Protocol summary

Study aim
Design and evaluation of lifestyle education intervention based on health thinking to pre-school children and parents - application of Freire's theory and Pender's health promotion
Design
According to the previous study, the sample size was 104 people with a 10% chance of dropping out. Two preschools from the test group and one preschool from the control group will be randomly selected. Then, by tossing a coin, one preschool will be selected as the first intervention group and the other as the second intervention group.
Settings and conduct
Place of study, preschools of the third and fourth districts of Shiraz, holding training sessions along with showing videos in the application
Participants/Inclusion and exclusion criteria
Inclusion criteria: Preschool child and parent Expression of desire and completion of informed consent form by parents Having a smartphone to view the application in the family Exclusion criteria: Reluctance to continue participating in the study Absence of more than two sessions in educational classes (in the case of parents) Moving the child to preschool during the study Failure to complete the test post
Intervention groups
Educational interventions will take place for 12 sessions in the children's group and 9 sessions in the parents' group. There will be no intervention in the control group. Questionnaires will be completed in three stages (before, two months and four months after the study) in all three groups.
Main outcome variables
Healthy lifestyle behaviors, critical thinking, creative thinking, caring thinking.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230703058651N1
Registration date: 2023-08-29, 1402/06/07
Registration timing: prospective

Last update: 2023-08-29, 1402/06/07
Update count: 0
Registration date
2023-08-29, 1402/06/07
Registrant information
Name
Zakieh Khoramaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1000
Email address
zkhoramaki@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of lifestyle education intervention based on health thinking to preschool children and parents - application of Freire's theory and Pender's health promotion
Public title
lifestyle education based on health thinking to preschool children and parents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Preschool child and parent Expression of desire and completion of informed consent form by parents Having a smartphone to view the application in the family
Exclusion criteria:
Children with special needs
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the multi-stage cluster sampling method will be used. At first, one area will be selected as the test group and one area will be selected as the control group between areas three and four randomly using a coin toss. Therefore, by preparing a list of preschools and kindergartens with morning shift preschools, two preschools from the test group area and one preschool from the control group area will be randomly selected. From the two preschools of the test group, randomly using a coin toss, one preschool as the first intervention group in which only children will participate in the intervention and one preschool as the second intervention group in which only parents Children will participate in the intervention, they will be selected. After visiting each preschool, depending on the number of preschool classes and the number of children in each class, one or two classes with all the numbers are randomly selected and all students and parents of that class are included in the study.
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 Health, Nutrition and Food Sciences Schools - Shiraz University of Medical Scien
Street address
No. 2, Roudaki Ave., Zand Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7135744661
Approval date
1981-09-12, 1360/06/21
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.040

Health conditions studied

1

Description of health condition studied
Teaching healthy lifestyle behaviors based on health thinking
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Critical thinking
Timepoint
Before the start of the intervention, two and four months after the end of the study
Method of measurement
Critical Thinking Scale through Philosophical Inquiry for Children 5-6 Years Old

2

Description
Creative thinking
Timepoint
Before the start of the intervention, two and four months after the end of the study
Method of measurement
Torrance Creativity Assessment (visual

3

Description
Caring thinking
Timepoint
Before the start of the intervention, two and four months after the end of the study
Method of measurement
Devereux Student Strengths Assessment

4

Description
Devereux StudentStrengths Assessment
Timepoint
Before the start of the intervention, two and four months after the end of the study
Method of measurement
HPLPII (health-promoting lifestyle profile II)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group's 5 to 7-year-old preschool children are taught healthy lifestyle behaviors based on health thinking during 12 sessions. According to the level of each child in terms of healthy lifestyle behaviors and the DESSA questionnaire, a side program including an additional educational session and providing more educational content is on the agenda. In order to design the questions of the educational sessions, in addition to examining and including some questions of the Durex student ability assessment questionnaire, from the book Hospital of Dolls written by Anne Margaret Sharp and Urance Splitter and translated by Fatemeh Ranjbaran and Mana Par, which is included in the study by Jafari et al., as well as the study by Gasparatou and Kampeza and the experiences of the research team will be used. For the design of worksheets, games and the use of children's poems related to educational subjects, the opinions of child psychologists and children's writers and poets will be used respectively. For each health-style behavior, after reading a poem, playing a game, completing a worksheet, and showing a video (depending on the type of behavior), we ask children questions to begin the introduction phase based on SHOWED: What do we see here? ? What has happened? What does this have to do with our lives? Why does the person not understand the problem? How can this person be empowered? What can we do about it? Then we wait for the children's answers by posing each question, and then we start the dialogue or rethinking stage and like a mirror, we repeat the children's answers so that they think about it again. We use the constructs of Pender's model, i.e. perceived benefits and obstacles, to educate the child about behavior (Freire's model). As much as we can bring children closer to asking questions of values than behavior, we have done better in applying thinking at higher levels. In the meantime, drawing pictures, solving puzzles or creative games and completing worksheets are also used to help children understand more about behavior. Also, children are asked to express their memories and experience or their family and friends from performing the desired behavior and think that with the new learning, is it necessary to change their behavior and structure We use the transformation of Freire's theory about the interpersonal and situational effects of the model. Then we ask the children to imagine themselves in the situation of performing the desired behavior and talk about their positive and negative feelings and emotions, and finally we ask the children to divide the behavior into small parts using role playing. , perform it (self-efficacy) and then tell themselves how their behavior was different from the behavior they observed in the film (critical awareness) and then at the beginning of each session, the children give explanations about how well they were able to perform the behavior. or have a short conversation about what they thought about it (commitment to action).
Category
Lifestyle

2

Description
Intervention group's mothers of preschool children are taught healthy lifestyle behaviors based on healthy thinking during 9 sessions. In parent meetings, the above steps start with focusing on the child's behaviors, and then on the six behaviors of a healthy lifestyle, in addition to raising awareness, criticism, questions and answers, and discussions about each behavior based on the structure. Pender and Freire's health model, which is focused on children's behavior, educational contents related to adults are also delivered to them.
Category
Lifestyle

3

Description
Control group: A control group of 5-7 year old preschool children
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Tree Shiraz district education department
Full name of responsible person
Marzieh Sadeghi
Street address
Astane three roads, Siboyeh Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7134785475
Phone
+98 71 3738 2318
Email
info@medu.gov.ir
Web page address
https://fars.medu.gov.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
مهین نظری
Street address
Administration Building of Shiraz University of Medical Sciences Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2884
Email
gsia@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shiraz, Koi Zahra, Fateh El Mobin Alley, Faculty of Health, 3rd floor
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
0098 71 3725100
Email
Manazari@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shiraz, Koi Zahra, Fateh El Mobin Alley, Faculty of Health, 3rd floor
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Manazari@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zakieh Khoramaki
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No. 2, Roudaki Ave., Zand Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7135744661
Phone
+98 71 7251 0001
Email
zkhoramaki@sums.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Educational videos
When the data will become available and for how long
2 Years
To whom data/document is available
National Organization of Education and Training
Under which criteria data/document could be used
In order to receive personal non-identifiable data or other documentation of this study, real people should correspond with the researchers via e-mail zkhoramaki@sums.ac.ir and mention the reason for the request in their letter, so that after review by the research team, Requests should be sent to them. In the case of legal entities, in addition to correspondence and providing the reason for the request, a written request signed by the relevant organization must also be sent.
From where data/document is obtainable
Correspond with Ms. Zakieh Khoramaki by e-mail at zkhoramaki@sums.ac.ir or receive the documents by visiting in person with a written request to the Health Promotion Department of Shiraz located on Razi Blvd. (Ms. Dr. Mahin Nazari).
What processes are involved for a request to access data/document
The request should be sent via e-mail zkhoramaki@sums.ac.ir. Then the request will be reviewed by the research team within a week and if approved, the requested items will be sent to them.
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