Design, implementation and evaluation of the Impact of educational intervention based on the integrated social marketing approach for regular physical activity among female students
1. Determining and comparing the amount of regular physical activity in female high school students before and after the intervention in the intervention and control groups
2. Determining and comparing the rate of change in the structures of the transnational model in female high school students before and after the intervention in the intervention and control groups.
Design
In this study, we will have an intervention group and a control group, the first high school girls will be randomly placed in one of the following two groups:
108 students will receive an educational intervention designed based on a social marketing approach.
108 students in the control group will not receive any intervention from the research team
Settings and conduct
The statistical population of all female students who are studying in the first secondary schools of Kermanshah and in terms of regular physical activity according to the stages of behavior change in the pre-operational group (pre-thinking-thinking-preparation) and operational (practice and maintenance) and They are willing to participate in the study
Participants/Inclusion and exclusion criteria
1) Conscious consent of first grade high school students in Kermanshah to participate and continue their studies
2) Student parental consent for their participation in the study
1) Transfer from the sample school during the study
2) Lack of desire to continue participating in the study
3) Having an incurable disease and physical and mental condition related to physical activity to participate in the study
Intervention groups
Student intervention will focus on regular physical activity (daily walking and aerobic exercise) according to ACSM's (134) ACSM Guidelines for Exercise Testing and Prescription.
Main outcome variables
Changes in the amount of regular physical activity and changes in the structures of the meta-theoretical model
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200621047858N1
Registration date:2020-07-25, 1399/05/04
Registration timing:prospective
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Azam Geravandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0360
Email address
geravandi_a88@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of the Impact of educational intervention based on the integrated social marketing approach for regular physical activity among female students
Public title
Impact of educational intervention based on the integrated social marketing approach for regular physical activity among female students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent of high school students in Kermanshah to participate and continue their studies
Student parental consent for their participation in the study
Kermanshah high school female high school students (seventh, eighth, ninth grade)
Students in the age group of 10 to 19 years
Exclusion criteria:
1) Transfer from the sample school during the study
Lack of desire to continue participating in the study
3) Having an incurable disease and physical and mental condition related to physical activity to participate in the study
Age
From 10 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
216
Randomization (investigator's opinion)
Randomized
Randomization description
To select intervention and control groups, first Kermanshah city is divided into north and south, then the covered schools in these areas are divided into control and intervention group in order to prevent the dissemination of information in a simple random way. In each area (north and south of the city) using the division of the school education department into three categories (rich, low-income and low-income) and a simple random method is selected from each category of one school (3 intervention schools And 3 control schools) and in the next stage, 3 classes from each grade (seventh, eighth, ninth) are selected after each school. The sample size required for the intervention and control group is calculated as 108 people, which requires 36 students for each school and 12 students from each grade.
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 Hamadan University of Medical Sciences
Street address
Hamedan, Shahid Fahmideh St., in front of People's Park, Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2020-01-25, 1398/11/05
Ethics committee reference number
IR.UMSHA.REC.1398.952
Health conditions studied
1
Description of health condition studied
Sedentary lifestyle and lack of regular physical activity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of intervention in the stages of behavior change and passing from the pre-operational stage to the operational stage And increase self-efficacy in individuals
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Standard questionnaire:The method of data collection will be in the form of a questionnaire and through self-report. Due to the fact that this study uses a transtheoretical model, the data collection tool follows this model. The Marcus et al. Scale is used to measure the stages of change. This scale includes a 5-choice question in which a person chooses only one option according to their physical activity conditions. According to this scale, people in terms of physical activity behavior are in one of the 5 stages of pre-thinking, thinking, preparation, action and maintenance. The criterion for physical activity in this study is activity that is performed at least 3-5 times a week for at least 30 minutes each time; In such a way that it increases the heart rate and respiration and the person sweats, such as brisk walking and cycling. The Norman test will be used to measure change (cognitive-behavioral) processes. Also, Nig et al.'s questionnaire will be used to prepare a questionnaire related to measuring students' self-efficacy, and a questionnaire prepared by Blanchard et al. Will be used to measure decision-making balance.
Secondary outcomes
1
Description
Regular physical activity and changes in body mass index
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Standard questionnaire:The questions related to this section will be related to the International Physical Activity Questionnaire (IPAQ) which examines the status of physical activity in the research sample. This questionnaire is asked in the mode of moderate to severe physical activity and walking during the week. Also, the FITT protocol is used to determine the level of physical activity, which stands for frequency, intensity, time and type. F number of repetitions of physical activity per week, I degree of activity intensity, T is the length of time spent on physical activity, T is the type of physical activity.
Intervention groups
1
Description
Intervention group: Social Marketing Planning + FITT Protocol + ACSM Protocol(Educational interventions are designed based on the results of the first and second phases of the study (qualitative and quantitative study) and the placement of people in different stages of pre-operation (pre-thinking and thinking) and operational (readiness-action and maintenance). The educational package contains theory and Practical educational CD, motion graphics, posters and banners and pedometers. The educational content will be based on the following axes:1. Providing information about diseases caused by inactivity and the role of physical activity in reducing the complications of diseases 2. The benefits of regular physical activity in improving academic and physical performance 3. Appropriate amount and time of regular physical activity 4. Increase students' self-efficacy and emphasize existing benefits and barriers A total of 4 training sessions are planned for those who will be held in the pre-operational phase and two sessions for those who are in the operational phase. Each training session lasts 45 to 60 minutes. Practical training sessions for each class are provided by the physical education instructor in the presence of the researcher in coordination with the school principal in the school gym or prayer hall. According to the ACSM protocol, practical movement training in small groups to learn warm-up exercises, aerobic exercises, Flexibility movements, and muscle strength and cooling will be performed.)
Category
Behavior
2
Description
Control group:They will not receive any intervention from the research team and will be covered by the usual school curriculum.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah girls' secondary schools
Full name of responsible person
Azam Geravandi
Street address
Hamadan, Shahid Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1646
Email
geravandi_a88@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azam Geravandi
Street address
Hamadan, Shahid Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1646
Email
geravandi_a88@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice -Chancellor for Research, Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Azam Geravandi
Position
PhD student in health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hamadan, Shahid Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1646
Email
geravandi_a88@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azam Geravandi
Position
PhD student in health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hamadan, Shahid Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1646
Email
geravandi_a88@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azam Geravandi
Position
PhD student in health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hamadan, Shahid Fahmideh St, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1646
Email
geravandi_a88@yahoo.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
Due to the confidentiality of the participants' information, the data file will not be published
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available