Designing, Implementation and Evaluation of Skill Training Intervention Based on the Healthy Lifestyle Counselling Module (5As model) in the Ira PEN Program among Health Workers: A Methodological and Interventional Study
Design and psychometrics of a healthy lifestyle counseling skill assessment tool by health workers in the IraPEN program
Determining the Impact of Skill Intervention in Healthy Lifestyle Counseling based on 5As Model in the IraPEN Program for Health Workers
Design
This study is a field trial with a control group, single-blind, randomized and has a 2-month follow-up phase. To randomize, several numbers are randomly selected from the list of health databases.
Settings and conduct
This study is performed in the environment of health centers. After selecting the intervention and control group, a checklist for health providers and a questionnaire for clients about healthy lifestyle counseling are completed. Then, for the members of the intervention group, a training workshop will implement and a short training clip will be shown to them and they will participate in a virtual training course. After the intervention, the checklist and questionnaire are completed again. In this study, health providers do not know whether they are in the intervention group or not. Observers that will be complete checklist and questionnaire, are also blind to the intervention and control group.
Participants/Inclusion and exclusion criteria
Health workers Group:
Inclusion criteria, Health workers that work in health centers
Exclusion criteria, Reluctance to continue cooperation during the study
Recipients Consulting Group:
Inclusion criteria, People in their 30s and 70s
Exclusion criteria, Reluctance to continue cooperation during the study
Intervention groups
1. Participate in a training workshop
2. Participate in a virtual training course
3. Watch educational short videos
Main outcome variables
1. Change the skills of health workers in providing healthy lifestyle counseling
2. Change counselors' behavior in relation to a healthy lifestyle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201222049800N1
Registration date:2021-05-03, 1400/02/13
Registration timing:prospective
Last update:2021-05-03, 1400/02/13
Update count:0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Najmolmolook َAmini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6345 3342
Email address
namini@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing, Implementation and Evaluation of Skill Training Intervention Based on the Healthy Lifestyle Counselling Module (5As model) in the Ira PEN Program among Health Workers: A Methodological and Interventional Study
Public title
The effect of Skill Training Intervention Based on the Healthy Lifestyle Counselling Module(5As model)
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Health workers working in health centers
People between the ages of 30 and 70 who receive cardiovascular risk assessment services from health centers
Exclusion criteria:
Reluctance to cooperate in the study
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
184
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling between 3 health networks under coverage of Tehran University of Medical Sciences, 2 networks were selected by simple randomization and lottery method, then 2 networks were again, assigned to the intervention and control groups by simple randomization and lottery method. Since each network covers 45 or more health centers and there are 3 health workers in each health centers, sampling at this stage will be done in a stratified. randomization manner. That is, in each network, according to the sample size (92 people), 31 health centers will be randomly selected from the list according to the table of random numbers, and in each center, all 3 health providers will be included in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, health providers did not know whether they were in the intervention or control group. Counseling service is provided routinely and the checklist is completed by an observer imperceptibly during routine monitoring of the health system.
2. Observers complete the counseling checklist imperceptibly at the same time as monitoring other health services. However, they do not know in which intervention or control group health care providers are.
Placebo
Not used
Assignment
Parallel
Other design features
n this study, for the first time in Iran, using a healthy lifestyle module that is recommended in 2018 by the World Health Organization for the training of health workers and is based on the 5As model, a training intervention, be designed, implemented and evaluated and its results presented to the managers and decision makers of the IraPEN program. One of the innovative aspects of this research is the design and psychometrics of the counseling skills training checklist and the innovation of educational intervention in the form of electronic content and its sharing through the virtual education system and social network. In this study, the intervention is performed only for the intervention group and includes a healthy lifestyle counseling training program. And no intervention is performed on the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Health and Neuroscience Research Center, Shahid Beheshti University
Street address
School of Health and Safety, Daneshjoo Blvd, Velenjak St.
City
Tehran
Province
Tehran
Postal code
198396-9411
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.SBMU.PHNS.REC.1398.172
Health conditions studied
1
Description of health condition studied
Healthy Life Style Counsseling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Healthy lifestyle counseling skill
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Observation with checklist
2
Description
Healthy lifestyle behaviors based on SIB system
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Data recorded in the SIB system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1. Participate in a healthy lifestyle counseling workshop for 2 days and 16 hours with a role-playing teamwork 2. Watch a healthy lifestyle counseling training video for 45 minutes. Watch a healthy lifestyle training motion graph for 10 minutes 3. Participate in a virtual training course and online exam and receive a course certificate
Category
Behavior
2
Description
Control group: They do not participate in any training course and have received only the relevant instructions, and when providing the service, the electronic system provides general recommendations for training to the clients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health services
Full name of responsible person
Najmolmolook Amini
Street address
Shafiee Alley, Vesal Street, South Tehran Health Center
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6345 3342
Fax
+98 21 6345 3104
Email
namini@farabi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Delavari
Street address
First Floor, Ministry of Health Building, Hafez St., Jomhouri Intersection.
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6345 3102
Fax
+98 21 6345 3104
Email
namini@farabi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Najmolmolook Amini
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
First Floor, Ministry of Health Building, Hafez St., Jomhouri Intersection,
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6345 3342
Fax
+98 21 6345 3104
Email
namini@farabi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohtasham Ghaffari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Health and Safety, Velenjak St., Daneshjoo Blvd
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
00982122432040-41
Fax
+98 21 2243 2037
Email
mohtashamghaffari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Najmolmolook Amini
Position
student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hafez St., Jomhory Intersection, Ministry of Health Building, First Floor
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6345 3342
Fax
+98 21 6345 3104
Email
namini@farabi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of participants' personal information
Study Protocol
No - There is not 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