Educational Programme Impact on Serum Phosphate Control
- Conditions
- Renal Insufficiency, Chronic
- Interventions
- Other: Educational Programme
- Registration Number
- NCT02626676
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels \> 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric, clinical, demographic and laboratory parameters (serum phosphorus concentration will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention.
- Detailed Description
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels \> 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric (weight, height, body mass index), clinical, demographic (sex, age, time on dialysis programme, literacy/schooling) and laboratory parameters (phosphate serum levels) will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention. Reduction of phosphate serum levels and positive/negative behavioral changes will be the evaluated outcomes. Statistical Analyses will be carried out in order to compare the effect of educational programme on phosphate serum levels and on the behaviour changes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- patients who freely consent to participate in this study
- aged from 18 years or older
- both genders
- phosphate serum levels higher than 5.5 mg/dl (last 3 consecutive monthly measures)
- patients who do not consent to participate in this study
- pregnant
- cognitive deficit
- mental diseases
- patients whose phosphate serum levels lower than 5.5 mg/dl or equal to 5.5 mg/dl
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Educational Programme Group Educational Programme Stage 5D Chronic Kidney Disease Patients on high-efficiency hemodialysis programme - 4-hour sessions, 3 times a week will be followed up
- Primary Outcome Measures
Name Time Method Reduction of PhosphateSerum Level 3 months Phosphate Serum Levels above or equal 5.5 mg/dl will be monitored in order to identify reduction
- Secondary Outcome Measures
Name Time Method Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior 3 months After intervention (3 months), it will be identified whether patients show Positive or Negative Behavioral change (according to the transtheoretical model of eating behavior) will be identified
Trial Locations
- Locations (1)
RenalClass, Dialysis Centre
🇧🇷Sao Paulo, Brazil