This Randomized Controlled Trial aims to Evaluate the Effectiveness of Interventions Based on Transtheoritical Model on Womens Self-care Behavior With type 2 Diabetes in Qazvin. Inclusion Criteria: Diabetes; 60 years of age ;a Willingness to Participate in the Study; Reading and Writing; Having not acute or Chronic Disease other than Diabetes or a Prescribed Diet which Prevents them of Physical activity or Consumption of Fruits and Vegetables; the lack of advanced complications from diabetes and taking sedatives or other medications; And Exclusion criteria: absence of more than two Itervention sessions; not wanting to continueto to Contribute ; to cause trouble or Inconvenience During the Intervention. Population smple :Women with Type 2 Diabetes and Sample size is 96 patients in the two Groups are equal . From Two Health centers in which the screening of Diabetes is done,Randomly assigned to a Treatment center and the other as a Controller are Selected. 48 people are Randomly selected at each center. Data were Collected using a Questionnaire based on Transtheoritical Model and Blood tests (HBA1C).Questionnaire will be distributed to Two times, before and Three Months after the End of the Intervene and Blood tests will done. In the Experimental group, the Intervention will be assessed model-based Intervention and control group not receiving the Intervention. At the End of the study ,Effect of Intervention will be Determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071514010N1
Registration date:2014-01-02, 1392/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-02, 1392/10/12
Registrant information
Name
Maryam Zavar Mogaddam
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 2256 4080
Email address
m.zavartoosi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Guilan University Of Medical Sciences
Expected recruitment start date
2013-05-28, 1392/03/07
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Educational Intervention Based on Transtheoritical Model on Self- care Behavior In Women With Type 2 Diabetes At Qazvin City In 1392
Public title
Effect of Intervention on Diabetes selfcare
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Diabetes; 60 years of age; a Willingness to Participate in the Study; Reading and Writing; Having not Acute or Chronic disease other than diabetes or a prescribed diet Which prevents them of Physical activity or Consumption of Fruits and Vegetables; The lack of Advanced Complications from Diabetes and Taking Sedatives or other Medications
Exclusion Criteria: Absence of More than Two Intervention Sessions; not wanting to Continue to Contribute; to Cause trouble or Inconvenience during the Intervention.
Age
To 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
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
Guilan University Of Medical Sciences
Street address
Martyr Siadati Street, Namjoo Street
City
Rasht
Postal code
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
4920101214
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
HBA1C
Timepoint
Before Intervention and 3 Months After Intervention
Method of measurement
Blood Tests
2
Description
Fruit and Vegetable Consumption
Timepoint
Before and Three Months after Education
Method of measurement
Sheet Report
3
Description
Physical Activity
Timepoint
Before and Three Months after Education
Method of measurement
GPAQ Questionnaire
Secondary outcomes
1
Description
Transtheoritical Model Structurs for Fruit and Vegetable Consumption
Timepoint
Before and Three Months After Intervention
Method of measurement
Model-based Questionnaire
2
Description
Transtheoritical Model Structurs for Physical Activities
Timepoint
Before and Three Months After Intervention
Method of measurement
Model-based Questionnaire
Intervention groups
1
Description
Intervention Based on Transtheoritical model to Improve Diabetic Women Self-care Behaviors In the Intervention Group .
Category
Prevention
2
Description
The control group did not receive the intervention and at the end, training package provide them .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tagavi Health Center
Full name of responsible person
Ms. Homayounfar
Street address
Dehkhoda Square
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Rabi Ullah Farmanbar
Street address
Department of Health, Siadati Street , Namjoo Street -
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Maryam Zavarmogaddam
Position
MSc in Health Education
Other areas of specialty/work
Street address
Mohammadieh
City
Qazvin
Postal code
3491737445
Phone
+98 28 1256 4080
Fax
Email
m.zavartoosi@yahoo,com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Rabiollah Farmanbar
Position
PhD in Health Education
Other areas of specialty/work
Street address
Department of Health of Guilan University of Medical Sciences Building , In front of Azodi Stadiums , Namjoo Ave , Rasht
City
Rasht
Postal code
3391
Phone
+98 13 1555 3202
Fax
+98 13 1323 4155
Email
farmanbar@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Maryam Zavarmogaddam
Position
MSc in Health Education
Other areas of specialty/work
Street address
Mohammadieh
City
Qazvin
Postal code
Phone
00
Fax
Email
m.zavartoosi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)