Developing and evaluating of an educational intervention based on social cognitive theory in promoting self-care behaviors in type 1 diabetes adolescents
Determining the effect of educational intervention based on the aspects of social cognitive theory in promoting self-care behaviors in adolescents with type 1 diabetes in Isfahan
Design
The clinical trial has two groups of 40 intervention and control groups, with parallel groups, randomized
Settings and conduct
This study was performed on 80 adolescents with type 1 diabetes who regularly visit Isfahan Endocrine and Metabolism Center. They were divided into two intervention and control groups and each group was divided into 40 cases.the questionnaires will be completed before the intervention by the samples and only the intervention group will receive the training
Participants/Inclusion and exclusion criteria
Sample entry: Samples must be resident in Isfahan and have a willingness to participate in the study. Exit Samples: People with certain diseases are excluded from the study.
Intervention groups
The intervention group will participate in four training sessions based on social cognitive theory in order to improve their health care behavior and then will received virtual training for 3 months and patients in the control group only received routine services in the diabetes clinic and did not undergo an educational intervention
Main outcome variables
Self-efficacy, Self-care, Self-regulation, Expecting Outcome, Social Support
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190113042341N1
Registration date:2019-04-11, 1398/01/22
Registration timing:retrospective
Last update:2019-04-11, 1398/01/22
Update count:0
Registration date
2019-04-11, 1398/01/22
Registrant information
Name
Elham Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3242 3792
Email address
elhammolavi96@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing and evaluating of an educational intervention based on social cognitive theory in promoting self-care behaviors in type 1 diabetes adolescents
Public title
Impact of educational intervention on the promotion of juvenile behaviors infected with type 1 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Isfahan resident
Have type 1 diabetes
Age is 19-10 years old
Inclination to participate in the study (informed consent)
Exclusion criteria:
The disease that affects the research
Any conditions that the researcher feels will interfere with the participation of individuals or the evaluation of the results.
Age
From 10 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Among the available cases , randomly, the files of people who routinely visit the center are selected and contacted, and if they wish, they would collaborate with the researcher, and then cases will be divided into two groups include test and control 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hazer Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-02-27, 1396/12/08
Ethics committee reference number
IR.MUI.REC.1396.3.868
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Self-efficacy score in self-care behavior
Timepoint
Before intervention, directly after intervention, 3 months after intervention
Method of measurement
Questionnaire
2
Description
Self-regulation score in self-care behavior
Timepoint
Before intervention, directly after intervention, 3 months after intervention
Method of measurement
Questionnaire
3
Description
The score of social support perceived in self-care behavior
Timepoint
Before intervention, directly after intervention, 3 months after intervention
Method of measurement
Questionnaire
4
Description
Expected outcome score in self-care behavior
Timepoint
Before intervention, directly after intervention, 3 months after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
'' Intervention group: '' Participants will attend in 4 educational session for about 60-minute and then, to promote socially perceived social support, the group will be divided into 5 groups of 8 people and each person will be considered as a peer in each group. That these people should follow their group for 3 months and provide self-care.The purpose of these sessions is to educate participants on how to conduct positive and negative behaviors, whether or not to behave self-care, stress control, and stress management methods.
Category
Behavior
2
Description
"Control group:" Patients in the control group only received routine services in the diabetes clinic and did not undergo an educational intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Ahmadali Islami
Street address
Isfahan Endocrine and Metabolism Research Center, Sedigheh Tahereh Medical Research Complex, Khorram Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3244
Email
Eslami@hlth.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hazer Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
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
Elham Molavi Vardanjani
Position
MSc student of Health Education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3242
Email
Elhammolavi96@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmadali Eslami
Position
PhD of Health Education, Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3242
Email
eeslami@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Molavi Vardanjani
Position
MSc Student of Health Education
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3242
Email
Elhammolavi96@yahoo.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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