baseline and the fourth month

Title

Change from Baseline in the diet of behavior form at the sixth month

Description

Time Frame

Baseline and the sixth month

Title

Change from Baseline in the high phosphorus food frequency questionnaire at the third month

Description

Time Frame

Baseline and the third month

Title

Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month

Description

Time Frame

Baseline and the fourth month

Title

Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month

Description

Time Frame

Baseline and the sixth month

Title

Change from Baseline in the six major food frequency questionnaire at the third month

Description

Time Frame

Baseline and the third month

Title

Change from Baseline in the six major food frequency questionnaire at the fourth month

Description

Time Frame

Baseline and the fourth month

Title

Change from Baseline in the six major food frequency questionnaire at the sixth month

Description

Time Frame

Baseline and the sixth month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

51 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

liu-yin Liu

Phone

07-6150011

Ext

5121

ed113442@edah.org.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Hsin-Lan Wen

Phone

07-6150011

Ext

5121

ed100844@edah.org.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

liu-yin Liu

Organizational Affiliation

The Nursing department of EDAHospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Liu liu.yin

City

Kaohsiung

ZIP/Postal Code

84402

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liu liu.yin, postgraduate

Phone

07-6150011

Ext

5121

ed113442@edah.org.tw

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Based on the privacy and confidentiality factors of the subjects' personal data

Citations:

PubMed Identifier

26843138

Citation

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.

Results Reference

result

Links:

URL

https://consumer.fda.gov.tw

Description

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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs