Type 2 DiabetesNCT06769477
The Effect of Education Given to Type 2 Diabetics on Diabetes Self-management, Health Fatalism and Metabolic Parameters
A study testing Experimental Group in people with Type 2 Diabetes and Type 2 Diabetes Patients, run by Ataturk University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to examine the effects on diabetes self-management, health fatalism and metabolic parameters of individuals with type 2 diabetes. The study will be conducted in a health institution between February 2025 and May 2025 and participants will be assigned to experimental and control groups by simple random… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Type 2 Diabetes Patients
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having type 2 diabetes for at least 6 months
- To be over 18 years old
- Have sufficient communication skills to answer verbal and written questions and fulfill instructions
- Becoming literate
- No physical, cognitive or mental impairment in answering the questions
- Willingness to participate in research.
Who cannot join
- Under 18 years of age
- Being hospitalized in inpatient treatment institutions due to DM or DM complications during the research process
- The emergence of any health problem that prevents the person from continuing the research
- Do not leave the study voluntarily.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Manavgat and Aksu Family Health Center
Antalya, 07000
Gülşen Altuntaş Çalım, +905535383055, gulsenaltuntas13@hotmail.com
- Recruiting
Manavgat and Aksu Family Health Center
Antalya
Gülşen Altuntaş Çalım, PhD student, +905535383055, gulsenaltuntas13@hotmail.com
Gülşen ALTUNTAŞ ÇALIM, PhD student
About this study
Official title: The Effect of Training With Motivational Interviewing Based on Health Belief Model on Diabetes Self-Management, Health Fatalism and Metabolic Parameters in Individuals With Type 2 Diabetes: A Randomized Controlled Experimental Study
This study aims to examine the effects on diabetes self-management, health fatalism and metabolic parameters of individuals with type 2 diabetes. The study will be conducted in a health institution between February 2025 and May 2025 and participants will be assigned to experimental and control groups by simple random sampling method. The experimental group will be trained with motivational interviewing techniques based on the health belief model for 8 weeks, followed by sending reminder SMS for 4 weeks. The control group will receive no intervention. The study is expected to improve the self-care behaviors of individuals with diabetes by creating positive effects on diabetes management and health fatalism.
Read the detailed description
This study aims to determine the effect of education given with motivational interviewing technique structured according to the health belief model on diabetes self-management, health fatalism and metabolic parameters in individuals with type 2 diabetes. The research will be conducted in a pre-test and post-test randomized controlled experimental design.The population of the study will consist of individuals with type 2 diabetes who are registered in a health institution between February 2025 and May 2025 and who meet the research criteria. The sample determined by power analysis will consist of a total of 66 patients, 33 in the experimental group and 33 in the control group. Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be used to collect data from the experimental and control groups for pre-test and post-test. Weight, height, waist circumference and body mass index of the individuals will be measured by the researcher and HbA1c values of the last one month will be recorded. The experimental group will be given diabetes education with motivational interviewing technique structured according to the health belief model in line with the literature.Brochures and powerpoint presentations will be prepared as training materials. Trainings will be held in the training room on the days and times determined with the patients in 8 sessions lasting 30-40 minutes. At the end of the training, an SMS message will be sent once a week for four weeks. At the end of each visit, the next visit will be scheduled. Trainings will be conducted face-to-face by the researcher. The control group will not receive any training. After the completion of the trainings, a post-test will be administered to both the experimental and control groups. In the evaluation of the data; numbers, percentages, standard deviation, mean, minimum and maximum values, Chi-square, Fisher-Freeman-Halton Exact Test, Paired Samples t-test and Independent Samples t-test will be used.
- Conditions
- Type 2 Diabetes, Type 2 Diabetes Patients
- Being tested
- Experimental Group
- Keywords
- health belief model, motivational interview, self-management, health fatalism, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
individuals will receive diabetes education with motivational interviewing technique based on health belief model
| Study group | Role | What they receive |
|---|---|---|
| group receiving diabetes education with motivational interviewing technique | Active comparator | Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied to the experimental group before the training. then, diabetes education will be given to the individuals in the experimental group one day a week with the motivational interviewing technique based on the health belief model. 8 weeks of training will be given in total and then 4 weeks of informative reminder sms will be sent about diabetes education. After the training is over, Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied. Receives: Other: Experimental Group |
| group with no intervention | No intervention | The control group will be administered the Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale at the first encounter. After 3 months, the Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied again. No application will be made to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 DM Self-Management Scale (SMS)
The scale assesses self-management It has 3 sub-dimensions.These dimensions consist of 11 questions consisting of "Healthy Lifestyle Behaviors" dimension, consisting of 4 questions "Health Services Utilization" dimension and "Blood Sugar Management" dimension. Scoring: Always 5, Often 4, Sometimes 3, Rarely 2, Never 1.
(-Healthy Lifestyle Subdimension= HLBD-1+ HLBD-2+ HLBD-3+ HLBD-4+ HLBD-5+ HLBD-6+ HLBD-7+ SYBD-8+ SYBD-9+ SYBD-10+ SYBD-11.) (-Blood Glucose Management Subscale= BSM-1+ BSM-2+ BSM-3+ BSM-4) (-Health Services Utilization Subdimension= SHK-1+ SHK-2+ SHK-3+ SHK-4) (-Diabetes Self-Management Scale score=SMDI Subdimension+CSM Subdimension +SCC Subdimension.) There are no reverse items in the scale. High scores indicate good self-management, low scores indicate and poor self-management. The minimum score that can be obtained from the Type 2 self-management scale is 19 and the maximum score is 95.
