Protocol summary

Study aim
Evaluation of the effectiveness of an educational intervention based on the five-step counseling model on the status of physical activity and body image in employees of Khorasan Razavi Water Authority
Design
Eighty employees were randomly divided into intervention and control groups using a random number table. Each participant was assigned a code. The intervention will be administered to the intervention group in 4 sessions of 30-minute.
Settings and conduct
The study population consisted of men and women working in Khorasan Razavi Water Authority, Mashhad. Two centers were randomly assigned to the control group and educational intervention. The members of the intervention group are given training based on the counseling model 5 steps and the members of the control group do not receive any training and after 3 months, they are evaluated through a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Employees who work in the health care network Employees who are not prohibited from physical activity or diet. Be able to give informed consent. They do not have health disorders. Exclusion Criteria: Failure to complete the post-test questionnaire. Not participating in training sessions Having a specific illness during the implementation of the plan prevents related activities.
Intervention groups
All participants (n=80) were allocated into an educational intervention (n=40) group and a control group (n=40). In the intervention group, the educational intervention was conducted based on the five-step counseling model with the main focus on the improvement of physical activity and body image concerns. The control group did not receive any intervention education.
Main outcome variables
Body image score, body satisfaction, Physical activity,

General information

Reason for update
Acronym
5A
IRCT registration information
IRCT registration number: IRCT20160917029843N15
Registration date: 2021-07-01, 1400/04/10
Registration timing: prospective

Last update: 2021-07-01, 1400/04/10
Update count: 0
Registration date
2021-07-01, 1400/04/10
Registrant information
Name
Mohammad Vahedian-Shahroodi
Name of organization / entity
Social Determinants of Health Research Center, Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3189 2202
Email address
vahedianm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on five-step Counseling model on the stages of change in physical activity and body image in employees of Khorasan Razavi Regional Water Company
Public title
The effect of five-step Counseling model on the stages of change and body image in employees of Khorasan Razavi Regional Water Company
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All of the participantes workers in the health network. They have no prohibition on physical activity or diet. They are able to give informed consent. They do not suffer health impairments.
Exclusion criteria:
Failure to complete the post-test questionnaire. Not participating in training sessions Having a specific illness during the intervention that prevents related activities
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a quasi-experimental study. Khorasan Regional Water Organization consists of 2 centers in 2 separate regions. From these two centers in Mashhad, one center is randomly selected as a control group and another center as an intervention group. In this study, 80 employees who are in the intention and readiness stage have been randomly selected from 2 existing centers based on a table of random numbers and (randomized will be done during this stage) they are allocated into groups of control (40 people) and intervention (40 people). To use the random number table, the exact number of eligible participants in each center is first determined; then, we will consider them a code or number.
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
Ethics committee of Mashhad University of Medical Sciences
Street address
University 18 Ave., School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.MUMS.REC.1400.052

Health conditions studied

1

Description of health condition studied
Body image score
ICD-10 code
ICD-10 code description

2

Description of health condition studied
body satisfaction status
ICD-10 code
ICD-10
ICD-10 code description

3

Description of health condition studied
Physical activity
ICD-10 code
Y93.6A
ICD-10 code description
Activity, physical games generally associated with school recess, summer camp and children

Primary outcomes

1

Description
Body imaging score
Timepoint
Before intervention, immediately after intervention, 3 months after intervention
Method of measurement
a self-administered Multidimensional Body-Self Relations Questionnaire (MBSRQ)

2

Description
body satisfaction score
Timepoint
Before intervention, immediately after intervention, 3 months after intervention
Method of measurement
a self-administered Multidimensional Body-Self Relations Questionnaire (MBSRQ)

3

Description
Physical activity status
Timepoint
Before intervention, immediately after intervention, 3 months after intervention
Method of measurement
International Physical Activity Questionnaire(IPAQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: this group includes 40 regional water employees of Khorasan who are eligible to enter the study. The educational intervention was performed by educators specializing in health education and health promotion and a psychologist. In the intervention group, all participants receive a training program for one month through four workshops (one hour). All workshops were conducted based on the strategies of the 5-step counseling educational model to improve body posture and promote physical activity behaviors. In the intervention sessions, lectures, instructional videos, and pamphlets are used. A virtual sister group was also formed for information and group discussions.
Category
Behavior

2

Description
Control group:The control group did not receive any training program
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorasan Razavi Regional Water Company
Full name of responsible person
Mohammad Vahedian-shahroodi
Street address
University 18 Ave., School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2202
Email
vahedianm@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghdi
Street address
NO 18, Daneshgah. School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2202
Email
vahedianm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Vahedian-Shahroudi
Position
Academic Staff - Associate of Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Daneshgah 18. School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2202
Email
vahedianm@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Vahedian Shahroudi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
NO 18, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3854 4633
Email
vahedianm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Vahedian-Shahroodi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No 18, Danshgah 18 Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3854 4633
Email
vahedianm@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Potential data can be shared only after identification
When the data will become available and for how long
Get started one month after the results are published
To whom data/document is available
Researchers working in academia and academic
Under which criteria data/document could be used
The data are sent by official request through academic or organizational emails of the researchers after confirmation and identification of the
From where data/document is obtainable
Dr. vahedian : vahedianm@mums.ac.ir
What processes are involved for a request to access data/document
The data are sent by official request through academic or organizational emails of the researchers after confirmation and identification of the sender.
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