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

NCT07212218 | Not Yet Recruiting

• 2 other identifiers: SBU-HSBE-T1D-012023/3-3/10
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change in HbA1c (%)

  Baseline and 12 weeks after intervention

Study Arms (2)

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

Behavioral: Health Promotion Model-Based Education and Motivational Interviewing

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

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Umraniye Training and Research Hospital, Pediatric Endocrinology Clinic

Istanbul, Istanbul, 34764, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gözde Ekşi, PhD Candidate

  University of Health Sciences, Hamidiye Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GÖZDE EKŞİ, PhD Candidate

CONTACT

+905537087453; c.gozdeksi53@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Public Health Nursing, Sağlık Bilimleri Üniversitesi

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)