- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02626676
Educational Programme Impact on Serum Phosphate Control (EPIC)
February 17, 2017 updated by: Marcus Vinicius de Souza Joao Luiz, University of Sao Paulo
Nutrition 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sao Paulo, Brazil, 01239-040
- RenalClass, Dialysis Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Educational Programme consists of lectures and group dynamics about nutrition during hemodialysis sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marcus Vinicius SJ LUIZ, MSc, PharmD, University of São Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
December 6, 2015
First Submitted That Met QC Criteria
December 8, 2015
First Posted (Estimate)
December 10, 2015
Study Record Updates
Last Update Posted (Actual)
February 20, 2017
Last Update Submitted That Met QC Criteria
February 17, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USAoPaulo EPIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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