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Completed

NCT Number: NCT02626676

Educational Programme Impact on Serum Phosphate Control

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RenalClass, Dialysis Centre

São Paulo, 01239-040, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational programme

Other

Educational Programme consists of lectures and group dynamics about nutrition during hemodialysis sessions.

Primary outcomes

  1. Reduction of PhosphateSerum Level

    Time frame: 3 months

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

Secondary outcomes

  1. Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Nutrition Educational Programme Impact on Serum Phosphate Control

Acronym: EPIC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2015
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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