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NCT Number: NCT07212218

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

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umraniye Training and Research Hospital, Pediatric Endocrinology Clinic

Istanbul, 34764, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Diabetes Self-Management Scale

    Time frame: Baseline and 12 weeks after intervention

    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.

  2. Change in Quality of Life (PedsQL Diabetes Module)

    Time frame: Baseline and 12 weeks after intervention

    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.

Secondary outcomes

  1. Change in HbA1c (%)

    Time frame: Baseline and 12 weeks after intervention

    HbA1c values will be obtained from patients' routine clinical records measured by endocrinologists

Study contacts

Contact information is provided by the study sponsor or research team.

GÖZDE EKŞİ, PhD Candidate

CONTACT

[email protected]

+905537087453

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Acronym: HPM-T1D-MI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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