Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT07212218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Promotion Model-Based Education and Motivational Interviewing for Parents of Children With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Children with type 1 diabetes and their parents who voluntarily agree to receive the education will be included in the intervention group, while those who do not wish to participate in the training but agree to complete the assessments will be included in the control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes Self-Management Scale', 'timeFrame': 'Baseline and 12 weeks after intervention', 'description': 'The Diabetes Self-Management Scale will be used to assess self-management skills of children with type 1 diabetes. Scores will be compared between baseline and post-intervention assessments.'}, {'measure': 'Change in Quality of Life (PedsQL Diabetes Module)', 'timeFrame': 'Baseline and 12 weeks after intervention', 'description': 'Quality of life in children with type 1 diabetes will be assessed using the PedsQL Diabetes Module. Scores will be compared between baseline and post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c (%)', 'timeFrame': 'Baseline and 12 weeks after intervention', 'description': "HbA1c values will be obtained from patients' routine clinical records measured by endocrinologists"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus', 'Diabetes Self-Management', 'Quality of Life', 'Health Promotion Model (HPM)', 'Motivational Interviewing (MI)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/12610013/', 'label': 'This article reports the development and validation of the PedsQL Diabetes Module, which will be used in this study to assess quality of life in children with type 1 diabetes.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/23937988/', 'label': 'The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/38119244/', 'label': 'This article provides the 2024 American Diabetes Association Standards of Care in Diabetes, which serve as evidence-based clinical guidelines for diabetes management and are referenced in the study protocol.'}]}, 'descriptionModule': {'briefSummary': "This quasi-experimental study will aim to evaluate the effects of Health Promotion Model-based education and motivational interviewing on diabetes self-management and quality of life among parents of children diagnosed with type 1 diabetes. Eligible and voluntary parents will receive structured education sessions and motivational interviews designed to support diabetes management and improve quality of life. Outcomes will be assessed using validated questionnaires on diabetes self-management and quality of life, as well as HbA1c values obtained from patients' routine medical records. The study will examine whether parent-focused interventions can enhance diabetes management in children and families.", 'detailedDescription': "This quasi-experimental study will be conducted to evaluate the effectiveness of Health Promotion Model-based education combined with motivational interviewing for parents of children diagnosed with type 1 diabetes. The theoretical framework will be based on Pender's Health Promotion Model, which emphasizes self-efficacy, perceived benefits, perceived barriers, and interpersonal influences in promoting health behaviors. Motivational interviewing techniques will be integrated to strengthen parental engagement and support behavioral change.\n\nParticipants will not be randomized into groups. Instead, parents who voluntarily accept to receive the education will form the intervention group, while those who prefer not to participate in the training but agree to complete the evaluation will form the control group. The intervention will consist of structured education sessions lasting approximately 50-60 minutes, delivered in the pediatric endocrinology clinic setting, followed by motivational interviews.\n\nData will be collected at baseline and 12 weeks after the intervention. The evaluation will include validated measurement tools such as the Diabetes Self-Management Scale, the Pediatric Quality of Life Inventory (PedsQL) Diabetes Module, and HbA1c values obtained from patients' routine medical records. The study is anticipated to provide evidence on the effectiveness of Health Promotion Model-based education and motivational interviewing in strengthening parental support, thereby improving diabetes self-management in children with type 1 diabetes and enhancing quality of life for both children and their families."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Children aged 8-12 years with type 1 diabetes diagnosed for ≥ 1 year HbA1c ≥ 7% Using insulin pen for treatment Able to read and write Living in Istanbul No intellectual disability No other chronic disease Parent able to communicate by phone and use social media apps (e.g., WhatsApp, Zoom) Both child and parent willing to participate\n\nExclusion Criteria:\n\n* sychiatric disorder diagnosis Type 1 diabetes diagnosis \\< 1 year Using insulin pump or other treatment methods Having another type of diabetes Not in the 8-12 age range Illiteracy (child or parent) Presence of another chronic disease Parent unable to use phone or social media apps Child and/or parent unwilling to participate'}, 'identificationModule': {'nctId': 'NCT07212218', 'acronym': 'HPM-T1D-MI', 'briefTitle': 'Health Promotion Model-Based Education and Motivational Interviewing for Parents of Children With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'THE EFFECT OF HEALTH PROMOTION MODEL-BASED EDUCATION AND MOTIVATIONAL INTERVIEWS GIVEN TO PARENTS OF CHILDREN DIAGNOSED WITH TYPE 1 DIABETES ON DIABETES SELF-MANAGEMENT AND QUALITY OF LIFE', 'orgStudyIdInfo': {'id': 'SBU-HSBE-T1D-01'}, 'secondaryIdInfos': [{'id': '2023/3-3/10', 'type': 'OTHER', 'domain': 'Sağlık Bilimleri Üniversitesi Hamidiye Clinical Research Ethics Committe'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Children with type 1 diabetes and their parents who voluntarily agree to participate will receive Health Promotion Model-based education sessions (\\~50-60 minutes) and motivational interviewing', 'interventionNames': ['Behavioral: Health Promotion Model-Based Education and Motivational Interviewing']}, {'type': 'NO_INTERVENTION', 'label': 'CONTROL Group', 'description': 'Children with type 1 diabetes and their parents in the control group will not receive any structured education or motivational interviewing during the study period. They will complete the same assessments (Diabetes Self-Management Scale, PedsQL Diabetes Module, and HbA1c data from medical records) at baseline and at 12 weeks. After study completion, they will be provided with the educational content'}], 'interventions': [{'name': 'Health Promotion Model-Based Education and Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'Structured education sessions based on the Health Promotion Model will be delivered, followed by motivational interviewing techniques to enhance parental engagement and support diabetes management and quality of life.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34764', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Umraniye Training and Research Hospital, Pediatric Endocrinology Clinic', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'GÖZDE EKŞİ, PhD Candidate', 'role': 'CONTACT', 'email': 'c.gozdeksi53@gmail.com', 'phone': '+905537087453'}], 'overallOfficials': [{'name': 'Gözde Ekşi, PhD Candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Health Sciences, Hamidiye Institute of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. Only aggregate data will be reported.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student, Public Health Nursing, Sağlık Bilimleri Üniversitesi', 'investigatorFullName': 'Gözde EKŞİ', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}