Comparison of physical activity , emotion related to physical activity interests barriers & self efficacy perceived interpersonal relationships commitment levels preferences pressing demands in the two
Design
The number of 128 patients is entered into the study , using the random permutation block method with the size of block 4 ( using the random permutation table ) into two groups of intervention and random assignment control .
Settings and conduct
Hospital diabetic clinics of Imam Khomeini and Gulistan, 128 women - 30 to 60 years with Type II diabetes , specimens will be studied in accordance with the method of random permutation blocks , with written consent and awareness of confidentiality and purpose of conducting research , according to terms of entry conditions
Participants/Inclusion and exclusion criteria
The ability to participate in training sessions ، Lack of medical ban on physical activity،Lack Pregnancy
Measures of departure
Lack of participation in more than one training session
Pregnancy during the course of the educational intervention
Intervention groups
Education based on the Pender’s Health Promotion will be presented for intervention group.
Main outcome variables
Interests , barriers perceived , related sense of activity , interpersonal relationships , commitment to design , instant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180514039655N1
Registration date:2018-07-02, 1397/04/11
Registration timing:retrospective
Last update:2018-07-02, 1397/04/11
Update count:0
Registration date
2018-07-02, 1397/04/11
Registrant information
Name
Soghra Rouholamini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3447 8315
Email address
rouholamini.s@ajumas.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-14, 1397/02/24
Expected recruitment end date
2018-06-14, 1397/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on the Pender’s Health Promotion Model on physical activity of women with type II diabetes
Public title
Education and physical activity in women with type II diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The ability to participate in training sessions
Having read and write literacy
In ahvaz city residence
Lack of medical ban on physical activity
Lack Pregnancy
For at least one year of the diagnosis of the past
Exclusion criteria:
Lack of participation in more than one training session
Pregnancy during the course of the educational intervention
Age
From 30 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
randomly and according to the permutation block method , which is the size of block 4
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
National Ethics Committee in biomedical research
Street address
Ahvaz University of Medical Sciences, golestan region
City
ahvaz
Province
Khouzestan
Postal code
6164773748
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
ir.ajums.rec.1397.108
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E13
ICD-10 code description
Other specified diabetes mellitus
Primary outcomes
1
Description
Timepoint
Method of measurement
2
Description
Physical activity
Timepoint
monthly
Method of measurement
Beak’s physical activity questionnaire
Secondary outcomes
1
Description
Perceived benefits
Timepoint
monthly
Method of measurement
Investigative - based questionnaire based on improvement of health promotion pattern constructs
2
Description
Perceived barriers
Timepoint
monthly
Method of measurement
Investigative - based questionnaire based on improvement of health
3
Description
Perceived self- efficacy
Timepoint
monthly
Method of measurement
Investigative - based questionnaire based on improvement of health
4
Description
Activity related affect
Timepoint
monthly
Method of measurement
Investigative - based questionnaire based on improvement of health
5
Description
Inter personal influences
Timepoint
monthly
Method of measurement
Investigative - based questionnaire based on improvement of health
6
Description
Situetional influences
Timepoint
monthly
Method of measurement
Investigative - based questionnaire based on improvement of health
7
Description
Commitment to a plan of action
Timepoint
monthly
Method of measurement
Investigative - based questionnaire based on improvement of health
8
Description
Immediate competing demands and preferences
Timepoint
monthly
Method of measurement
Investigative - based questionnaire based on improvement of health
Intervention groups
1
Description
Intervention group: 1- After presenting the necessary explanations to the participants in the study and obtaining informed consent of them , the questionnaires will be placed at the disposal of the two groups . After completing preliminary questionnaires by the participants , the data will be analysed . 2- The training planning is then designed to focus on constructs of improved health promotion and the results of pre - test data analysis for the test group . 3- Then , 45 minutes training sessions ( two sessions per week ) will be considered for the test group . female control groups also
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
hospitals diabetes clinices of emam khomeyni & golestan
Full name of responsible person
dr. mahin gheybi zadeh
Street address
Ahvaz University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
6164773748
Phone
+98 61 3447 8315
Fax
+98 61 3447 8315
Email
gheibizadeh-m@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
dr. mahin gheibizadeh
Street address
Ahvaz University of Medical Sciences, golestan region
City
Ahvaz
Province
Khouzestan
Postal code
6164773748
Phone
+98 61 3384 8827
Email
gheibizadeh-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
دکتر مهین غیبی زاده
Position
Faculty , Faculty of Nursing and midwifery College
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
AhaAhvaz University of Medical Sciences, golestan region
City
Ahvaz
Province
Khouzestan
Postal code
6164773748
Phone
+98 61 3373 8394
Fax
+98 61 3373 8394
Email
gheibizadeh-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
dr. mahin gheybi zadeh
Position
Faculty , Faculty of Nursing and midwifery College
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6164773748
Phone
+98 61 3384 8827
Fax
+98 61 3384 8827
Email
gheibizadeh-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
dr.mahin gheibizadeh
Position
Faculty , Faculty of Nursing and midwifery College
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz University of Medical Sciences, golestan region
City
Ahvaz
Province
Khouzestan
Postal code
6164773748
Phone
+98 61 3373 8394
Fax
+98 61 3373 8394
Email
gheibizadeh-m@ajums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total of the potential data is beyond theunstoppable of individuals .
When the data will become available and for how long
Starting accession period 6 months after the results are published
To whom data/document is available
It will be available for researchers at academic and academic institutions .
Under which criteria data/document could be used
in order to investigate the relevant researches
From where data/document is obtainable
Email Addressب
What processes are involved for a request to access data/document
For Abstract visit to e - mail and to use this thesis at the Central Library of Tehran University of Medical Sciences .