Type 1 Diabetes MellitusHPM-T1D-MINCT07212218
Health Promotion Model-Based Education and Motivational Interviewing for Parents of Children With Type 1 Diabetes
A study testing Health Promotion Model-Based Education and Motivational Interviewing in people with Type 1 Diabetes Mellitus and Diabetes Self-Management, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Diabetes Self-Management, Quality of Life
- What is being tested?
- Health Promotion Model-Based Education and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Umraniye Training and Research Hospital, Pediatric Endocrinology Clinic
Istanbul, Istanbul, 34764
About this study
Official 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
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.
Read the 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)
- Being tested
- Health Promotion Model-Based Education and Motivational Interviewing
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Promotion Model-Based Education and Motivational InterviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12 weeks after intervention
Secondary outcomes (1)
Change in HbA1c (%)
HbA1c values will be obtained from patients' routine clinical records measured by endocrinologists
Measured: Baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde EKŞİ, Saglik Bilimleri Universitesi
- Investigators
- Gözde Ekşi, PhD Candidate, Principal investigator, University of Health Sciences, Hamidiye Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212218
- Sponsor's protocol ID
- SBU-HSBE-T1D-01
- Other IDs
- 2023/3-3/10
- Acronym
- HPM-T1D-MI
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. Only aggregate data will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07212218
- Acronym / sponsor ID
- HPM-T1D-MI / SBU-HSBE-T1D-01
- Conditions
- Type 1 Diabetes Mellitus, Diabetes Self-Management, Quality of Life, Health Promotion Model (HPM), Motivational Interviewing (MI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Health Promotion Model-Based Education and Motivational InterviewingChildren 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 |
| 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 |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Promotion Model-Based Education and Motivational InterviewingStructured 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
1 secondary outcome
Change in HbA1c (%)
Time frame: Baseline and 12 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- 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.Link provided by the sponsor.
- The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic controlLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns. Only aggregate data will be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gözde Ekşi, PhD Candidate principal investigator
University of Health Sciences, Hamidiye Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Promotion Model-Based Education and Motivational Interviewing in people with Type 1 Diabetes Mellitus and Diabetes Self-Management, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GÖZDE EKŞİ, PhD Candidate (+905537087453, c.gozdeksi53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management Scale (time frame: Baseline and 12 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.