The effect of Islamic lifestyle based model education on quality of life, lifestyle and blood glucose control indices in pre-diabetic patients in Lamerd city, 2017
Determining the effect of education based on Islamic lifestyle model on quality of life, lifestyle and blood glucose control indices of pre-diabetes individuals, in the event of the effectiveness of diabetes policy makers in planning and controlling diabetes
Design
This is a randomized controlled clinical trial conducted on 76 pre-diabetes patients in Lamard. The subjects are randomly divided into two groups of 38 test and control groups
Settings and conduct
Among the people who came to Lamerd City Libraries and have fasting blood glucose levels in pre-diabetes range, they will be checked again if they are satisfied with Sedigheh Tahereh's clinic lab. Blood pressure and fasting blood glucose will be checked if they were still within range. Will enter the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Do not use drugs that increase or decrease blood glucose
Absence of chronic hemolytic anemia (sickle cell anemia, thalassemia)
Lack of mental illness
Being Muslim
Exit criteria:
Positive pregnancy test
Intervention groups
Intervention and educational package based on the model of Islamic lifestyle (individual scale) Dr. Kaviani will be presented by a researcher in the presence of a religious expert during 4 sessions of an hour and a half. The control group receives an educational pamphlet on pre-diabetes care.
Main outcome variables
Fasting blood glucose, Glycosylated hemoglobin,life style and Quality of Life,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150529022466N14
Registration date:2018-05-14, 1397/02/24
Registration timing:registered_while_recruiting
Last update:2018-05-14, 1397/02/24
Update count:0
Registration date
2018-05-14, 1397/02/24
Registrant information
Name
Shahnaz Pouladi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 374 0061
Email address
sh.pooladi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Islamic lifestyle based model education on quality of life, lifestyle and blood glucose control indices in pre-diabetic patients in Lamerd city, 2017
Public title
Study of Islamic lifestyle education in pre-diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
✓ Fasting blood sugar between 125-100 mg / dL or hemoglobin glycolysis between 5/7 -6/4 percent
Do not use drugs that increase or decrease blood glucose
Non-chronic diseases of hemolytic anemia (sickle cell anemia, thalassemia
No pregnancy history in women participating in the study
No mental illness
Being Muslim
Exclusion criteria:
Positive pregnancy test for women participating in the study during the study.
Incomplete filling in the questionnaire
Lack of regular attendance at training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Use the random numbers table
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 Bushehr University of Medical Sciences
Street address
School of nursing and midwifery; Bushehr University of medical sciences; Rishehr avenue; Sabzabad avenue; Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
IR. BPUMS.REC.1396.107
Health conditions studied
1
Description of health condition studied
Pre-diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Glycosylated hemoglobin
Timepoint
Before the intervention and three months after the initial measurement
Method of measurement
Device and Kite Srastat - Manually,
2
Description
Fasting blood suga
Timepoint
Before the intervention and three months after the initial measurement
Method of measurement
deviceDeroi autoanalyzer by calorimetric enzyme method
3
Description
Quality of Life
Timepoint
Before the intervention and repeat one and three months after the intervention
Method of measurement
World Health Organization Quality of Life questionnaire 26 questions (quality of life)
4
Description
life style
Timepoint
Before the intervention and repeat one and three months after the intervention
Method of measurement
Lifestyle Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention of this study is based on the curriculum provided by the researcher. The designed education is based on the Islamic lifestyle tree (individual scale), Dr. Kaviani (2009), in three areas: personal, family and social. The contents of the training are verified by a religious and scientific expert. Training in four sessions of an hour and a half during two weeks for an intervention group divided into two groups of 19 will be presented by a researcher in the presence of a religious expert in a lecture and by PowerPoint at the educational hall of the Vali Asr Hospital. In order to remind the materials presented at the end of the sessions, they will be followed up the next week by telephone, so that during these two weeks people will be contacted twice about the implementation of Islamic lifestyle education (nutrition, physical activity, physical activity And .....) Questions will be asked. If less than 70% of the lessons learned after the second call are taught, they will be excluded from the study. We will answer them if they have a question.
Category
Lifestyle
2
Description
Control group: At the end of the study, a pre-diabetes control brochure will be delivered to the control group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Lamard Hospital
Full name of responsible person
soraya sadeghinursing student of master degree
Street address
Valiasr Ave, Valiasr Blvd, lamerd Town
City
Lamerd
Province
Fars
Postal code
7434174196
Phone
+98 71 5272 2201
Fax
+98 71 5272 1006
Email
ssadeghi6584@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Sedigheh Tahereh Clinic
Full name of responsible person
soraya sadeghinursing student of master degree
Street address
Imam Khomeini Square, Next to the Lamer Healthcare Network, Lamerd Town
City
Lamerd
Province
Fars
Postal code
7434159614
Phone
+98 71 5272 2530
Fax
+98 71 5272 2531
Email
ssadeghi6584@gmail.com
Web page address
3
Recruitment center
Name of recruitment center
Dr. Razavi's lab
Full name of responsible person
soraya sadeghi nursing student of master degree
Street address
Imam Khomeini Square,Behind the Saderat Bank
City
Lamerd
Province
Fars
Postal code
7434153919
Phone
+98 71 5272 1928
Fax
+98 71 5272 5754
Email
ssadeghi6584@gmail.com
Web page address
https://bankpezeshkan.com
4
Recruitment center
Name of recruitment center
Dr. Mohammadian lab
Full name of responsible person
soraya sadeghinursing student of master degree
Street address
Shahed Ave,, next to Tohid passenger
City
Lamerd
Province
Fars
Postal code
7434153639
Phone
+98 71 5272 5540
Fax
+98 71 5272 5541
Email
ssadeghi6584@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
دکتر غلامرضا خمیسی پور
Street address
Vice chancellor for research, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
ssadeghi6584@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pooladi
Position
رئیس دانشکده پرستاری علوم پزشکی بوشهر
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zabzabad Avu, University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
pouladi2008@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
دکتر شهناز پولادی
Position
رئیس دانشکده پرستاری
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
pouladi2008@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Shahnaz Pooladi
Position
Faculty of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Fars
Postal code
7518759577
Phone
+98 77 3345 0187
Email
Pouladi2008@yahoo.com
Web page address
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
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available