Measured: three months
Secondary outcomes (1)
Health Fatalism Scale
The scale consists of one sub-dimension and 17 items. The scale is a Likert-type scale answered as ''strongly disagree'', ''disagree'', ''undecided'', ''agree'', ''strongly agree''. The minimum score obtained from the Health Fatalism Scale is 17 and the maximum score is 85. Cronbach α Coefficient of the scale is 0.91.An increase in the score on the scale indicates an increase in fatalism.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Feb 2025
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the experimental group will be trained with motivational technique. the control group will not receive any intervention
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşen Altuntas Çalım, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769477
- Sponsor's protocol ID
- AU-SBF-GAÇ-01
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training With Motivational Interviewing Based on Health Belief Model on Diabetes Self-Management, Health Fatalism and Metabolic Parameters in Individuals With Type 2 Diabetes: A Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT06769477
- Acronym / sponsor ID
- AU-SBF-GAÇ-01
- Conditions
- Type 2 Diabetes, Type 2 Diabetes Patients
- Keywords
- health belief model, motivational interview, self-management, health fatalism, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 Jan 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 study aims to examine the effects on diabetes self-management, health fatalism and metabolic parameters of individuals with type 2 diabetes. The study will be conducted in a health institution between February 2025 and May 2025 and participants will be assigned to experimental and control groups by simple random sampling method. The experimental group will be trained with motivational interviewing techniques based on the health belief model for 8 weeks, followed by sending reminder SMS for 4 weeks. The control group will receive no intervention. The study is expected to improve the self-care behaviors of individuals with diabetes by creating positive effects on diabetes management and health fatalism.
Detailed description
This study aims to determine the effect of education given with motivational interviewing technique structured according to the health belief model on diabetes self-management, health fatalism and metabolic parameters in individuals with type 2 diabetes. The research will be conducted in a pre-test and post-test randomized controlled experimental design.The population of the study will consist of individuals with type 2 diabetes who are registered in a health institution between February 2025 and May 2025 and who meet the research criteria. The sample determined by power analysis will consist of a total of 66 patients, 33 in the experimental group and 33 in the control group. Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be used to collect data from the experimental and control groups for pre-test and post-test. Weight, height, waist circumference and body mass index of the individuals will be measured by the researcher and HbA1c values of the last one month will be recorded. The experimental group will be given diabetes education with motivational interviewing technique structured according to the health belief model in line with the literature.Brochures and powerpoint presentations will be prepared as training materials. Trainings will be held in the training room on the days and times determined with the patients in 8 sessions lasting 30-40 minutes. At the end of the training, an SMS message will be sent once a week for four weeks. At the end of each visit, the next visit will be scheduled. Trainings will be conducted face-to-face by the researcher. The control group will not receive any training. After the completion of the trainings, a post-test will be administered to both the experimental and control groups. In the evaluation of the data; numbers, percentages, standard deviation, mean, minimum and maximum values, Chi-square, Fisher-Freeman-Halton Exact Test, Paired Samples t-test and Independent Samples t-test will be used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the experimental group will be trained with motivational technique. the control group will not receive any intervention
| Arm | Type | Receives |
|---|---|---|
| group receiving diabetes education with motivational interviewing technique | Active comparator | Other: Experimental GroupPatient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied to the experimental group before the training. then, diabetes education will be given to the individuals in the experimental group one day a week with the motivational interviewing technique based on the health belief model. 8 weeks of training will be given in total and then 4 weeks of informative reminder sms will be sent about diabetes education. After the training is over, Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied. |
| group with no intervention | No intervention | –The control group will be administered the Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale at the first encounter. After 3 months, the Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied again. No application will be made to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having type 2 diabetes for at least 6 months
- To be over 18 years old
- Have sufficient communication skills to answer verbal and written questions and fulfill instructions
- Becoming literate
- No physical, cognitive or mental impairment in answering the questions
Key exclusion criteria (4 listed)
- Under 18 years of age
- Being hospitalized in inpatient treatment institutions due to DM or DM complications during the research process
- The emergence of any health problem that prevents the person from continuing the research
- Do not leave the study voluntarily.
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 |
|---|---|---|
| Experimental Groupindividuals will receive diabetes education with motivational interviewing technique based on health belief model | Other | group receiving diabetes education with motivational interviewing technique |
Primary outcome
Type 2 DM Self-Management Scale (SMS)
Time frame: three months
The scale assesses self-management It has 3 sub-dimensions.These dimensions consist of 11 questions consisting of "Healthy Lifestyle Behaviors" dimension, consisting of 4 questions "Health Services Utilization" dimension and "Blood Sugar Management" dimension. Scoring: Always 5, Often 4, Sometimes 3, Rarely 2, Never 1. (-Healthy Lifestyle Subdimension= HLBD-1+ HLBD-2+ HLBD-3+ HLBD-4+ HLBD-5+ HLBD-6+ HLBD-7+ SYBD-8+ SYBD-9+ SYBD-10+ SYBD-11.) (-Blood Glucose Management Subscale= BSM-1+ BSM-2+ BSM-3+ BSM-4) (-Health Services Utilization Subdimension= SHK-1+ SHK-2+ SHK-3+ SHK-4) (-Diabetes Self-Management Scale score=SMDI Subdimension+CSM Subdimension +SCC Subdimension.) There are no reverse items in the scale. High scores indicate good self-management, low scores indicate and poor self-management. The minimum score that can be obtained from the Type 2 self-management scale is 19 and the maximum score is 95.
1 secondary outcome
Health Fatalism Scale
Time frame: three 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 25 Feb 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Type 2 Diabetes and Type 2 Diabetes Patients, run by Ataturk University at 2 sites 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Gülşen Altuntaş Çalım, PhD student (+905535383055, gulsenaltuntas13@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 DM Self-Management Scale (SMS) (time frame: three 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 25 Feb 2025.