Diabetes MellitusNCT05545722
The Effect of Life Coaching With Diabetes on Glycemic Control, Strengthening Diabetes and Self-management
A study testing life coaching group with diabetes in people with Diabetes Mellitus and Nurse-Patient Relations, run by Tuğba Bilgehan at 1 site in Turkey (Türkiye).
Trial summary
Diabetes Mellitus (DM) is an endocrine and metabolic disease that is characterized by hyperglycemia, develops microvascular and macrovascular complications, and requires chronic and continuous care. is a disease. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Nurse-Patient Relations, Nurse's Role
- What is being tested?
- life coaching group with diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient;
- Being between the ages of 18-65,
- Being literate,
- Having a smart phone and being able to use it actively,
- Having been diagnosed with type 2 diabetes at least 1 year ago,
- No chronic complications related to diabetes have developed,
Show all 10Show fewer
- HbA1c > 7,
- Absence of any psychiatric or mental problems,
- Having the cognitive competence to answer questions,
- Willingness to participate in the research
Who cannot join
- • The patient's desire to leave the study,
- Inability to reach the patient by phone
- Having advanced retinopathy, nephropathy, neuropathy, foot wound,
- Being pregnant,
- Being diagnosed with cancer, having myocardial infarction in the last 3 months,
- Having type 1 diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes Mellitus (DM) is an endocrine and metabolic disease that is characterized by hyperglycemia, develops microvascular and macrovascular complications, and requires chronic and continuous care. is a disease. According to IDF 2019 data, it is predicted that the number of diabetics in the world, which was 463 million in 2019, will reach 700 million in 2045 with an increase of 51%. The global prevalence of diabetes between the ages of 20-79 in 2019 is 9.3%, and it is estimated to increase to 10.2% in 2030 and 10.9% in 2045. Our country, on the other hand, has the highest prevalence with a rate of 11.1% among European countries. According to the IDF 2019 Diabetes Atlas data, 6.6 million people with diabetes live in our country as of 2019, and it is estimated that this rate will reach 10 million by 2045.
American Diabetes Association (American Diabetes Association) and American Association of Clinical Endocrinologists (American Association of Clinical Endocrinologists) to achieve the goals of treatment and care in individuals with diabetes; emphasizes the need for regulation of nutrition, regulation of physical activity, regulation of pharmacological treatment, diabetes education, continuous monitoring and health controls. Individuals with diabetes should receive diabetes self-management education and support when necessary. Diabetes self-management is defined as the process of facilitating the knowledge, skills and abilities necessary for the individual's self-care. Individuals with diabetes who are competent and skilled in self-management can improve their health outcomes. The American Diabetes Association (ADA) defines diabetes self-management education as a process that begins at the diagnosis stage and continues, based on an individual-centered approach and making joint decisions to facilitate the knowledge, skills and abilities necessary for the self-care of diabetes patients.
Read more
The purpose of diabetes self-management is for diabetics to develop new skills and behaviors that support self-management goals, and to form habits. The general goals of diabetes self-management education are to support individuals diagnosed with diabetes to make conscious decisions, solve problems, perform self-care behaviors, and improve their metabolic results, health status and quality of life. Diabetes patients need knowledge, skills and motivation to strengthen their diabetes by providing self-management. The nurse helps the patient to adapt to the disease and achieve the ability to perform self-care by counseling and training individuals. Coaching sessions are used to strengthen self-management and diabetes in diabetes. The coach is the person who provides the necessary motivation to maximize the strengths of the client, to ensure that the potentials are fully used through continuous education, to develop new skills and activities to be more effective, to be ready for new responsibilities and to manage himself. Life Coaching with Diabetes is based on the basic principles and principles of professional life coaching practices (ICF-International Coaching Federation), aiming at behavioral change in approaches related to diabetes lifestyle. Life coaching with diabetes is to give practical applications to people who have been diagnosed with diabetes in order to gain necessary changes in life through coaching.
