Diabetes MellitusNCT06727123
The Effect of Motivational Interviewing on Diabetes Self-Management in Diabetic Patients
A study testing motivational interviewing in people with Diabetes Mellitus, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
Diabetes is a chronic metabolic disorder characterized by high blood sugar due to problems with insulin production or function. Its prevalence has increased significantly in recent decades due to sedentary lifestyles, unhealthy diets, and increasing obesity rates. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- motivational interviewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 20 Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who agree to participate in the study voluntarily, can speak and understand Turkish, can communicate comfortably, have no hearing, comprehension or vision problems, are literate, use a smartphone, have Type 2 Diabetes and have HbA1c ≥ 7% will be included in the study.
Who cannot join
- Patients with cognitive dysfunction and those using antipsychotic medication will not be included.
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
Istanbul Beykent University
Istanbul
Sule Ç Calisir Kundakci, RN, +905467873906, sulecalisir@gmail.com
Sule Calisir Kundakci, RN
About this study
Official title: The Effect of Motivational Interviewing on Diabetes Self-Management in Type 2 Diabetic Patients
Diabetes is a chronic metabolic disorder characterized by high blood sugar due to problems with insulin production or function. Its prevalence has increased significantly in recent decades due to sedentary lifestyles, unhealthy diets, and increasing obesity rates. Type 2 diabetes, in particular, is a major global and national health problem with projections showing that it continues to grow. Effective diabetes management requires patients to adopt healthy behaviors such as following a diet plan, monitoring blood sugar, increasing physical activity, and avoiding risky habits such as smoking. Inadequate adherence to treatment can lead to serious complications such as cardiovascular disease and kidney damage, which can be a burden to patients, families, and healthcare systems. Motivational interviewing, a patient-centered approach, helps individuals overcome resistance to behavioral change. This study was designed experimentally to determine the effect of motivational interviewing on diabetes self-management in patients with type 2 diabetes.
Read the detailed description
Diabetes is defined as a chronic metabolic disorder characterized by high blood sugar levels. Abnormalities in insulin production, function, or both are considered the primary causes of the disease. The epidemiology of diabetes has changed significantly over the last three decades. Diabetes mellitus is one of the most important health problems for both patients and society due to its high mortality, morbidity, and associated costs. The prevalence of diabetes continues to increase globally, driven by advances in technology, sedentary lifestyles, and increasing rates of obesity. Among these factors, the shift towards less active lifestyles plays a central role, with many individuals spending long periods sitting or engaging in low-energy activities. In addition, poor dietary habits, including increased consumption of high-calorie, processed foods, have increased the risk of developing diabetes, especially type 2 diabetes. In Turkey, the prevalence of type 2 diabetes reported in 2020 has shown a significant increase and is expected to increase further by 2050 if current trends continue. Effective treatment for diabetes requires patients to adopt positive attitudes and behaviors towards managing their health. However, many individuals have difficulty maintaining long-term lifestyle changes. Poor adherence to treatment plans and poor disease management often lead to a variety of complications, including acute and chronic health problems. These complications, such as cardiovascular disease, neuropathy, and kidney damage, impose a significant caregiving burden on individuals with diabetes, their families, and society as a whole. To alleviate these problems, individuals must engage in effective self-management to control their disease and prevent complications. Self-management refers to the individual's responsibility to maintain and improve their health. Diabetes self-management aims to normalize blood sugar levels and reduce the risk of long-term complications. Key practices include developing a personalized nutrition plan, monitoring blood sugar levels, maintaining metabolic control, increasing physical activity, and avoiding risky behaviors such as smoking or excessive alcohol consumption. Despite its importance, individuals living with diabetes often face challenges in adopting the lifestyle, behavioral, and psychological changes necessary for effective management. Motivational interviewing is an evidence-based approach that helps individuals resolve the dilemma of behavioral change and facilitates treatment adherence for chronic conditions such as diabetes. This patient-centered method emphasizes understanding the patient's unique challenges and goals, tailoring strategies to their specific needs, and encouraging autonomy. This study aims to evaluate the impact of motivational interviewing on diabetes self-management in patients with type 2 diabetes. It seeks to understand whether this approach can improve health outcomes by encouraging better adherence to treatment plans and supporting sustainable behavioral change, ultimately enhancing disease management in individuals coping with diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- motivational interviewing, Control
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingOther
Motivational interviews will be conducted with diabetic patients for 6 months. Patients will be trained before starting the interviews.
ControlOther
No application will be made. Routine follow-ups will be made.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Motivational interviews will be conducted with diabetic patients for 6 months. Patients will be trained before starting the interviews. Receives: Other: motivational interviewing |
| Control | Experimental | No application will be made. Routine follow-ups will be made. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self-Management
Type 2 Diabetes Self-Management Scale
Measured: 6 months
Secondary outcomes (1)
HbA1c
Routine blood value monitoring
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Calisir Kundakci, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727123
- Sponsor's protocol ID
- SCK22T24
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing on Diabetes Self-Management in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT06727123
- Acronym / sponsor ID
- SCK22T24
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 10 Dec 2024 (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.
