Study of the effect of group- based education of gluten-free diet on knowledge, quality of life, clinical signs and body mass index in patients with Celiac disease
Determination of the effect of group- based education of gluten-free diet on knowledge, quality of life, clinical signs and body mass index in patients with Celiac disease
Design
The study will be conducted in a controlled clinical trial with parallel and randomized groups and participants will be randomly divided into two groups based on their age and sex.
Settings and conduct
This interventional study will be conducted on 140 patients with Celiac disease aged 18-55 years who are referred to Imam Reza Medical Center. After obtaining written informed consent, if there are necessary inclusion criteria, they will be included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Volunteers with celiac disease diagnosed with biopsy.
2-Age 18-55 years
3-Compliance with gluten-free diet for more than three months
4-Ability to read and write
Exclusion criteria:
Types of malignancies
Autoimmune diseases such as type 1 diabetes and thyroid disease
Intestinal diseases
Metabolic bone diseases
Liver disease
Intervention groups
Intervention group :In the intervention group, in addition to the usual education provided at the Celiac clinic by a nutritionist aware of the gluten-free diet, people in groups of 10 will also receive 3 group education sessions.
Control group:In the control group, patients with Celiac disease, referring to the Celiac clinic, they will benefit from individual counseling provided by a nutritionist who is aware of the gluten-free diet and gluten-free diet .
Main outcome variables
1-Knowledge
2-Quality of life
3-Clinical signs
4-Body mass index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080904001197N21
Registration date:2019-05-23, 1398/03/02
Registration timing:prospective
Last update:2019-05-23, 1398/03/02
Update count:0
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
Reza Mahdavi
Name of organization / entity
Faculty of Health & Nutrition, Tabriz UniV. of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7584
Email address
mahdavir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-28, 1398/03/07
Expected recruitment end date
2019-06-28, 1398/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of group- based education of gluten-free diet on knowledge, quality of life, clinical signs and body mass index in patients with Celiac disease
Public title
The effect of group- based education of gluten-free diet in patients with Celiac disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteers with Celiac disease diagnosed with biopsy
Volunteers with Celiac disease diagnosed with biopsy
Compliance with gluten-free diet for more than three months
Ability to read and write
Exclusion criteria:
Types of malignancies
Autoimmune diseases such as type 1 diabetes and thyroid disease
Intestinal diseases
Metabolic bone diseases
Liver disease
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be divided into two groups based on age and sex using random blocks.
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Approval date
2019-04-25, 1398/02/05
Ethics committee reference number
IR.TBZMED.REC.1398.075
Health conditions studied
1
Description of health condition studied
Celiac disease
ICD-10 code
K90.0
ICD-10 code description
Celiac disease
Primary outcomes
1
Description
Knowledge of patients with Celiac Disease
Timepoint
Before the intervention After the end of the intervention Three months after the end of the intervention
Method of measurement
Knowledge questionnaire designed by the researcher
2
Description
Quality of life in patients with Celiac disease
Timepoint
Before the intervention After the end of the intervention Three months after the end of the intervention
Method of measurement
SF-36 (Short Form Health Survey) questionnaire
3
Description
Clinical signs of patients with Celiac disease
Timepoint
Before the intervention After the end of the intervention Three months after the end of the intervention
Before the intervention After the end of the intervention Three months after the end of the intervention
Method of measurement
Dividing the weight in kilograms by squared height in meters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the usual education provided at the Celiac clinic by a nutritionist aware of the gluten-free diet, people in groups of 10 will also receive 3 group education sessions.Educational contents include generalized Celiac disease, gluten-free diet, and checking problems and at the end of each session, there will be a question and answer. Educational topics will include the definition of the disease, the causes of disease, symptoms, diagnosis, treatment, the definition of gluten, gluten-free diet and its importance, nonconformity of gluten-free diet complications, how to read the food label and the choice of gluten-free foods.
Category
Treatment - Other
2
Description
Control group: In the control group, patients with Celiac disease, referring to the Celiac clinic, they will benefit from individual counseling provided by a nutritionist who is aware of the gluten-free diet and gluten-free diet and how to comply with it, nonconformity of gluten-free diet complications and how to read food labels and select gluten-free products will be taught.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Medical Research and Training Hospital
Full name of responsible person
Zahra Akbari Namvar
Street address
Golgasht Ave., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 6923
Email
info@imamreza.tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Akbari Namvar
Street address
Golgasht Ave., Azadi Ave .,Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
Email
nut-rc@tbzmed.ac.ir
Web page address
http://tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Akbari Namvar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition & Food Sciences Faculty, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
zahranamvar1993@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Reza Mahdavi
Position
Ph.D of Nutrition, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Nutrition & Food Sciences Faculty, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
mahdavir@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Akbari Namvar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition & Food Sciences Faculty, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
zahranamvar1993@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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