Type2 DiabetesNCT05030844
The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With T2DM
A study testing IMB model based Diabetes Education and Motivational Interviewing in people with Type2 Diabetes and Self Efficacy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing for adults with Type 2 diabetes on care outcomes This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing interventions on care outcomes for… Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Self Efficacy, Self Management
- What is being tested?
- IMB model based Diabetes 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
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2021to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those between the ages of 30-64
- Receiving insulin therapy
- BMI value of 25 and above
- HbA1c of 7 and above
- At least primary school graduate and can speak Turkish
- No communication barrier (speech, vision or hearing problem)
- Having a smart phone and internet access
- Individuals who agree to participate in the research.
Who cannot join
- Those who have retinopathy at a level that may hinder the sense of sight.
- Those with neuropathy at a level that prevents them from doing their daily physical activities
- Diagnosed with kidney failure
- Using an insulin pump
- Pregnant
- Those with a diagnosis of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With Type 2 Diabetes-A Randomized Controlled Study: Randomized Controlled Trial
This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing for adults with Type 2 diabetes on care outcomes This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing interventions on care outcomes for adults with Type 2 diabetes (diabetes knowledge, health belief, self-efficacy, self-management, HbA1c and BKİ).
Read the detailed description
This study was conducted to examine the effects of Information, Motivation and Behavioral Skills (IMB) model-based diabetes education and motivational interviewing on care outcomes in adults with Type 2 diabetes. The study is a single-blind, randomized controlled trial with pre-test, post-test and follow-up test measurements from experimental research designs. The study was carried out in the Endocrinology and Metabolic Diseases Polyclinic, and the data were collected between June 2021 and February 2022. The sample of the study (intervention group=30, control group=30) consisted of 60 individuals with type 2 diabetes. Study data were collected with Adult Diabetes Information Scale, Health Belief Model Scale, Diabetes Self-Efficacy Scale, Diabetes Self-Management Scale and metabolic control parameters follow-up form. IMB model-based diabetes education and motivational interview program were applied to the individuals in the experimental group for three months. Initially, diabetes education was given in small groups in four sessions, then Motivational Interviews were held individually every two weeks for a total of five sessions via WhatsApp.
- Conditions
- Type2 Diabetes, Self Efficacy, Self Management, HbA1c, BMI
- Being tested
- IMB model based Diabetes Education and Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB model based Diabetes Education and Motivational InterviewingBehavioural
IMB model-based interventions were applied to the intervention group for 3 month. For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks. Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers. For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | IMB model-based interventions were applied to the intervention group for 3 month. For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks. Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers. For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week. Receives: Behavioral: IMB model based Diabetes Education and Motivational Interviewing |
| Control Group | No intervention | The control group received routine nursing care in the endocrine policlinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in diabetes knowledge level of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Knowledge Scale.
This scale was used to measure the knowledge component in the IMB model of individuals. The scale was developed by Erener Yavuz and Erol (2019) to measure the knowledge level of adults with diabetes. The scale consists of 5 sub-dimensions, including General Information on Diabetes (6 items), Blood Glucose Measurements and Values (5 items), Diabetes Risk Factors (4 items), Diabetes Symptoms (8 items), Diabetes Complications (5 items), and 28 consists of matter. Scale answers consist of two sets of items, true and false. Among the yes/no/don't know answer type questions, 1 point is given to those who give correct answers, 0 points are given to those who do not know and give wrong answers. The maximum score that can be obtained from the scale is 28, and the minimum score is 0.
Measured: baseline, 3rd month and 6 rd month
The change in diabetes health belief of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Health Belief Model Scale in Diabetes Patients.
This scale was used to measure the individual motivation component in the IMB model of individuals. The scale consists of 5 sub-dimensions and 33 items: perceived sensitivity (4 items), perceived seriousness (3 items), perceived benefits (7 items), perceived barriers (9 items), recommended health-related activities (10 items). The mean score of each sub-dimension is determined by dividing the total scores of all items in the sub-dimension by the total number of items. The total scale mean score is calculated by dividing the total scores of all scale items by the total number of items. The minimum score for each item is 1 and the maximum score is 5. Rating was made as strongly disagree (1), strongly agree (5). Low scores indicate negative and high scores indicate positive health beliefs. If the mean score for each item is 4 and above, it indicates high or positive health belief, and if the mean score is less than 4, it indicates low health belief.
Measured: baseline, 3rd month and 6 rd month
The change in diabetes self efficacy of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Efficacy Scale.
