Health Promotion Model-Based Education and Motivational Interviewing for Parents of Children With Type 1 Diabetes

NCT ID: NCT07212218

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-08-01

Brief Summary

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.

Detailed Description

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.

Conditions

Type 1 Diabetes Mellitus; Diabetes Self-Management; Quality of Life; Health Promotion Model (HPM); Motivational Interviewing (MI)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Health Promotion Model-Based Education and Motivational Interviewing

Intervention Type: 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.

CONTROL Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health Promotion Model-Based Education and Motivational Interviewing

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Gözde EKŞİ

PhD Student, Public Health Nursing, Sağlık Bilimleri Üniversitesi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gözde Ekşi, PhD Candidate

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences, Hamidiye Institute of Health Sciences

Locations

Umraniye Training and Research Hospital, Pediatric Endocrinology Clinic

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

GÖZDE EKŞİ, PhD Candidate

Role: CONTACT

c.gozdeksi53@gmail.com

+905537087453

Related Links

https://pubmed.ncbi.nlm.nih.gov/12610013/

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.

https://pubmed.ncbi.nlm.nih.gov/23937988/

The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control

https://pubmed.ncbi.nlm.nih.gov/38119244/

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.

Other Identifiers

2023/3-3/10

Identifier Type: OTHER

Identifier Source: secondary_id

SBU-HSBE-T1D-01

Identifier Type: -

Identifier Source: org_study_id