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Study the effect of interactive education on adherence to diet ,quality of life and functional indicators in patients with celiac disease

Protocol summary

Study aim
Determining the effect of interactive education on adherence to diet, quality of life and performance indicators in patients with celiac disease
Design
Controlled clinical trial, community-based and pragmatic, parallel groups, randomized
Settings and conduct
The study will be performed after obtaining research approval from the ethics committee. The eligible participants will be invited to the Celiac center of Buali Hospital. After selecting the subjects of the study, the demographic information of participants, as well as the necessary data about their quality of life, diet adherence, functional index, and body mass index, will be recorded. The intervention will include 4 sessions of classes (90 min each session) for the experimental group. On the other hand, those in the control group will receive the usual care services. Before and after three months, participants will be asked to fill out the quality of life and diet adherence questionnaires. Furthermore, there will be an assessment of their body mass index and functional index.
Participants/Inclusion and exclusion criteria
Inclusion criteria: above 18 years old, no chronic disease (e.g., diabetes), hypothyroidism, hyperthyroidism, no mental disorders, no problem in communication (e.g., blindness or deafness), and non-pregnant women Exclusion criteria: special and incurable diseases, inability to learn
Intervention groups
Intervention group: This group will receive 4 sessions of interactive education (90 min each session). Control group: This group will have a booklet on Celiac after the intervention.
Main outcome variables
Gluten free diet adherence, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170926036426N4
Registration date: 2019-04-09, 1398/01/20
Registration timing: retrospective

Last update: 2019-04-09, 1398/01/20
Update count: 0
Registration date
2019-04-09, 1398/01/20
Registrant information
Name
fatihe kermansaravi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 1415
Email address
kermansaravi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-09, 1397/06/18
Expected recruitment end date
2019-01-08, 1397/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of interactive education on adherence to diet ,quality of life and functional indicators in patients with celiac disease
Public title
The effect of interaction education on patients with celiac disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Celiac disease, the diagnosis of celiac disease, is documented by a specialist in the medical records of the patient no chronic disease (e.g., diabetes), hypothyroidism, hyperthyroidism no mental disorders no problem in communication (e.g., blindness or deafness) non-pregnant women above 18 years old
Exclusion criteria:
special and incurable diseases inability to learn
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The patients referring to the celiac center of Buali hospital will be randomly selected and divided into two groups of experimental and control. In doing so, two cards were assigned as A and B, where A refers to the experimental group and B denotes control group. The subjects of the study will be asked to choose a card, and accordingly participants will be randomly placed in the control and experimental groups.
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
Ethics Committee of Zahedan University of Medical Sciences
Street address
Campus Office Complex, Zahedan University of Medical Sciences and Health Services,Khalig Phars Blvd,Doctor Hesabi square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IR.ZAUMS.REC.1397.185

Health conditions studied

1

Description of health condition studied
Celiac
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Compliance with a gluten-free diet
Timepoint
Before the intervention and 4 weeks after providing interactive education
Method of measurement
Dietary compliance questionnaire

2

Description
Quality of Life
Timepoint
Before the intervention and 4 weeks after providing interactive education
Method of measurement
Quality of life questionnaire for patients with celiac disease

3

Description
Serum iron
Timepoint
Measurement of serum iron before intervention and four months after intervention
Method of measurement
Perform a test with a fully automatic B.T 3000 machine

4

Description
Serum vitamin D
Timepoint
Measurement of serum vitamin D before intervention and four months after intervention
Method of measurement
Performing the experiment with FOMO ELITE ARIDER

5

Description
Body mass index
Timepoint
Measurement of height and weight before intervention and four months after intervention
Method of measurement
Height and weight measurements with HBMI PLUS-CR device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Providing interactive education on the diet of patients with celiac disease who provided this training for four sessions of 90 minutes over a period of four weeks in groups of 7 to 9 with active participation of the patient in the formulation of content based on the content of the training, discussion and the exchange of ideas and questions and questions will be provided by the researcher.
Category
Behavior

2

Description
Control group: Receive no training about gluten free diet, they will receive a booklet on the topic of celiac disease after the intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Celiac Counseling Center of Buali Hospital in Zahedan
Full name of responsible person
Rostam Shahraki
Street address
Boali Hospital, Amiralmomenin Street, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 1322 8101
Email
boali@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Campus Administration Complex, Zahedan University of Medical Sciences and Health Services,.-Persian Gulf Blvd-Dr. Hassabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Gharebaghi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Nursing and Midwifery Faculty,Mashahir Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
f.gharebaghi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Gharebaghi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Nursing and Midwifery Faculty,Mashahir Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
f.gharebaghi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Gharebaghi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.8,Yazdan Apartment,Mohammadiye 6,Majidiye 9. Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9315833333
Phone
+98 51 3524 9571
Email
f.gharebaghi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about individuals without the name and last name
When the data will become available and for how long
Three months after the publication of the results, access to the documentation will be available.
To whom data/document is available
This will be available for researchers working in academic and scientific institutions and industry professionals.
Under which criteria data/document could be used
For use in scientific papers
From where data/document is obtainable
Use the person's email Fatemeh gharehbaghy as f.gharebaghi@yahoo.com
What processes are involved for a request to access data/document
Send an e-mail for permission from authors
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