The "Self-Efficacy Scale" for diabetes management in type 2 diabetes patients was developed to determine the perception of diabetes patients' own power to carry out their own care activities. The items that make up the scale are based on the following activities. Activities to be done for diabetes treatment (drug use, diet, physical exercise), self-monitoring, self-control (knowing the value of blood sugar, body weight, foot control, general health), regulating their own activities (hypoglycemia, hyperglycemia correction, preparing for vacation) change in diet, overweight, self-control in case of illness and stress). The scale consists of 20 items. The lowest score to be taken from the scale is 20, and the highest score is 100.
Measured: baseline, 3rd month and 6 rd month
The change in diabetes self managament of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Management Scale
This scale was used to measure the behavioral component of individuals in the IMB model. The validity and reliability study of the Turkish Diabetes Self-Management Perception Scale was conducted by Eroğlu and Sabuncu (2018). The scale consists of 16 items and 4 sub-dimensions and is a 4-point Likert type. Glucose Management sub-dimension: Items 4, 6, 10, 12 (items 4 and 12 are about drug use, items 1, 6 and 10 are about blood glucose monitoring). Diet Control sub-dimension: Items 2, 5, 9, 13. Physical Activity sub-dimension: Items 8, 11, 15. Use of Health Services sub-dimension: It consists of 3, 7, 14, and 16 items. The DMS scale consists of 16 items, 7 of which are straight and 9 of which are reversed. The scores of the items numbered "5, 7, 10, 11, 12, 13, 14, 15 and 16" in the scale are calculated by reversing them. Diabetes self-management increases as the score gets closer to 10.
Measured: baseline, 3rd month and 6 rd month
Secondary outcomes (1)
Metabolic control variables
Measurement of changes in HbA1c and Body Mass Index levels of individuals with Type 2 diabetes at 3rd month and 6 rd month
Measured: baseline, 3rd month and 6 rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start14 Jul 2021
- Primary completion14 Oct 2021
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel group randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDA KILINÇ, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030844
- Sponsor's protocol ID
- EKILINC
- Status last verified
- Oct 2022
- First submitted
- 30 Aug 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilinc Isleyen E, Kartal A. The effect of information, motivation and behavioural skills model-based Diabetes Education and Motivational Interview Program on health outcomes in middle-aged adults with type 2 diabetes: a randomised controlled study. Psychogeriatrics. 2025 Jan;25(1):e13219. doi: 10.1111/psyg.13219. Epub 2024 Nov 19.
PubMed 39562051
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With Type 2 Diabetes-A Randomized Controlled Study: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05030844
- Acronym / sponsor ID
- EKILINC
- Conditions
- Type2 Diabetes, Self Efficacy, Self Management, HbA1c, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 1 Sep 2021 (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 was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing for adults with Type 2 diabetes on care outcomes This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing interventions on care outcomes for adults with Type 2 diabetes (diabetes knowledge, health belief, self-efficacy, self-management, HbA1c and BKİ).
Detailed description
This study was conducted to examine the effects of Information, Motivation and Behavioral Skills (IMB) model-based diabetes education and motivational interviewing on care outcomes in adults with Type 2 diabetes. The study is a single-blind, randomized controlled trial with pre-test, post-test and follow-up test measurements from experimental research designs. The study was carried out in the Endocrinology and Metabolic Diseases Polyclinic, and the data were collected between June 2021 and February 2022. The sample of the study (intervention group=30, control group=30) consisted of 60 individuals with type 2 diabetes. Study data were collected with Adult Diabetes Information Scale, Health Belief Model Scale, Diabetes Self-Efficacy Scale, Diabetes Self-Management Scale and metabolic control parameters follow-up form. IMB model-based diabetes education and motivational interview program were applied to the individuals in the experimental group for three months. Initially, diabetes education was given in small groups in four sessions, then Motivational Interviews were held individually every two weeks for a total of five sessions via WhatsApp.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a parallel group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: IMB model based Diabetes Education and Motivational InterviewingIMB model-based interventions were applied to the intervention group for 3 month. For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks. Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers. For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week. |
| Control Group | No intervention | –The control group received routine nursing care in the endocrine policlinic. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Those between the ages of 30-64
- Receiving insulin therapy
- BMI value of 25 and above
- HbA1c of 7 and above
- At least primary school graduate and can speak Turkish
Key exclusion criteria (6 listed)
- Those who have retinopathy at a level that may hinder the sense of sight.
