Educational Programme Impact on Serum Phosphate Control

NCT ID: NCT02626676

Last Updated: 2017-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Educational Programme Group

Stage 5D Chronic Kidney Disease Patients on high-efficiency hemodialysis programme - 4-hour sessions, 3 times a week will be followed up

Group Type EXPERIMENTAL

Educational Programme

Intervention Type OTHER

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

Interventions

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Educational Programme

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Marcus Vinicius de Souza Joao Luiz

MSC., Pharm.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcus Vinicius SJ LUIZ, MSc, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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RenalClass, Dialysis Centre

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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USAoPaulo EPIC

Identifier Type: -

Identifier Source: org_study_id

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