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Comparing the Effectiveness of Motivational Interviewing and Self Knowledge Sources on life style .in Patients with type II diabetes.

Protocol summary

Study aim
Determine the effectiveness of Motivational Interviewing and education Self Knowledge Sources on life style .in Patients with type II diabetes.
Design
‏ 80 patients were selected randomly and randomly divided into two groups of 40 patients. Then, patients at the Firouzgar Hospital were exposed to motivational interviewing and patients at Imam Reza Hospital were trained by Self Knowledge Sources
Settings and conduct
40 patients from Imam Reza Hospital and 40 patients from Firouzgar Hospital will be selected randomly. For both groups, a preliminary pre-test is performed. Then, patients in the Firouzgar Hospital are are exposed to motivational interview for 10 sessions; and Imam Reza Hospital patients are exposed to Self Knowledge Sources for 10 sessions. Finally, the post-test is executed and the data is analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged over 35 Not having another chronic disease Having Type 2 Diabetes Exclusion Criteria‏ History of the disease less than 1 year Use of non-diabetic drugs Alcohol or substance abuse Simultaneously undergo another psychological treatment Except motivational interviewing and education Self Knowledge Sources
Intervention groups
. In the first group, patients receive 10 sessions of motivational interviewing for 2 two hours.and the second group patients receive 10 sessions of education Self Knowledge Sources for 2 two hours.
Main outcome variables
life style: , lifestyle is a combination of behavioral patterns and individual habits throughout life, including nutrition, physical activity, stress, smoking and the quality of sleep that arose after being socialized. The lifestyle is a multifaceted phenomenon that all The aspects of everyday life, sleep, food, health, customs, work, play, entertainment, time spent, consensus, thinking, behavior, feelings and emotions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180710040411N2
Registration date: 2018-11-14, 1397/08/23
Registration timing: retrospective

Last update: 2018-11-14, 1397/08/23
Update count: 0
Registration date
2018-11-14, 1397/08/23
Registrant information
Name
Javad Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0061
Email address
sa.khanjani@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-26, 1396/08/04
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Motivational Interviewing and Self Knowledge Sources on life style .in Patients with type II diabetes.
Public title
Comparing the Effectiveness of Motivational Interviewing and Self Knowledge Sources on life style .in Patients with type II diabetes.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aged over 35 Having Type 2 Diabetes Not having another chronic disease
Exclusion criteria:
History of illness less than 1 year Use of non-diabetic drugs Alcohol or substance abuse Simultaneously undergo another psychological treatment except motivational interviewing and Self Knowledge Sources
Age
From 35 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
In order to select the samples in the experimental and control groups, simple random method with Using random numbers, was used. Cluster randomization method was used. Thus, beetween Firouzgar Hospital and Imam Reza Hospital, with using random numbers, patients with type 2 diabetes in Firouzgar Hospital was selected as the experimental group. Also, Imam Reza hospital patients were selected as control group.
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
The Ethics Committee of the Research Institute of the Baqiyatallah University of Medical Sciences
Street address
Health and Nutrition Research Center, Research Institute Building, Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Sheikh Bahayi Ave., Mulla Sadra Ave., Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
ندارم
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR. BMSU.REC.1396.311

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Lifestyle A combination of behavioral patterns and individual habits throughout life such as nutrition, physical activity, stress, smoking and the quality of sleep that arose after socialization.
Timepoint
Before intervention and after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 40 patients with type 2 diabetes mellitus in Firouzgar Hospital that exposed to Self Knowledge Sources for 10 sessions.
Category
Rehabilitation

2

Description
Control group: 40 patients with type 2 diabetes mellitus in Emam Reza Hospital that exposed to motivational interviews for 10 sessions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Mehrnoush Isanlou
Street address
Firouzgar Hospital, Behafarin.St., Karim Khan St., Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
bbahmani43@yahoo.com

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Abolfazl Rahimi Zarchi
Street address
Imam Reza Hospital, above the Embassy of Pakistan, Etemadzadeh Ave., West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
bbahmani43@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Fatemeh Rahmati
Street address
Health and Nutrition Research Center, Research Institute Building, Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Sheikh Bahayi Ave., Mulla Sadra Ave., Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
ندارم
Phone
+98 21 8248 2468
Email
rahmati.fatemeh90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
5
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Javad Kazemi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Health and Nutrition Research Center, Research Institute Building, Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Sheikh Bahayi Ave., Mulla Sadra Ave., Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
65571-37347
Phone
+98 21 8248 2468
Email
kazemi012@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Javad Kazemi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Health and Nutrition Research Center, Research Institute Building, Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Sheikh Bahayi Ave., Mulla Sadra Ave., Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
65571-37347
Phone
+98 21 8248 2468
Email
kazemi012@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Javad Kazemi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Health and Nutrition Research Center, Research Institute Building, Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Sheikh Bahayi Ave., Mulla Sadra Ave., Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
65571-37347
Phone
+98 21 8248 2468
Email
kazemi012@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results will be published without mentioning the names of the participants
When the data will become available and for how long
10 months
To whom data/document is available
Supervisors-Researchers - Journalists
Under which criteria data/document could be used
The data will be published without mentioning the names of individuals for presentation in research journals.
From where data/document is obtainable
Will be consulted by the University's Ethics Committee
What processes are involved for a request to access data/document
About three months after the completion of the project, the results of the research will be received by the applicant.
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