Clinical trial NCT05897502: 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
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Kidney Disease
Hyperphosphatemia
Keywords: hemodialysis,nutrition education,The Transtheoretical Model
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 43
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Biochemical value (Albumine) at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in Biochemical value (Albumine) at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in Biochemical value (Albumine) at the sixth month
timeFrame: Baseline and the sixth month
measure: Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in Biochemical value( normalized protein catabolic rate) at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in Biochemical value( normalized protein catabolic rate) at the sixth month
timeFrame: Baseline and the sitxth month
measure: Change from Baseline in Biochemical value(cholesterol )at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in Biochemical value(cholesterol )at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in Biochemical value(cholesterol )at the sixth month
timeFrame: Baseline and and the sixth month
measure: Change from Baseline in Biochemical value(creatine)at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in Biochemical value(creatine) at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in Biochemical value(creatine) at the sixth month
timeFrame: Baseline and the sixth month
measure: Change from Baseline in Biochemical value( Phosphate) at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in Biochemical value( Phosphate) at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in Biochemical value( Phosphate) at the sixth month
timeFrame: Baseline and the sixth month
measure: Change from Baseline in body measurement ( Hand grip strength ) at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in body measurement ( Hand grip strength ) at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in body measurement ( Hand grip strength ) at the sixth month
timeFrame: Baseline and the sixth month
measure: Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the sixth month
timeFrame: Baseline and the six month
Secondary outcomes:
measure: Change from Baseline in the diet of knowledge form at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in the diet of knowledge form at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in the diet of knowledge form at the sixth month
timeFrame: Baseline and the sixth month
measure: Change from Baseline in the diet of attitude form at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in the diet of attitude form at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in the diet of attitude form at the sixth month
timeFrame: Baseline and the sixth month
measure: Change from Baseline in the diet of behavior form at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in the diet of behavior form at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in the diet of behavior form at the sixth month
timeFrame: Baseline and the sixth month
measure: Change from Baseline in the high phosphorus food frequency questionnaire at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month
timeFrame: Baseline and the sixth month
measure: Change from Baseline in the six major food frequency questionnaire at the third month
timeFrame: Baseline and the third month
measure: Change from Baseline in the six major food frequency questionnaire at the fourth month
timeFrame: Baseline and the fourth month
measure: Change from Baseline in the six major food frequency questionnaire at the sixth month
timeFrame: Baseline and the sixth month
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Liu liu.yin
Study officials:
affiliation: The Nursing department of EDAHospital
name: liu-yin Liu
role: PRINCIPAL_INVESTIGATOR
References:
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.