The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
Recruitment status was Recruiting
Dietary Phosphorus Education Program can improve patients' knowledge, attitude and behavior of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of hemodialysis patients.
The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin < 4.0 mg/dL, or serum phosphate > 5.0 mg/dL, are eligible for inclusion.
Subjects will be enrolled into this trial after signed informed consent. We expect to recruit 60 subjects. Patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly. We will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions.
At baseline, the investigators collect demography and pre-test KAP questionnaires among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview and record their answers. Dietary Phosphorus Education is a 6-month program and be implemented by dietitians and investigators, including education, nutritional counseling and dietary records monthly.
The first month was intensive weekly education sessions, each 20 to 30 minutes. Second and third month were monthly education sessions, each 20 to 30 minutes. There are total 6 sessions in this trial. The last 3 months will follow-up periods, will collect anthropometry data monthly, biochemistry measurements and 3-day dietary records among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview or phone-interview to complete each dietary record. Investigator collect post-test KAP questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects in the end of the trial,. If subjects are illiterate then investigators interview subjects and record.
This is a 6-months trial and retrospective study to collect anthropometry, biochemical measurements and 3-day dietary records from control subjects monthly.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient|
- The difference of biochemistry values including phosphate, calcium-phosphate product, albumin, etc. [ Time Frame: first month ] [ Designated as safety issue: No ]
- The difference of knowledge, attitude and practice (KAP) questionnaire's scores during the study program. [ Time Frame: third month ] [ Designated as safety issue: No ]
- To estimate subjects' protein and calorie intake according to 3-day dietary records. [ Time Frame: sixth month ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: Dietary Phosphorus Education Program||
Dietary Phosphorus Education Program
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245517
|Contact: Shwu-Huey Yang, PhD||886-2-27361661 ext firstname.lastname@example.org|
|Taipei Medical University - WanFang Hospital||Recruiting|
|Contact: Shwu-Huey Yang 886-2-27361661 ext 6568 email@example.com|
|Principal Investigator:||Shwu-Huey Yang||Taipei Medical University|