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Educational Programme Impact on Serum Phosphate Control

Not Applicable
Completed
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
Inclusion Criteria
  • 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)
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Educational Programme GroupEducational ProgrammeStage 5D Chronic Kidney Disease Patients on high-efficiency hemodialysis programme - 4-hour sessions, 3 times a week will be followed up
Primary Outcome Measures
NameTimeMethod
Reduction of PhosphateSerum Level3 months

Phosphate Serum Levels above or equal 5.5 mg/dl will be monitored in order to identify reduction

Secondary Outcome Measures
NameTimeMethod
Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior3 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

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