Determination of the effect of empowerment program on Mothers' Knowledge And metabolic control of preschool children with type 1 diabetes
Design
Clinical trial without control group Community based and pragmatic
With a single-party design, , randomized strain
Settings and conduct
This is a semi-experimental study contains a single-group pretest-post test plan. The purpose is to empower mothers who have pre-school children with type 1 diabetes. It will be held on five sessions in the classroom of hospital, for investigation the effect of program on mothers knowledge and the metabolic control of their children.
Participants/Inclusion and exclusion criteria
Inclusion criteria for mothers:
1. Mothers who have pre-school children with type -1 diabetes, according to their physician's diagnosis
2. There is no chronic illness other than diabetes, in pre-school children (according to the medical records).
3. Minimum abilities of mothers in reading and writing skills.
4. Non-participation of mothers in similar training courses.
5. There is no other children with chronic disease in the family.
Inclusion criteria for children :
1. Pre-school children who have diabetes with range of 3 to 6 years old.
2. There is no chronic disease other than type 1 diabetes Based on medical reports on their case.
3-At least one month has passed since the children had been diagnosed with diabetes
Exclusion criteria:
1.Cancellation of samples for continuing the study.
2. Hospitalization of children.
3. More than one absence of mothers in session.
Intervention groups
Mothers who have pre-school children with type 1 diabetes
Main outcome variables
Increasing the sense of empowerment of mothers
Increasing the knowledge of mothers about diabetes
Better metabolic control in preschool children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039196N1
Registration date:2018-07-06, 1397/04/15
Registration timing:prospective
Last update:2018-07-06, 1397/04/15
Update count:0
Registration date
2018-07-06, 1397/04/15
Registrant information
Name
Maryam Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3365 1678
Email address
m.mansori@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of an Empowerment Program on Mothers’ Knowledge and Metabolic Control of Pre-school Children with type I Diabetes
Public title
The Impact of Empowerment Program on Children's Diabetes Control
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers Entry Criteria
Mothers of preschool children with type 1 diabetes according to their physician's diagnosis
Having at least reading and writing skills in mothers
Child entry criteria:
Preschool children with diabetes aged 3 to 6 years old
At least one month from the onset of diabetes.
Exclusion criteria:
Cases of any chronic disease other than diabetes in preschool children (according to medical records)
Mother companies participate in similar training courses
There is another child in the family with chronic disease
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
More than 1 sample in each individual
Number of samples in each individual:
2
Measurement of knowledge in mothers once before intervention and once immediately after intervention and 3 months after intervention and in children with diabetes, HbA1c levels were measured before and after intervention.measured before and after intervention.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of medical science
Street address
Hemat Highway, University of Iran
City
Tehran
Province
Tehran
Postal code
12458769
Approval date
2018-02-04, 1396/11/15
Ethics committee reference number
IR.IUMS.FMD.REC1396.9311687008
Health conditions studied
1
Description of health condition studied
Dont have
ICD-10 code
ندارد
ICD-10 code description
ندارد
Primary outcomes
1
Description
HbA1C levels in preschool children with type 1 diabetes, measured by HbA1C.
Timepoint
Before intervention and 3 months after intervention.
Method of measurement
It will be done with an experienced person in the lab of hospital by measuring level of HBA1C taking venous blood as a sample and using a Nakokard device (calibrated)
2
Description
Measuring diabetic knowledge of mothers of preschool children with type 1 diabetes
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Through Michigan Knowledge Assessment Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A five-session empowerment program will be held in a lecture-lesson for mothers with preschool children with diabetes to measure the effect of this program on raising the knowledge of mothers and as a result of metabolic control in their children.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghods Children's Hospital
Full name of responsible person
Maryam Mansory
Street address
Valiasr St., Ghods Hospital
City
Qazvin
Province
Qazvin
Postal code
1365775
Phone
+98 28 3365 1678
Email
m.mansouri@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
morteza naserbakht
Street address
Hemmat Highway Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 17 2336 2621
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Mansory
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hemmat Highway. Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 17 2336 2621
Email
adminsite@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Mansory
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hemmat Highway. Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 17 2336 2621
Email
adminsite@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Mansory
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hemmat Highway. Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 28 3365 1678
Email
m.1990mansouri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
After completing the plan, the result of this study and the outcome of the study will be discussed publicly
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Use the results of this research
From where data/document is obtainable
m.1990mansouri@g mail.com
What processes are involved for a request to access data/document