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Completed

NCT Number: NCT05897502

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

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Key information

Conditions

End-stage Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

51 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liu liu.yin

Kaohsiung City, 84402, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimedia Education

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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.

  21. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

Liu, Liu-Yin

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 9, 2023
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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