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| ID | Type | Description | Link |
|---|---|---|---|
| 2023/3-3/10 | Other Identifier | Sağlık Bilimleri Üniversitesi Hamidiye Clinical Research Ethics Committe |
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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.
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.
Participants 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.
Data 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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 |
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| CONTROL Group | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Promotion Model-Based Education and Motivational Interviewing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Self-Management Scale | 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. | Baseline and 12 weeks after intervention |
| Change in Quality of Life (PedsQL Diabetes Module) | 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. | Baseline and 12 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (%) | HbA1c values will be obtained from patients' routine clinical records measured by endocrinologists | Baseline and 12 weeks after intervention |
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Inclusion Criteria:
- 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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GÖZDE EKŞİ, PhD Candidate | Contact | +905537087453 | c.gozdeksi53@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gözde Ekşi, PhD Candidate | University of Health Sciences, Hamidiye Institute of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umraniye Training and Research Hospital, Pediatric Endocrinology Clinic | Istanbul | Istanbul | 34764 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| 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. | View source |
| The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control | View source |
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Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. Only aggregate data will be reported.
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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.
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| 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. | View source |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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