Assessing the effect of nutrition education on the "My plate" guide on anthropometric indices and some biochemical parameters compared to the usual education in children and adolescents with type 1 diabetes
The Effect of Nutrition Education Based on My plate Guide Compared to Normal Training in Type 1 Diabetes
Design
The total number of samples was randomly assigned to two groups by random allocation method, Experimentation Clinical control and intervention group with parallel and one-blind groups
Settings and conduct
This study was conducted at the Imam Hussein Hospital in Diabetes Clinic.The participants have been blinded.
Participants/Inclusion and exclusion criteria
No other illness other than type 1 diabetes,Infectious diseases and diseases other than diabetes
Intervention groups
A group was trained on "My plate" and group of control group was under regular training.
Main outcome variables
The mean of cholesterol, LDL, fasting blood glucose, systolic blood pressure and diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039665N1
Registration date:2018-11-05, 1397/08/14
Registration timing:retrospective
Last update:2018-11-05, 1397/08/14
Update count:0
Registration date
2018-11-05, 1397/08/14
Registrant information
Name
Zahra Behrouz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 1686
Email address
zahra.behrouz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-03-16, 1395/12/26
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2017-03-16, 1395/12/26
Trial completion date
empty
Scientific title
Assessing the effect of nutrition education on the "My plate" guide on anthropometric indices and some biochemical parameters compared to the usual education in children and adolescents with type 1 diabetes
Public title
Study the effect of nutrition education on the "My plate" guide on type 1 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Girl and boy, aged 8 to 14 years old
There is no other illness other than type 1 diabetes
Over the past month, They have not followed a particular diet
The disease is newly diagnosed and has not followed a specific exercise program
Not taking medications that affect serum lipids and high blood pressure
Exclusion criteria:
Infectious diseases and diseases other than diabetes
Age
From 8 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
72
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done based on random assignment and blocked
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study were kept blind to the study groups and the participants did not meet and contact the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Azadi Square, hazar Jarib St.
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
IR.MUI.REC.1394.3.965
Health conditions studied
1
Description of health condition studied
Diabetes type 1
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Hemoglobin A1C
Timepoint
3 months
Method of measurement
Blood tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Learn "My plate" :The intervention group received my plate and my plate and diet training. The duration of the intervention was three months
Category
Lifestyle
2
Description
Control group: "Routine training" :The control group received routine training based on substitution lists and diet. The study included two intervention and control groups.The duration of the intervention was three months
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Zahra Behrouz
Street address
Imam Hossein Hospital, Imam Khomeini Street
City
Esfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
zahra.behrouz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Shaghayegh Hagh Joy Javanmard
Street address
Isfahan University of Medical Sciences and Health Services, No. 4, Tehran, Iran. Headquarters - Deputy of Research and Technology of the University
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
http://research.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
90
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
Zahra Behrouz
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hezar jarib street,Azadi Square
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
zahra.behrouz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Behrouz
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
University of medical sience of Esfahan,Hezar jarib street ,Azadi square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3778 1686
Fax
Email
zahra.behrouz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Behrouz
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Medical of sience university of Esfahan, Hezar jarib street,Azadi square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3778 1686
Fax
Email
zahra.behrouz@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the primary and secondary outcome is shared.
When the data will become available and for how long
Get started 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
For those working in this field
From where data/document is obtainable
zahra.behrouz@yahoo.com
What processes are involved for a request to access data/document