Protocol summary

Summary
The purpose of this study is to investigate the Effect of intervention based on Stage of Change Model on the promotion of physical activity of Health Volunteer in Rasht. This study is a randomized controlled trial. The sample size included 160 health active volunteers in health centers in Rasht. Urban health centers will allocate randomly into the intervention and control groups. Inclusion criteria: Willingness to cooperate; the lack of obvious physical problems to do physical activity. Exclusion criteria: Not wanting to continue to work for any reason; illness or accident occurring during the study; The absence of more than one training session; and the absence of pre-test or post-test session. In winter of 2014, Interventional group (80 health volunteers) will receive the intervention based on Stage of Change Model, including: 40 training sessions will be held (each session 45 to 60 minutes lasts, for 8 subgroups, each group: 11 to 14 participants) by lectures, individual counseling, group discussions, role playing, rewarding and texting and also by applying posters, pamphlets, flyers, educational videos and PowerPoint slides. The control group will not receive any intervention by the researcher. Evaluations will conducted by Stage of Change in physical activity behavior, before intervention and after 3 months. After the intervention, we expect significant progress in Stage of changes in physical activity and daily physical activity in the intervention group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051922328N1
Registration date: 2015-08-06, 1394/05/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Sakineh Keshavarz Mohammadian
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 5073
Email address
s_keshavarz_m@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intervention based on Stage of Change Model on the promotion of physical activity of Health Volunteers
Public title
Promoting physical activity in Health Volunteers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Being active as health volunteers in one of the health centers in Rasht; Attendance at weekly meetings contacts in health centers; Willingness to cooperate; The lack of obvious physical problems to do physical activity. Exclusion criteria: Not wanting to continue to work for any reason; Illness or accident occurring during the study; The absence of more than one training session; and the absence of pre-test or post-test session
Age
From 18 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done using random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
centeral Office of Guilan University of Medical Sciences, Parastar Street, Rasht, IRAN
City
Rasht
Postal code
4193713111
Approval date
2014-08-19, 1393/05/28
Ethics committee reference number
4930231609

Health conditions studied

1

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

Primary outcomes

1

Description
physical activity stage of change
Timepoint
pre intervention; 3 months after intervention
Method of measurement
Validated questionnaire of Stage of Change Model

2

Description
Physical Activity (METs)
Timepoint
pre intervention; 3 months after intervention
Method of measurement
International Physical Activity Questionnaire(IPAQ)- Long form (Metabolic Equivalent of Tasks-METs)

Secondary outcomes

empty

Intervention groups

1

Description
In interventional group: Stage of Change Model theory based intervention, including: 40 training sessions will be held (each session 45 to 60 minutes lasts, for 8 subgroups, each group: 11 to 14 participants) about increase knowledge about physical activity behavior; self-efficacy; pros and cons in physical activity behavior; goal setting in physical activity; time management to fit physical activity behavior in daily life and using training methods including: lectures; individual counseling; group discussions; role playing; reward and texting and also by applying posters; pamphlets; flyers; educational videos and PowerPoint slides.Evaluations will conducted by Stage of Change in physical activity behavior, before intervention and after 3 months.
Category
Lifestyle

2

Description
Control group: Control group(80 persons) will not receive any intervention by the researcher. Evaluations will conducted by Stage of Change in physical activity behavior, before intervention and after 3 months.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasht Health Center
Full name of responsible person
Dr. Hojjat Najafzadeh
Street address
Rasht Health Center-Saadi street.Rasht.Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Vice chancellor for Research, Guilan University of Medical Sciences
Street address
opposite of Sepah Bank, Shahid Beheshti Blvd.(west), Rasht, Guilan, Iran.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, 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
Guilan University of Medical Sciences
Full name of responsible person
Sakineh Keshavarz Mohammadian
Position
MSc Student of Health Education and promotion
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences, Opposite of Alzahra Hospital, Shahid Siadaty street, Namju boulevard, Rasht, Iran.
City
Rasht
Postal code
Phone
+98 13 3334 5416
Fax
Email
S_keshavarz_m@gums.ac.ir; s_keshavarz_m@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
Associate Professor of Health Education and promotion,
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences, Opposite of Alzahra Hospital, Shahid Siadaty street, Namju boulevard, Rasht, Iran.
City
Rasht
Postal code
Phone
+98 13 3334 5416
Fax
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
Sakineh Keshavarz Mohammadian
Position
MSc Student of Health Education and promotion
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences, Opposite of Alzahra Hospital, Shahid Siadaty street, Namju boulevard, Rasht, Iran.
City
Rasht
Postal code
Phone
+98 13 3334 5416
Fax
Email
S_keshavarz_m@gums.ac.ir; s_keshavarz_m@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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