Determining the effect of educational intervention based on transtheoretical model on dairy consumption of 10th and 11th grade female students in Sowmehsara public schools
Design
A clinical trial with a control and intervention group, with parallel, non-randomized groups of 49 people in each group and due to the limited number of selected clusters, random allocation is not possible.
Settings and conduct
The place of study is the city of Sowmehsara. The city of Soomehsara has 2 public girls' schools in the second grade of high school. Two classes from Narjes School for control (49 people) and 2 classes from Afaf School for intervention group (49 people). The students of the intervention group are divided into 4 groups of 12-12 people. The educational content of each session will include general and specific trainings. One month after the educational intervention, the questionnaires are completed again by the students of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: employment in the tenth and eleventh grade, having the consent to participate in the study
Exclusion criteria: Having a special diet related to the consumption of dairy products prescribed by a specialist according to the student statement
Intervention groups
Intervention group: Educational intervention in 4 sessions that will be about all structures according to the need and low scores directly and using the lecture method, participatory methods such as question and answer activation, group discussion and brainstorming.
Control group: During the intervention and one month of follow-up, the control group will not receive training and after completing the study, educational booklets will be provided to them.
Main outcome variables
Dairy consumption status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200718048132N1
Registration date:2020-11-04, 1399/08/14
Registration timing:retrospective
Last update:2020-11-04, 1399/08/14
Update count:0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Nooshin Rouhani tonkaboni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3384 9411
Email address
nrouhani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-09-12, 1399/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational intervention based on the TransTheoretical Model on dairy consumption of girl students of 10th and 11th grade
Public title
The effect of an educational intervention based on the TransTheoretical Model on dairy consumption of girl students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Study in the tenth and eleventh grades
Having the consent to participate in the study
Exclusion criteria:
Having a special diet related to the consumption of dairy products prescribed by a specialist, according to the student statement
Age
From 15 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
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 Committee of Guilan University of Medical Sciences
Street address
Former building of the Azad University - Rasht School of Health (new building)- – Behind of the building of the Radio and Television Organization-- Resalat St- Rasht-Islamic Republic of Iran.
City
rasht
Province
Guilan
Postal code
4185733411
Approval date
2020-07-01, 1399/04/11
Ethics committee reference number
IR.GUMS.REC.1399.132
Health conditions studied
1
Description of health condition studied
The effect of an educational intervention based on the TransTheoretical Modelon dairy consumption of students
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dairy consumption status
Timepoint
Before the intervention and one month after the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Student Awareness Score
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Using a researcher-made questionnaire (12 questions)
2
Description
Student change process score
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Using a researcher-made questionnaire (20 questions)
3
Description
Student decision balance score
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Using a researcher-made questionnaire (17 questions)
4
Description
Students' self-efficacy score
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Using a researcher-made questionnaire (10 questions)
Intervention groups
1
Description
Intervention group: In the case of educational intervention, the training program will be held once a week for 30-45 minutes. In this intervention, all of the constructs, based on the research requirements and low scores regarding them, will be taught directly through employing lecture method, appropriate participatory methods such as question and answer activation, group discussion. The educational content of each session will include general and specific training according to the stages of students' change in dairy consumption. General training strategies in the program include: Drawing attention to the program through informing participants regarding the recommended amount of milk and its products, the importance of its consumption during adolescence and the side effects resulting from lack of its consumption. Specific training is based on improving the constructs of trans-theoretical model regarding self-efficacy, change processes (cognitive and behavioral) and decisional balance (perceived barriers and benefits), and the stages of subjects' change. General topics of educational materials include: The importance of nutrition during adolescence, the food pyramid and the role of each group in body health, the importance and role of milk and its products in body health, the role of calcium in the body, the side effects of insufficient calcium intake, the role of dairy in preventing osteoporosis, diseases related to low consumption of dairy products, benefits of dairy consumption on body health, perceived barriers regarding dairy consumption, ways of overcoming barriers considering dairy consumption and increasing self-awareness, environmental reevaluation, self-reappraisal, self-liberation, counterconditioning, reinforcement management, stimulus control, helping relationships, social liberation, and perceived ways to enhance perceived self-efficacy for increasing dairy consumption.
Category
Behavior
2
Description
Control group: During the intervention and one month of follow-up, the control group will not receive training and after the intervention, educational booklets will be provided to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Efaf High School
Full name of responsible person
Shahla Fazel Toulami
Street address
Broshnavard St., Hosseini Panah St.
City
sowmesara
Province
Guilan
Postal code
4361957674
Phone
+98 13 4432 8599
Email
shahlafa2013@gmail.com
2
Recruitment center
Name of recruitment center
Narjes High School
Full name of responsible person
Leila Faizi Khakiani
Street address
Jafari Street, in front of Mosalla
City
sowmesara
Province
Guilan
Postal code
4331666419
Phone
+98 13 4432 3150
Email
h.nejadhoseini@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Vice Chancellor for Research and Technology-Opposite to 17 Shahrivar Hospital - Old Building of the Faculty of Health -Shahid Siadati St-Namjoo St
Former building of Azad University - Rasht School of Health (new building)-Behind the building of the Radio and Television Organization-Resalat St
City
rasht
Province
Guilan
Postal code
4185733411
Phone
+98 13 3384 9411
Email
nrouhani@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Noushin Rouhani Tonekaboni
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Former building of Azad University - Rasht School of Health (new building)-Behind the building of the Radio and Television Organization-Resalat St
City
rasht
Province
Guilan
Postal code
4185733411
Phone
+98 13 3384 9411
Email
nrouhani@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the frequency distribution of students in the stages of changing dairy consumption, student awareness, change process, decision balance and self-efficacy
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
University professors and students
Under which criteria data/document could be used
For similar studies
From where data/document is obtainable
By contacting the email nrouhani@gums.ac.ir
What processes are involved for a request to access data/document