Protocol summary

Study aim
The aim of this study was to evaluate the effect of an educational program based on the theory of planned behavior in physical activity in health volunteers of Shushtar city.
Design
A concealed, randomized, controlled clinical trial with a parallel group design of 110 female health volunteers (55 volunteers in the intervention group; 72 volunteers in the control group), enrolling from December 4 to 25, 2015, they entered the study, and following for 3 months after the end of the intervention.
Settings and conduct
Educational intervention was conducted through group education on female health volunteers in Shushtar. Also, they took a walking program for 3 months.
Participants/Inclusion and exclusion criteria
The inclusion criteria were: Holding health volunteer cards; At least one-year experience of cooperation with healthcare centers; No problems in terms of participation in educational classes; Consent to participate in the research study; Ability to read and write; Lack of any apparent mental and physical diseases influencing physical activity. The exclusion criteria comprised of unwillingness to continue cooperation, emergence of physical problems preventing physical activity, and migration to other cities.
Intervention groups
The intervention group received educational interventions related to physical activity in 3 sessions and a three-month walk program.
Main outcome variables
The mean score of physical activity, and the physiological cost index.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120910010804N12
Registration date: 2018-07-01, 1397/04/10
Registration timing: retrospective

Last update: 2018-07-01, 1397/04/10
Update count: 0
Registration date
2018-07-01, 1397/04/10
Registrant information
Name
Marzieh Araban
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
تهران
Email address
m.araban@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-31, 1395/05/10
Expected recruitment end date
2016-08-26, 1395/06/05
Actual recruitment start date
2016-07-31, 1395/05/10
Actual recruitment end date
2016-09-03, 1395/06/13
Trial completion date
empty
Scientific title
Determining the Effect of Intervention on Health Education Based on the Planned Behavior Theory for Promoting Physical Activity in Women Health Volunteers of Health Centers in Shushtar
Public title
The effect of educational intervention on the promotion of physical activity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Holding health volunteer cards; At least one-year experience of cooperation with healthcare centers; No problems in terms of participation in educational classes; Consent to participate in the research study; Ability to read and write; Lack of any apparent mental and physical diseases influencing physical activity.
Exclusion criteria:
Unwillingness to continue cooperation; Emergence of physical problems preventing physical activity; Migration to other cities.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Actual sample size reached: 110
Randomization (investigator's opinion)
Randomized
Randomization description
At first, a list of health volunteers was prepared and then they were divided into two intervention and control groups (each group of 55) using the the random numbers table and by lottery method
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2016-07-23, 1395/05/02
Ethics committee reference number
IR.AJUMS.REC.1395.274

Health conditions studied

1

Description of health condition studied
physical activity
ICD-10 code
Y93.01
ICD-10 code description
Activity, walking, marching and hiking

Primary outcomes

1

Description
Attitude toward physical activity
Timepoint
Before the intervention and 6 months after educational intervention
Method of measurement
Planned Behavior Theory constructs questionnaire

2

Description
Subjective norms about physical activity
Timepoint
Before the intervention and 6 months after educational intervention
Method of measurement
Planned Behavior Theory constructs questionnaire

3

Description
Perceived behavioral control about physical activity
Timepoint
Before the intervention and 6 months after educational intervention
Method of measurement
Planned Behavior Theory constructs questionnaire

4

Description
Behavioral intention to physical activity
Timepoint
Before the intervention and 6 months after educational intervention
Method of measurement
Physical Activity Readiness Questionnaire

Secondary outcomes

1

Description
Mean score of physical activity
Timepoint
Before the intervention and 6 months after educational intervention
Method of measurement
International Physical Activity Questionnaire

2

Description
Physiological cost index
Timepoint
Before the intervention and 6 months after educational intervention
Method of measurement
By Polar Heart Rate Monitor

Intervention groups

1

Description
Intervention group: educational interventions related to physical activity of 3 sessions and walking for three months
Category
Behavior

2

Description
Control group:no educational intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shushtar Health Centers
Full name of responsible person
Marzieh Araban
Street address
Taleghani Street, Shoushtar Health Center
City
Shushtar
Province
Khouzestan
Postal code
6451646441
Phone
+98 61 2622 8591
Email
arabanm@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmalzadeh
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Sciences, Golestan Road, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8269
Fax
+98 61 3373 8269
Email
arabanm@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
Marzieh Araban
Position
Faculty Members
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
خوزستان، اهواز، خیابان گلستان، دانشگاه علوم پزشکی جندی شاپور، مرکز تحقیقات عوامل اجتماعی موثر بر سلامت اهواز
City
Ahvaz
Province
Khouzestan
Postal code
61357-15974
Phone
+98 61 3373 8269
Fax
+98 61 3373 8269
Email
arabanm@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Araban
Position
Faculty Members
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Sciences, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8269
Fax
+98 61 3373 8269
Email
Arabanm@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Araban
Position
Faculty Members
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Social Determinants of Health Research Center, Jondishapour University of Medical Sciences, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8269
Fax
+98 61 3373 8269
Email
arabanm@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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on primary and secondary outcome will be shared in the form of a spss file
When the data will become available and for how long
The access period will be September of 2018.
To whom data/document is available
Researchers of academic institutions
Under which criteria data/document could be used
The researcher will give the data to other researchers for scientific use only.
From where data/document is obtainable
Send an e-mail to arabanm@ajums.ac.ir
What processes are involved for a request to access data/document
People who want the data, send your request by e-mail to the above address. The researcher, after consulting the research team, sends the data to them, if they agree.
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