- Those with neuropathy at a level that prevents them from doing their daily physical activities
- Diagnosed with kidney failure
- Using an insulin pump
- Pregnant
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 |
|---|---|---|
| IMB model based Diabetes Education and Motivational InterviewingIMB model-based interventions were applied to the intervention group for 3 month. For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks. Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers. For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week. | Behavioural | Intervention Group |
Primary outcome
The change in diabetes knowledge level of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Knowledge Scale.
Time frame: baseline, 3rd month and 6 rd month
This scale was used to measure the knowledge component in the IMB model of individuals. The scale was developed by Erener Yavuz and Erol (2019) to measure the knowledge level of adults with diabetes. The scale consists of 5 sub-dimensions, including General Information on Diabetes (6 items), Blood Glucose Measurements and Values (5 items), Diabetes Risk Factors (4 items), Diabetes Symptoms (8 items), Diabetes Complications (5 items), and 28 consists of matter. Scale answers consist of two sets of items, true and false. Among the yes/no/don't know answer type questions, 1 point is given to those who give correct answers, 0 points are given to those who do not know and give wrong answers. The maximum score that can be obtained from the scale is 28, and the minimum score is 0.
The change in diabetes health belief of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Health Belief Model Scale in Diabetes Patients.
Time frame: baseline, 3rd month and 6 rd month
This scale was used to measure the individual motivation component in the IMB model of individuals. The scale consists of 5 sub-dimensions and 33 items: perceived sensitivity (4 items), perceived seriousness (3 items), perceived benefits (7 items), perceived barriers (9 items), recommended health-related activities (10 items). The mean score of each sub-dimension is determined by dividing the total scores of all items in the sub-dimension by the total number of items. The total scale mean score is calculated by dividing the total scores of all scale items by the total number of items. The minimum score for each item is 1 and the maximum score is 5. Rating was made as strongly disagree (1), strongly agree (5). Low scores indicate negative and high scores indicate positive health beliefs. If the mean score for each item is 4 and above, it indicates high or positive health belief, and if the mean score is less than 4, it indicates low health belief.
The change in diabetes self efficacy of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Efficacy Scale.
Time frame: baseline, 3rd month and 6 rd month
The "Self-Efficacy Scale" for diabetes management in type 2 diabetes patients was developed to determine the perception of diabetes patients' own power to carry out their own care activities. The items that make up the scale are based on the following activities. Activities to be done for diabetes treatment (drug use, diet, physical exercise), self-monitoring, self-control (knowing the value of blood sugar, body weight, foot control, general health), regulating their own activities (hypoglycemia, hyperglycemia correction, preparing for vacation) change in diet, overweight, self-control in case of illness and stress). The scale consists of 20 items. The lowest score to be taken from the scale is 20, and the highest score is 100.
The change in diabetes self managament of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Management Scale
Time frame: baseline, 3rd month and 6 rd month
This scale was used to measure the behavioral component of individuals in the IMB model. The validity and reliability study of the Turkish Diabetes Self-Management Perception Scale was conducted by Eroğlu and Sabuncu (2018). The scale consists of 16 items and 4 sub-dimensions and is a 4-point Likert type. Glucose Management sub-dimension: Items 4, 6, 10, 12 (items 4 and 12 are about drug use, items 1, 6 and 10 are about blood glucose monitoring). Diet Control sub-dimension: Items 2, 5, 9, 13. Physical Activity sub-dimension: Items 8, 11, 15. Use of Health Services sub-dimension: It consists of 3, 7, 14, and 16 items. The DMS scale consists of 16 items, 7 of which are straight and 9 of which are reversed. The scores of the items numbered "5, 7, 10, 11, 12, 13, 14, 15 and 16" in the scale are calculated by reversing them. Diabetes self-management increases as the score gets closer to 10.
1 secondary outcome
Metabolic control variables
Time frame: baseline, 3rd month and 6 rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 39562051Kilinc Isleyen E, Kartal A. The effect of information, motivation and behavioural skills model-based Diabetes Education and Motivational Interview Program on health outcomes in middle-aged adults with type 2 diabetes: a randomised controlled study. Psychogeriatrics. 2025 Jan;25(1):e13219. doi: 10.1111/psyg.13219. Epub 2024 Nov 19.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMB model based Diabetes Education and Motivational Interviewing in people with Type2 Diabetes and Self Efficacy, run by Pamukkale University 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 4 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in diabetes knowledge level of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Knowledge Scale. (time frame: baseline, 3rd month and 6 rd month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05030844, which also lists 1 linked publication.
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 4 Oct 2022.