Clinical trial NCT02626676: Educational Programme Impact on Serum Phosphate Control
Official title: Nutrition Educational Programme Impact on Serum Phosphate Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Keywords: renal dialysis, hyperphosphatemia, educational programme
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

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

Primary outcomes:
measure: Reduction of PhosphateSerum Level
timeFrame: 3 months
Secondary outcomes:
measure: Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: RenalClass, Dialysis Centre
Study officials:
affiliation: University of Sao Paulo
name: Marcus Vinicius SJ LUIZ, MSc, PharmD
role: PRINCIPAL_INVESTIGATOR
References: