Health Education(HPM)NCT06392035
Breakfast Training Based on PENDER's Health Promotion Model (HPM)
A study testing health education, web-based education in people with Health Education, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Nutrition of school-age children is very important. Children at this age need to eat three main meals and at least one snack every day. Breakfast, among the main meals, is an important component of a healthy diet and is vital for healthy and normal development, especially in children and adolescents. T.R. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Health Education
- What is being tested?
- health education, web-based education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2024to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Being a 7th grade student of secondary school,
- Not having a chronic disease
- Students who voluntarily agreed to participate in the research and received consent from their parents.
Who cannot join
- • Not being a 7th grade student of secondary school,
- Having a chronic disease
- Students who do not agree to participate in the research voluntarily and whose parents\' consent cannot be obtained
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Seçil Duran Yilmaz
Karaman
Karaman İl Milli Eğitim Müdürlüğü
About this study
Official title: Determining the Effect of Nutrition Education Based on PENDER's Health Promotion Model on the Breakfast Habits of Secondary School Students
Nutrition of school-age children is very important. Children at this age need to eat three main meals and at least one snack every day. Breakfast, among the main meals, is an important component of a healthy diet and is vital for healthy and normal development, especially in children and adolescents. T.R. According to TÜBER prepared by the Ministry of Health, the most frequently skipped meal among school-age children is breakfast. It is necessary to raise awareness in parents and children about regular breakfast consumption and frequency and to instill healthy lifestyle behaviors. It is aimed to regulate breakfast consumption and frequency in parents and children with a web-based training based on PENDER Health Promotion Model (HGM).
Read the detailed description
Before starting the study, students and parents will be informed in writing and verbally. Then, a pre-test will be applied with the specified data collection tools to students and parents who agree to participate in the research. Then, a 6-week web-based training on breakfast consumption based on PENDER's Health Promotion Model will be given. After the training, a post-test will be applied with data collection tools. Then the pre-test and post-test data will be analyzed.
- Conditions
- Health Education
- Being tested
- health education, web-based education
- Keywords
- Breakfast Consumption, School Age Children, Health Promotion Model
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health education, web-based educationOther
Data collection tools will be filled in by two study groups (experimental group, control group) and based on the pre-test results of both groups, Pender\'s SGM-based breakfast training will be given only to the experimental group. No intervention will be made to the control group. In this study, a total of 6 sessions will be held for the experimental group for 6 weeks (one session per week), each lasting 40 minutes. In these sessions, web-based training will be given every week according to the components of the model and will be supported with written and visual brochures.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention will be made to the participants in the control group. A pre-test will be administered before the study and a post-test will be administered after the study. |
| Intervention Group | Experimental | Secondary schools located in Karaman city center will be visited. The researcher will introduce himself and explain the purpose of the research.
A research inclusion form will be applied to those who agree to participate in the research.
"Sociodemographic Data Form", "Nutrition Behavior Scale", "Parental Questionnaire" and "Tool for Measuring the Health Promotion Model Related to Breakfast Consumption" will be applied as pre-test forms to the participants who meet the inclusion criteria. Participants will be assigned randomization by someone other than the researcher. After randomization assignment, a 6-week web-based training based on PENDER's Health Promotion Model, prepared in line with the literature, will be applied. Receives: Other: health education, web-based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teaching children the habit of regular breakfast
Children will be taught regular breakfast habits. Here, weight, height and BMI status will be examined. Weight in kilograms; Height will be measured in metres. Weight and height will be combined. BMI will be reported in kg/m^2.
Measured: at the end of the 1th weeks
Teaching children the habit of regular breakfast
Children will be taught regular breakfast habits. Here, weight, height and BMI status will be examined. Weight in kilograms; Height will be measured in metres. Weight and height will be combined. BMI will be reported in kg/m^2.
Measured: at the end of the 6th weeks
Secondary outcomes (3)
"Health Promotion Model Related to Breakfast Consumption (first week) )
Health Promotion Model Related to Breakfast Consumption scale consists of 10 sub-dimensions and 58 items.
Previous Relevant Behavior (first 10 questions - score range 10-50) Perceived Usefulness (questions 11-16 - score range 6-30) Perceived Obstacles (questions 17-24-score range 8-40) Perceived Self-Efficacy (questions 25-32 - score range 8-40) Positive Impact (33,34 questions - score range 2-10) Negative Impact (35,36 questions - score range 2-10) Interpersonal Influences (questions 37-46 - score range 10-50) Situational Effects (questions 47,48,49 - score range 3-15) Instant Competing Demands and Preferences (questions 50,51,52,53 - score range 4-20) Planning Commitment (questions 54-58 - score range 5-20)
Measured: at the end of the 1th weeks
Nutrition behavior scale (first week)
Children's food consumption was evaluated with the "Nutrition Behavior Scale" developed within the scope of CATCH (Child and Adolescent Trial for Cardiovascular Health)HBQ (Health Behavior Questionnaire). The scale consists of 14 visual items with low-fat/salty and high-fat/salty food options to determine children's food consumption. Children are shown comparable foods and asked which of the two foods is more common (often).
