The purpose of this study was to conduct a educational program on the nutritional management of patients with type 2 diabetes will be performed in 112 cases of diabetes that referred to the Diabetes Research Center of Hamadan that randomly will be divided in 2 groups : interposition and control.
Inclusion criteria: definitive diagnosis of type 2 diabetes, satisfaction of participate in the study, having health records in diabetes research center of Hamedan, ability to participate in training sessions.
Exclusion criteria: non-appearance regular training sessions.
Intervention consisted of: educational program designed HbA1c test after three months of training in the intervention group. In control group only HbA1c testing will be performed. The intervention will be from 25 Aprill to 5 May 2015.
The implications of the study include: influence of educational programs designed to inform, health Locus of Control, efficacy, perceived barriers and nutritional management.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030421330N1
Registration date:2015-05-24, 1394/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-24, 1394/03/03
Registrant information
Name
Azam Samadi
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 38254576
Email address
a.samadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Hamedan University of Medical Science.
Expected recruitment start date
2015-01-24, 1393/11/04
Expected recruitment end date
2015-03-16, 1393/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of educational intervention on nutritional management among patients with type 2 diabetes
Public title
Effect of nutrition in diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: definitive diagnosis of type 2 diabetes, satisfaction of participate in the study, having health records in diabetes research center of Hamedan, ability to participate in training sessions.
Exclusion criteria: non-appearance regular training sessions.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
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
Ethics Committee of Hamedan Universite of Meical Science
Street address
Shahid Fahmideh st
City
Hamean
Postal code
65155
Approval date
2015-01-24, 1393/11/04
Ethics committee reference number
16/35/9/5420/p
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10,E11,E1
ICD-10 code description
DIABETES MELLITUS
Primary outcomes
1
Description
HbA1c
Timepoint
Three months after the intervention
Method of measurement
In the laboratory
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group: training program designed for 4 sessions and a training manual reminder of last training sessions a month after making Glycosylated Hemoglobin test will be three months after the last training session.
Category
Lifestyle
2
Description
Intervention in the control group: including Glycosylated Hemoglobin test three months after the last training session in the intervention group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center of Hamadan
Full name of responsible person
Kosari
Street address
Shariati Sq, Mirzadeh Eshghi St
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Hamedan University of Medical Science
Full name of responsible person
Doctor Said Bashirian President for Research and Technology
Street address
Shahid Fahmideh st
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Hamedan University of Medical Science
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
Hamedan University of Medical Science
Full name of responsible person
Azam Samadi
Position
Master Student Health Education
Other areas of specialty/work
Street address
Shahid Fahmideh st
City
Hamedan
Postal code
Phone
+98 138224576
Fax
-
Email
azamsamadi87@yahoo.com: a.samadi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Doctor Akram Karimi
Position
PhD
Other areas of specialty/work
Street address
Shahid Fahmideh St
City
Hamedan
Postal code
08138380026
Phone
+81 38380026
Fax
+98 912 611 6052
Email
karimi.a@umsha.ac.ir: karimi71813@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Azam Samadi
Position
Master Student
Other areas of specialty/work
Street address
Shahid Fahmideh St
City
Hamedan
Postal code
Phone
00
Fax
Email
azamsamadi87@yahoo.com: a,samadi2UMSHA.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)