Investigating the effect of educational intervention based on transtheoretical model on weight control behaviors in the staff of a law enforcement center
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General information
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2024-02-03, 1402/11/14
2024-02-03 00:00:00
Announcing the start and end dates of patient recruitment and the sample size realized
Announcing the trial termination date
Announcing the start and end dates of patient recruitment and the sample size realizedtrial termination date
اعلام تاریخ شروع و پایان بیمار گیری و حجم نمونه تحقق یافته
اعلام تاریخ خاتمه کارآزمایی
اعلام تاریخ شروع و پایان بیمار گیری و حجم نمونه تحقق یافتهخاتمه کارآزمایی
Protocol summary
Study aim
Investigating the effect of educational intervention based on transtheoretical model on weight control behaviors in the staff of a law enforcement center
Design
The clinical trial has two intervention and control groups, not blinded, on 90 patients and divided between the two groups in a non-random way based on the number in such a way that the odd number is in the intervention group and the even number is in the target group.
Settings and conduct
People included in the study, regardless of the group, will be weighed and blood tested at the prevention police dispensary located in Enghelab Square. Then the intervention group enters the process of training classes and is trained in ten 90-minute sessions. It should be noted that these classes are held in the prevention police. At this two-month time, the control group is not subjected to any intervention. After two months, weight and blood tests will be taken from all the people in the preventive police hospital. Now, with the obtained information, the effect of behavior change on people's weight is investigated.
Participants/Inclusion and exclusion criteria
Inclusion: employees with a body mass index (BMI) of 25 and above - age range from 20 to 50 years Exclusion: participating in a program Other training simultaneously or parallel to the intervention - Absence of specific heart, lung, etc. disease - Not requesting for retirement at least for the next 6 months - People who have had weight loss surgery - People who smoke
Intervention groups
There are two intervention and control groups in this study. For the intervention group: an intervention will be held in the form of training classes centered on exercise and diet change, and for the control group: no intervention, including classes, etc. will be conducted.
Main outcome variables
Weight; Blood Sugar; Cholesterol; Triglyceride
General information
Reason for update
Announcing the trial termination date
Acronym
IRCT registration information
IRCT registration number:IRCT20231007059643N1
Registration date:2023-11-30, 1402/09/09
Registration timing:prospective
Last update:2024-02-04, 1402/11/15
Update count:2
Registration date
2023-11-30, 1402/09/09
Registrant information
Name
Taghi Shahnazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6683 8871
Email address
saed.shahnazi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
2023-12-03, 1402/09/12
Actual recruitment end date
2023-12-05, 1402/09/14
Trial completion date
2024-02-03, 1402/11/14
Scientific title
Investigating the effect of educational intervention based on transtheoretical model on weight control behaviors in the staff of a law enforcement center
Public title
Investigating the effect of lifestyle on the weight of employees of a law enforcement center
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Employees with a body mass index (BMI) of 25 and above
Being in the age range of 20 to 50 years old
Exclusion criteria:
Failure to participate in another training program at the same time or parallel to the intervention
Absence of specific heart, lung, etc. disease
Not requesting for transfer or retirement at least for the next 6 months
People who have had weight loss surgery
People who smoke
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committees of Baqiyatallah Hospital
Street address
Quds Settlement (West) - Between South Flamak and Zarafshan, Simai Iran St. - Ministry of Health, Treatment and Medical Education Headquarters, Block A, 13th Floor
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-09-30, 1402/07/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.071
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity Due to Excess Calories
Primary outcomes
1
Description
Weight
Timepoint
Measurement Once at The Beginning of The Study (Before The Intervention) And Again 60 Days (2 Months) later at The End of The Study (After The Intervention)
Method of measurement
Scales
2
Description
Blood Sugar
Timepoint
Measurement Once at The Beginning of The Study (Before The Intervention) And Again 60 Days (2 Months) later at The End of The Study (After The Intervention)
Method of measurement
Blood Test
3
Description
Cholesterol
Timepoint
Measurement Once at The Beginning of The Study (Before The Intervention) And Again 60 Days (2 Months) later at The End of The Study (After The Intervention)
Method of measurement
Blood Test
4
Description
Triglyceride
Timepoint
Measurement Once at The Beginning of The Study (Before The Intervention) And Again 60 Days (2 Months) later at The End of The Study (After The Intervention)
Method of measurement
Blood Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a group of 45 people who participate in the following classes for ten 90-minute sessions during 8 weeks: Familiarity with obesity and its factors - Knowledge of healthy eating - Knowledge of body metabolism - Increasing self-efficacy - Principles of weight loss and eating patterns - exercise and its effects - planning for weight loss - preparation for weight loss - diet design - getting to know the stages and processes of change
Category
Lifestyle
2
Description
Control group: a group of 45 people with a body mass index above 25 with individual numbers who do not participate in any classes or interventions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Prevention police health
Full name of responsible person
Taghi Shahnazi
Street address
Jandarmery Street ٍٍEnghelab Square
City
Tehran
Province
Tehran
Postal code
1314633751
Phone
+98 21 6398 1277
Email
saed.shahnazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Abasali Imani Foladi
Street address
Vanak Square, Mollasadra St., South Sheikh Bahai St
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
azmoon@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Taghi Shahnazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Health
Street address
At the end of Imam Khomeini Street, Mirzaei Alley, No. 8, Mashaikh Dead end
City
Tehran
Province
Tehran
Postal code
1348543853
Phone
+98 21 6683 8871
Email
saed.shahnazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Taghi Shahnazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Health
Street address
At the end of Imam Khomeini street, Mirzaei alley, No. 8, Mashaikh dead end
City
Tehran
Province
Tehran
Postal code
1348543853
Phone
+98 21 6683 8871
Email
saed.shahnazi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Taghi Shahnazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Health
Street address
At the end of Imam Khomeini Street, Mirzaei Alley, No. 8, Mashaikh Dead end
City
Tehran
Province
Tehran
Postal code
1348543853
Phone
+98 21 6683 8871
Email
saed.shahnazi@gmail.com
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