Evaluating the effectiveness of educational intervention on the nutritional behavior and physicalactivity in patients with type 2 diabetic based on KirkPatrick’s model
Evaluation of the Effectiveness of Educational Intervention on the Nutritional Behavior and Physical Activity of Diabetic Patients Referring to Health Care Centers Affiliated to Shiraz University of Medical Sciences Based on the Kirk Patrick Model
Design
Clinical trial with intervention and control group
Settings and conduct
Organizing training sessions in diabetes clinics in comprehensive health centers affiliated to Shiraz University of Medical Sciences and completing satisfaction questionnaire related to participation in research.
Participants/Inclusion and exclusion criteria
Entry requirements: Diabetics over 30 years of age; Have a history of 1 year old diabetic disease with reading and writing skills. Conditions of non-entry: lack of participation in the classroom and reluctance to cooperate in research.
Intervention groups
Control group: no intervention for the control group will be performed.
Intervention group: for this group, training sessions on the effects of regular exercise and proper diet are conducted and after 2 months the results of the tests are compared with the control group.
Main outcome variables
Reduce the complications of diabetes and improve the health of these patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181219042057N1
Registration date:2019-05-24, 1398/03/03
Registration timing:retrospective
Last update:2019-05-24, 1398/03/03
Update count:0
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Maryam Mehranpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3633 2905
Email address
m.mehranpour2522@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-20, 1398/01/31
Expected recruitment end date
2019-05-19, 1398/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of educational intervention on the nutritional behavior and physicalactivity in patients with type 2 diabetic based on KirkPatrick’s model
Public title
The effect of education on diet and physical activity on reducing blood glucose
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
History of type 2 diabetes for at least one year
Having at least 30 years of age for participants
Having reading and writing skills
Lack of other underlying diseases other than diabetes
Exclusion criteria:
The patient's unwillingness to continue to collaborate in the research
Missing more than one session in training classes
Patient admission to the hospital during the duration of the research
Failure to reenter the patient to complete the questionnaire
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
no 11/2 , andishe ave , farhangshahr blvd
City
shiraz
Province
Fars
Postal code
7185954992
Approval date
2019-01-11, 1397/10/21
Ethics committee reference number
IR.SUMS.REC.1397.916
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E12
ICD-10 code description
Diabetes Mellitus
Primary outcomes
1
Description
The effect of training on reducing blood glucose levels
Timepoint
Beforem, immediately and two months after the intervention
Method of measurement
Check blood glucose
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: The training group will be involved in the first training session on the objectives of the design and the motivation survey. During the other three sessions, the effect of the activity and observation of low-fat and low calorie diet will be explained and the motivational questionnaire will be repeated by the participants. Will be completed. The duration of each session will be up to 1.5 hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim Health Center
Full name of responsible person
Dr Mohammadi
Street address
Farhangshahr Blv , Hakim health center
City
Shiraz
Province
Fars
Postal code
7185643565
Phone
+98 71 3633 2905
Email
z.talebi_arc89@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Poostforoosh
Street address
Zand Street, Central Building of Shiraz University of Medical Sciences Shiraz city
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yektatalab
Position
Ph.D. in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square, School of Nursing and Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14338
Phone
+98 71 3647 4254
Email
shahrzadyekta@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yektatalab
Position
ph.d in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square, School of Nursing and Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3647 4254
Email
shahrzadyekta@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Mehranpour
Position
nursing expert
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Andishe Ave,Farhangshahr Blvd
City
Shiraz
Province
Fars
Postal code
7185643565
Phone
+98 71 3621 0535
Email
m.mehranpour2522@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available