Protocol summary
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Study aim
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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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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Weight; Blood Sugar; Cholesterol; Triglyceride
General information
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Reason for update
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Announcing the trial termination date
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Acronym
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IRCT registration information
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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
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Registration date
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2023-11-30, 1402/09/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-11, 1402/08/20
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Expected recruitment end date
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2024-01-10, 1402/10/20
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Actual recruitment start date
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2023-12-03, 1402/09/12
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Actual recruitment end date
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2023-12-05, 1402/09/14
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Trial completion date
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2024-02-03, 1402/11/14
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Scientific title
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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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Public title
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Investigating the effect of lifestyle on the weight of employees of a law enforcement center
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-09-30, 1402/07/08
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Ethics committee reference number
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IR.BMSU.BAQ.REC.1402.071
Health conditions studied
1
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Description of health condition studied
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Obesity
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ICD-10 code
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E66.0
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ICD-10 code description
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Obesity Due to Excess Calories
Primary outcomes
1
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Description
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Weight
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Timepoint
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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)
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Method of measurement
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Scales
2
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Description
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Blood Sugar
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Timepoint
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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)
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Method of measurement
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Blood Test
3
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Description
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Cholesterol
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Timepoint
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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)
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Method of measurement
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Blood Test
4
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Description
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Triglyceride
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Timepoint
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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)
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Method of measurement
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Blood Test
Intervention groups
1
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Description
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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
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Category
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Lifestyle
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bagheiat-allah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available