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

May 15, 2024 updated by: Liu, Liu-Yin

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 84402
        • Liu liu.yin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and the third month
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
Baseline and the fourth month
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
Baseline and the sixth month
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
Baseline and the third month
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
Baseline and the fourth month
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
Baseline and the sitxth month
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
Baseline and the third month
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
Baseline and the fourth month
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
Baseline and and the sixth month
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
Baseline and the third month
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
Baseline and the fourth month
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
Baseline and the sixth month
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
Baseline and the third month
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
Baseline and the fourth month
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
Baseline and the sixth month
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
Baseline and the third month
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
Baseline and the fourth month
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
Baseline and the sixth month
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.
Baseline and the third month
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.
Baseline and the fourth month
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.
Baseline and the six month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the diet of knowledge form at the third month
Time Frame: 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
Baseline and the third month
Change from Baseline in the diet of knowledge form at the fourth month
Time Frame: 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
Baseline and the fourth month
Change from Baseline in the diet of knowledge form at the sixth month
Time Frame: 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
Baseline and the sixth month
Change from Baseline in the diet of attitude form at the third month
Time Frame: 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
Baseline and the third month
Change from Baseline in the diet of attitude form at the fourth month
Time Frame: 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
Baseline and the fourth month
Change from Baseline in the diet of attitude form at the sixth month
Time Frame: 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
Baseline and the sixth month
Change from Baseline in the diet of behavior form at the third month
Time Frame: 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
Baseline and the third month
Change from Baseline in the diet of behavior form at the fourth month
Time Frame: 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
Baseline and the fourth month
Change from Baseline in the diet of behavior form at the sixth month
Time Frame: 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
Baseline and the sixth month
Change from Baseline in the high phosphorus food frequency questionnaire at the third month
Time Frame: 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.
Baseline and the third month
Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month
Time Frame: 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.
Baseline and the fourth month
Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month
Time Frame: 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.
Baseline and the sixth month
Change from Baseline in the six major food frequency questionnaire at the third month
Time Frame: 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
Baseline and the third month
Change from Baseline in the six major food frequency questionnaire at the fourth month
Time Frame: 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
Baseline and the fourth month
Change from Baseline in the six major food frequency questionnaire at the sixth month
Time Frame: 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
Baseline and the sixth month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liu, Liu-Yin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: liu-yin Liu, The Nursing department of EDAHospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings