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Design and evaluation of nutrition education program based on health belief model (HBM) and its effect on the promotion of nutritional intake, quality of life and some nutritional and clinical outcomes in patients undergoing hemodialysis

Protocol summary

Summary
The purpose of this study is design and determine the effects of nutrition education based on health belief model (HBM) and its effect on the promotion of nutritional intake, quality of life and some nutritional and clinical outcomes in patients undergoing hemodialysis. This study is a randomized clinical trial with a control group design. The main inclusion criteria include : chronic kidney disease, hemodialysis for at least 6 months, age range 60-20 years. 100 patients were randomly divided into intervention and control groups that 50 people are in each group. The experimental group trained nutrition education to patients treated with hemodialysis in 8 one-hour sessions in 4 weeks. The outcomes of this study are: feeding behavior (particularly food), quality of life and nutritional consequences (particularly of nutrients, weight and body mass index) and clinical consequences (CRP, FBS, creatinine, BUN, hemoglobin, hematocrit, P, calcium, sodium, potassium, systolic and diastolic blood pressure).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081811763N29
Registration date: 2017-09-27, 1396/07/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of nutrition education program based on health belief model (HBM) and its effect on the promotion of nutritional intake, quality of life and some nutritional and clinical outcomes in patients undergoing hemodialysis
Public title
Effect of nutrition education on patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic kidney disease; hemodialysis for at least 6 months; age range 60-20 years; having stable conditions; lack of malignancies; absence on the waiting list for a kidney transplant in the next 6 months; the ability to collaborate on a single project and participate in meetings and training group; no pregnancy and breastfeeding. Exclusion criteria: lack of desire to continue cooperation; the displacement of dialysis centers to other centers for any reason; history of acute diseases and malignancies; the need to link the project for any reason.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Street
City
Isfahan
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.MUI.REC.1394.3.962

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Quality of life
Timepoint
Before, after and 3 months after intervention
Method of measurement
Questionnaire

2

Description
Nutritional intake
Timepoint
Before, after and 3 months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Nutrient intake
Timepoint
Before, after and three months after intervention
Method of measurement
Questionnaire

2

Description
weight
Timepoint
Before, after and three months after intervention
Method of measurement
Questionnaire

3

Description
Body Mass Index
Timepoint
Before, after and three months after intervention
Method of measurement
Using the formula weight (kg) / height (m) 2

4

Description
CRP
Timepoint
Before, after and three months after intervention
Method of measurement
ELISA

5

Description
FBS
Timepoint
Before, after and three months after intervention
Method of measurement
The enzyme glucose oxidase method

6

Description
Creatinine
Timepoint
Before, after and three months after intervention
Method of measurement
Jaffe method

7

Description
BUN
Timepoint
Before, after and three months after intervention
Method of measurement
Chemical diacetyl Mvnvaksym

8

Description
Serum sodium
Timepoint
Before, after and three months after intervention
Method of measurement
Spectrophotometry

9

Description
Serum potassium
Timepoint
Before, after and three months after intervention
Method of measurement
Spectrophotometry

10

Description
Serum calcium
Timepoint
Before, after and three months after intervention
Method of measurement
Colorimetric

11

Description
Serum phosphorus
Timepoint
Before, after and three months after intervention
Method of measurement
Spectrophotometry

12

Description
Hemoglobin
Timepoint
Before, after and three months after intervention
Method of measurement
Photometry

13

Description
Hematocrit
Timepoint
Before, after and three months after intervention
Method of measurement
Calculated (HCT = RBC x MCV)

14

Description
Systolic blood pressure
Timepoint
Before, after and three months after intervention
Method of measurement
Mercury manometers

15

Description
Diastolic blood pressure
Timepoint
Before, after and three months after intervention
Method of measurement
Mercury manometers

Intervention groups

1

Description
For intervention group nutrition education appropriate to patients treated with hemodialysis, based on the latest scientific literature on such Krause's food & nutrition therapy, Modern nutrition in health and disease and Nutritional education National kidney foundation, 8 sessions in 4 weeks (each session an hour, individual training and in groups of 5-6 people, using educational pamphlets and manuals)
Category
Lifestyle

2

Description
The control group receive only the traditional training center offered.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis centers affiliated with the University
Full name of responsible person
Narjes Nooriani
Street address
Razi Hospital, Razi Square, Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Askari
Street address
Hezarjarib street, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences-Nutrition College
Full name of responsible person
Narjes Nooriani
Position
Masters student of nutrition
Other areas of specialty/work
Street address
Hezarjarib street
City
Isfahan
Postal code
Phone
00
Fax
Email
narjes.nooriani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
PHD
Other areas of specialty/work
Street address
hezarjerib street
City
Isfahan
Postal code
Phone
+98 31 3668 8487
Fax
Email
ASKARI@MUI.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Narjes Nooriani
Position
Masters student
Other areas of specialty/work
Street address
Hezarjarib street
City
Isfahan
Postal code
Phone
00
Fax
Email
narjes.nooriani@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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