Trying to find out what he ate. Scale items take values of -1 for unhealthy food and +1 for healthy food. The lowest and highest scores that can be obtained from this scale are between -14 and +14. A high total score from the scale indicates that you have healthy eating habits. The internal consistency reliability coefficient of the original scale was found to be 0.76, and the test-retest reliability was 0.58 (Edmunson et al., 1996). Scale validity and reliability study for this scale was conducted by Öztürk (2010).
Measured: at the end of the 1th weeks
Parent Questionnaire
The parent questionnaire contains 18 questions asked to parents about their children, created by the researcher by scanning the literature. The questionnaire will be scored between 18-90.
Measured: at the end of the 1th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start22 May 2024 (estimated)
- Primary completion22 Jul 2024 (estimated)
- Study completion22 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the research, an experiment and a control group will be selected.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Karadeniz Technical University
- Responsible party
- Principal investigator, Secil Duran Yilmaz, Karamanoğlu Mehmetbey University
- Investigators
- HAVVA KARADENİZ, Study director, Research Supervisör-hkmumcu@ktu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392035
- Sponsor's protocol ID
- 13562490-299-55
- Acronym
- (HPM)
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I may consider it in the future.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Nutrition Education Based on PENDER's Health Promotion Model on the Breakfast Habits of Secondary School Students
- ClinicalTrials.gov ID
- NCT06392035
- Acronym / sponsor ID
- (HPM) / 13562490-299-55
- Conditions
- Health Education
- Keywords
- Breakfast Consumption, School Age Children, Health Promotion Model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Karadeniz Technical University
- Study start
- 22 May 2024 (estimated)
- Primary completion
- 22 Jul 2024 (estimated)
- Study completion
- 22 Jul 2024 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nutrition of school-age children is very important. Children at this age need to eat three main meals and at least one snack every day. Breakfast, among the main meals, is an important component of a healthy diet and is vital for healthy and normal development, especially in children and adolescents. T.R. According to TÜBER prepared by the Ministry of Health, the most frequently skipped meal among school-age children is breakfast. It is necessary to raise awareness in parents and children about regular breakfast consumption and frequency and to instill healthy lifestyle behaviors. It is aimed to regulate breakfast consumption and frequency in parents and children with a web-based training based on PENDER Health Promotion Model (HGM).
Detailed description
Before starting the study, students and parents will be informed in writing and verbally. Then, a pre-test will be applied with the specified data collection tools to students and parents who agree to participate in the research. Then, a 6-week web-based training on breakfast consumption based on PENDER's Health Promotion Model will be given. After the training, a post-test will be applied with data collection tools. Then the pre-test and post-test data will be analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In the research, an experiment and a control group will be selected.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention will be made to the participants in the control group. A pre-test will be administered before the study and a post-test will be administered after the study. |
| Intervention Group | Experimental | Other: health education, web-based educationSecondary schools located in Karaman city center will be visited. The researcher will introduce himself and explain the purpose of the research. A research inclusion form will be applied to those who agree to participate in the research. "Sociodemographic Data Form", "Nutrition Behavior Scale", "Parental Questionnaire" and "Tool for Measuring the Health Promotion Model Related to Breakfast Consumption" will be applied as pre-test forms to the participants who meet the inclusion criteria. Participants will be assigned randomization by someone other than the researcher. After randomization assignment, a 6-week web-based training based on PENDER's Health Promotion Model, prepared in line with the literature, will be applied. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Being a 7th grade student of secondary school,
Key exclusion criteria (3 listed)
- • Not being a 7th grade student of secondary school,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health education, web-based educationData collection tools will be filled in by two study groups (experimental group, control group) and based on the pre-test results of both groups, Pender\'s SGM-based breakfast training will be given only to the experimental group. No intervention will be made to the control group. In this study, a total of 6 sessions will be held for the experimental group for 6 weeks (one session per week), each lasting 40 minutes. In these sessions, web-based training will be given every week according to the components of the model and will be supported with written and visual brochures. | Other | Intervention Group |
Primary outcome
Teaching children the habit of regular breakfast
Time frame: at the end of the 1th weeks
Children will be taught regular breakfast habits. Here, weight, height and BMI status will be examined. Weight in kilograms; Height will be measured in metres. Weight and height will be combined. BMI will be reported in kg/m^2.
Teaching children the habit of regular breakfast
Time frame: at the end of the 6th weeks
Children will be taught regular breakfast habits. Here, weight, height and BMI status will be examined. Weight in kilograms; Height will be measured in metres. Weight and height will be combined. BMI will be reported in kg/m^2.
3 secondary outcomes
"Health Promotion Model Related to Breakfast Consumption (first week) )
Time frame: at the end of the 1th weeks
Nutrition behavior scale (first week)
Time frame: at the end of the 1th weeks
Parent Questionnaire
Time frame: at the end of the 1th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No. I may consider it in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HAVVA KARADENİZ study director
Research Supervisör-hkmumcu@ktu.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education, web-based education in people with Health Education, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEÇİL DURAN YILMAZ (05465772813, secilduran.91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teaching children the habit of regular breakfast (time frame: at the end of the 1th weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.