Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT06392035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breakfast Training Based on PENDER's Health Promotion Model (HPM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In the research, an experiment and a control group will be selected.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-07-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Teaching children the habit of regular breakfast', 'timeFrame': 'at the end of the 1th weeks', 'description': '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.'}, {'measure': 'Teaching children the habit of regular breakfast', 'timeFrame': 'at the end of the 6th weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '"Health Promotion Model Related to Breakfast Consumption (first week) )', 'timeFrame': 'at the end of the 1th weeks', 'description': 'Health Promotion Model Related to Breakfast Consumption scale consists of 10 sub-dimensions and 58 items.\n\nPrevious 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)'}, {'measure': 'Nutrition behavior scale (first week)', 'timeFrame': 'at the end of the 1th weeks', 'description': '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).\n\nTrying 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).'}, {'measure': 'Parent Questionnaire', 'timeFrame': 'at the end of the 1th weeks', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breakfast Consumption', 'School Age Children', 'Health Promotion Model'], 'conditions': ['Health Education']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Being a 7th grade student of secondary school,\n\n * Not having a chronic disease\n * Students who voluntarily agreed to participate in the research and received consent from their parents.\n\nExclusion Criteria:\n\n* • Not being a 7th grade student of secondary school,\n\n * Having a chronic disease\n * Students who do not agree to participate in the research voluntarily and whose parents\\' consent cannot be obtained'}, 'identificationModule': {'nctId': 'NCT06392035', 'acronym': '(HPM)', 'briefTitle': "Breakfast Training Based on PENDER's Health Promotion Model (HPM)", 'organization': {'class': 'OTHER', 'fullName': 'Karamanoğlu Mehmetbey University'}, 'officialTitle': "Determining the Effect of Nutrition Education Based on PENDER's Health Promotion Model on the Breakfast Habits of Secondary School Students", 'orgStudyIdInfo': {'id': '13562490-299-55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Secondary schools located in Karaman city center will be visited. The researcher will introduce himself and explain the purpose of the research.\n\nA research inclusion form will be applied to those who agree to participate in the research.\n\n"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.', 'interventionNames': ['Other: health education, web-based education']}], 'interventions': [{'name': 'health education, web-based education', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karaman', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Karaman İl Milli Eğitim Müdürlüğü', 'role': 'CONTACT'}], 'facility': 'Seçil Duran Yilmaz', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'centralContacts': [{'name': 'SEÇİL DURAN YILMAZ', 'role': 'CONTACT', 'email': 'secilduran.91@gmail.com', 'phone': '05465772813'}], 'overallOfficials': [{'name': 'HAVVA KARADENİZ', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Supervisör-hkmumcu@ktu.edu.tr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I may consider it in the future.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karamanoğlu Mehmetbey University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karadeniz Technical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Secil Duran Yilmaz', 'investigatorAffiliation': 'Karamanoğlu Mehmetbey University'}}}}