ClinicalTrials.gg
CompletedNCT05897502Updated May 17, 2024

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

An interventional study of multimedia education in End-Stage Kidney Disease and Hyperphosphatemia, sponsored by Liu, Liu-Yin. Completed at 1 site in Taiwan. Open to participants aged 51 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by Liu, Liu-Yin · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
51 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • End-Stage Kidney Disease
  • Hyperphosphatemia

Keywords

  • hemodialysis,nutrition education,The Transtheoretical Model
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's enrollment of 43 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

This is the only study on the registry with Liu, Liu-Yin as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
51 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Clinical diagnosis of Alzheimer's Disease
  2. Malignant tumors, gastrointestinal cachexia, and catheterization
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    the theoretical model nutritional education

    instruction with multimedia

    Behavioral: multimedia education

  • Placebo comparator
    control

    instruction with traditional paper

    Behavioral: multimedia education

Interventions

  • Behavioralmultimedia 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.

    Also known as: instruction with traditional paper

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and the third month

  2. 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

    Time frame: Baseline and the fourth month

  3. 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

    Time frame: Baseline and the sixth month

  4. 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

    Time frame: Baseline and the third month

  5. 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

    Time frame: Baseline and the fourth month

  6. 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

    Time frame: Baseline and the sitxth month

  7. 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

    Time frame: Baseline and the third month

  8. 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

    Time frame: Baseline and the fourth month

  9. 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

    Time frame: Baseline and and the sixth month

  10. 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

    Time frame: Baseline and the third month

  11. 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

    Time frame: Baseline and the fourth month

  12. 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

    Time frame: Baseline and the sixth month

  13. 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

    Time frame: Baseline and the third month

  14. 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

    Time frame: Baseline and the fourth month

  15. 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

    Time frame: Baseline and the sixth month

  16. 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

    Time frame: Baseline and the third month

  17. 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

    Time frame: Baseline and the fourth month

  18. 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

    Time frame: Baseline and the sixth month

  19. 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.

    Time frame: Baseline and the third month

  20. 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.

    Time frame: Baseline and the fourth month

  21. 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.

    Time frame: Baseline and the six month

Secondary outcomes

  1. 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

    Time frame: Baseline and the third month

  2. 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

    Time frame: Baseline and the fourth month

  3. 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

    Time frame: Baseline and the sixth month

  4. 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

    Time frame: Baseline and the third month

  5. 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

    Time frame: Baseline and the fourth month

  6. 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

    Time frame: Baseline and the sixth month

  7. 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

    Time frame: Baseline and the third month

  8. 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

    Time frame: Baseline and the fourth month

  9. 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

    Time frame: Baseline and the sixth month

  10. 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.

    Time frame: Baseline and the third month

  11. 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.

    Time frame: Baseline and the fourth month

  12. 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.

    Time frame: Baseline and the sixth month

  13. 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

    Time frame: Baseline and the third month

  14. 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

    Time frame: Baseline and the fourth month

  15. 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

    Time frame: Baseline and the sixth month

07

Study locations

1 site
  • Liu liu.yin
    Kaohsiung, 84402, Taiwan
08

References and documents

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. PubMed 26843138 ↗

Individual participant data

Plan to share: No — Based on the privacy and confidentiality factors of the subjects' personal data

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2023 to primary completion in Jul 2023, 0 months.

Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 0 months is below that.

Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2023
First posted
Jun 9, 2023
StartActual
Jul 4, 2023
Primary completionActual
Jul 17, 2023
CompletionActual
Feb 29, 2024
Last update
May 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05897502
Lead sponsor
Liu, Liu-Yin
Responsible party
Liu, Liu-Yin (Nurse, E-DA Hospital) — Sponsor-investigator
First posted
Jun 9, 2023
Start date
Jul 4, 2023
Primary completion
Jul 17, 2023
Completion
Feb 29, 2024
Last update
May 17, 2024

Study contacts

liu-yin Liu
principal investigator · The Nursing department of EDAHospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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