Diabetes is a chronic metabolic disorder characterized by high blood sugar due to problems with insulin production or function. Its prevalence has increased significantly in recent decades due to sedentary lifestyles, unhealthy diets, and increasing obesity rates. Type 2 diabetes, in particular, is a major global and national health problem with projections showing that it continues to grow. Effective diabetes management requires patients to adopt healthy behaviors such as following a diet plan, monitoring blood sugar, increasing physical activity, and avoiding risky habits such as smoking. Inadequate adherence to treatment can lead to serious complications such as cardiovascular disease and kidney damage, which can be a burden to patients, families, and healthcare systems. Motivational interviewing, a patient-centered approach, helps individuals overcome resistance to behavioral change. This study was designed experimentally to determine the effect of motivational interviewing on diabetes self-management in patients with type 2 diabetes.
Detailed description
Diabetes is defined as a chronic metabolic disorder characterized by high blood sugar levels. Abnormalities in insulin production, function, or both are considered the primary causes of the disease. The epidemiology of diabetes has changed significantly over the last three decades. Diabetes mellitus is one of the most important health problems for both patients and society due to its high mortality, morbidity, and associated costs. The prevalence of diabetes continues to increase globally, driven by advances in technology, sedentary lifestyles, and increasing rates of obesity. Among these factors, the shift towards less active lifestyles plays a central role, with many individuals spending long periods sitting or engaging in low-energy activities. In addition, poor dietary habits, including increased consumption of high-calorie, processed foods, have increased the risk of developing diabetes, especially type 2 diabetes. In Turkey, the prevalence of type 2 diabetes reported in 2020 has shown a significant increase and is expected to increase further by 2050 if current trends continue. Effective treatment for diabetes requires patients to adopt positive attitudes and behaviors towards managing their health. However, many individuals have difficulty maintaining long-term lifestyle changes. Poor adherence to treatment plans and poor disease management often lead to a variety of complications, including acute and chronic health problems. These complications, such as cardiovascular disease, neuropathy, and kidney damage, impose a significant caregiving burden on individuals with diabetes, their families, and society as a whole. To alleviate these problems, individuals must engage in effective self-management to control their disease and prevent complications. Self-management refers to the individual's responsibility to maintain and improve their health. Diabetes self-management aims to normalize blood sugar levels and reduce the risk of long-term complications. Key practices include developing a personalized nutrition plan, monitoring blood sugar levels, maintaining metabolic control, increasing physical activity, and avoiding risky behaviors such as smoking or excessive alcohol consumption. Despite its importance, individuals living with diabetes often face challenges in adopting the lifestyle, behavioral, and psychological changes necessary for effective management. Motivational interviewing is an evidence-based approach that helps individuals resolve the dilemma of behavioral change and facilitates treatment adherence for chronic conditions such as diabetes. This patient-centered method emphasizes understanding the patient's unique challenges and goals, tailoring strategies to their specific needs, and encouraging autonomy. This study aims to evaluate the impact of motivational interviewing on diabetes self-management in patients with type 2 diabetes. It seeks to understand whether this approach can improve health outcomes by encouraging better adherence to treatment plans and supporting sustainable behavioral change, ultimately enhancing disease management in individuals coping with diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Other: motivational interviewingMotivational interviews will be conducted with diabetic patients for 6 months. Patients will be trained before starting the interviews. |
| Control | Experimental | Other: ControlNo application will be made. Routine follow-ups will be made. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who agree to participate in the study voluntarily, can speak and understand Turkish, can communicate comfortably, have no hearing, comprehension or vision problems, are literate, use a smartphone, have Type 2 Diabetes and have HbA1c ≥ 7% will be included in the study.
Key exclusion criteria (1 listed)
- Patients with cognitive dysfunction and those using antipsychotic medication will not be included.
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 |
|---|---|---|
| motivational interviewingMotivational interviews will be conducted with diabetic patients for 6 months. Patients will be trained before starting the interviews. | Other | Motivational Interviewing |
| ControlNo application will be made. Routine follow-ups will be made. | Other | Control |
Primary outcome
Diabetes Self-Management
Time frame: 6 months
Type 2 Diabetes Self-Management Scale
1 secondary outcome
HbA1c
Time frame: 6 months
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 10 Dec 2024.
- Individual participant dataSharing planned: Yes
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing in people with Diabetes Mellitus, run by University of Beykent 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 10 Dec 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management (time frame: 6 months). 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 10 Dec 2024.