1. Home
  2. Approved trials
  3. » فارسی

Effect of health education program based on Transtheoretical model on physical activity level of Ilam’s women

Protocol summary

Study aim
The effect of intervention based on transtheoretical model on physical activity level in women in Ilam
Design
Clinical trial with intervention and control group with volume of each group of 45 people
Settings and conduct
After analyzing the data obtained from the pre-test, an appropriate, applicable and informative educational intervention will be designed with an emphasis on the specified areas, and will be implemented with an effective solution. The study location will be health centers.
Participants/Inclusion and exclusion criteria
Inclusion criteria include consent to participate in the study, referring to the Comprehensive Health Services Center (people with active records), age 30-59 years, being in the pre-contemplation or thinking stage in terms of physical activity, and exclusion criteria including movement, unwillingness to continue the study, pregnancy, developing motor-restriction diseases such as rheumatoid arthritis, advanced heart disease with movement restriction, severe diabetic foot ulcer, and medications. This has caused imbalances and dizziness, such as some drugs prescribed in psychiatric disorders and neurological diseases, the absence of 20% and more is proportional to the number of classes held and the questionnaire is filled out.
Intervention groups
For the intervention group, group walking program, use of gym, educational package including pamphel and poster and use of pedding software are considered. The control group does not receive any training during this period. After the intervention, educational pamphulette will be provided to the control group in order to observe ethical principles.
Main outcome variables
The effect on the level of physical activity in the intervention group, the effect on the level of knowledge of the intervention group about the importance and benefits of physical activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200910048679N1
Registration date: 2020-09-28, 1399/07/07
Registration timing: retrospective

Last update: 2020-09-28, 1399/07/07
Update count: 0
Registration date
2020-09-28, 1399/07/07
Registrant information
Name
Fatemeh Shirzai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3331 4424
Email address
shirzadi-f@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-09-04, 1399/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of health education program based on Transtheoretical model on physical activity level of Ilam’s women
Public title
Effect of health education program based on Transtheoretical model on physical activity level of Ilam’s women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Referral to Comprehensive Health Services Center (people with active records) Age 30-59 years Being in the pre-contemplation or thinking stage in terms of physical activity
Exclusion criteria:
Relocate Unwillingness to continue studying Pregnancy Developing diseases that cause movement limitations, such as rheumatoid arthritis, advanced heart disease with movement limitations, severe diabetic foot ulcers Taking medications that cause imbalance and dizziness, such as some drugs prescribed in psychiatric disorders and neurological diseases Absence of 20% and more proportional to the number of classes held Fill out the questionnaire
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, ilam city is divided into two sections based on geographical location, and then one area is randomly determined as an intervention zone and one area as a control zone, in the next step, the sample framework (list of all comprehensive health centers) is prepared and randomly two centers are selected as intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
•Ethics committee of ilam University of Medical Sciences
Street address
Shahid shirzadi alley, jomhouri prince boulevard
City
Ilam
Province
Ilam
Postal code
69317-63116
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.MEDILAM.REC.1398.090

Health conditions studied

1

Description of health condition studied
physical activity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
physical activity
Timepoint
90day
Method of measurement
International Physical Activity Questionnaire Short Form,Researcher-made questionnaire

2

Description
The transtheoretical model and stages of change
Timepoint
90Day
Method of measurement
Researcher-made questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group was women aged 30-59 years who referred to health center. After random selection and obtaining written consent from them, questionnaires will be completed.The educational intervention will be based on the results of the pre-test for cognitive domain including group training using lecture by the researcher in 5 sessions, as well as for behavioral domain, group walking and the use of gym for participants, as well as an educational package containing pamphels and posters related to physical activity, which will be prepared by the researcher.
Category
Behavior

2

Description
Control group: The control group includes women aged 30-50 years who referred to the health center who have the characteristics of the intervention group. After random selection, pre-test questionnaires will be completed. There is no training for this group. After the end of the research, educational pamphulettes are provided to them in order to observe the ethical principles.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز سلامت شهری شماره 6 ایلام
Full name of responsible person
Shirzadi-fatemeh
Street address
Shirzadi Alley Jomh prince boulevard
City
Ilam
Province
Ilam
Postal code
69317-63116
Phone
+98 84 3331 4424
Email
fatemehshirzadi2017@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Mohammad Sadegh Abedzadeh
Street address
Pajoos research boulevard, Bangonjab
City
Ilam
Province
Ilam
Postal code
6931763116
Phone
+98 84 3331 4424
Email
fatemehshirzadi2017@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Shirzadi Fatemeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Shirzdi Alley, Jomhouri Blvd
City
Ilam
Province
Ilam
Postal code
6931763116
Phone
+98 84 3331 4424
Email
fatemehshirzadi2017@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shirzadi Fatemeh
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Shirzdi Alley, Jomhouri Blvd.
City
Ilam
Province
Ilam
Postal code
6931763116
Phone
+98 84 3331 4424
Email
fatemehshirzadi2017@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shirzadi Fatemeh
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Shirzdi Alley, Jomhouri Blvd
City
Ilam
Province
Ilam
Postal code
6931763116
Phone
+98 84 3331 4424
Email
fatemehshirzadi2017@gmail.com

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
Individual data and study outcomes
When the data will become available and for how long
6 Months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research on other age groups
From where data/document is obtainable
fatemehshirzadi2017@gmail.com
What processes are involved for a request to access data/document
One month after receiving the email
Comments
Loading...