Determine the effect of the theory-based educational intervention on the improvement of physical activities of middle-aged women referring to Ahwaz health centers
Design
The research units were randomly allocated into two intervention and control groups of 90 individuals
Settings and conduct
Ahwaz city was divided into 4 geographical regions with approximately equal populations of middle-aged women. Two centers (intervention and control groups) were selected in each region, and a total of 22 individuals were randomly in each center.The intervention program was conducted for a 2-month period for the intervention group. It consisted of 4 face-to-face consultation sessions, each for 90 minutes in a month, and 4 follow-up sessions (weeks 5- 8) after the consultation sessions for the intervention group.
Participants/Inclusion and exclusion criteria
women of 30-59 years of age, being able to read and write, not having chronic diseases such as cardiovascular or respiratory diseases or those that cause physical activities to be banned, not having mobility prohibition (able to move, participate in educational programs, and recommendations for physical activities), lack of pregnancy, lack of specific diseases, lack of a history of accidents resulted in a mental and physical problem during the past month , and willingness to participate in the research project. The exclusion criteria included the reluctance to participate in the study at any time and not attending various stages of the research (pre-education and post-education assessments, and educational sessions).
Intervention groups
The intervention program was conducted for a 2-month period for the intervention group. It consisted of 4 face-to-face consultation sessions, each for 90 minutes in a month, and 4 follow-up sessions (weeks 5- 8) after the consultation sessions for the intervention group.
Main outcome variables
Physical Activities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160418027449N2
Registration date:2019-01-31, 1397/11/11
Registration timing:retrospective
Last update:2019-01-31, 1397/11/11
Update count:0
Registration date
2019-01-31, 1397/11/11
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 372510015
Email address
trakhshani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-04-30, 1397/02/10
Trial completion date
2018-04-30, 1397/02/10
Scientific title
Effect of Theory-based Educational Interventions on Improvement of Physical Activities of Middle-aged Women Referring to Ahwaz Health Centers in 2017
Public title
Effect of Theory-based Educational Interventions on Improvement of Physical Activities of Middle-aged Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
women of 30-59 years of age
being able to read and write
not having chronic diseases such as cardiovascular or respiratory diseases or those that cause physical activities to be banned, not having mobility prohibition (able to move, participate in educational programs, and recommendations for physical activities)
lack of pregnancy
lack of specific diseases
lack of a history of accidents resulted in a mental and physical problem during the past month (traffic accident, death of a family member, etc.)
willingness to participate in the research project
Exclusion criteria:
Dissatisfaction of participate in the project
Absence in different stages of the project
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:
180
Actual sample size reached:
180
Randomization (investigator's opinion)
Randomized
Randomization description
We used the cluster sampling method. Firstly, Ahwaz city was divided into 4 geographical regions with approximately equal populations of middle-aged women. Two centers (intervention and control groups) were selected in each region, and a total of 22 individuals were randomly in each center.
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
Vice chancellery for research affairs
Street address
Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.SUMS.REC.1396.159
Health conditions studied
1
Description of health condition studied
physical activity
ICD-10 code
Z50.1
ICD-10 code description
Other physical therapy
Primary outcomes
1
Description
Physical Activities
Timepoint
Before and 8 weeks after the end of the intervention
Method of measurement
International Physical Activity Questionnaire
Secondary outcomes
1
Description
knowledge
Timepoint
Two month post intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Control group: Routine care
Category
Behavior
2
Description
Intervention group: Train the physical activity.intervention: included 4 face-to-face counseling sessions, Each session for one and half hours in a month and Four follow-up sessions.The first consultation session included completing questionnaire form for every person,Determining the health status of the individual.The second session involves group discussion between Participants in the study and comment on each Whether or not physical activity is beneficial .The Third session,the researcher evaluated the level of thinking and readiness with the presentation of educational films.The fourth meeting was spent on the achievement of the goals of the previous three sessions.At weeks 5, 6.7 and 8,investigated in the amount of individual advance in physical activity,consideration the amount of activity and alteration phase and encourage her and also reasons of her failure recognition and sport and health pamphlets were introduced. At the end of the eighth week,the researcher filled the questionnaire of the amount of physical activity and alteration phases for experiment and witness group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz health centers
Full name of responsible person
Taybeh Rakhshani
Street address
Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
trakhshani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Taybeh Rakhshani
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.,
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
trakhshani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Fatemeh Masrourpour
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
International affairs office, of Ahvaz Jundishapour University of Medical Sciences Golestan St., Ahvaz, Iran
City
shirz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3333 9194
Email
a.masrourpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tayebeh Rakhshani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
trakhshani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Masrourpour
Position
Health education expert
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
International affairs office, of Ahvaz Jundishapour University of Medical Sciences Golestan St., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 61 3333 9194
Email
a.masrourpour@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Any change or analysis in the data file requires coordination with the responsible layout
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
Only applicable to researchers
From where data/document is obtainable
Person in charge - Faculty of Health, Shiraz University of Medical Sciences
What processes are involved for a request to access data/document
First, send an application by e-mail. In case of non-response, contact the respondent