The effect of educational intervention based on diet-related beliefs on fasting blood glucose, HbA1c and type 2 diabetes patient’s adherence to healthy diet
The present study is a clinical trial aiming to determine the effect of educational intervention on type 2 diabetes patient’s adherence to healthy diet and glycemic control in Isfahan, Iran.
Design
A concealed, randomized, controlled clinical trial with a parallel group design of 145 patients (73 in the intervention group; 72 in the control group), enrolling between December 2017 and January 2018, and following for 3 months after the end of the intervention.
Settings and conduct
Educational intervention was conducted through group education and individual counseling on type 2 diabetes in Isfahan.
Participants/Inclusion and exclusion criteria
The inclusion criteria were: having a history of high or uncontrolled blood sugar; a disease history of three months or longer; lack of other chronic diseases (except diseases associated with complications of diabetes); not having previous experience of participating in training sessions similar to this study; and willingness to take part in the study.
Exclusion criteria: not having active records in diabetes clinics or healthcare centers; and having physical disease limiting patients to participate in training sessions.
Intervention groups
Intervention group: educational interventions related to diabetic diet in 8 sessions.
Control group: no educational intervention.
Main outcome variables
Mean score of fasting blood glucose.
Mean score of glycated hemoglobin in patients (HbA1c).
Nutritional behavior of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180308039008N1
Registration date:2018-04-15, 1397/01/26
Registration timing:retrospective
Last update:2018-04-15, 1397/01/26
Update count:0
Registration date
2018-04-15, 1397/01/26
Registrant information
Name
Arash Salahshouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3244
Email address
aidin_salahshoori@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
2017-12-01, 1396/09/10
Actual recruitment end date
2017-12-31, 1396/10/10
Trial completion date
empty
Scientific title
The effect of educational intervention based on diet-related beliefs on fasting blood glucose, HbA1c and type 2 diabetes patient’s adherence to healthy diet
Public title
The effect of educational intervention on type 2 diabetes patient’s adherence to healthy diet
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of high or uncontrolled blood sugar;
A disease history of three months or longer;
Lack of other chronic diseases (except diseases associated with complications of diabetes);
Not having previous experience of participating in training sessions similar to this study;
Willingness to take part in the study.
Exclusion criteria:
Not having active records in diabetes clinics or healthcare centers;
Having physical disease limiting patients to participate in training sessions.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Actual sample size reached:
145
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done systematically from the registers of diabetic patients and then, they were divided into two intervention and control groups using the random numbers table.
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 Isfahan University of Medical Sciences
Street address
Department of Health education and promotion, school of Health, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.MUI.REC.1396.3.522
Health conditions studied
1
Description of health condition studied
Care and examination of type 2 diabetes patient’s adherence to healthy diet
ICD-10 code
E12
ICD-10 code description
Care and examination of type 2 diabetes patient’s adherence to healthy diet
Primary outcomes
1
Description
Beliefs related to diabetic diet
Timepoint
Before the intervention and 3 months after educational intervention
Method of measurement
Researcher-made Questionnaire
Secondary outcomes
1
Description
Mean score of fasting blood glucose
Timepoint
Before the intervention and 3 months after the end of the educational intervention
Method of measurement
Laboratory tests
2
Description
Mean score of glycated hemoglobin in patients (HbA1c)
Timepoint
Before the intervention and 3 months after the end of the educational intervention
Method of measurement
Laboratory tests
3
Description
Nutritional behavior of patients
Timepoint
Before the intervention and 3 months after the end of the educational intervention
Method of measurement
Perceived Dietary Adherence Questionnaire
Intervention groups
1
Description
Intervention group: educational interventions related to diabetic diet in 8 sessions.
Category
Behavior
2
Description
Control group: no educational intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Arash Salahshouri
Street address
Department of Health education and promotion, school of Health, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3244
Fax
+98 31 3792 3244
Email
aidin_salahshoori@yahoo.com
2
Recruitment center
Name of recruitment center
Healthcare Center No.2, Isfahan
Full name of responsible person
Arash Salahshouri
Street address
Department of Health education and promotion, school of Health, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3244
Fax
+98 31 3792 3244
Email
aidin_salahshoori@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Attar
Street address
Department of Health education and promotion, school of Health, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3244
Email
aidin_salahshoori@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Arash Salahshouri
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Health education and promotion, school of Health, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3244
Email
Aidin_salahshoori@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Firoozeh Mostafavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health education and promotion, school of Health, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3244
Email
F_Mostafavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arash Salahshouri
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Health education and promotion, school of Health, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3244
Email
aidin_salahshoori@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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on primary and secondary outcome will be shared in the form of a spss file
When the data will become available and for how long
The access period will be from December 2018
To whom data/document is available
Researchers of academic institutions
Under which criteria data/document could be used
The researcher will give the data to other researchers for scientific use only.
From where data/document is obtainable
Send an e-mail to aidin_salahshoori@yahoo.com
What processes are involved for a request to access data/document
People who want the data, send your request by e-mail to the above address. The researcher, after consulting the research team, sends the data to them, if they agree.