- Problem and Sub-Problems H0: Diabetes life coaching given to individuals with Type 2 Diabetes has no effect on glycemic control, diabetes strengthening and self-management.
H1: Diabetes life coaching given to individuals with Type 2 Diabetes has an effect on glycemic control, strengthening diabetes and self-management.
- Aims and Expected Benefits of the Research This study was planned as a control group intervention study to determine the effect of diabetes coaching on glycemic control, diabetes strengthening and self-management in individuals with Type 2 Diabetes.
Expected benefits:
- Developing appropriate self-care activities (physical activity, medical nutrition, drug management, avoiding risky behaviors, etc.) by improving the self-management skills of the individual with diabetes,
- Individuals with diabetes become self-managed in their self-care practices,
- Ensuring metabolic control of the diabetic individual
- Developing decision-making and problem-solving skills of individuals with diabetes,
- Promoting diabetes coaching in the nursing profession and increasing its visibility and spreading diabetes coaching.
Read the detailed description
Research Method In the study, data will be collected by means of the data collection form, the diabetes strengthening scale, the diabetes self-management scale in people with type 2 diabetes, and based on the researcher's experiences and literature.
- Data collection form: It will be created by the researcher based on the literature. (such as age, gender, how many years have had diabetes).
- Diabetes strengthening scale: It has 3 sub-dimensions: management of psychosocial aspects in diabetes, level of dissatisfaction and readiness for change, setting and achieving diabetes goals.
- Diabetes self-management scale for people with type 2 diabetes: The scale developed by has 3 sub-dimensions: healthy lifestyle, blood sugar management, and use of health services. High scores on the scale indicate good self-management, and low scores indicate poor self-management.
- Conditions
- Diabetes Mellitus, Nurse-Patient Relations, Nurse's Role
- Being tested
- life coaching group with diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
life coaching group with diabetesBehavioural
Each patient was interviewed once a week. Coaching interviews were conducted one-on-one and in accordance with coaching principles.
| Study group | Role | What they receive |
|---|---|---|
| life coaching group with diabetes | Experimental | Individuals with diabetes in the intervention 1 group will be interviewed for 'life coaching with diabetes'. Coaching is a set of systems that make people think deeply and reveal their own awareness and potential. A coach is a person who deliberately applies all these systems with awareness. Life coaching sessions with diabetes are based on the philosophy of coaching. Sessions are continued with questions that will enable the individual to realize the deficiencies in diabetes self-management. It helps the person with diabetes to discover solutions.This training will last for 3 months, once in 10 days. A total of 9 interviews will be provided. Receives: Behavioral: life coaching group with diabetes |
| Standard diabetes education | Experimental | Standard diabetes education will be given to individuals with diabetes in this group. This training will last for 3 months, once in 10 days. A total of 9 interviews will be provided. Receives: Behavioral: life coaching group with diabetes |
| control group | No intervention | only pre-test and post-test were applied to this group. The patients in this group are the patient group who received training from the diabetes nurse of the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diabetes self-management skill scale
Diabetes self-management scale in people with type 2 diabetes: The score that can be obtained from the scale is between 95-19. A high score from the scale indicates good self-management, and a low score indicates poor self-management.
Measured: 12 weeks
Secondary outcomes (1)
Diabetes strengthening scale
Diabetes strengthening scale: The maximum score that can be obtained from the scale is 140, and the minimum score is 28. High scores in scale scoring indicate high levels of reinforcement; low scores indicate low levels of empowerment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Apr 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba Bilgehan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba Bilgehan, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545722
- Sponsor's protocol ID
- 2021-20
- Status last verified
- Sep 2022
- First submitted
- 22 May 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bilgehan T, Vardar Inkaya B. The effect of a holistic nurse coaching intervention on glycemic control, diabetes self-management, and empowerment: a randomized controlled trial. BMC Nurs. 2025 Jun 2;24(1):627. doi: 10.1186/s12912-025-03252-0.
PubMed 40457333
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Life Coaching With Diabetes on Glycemic Control, Strengthening Diabetes and Self-management
- ClinicalTrials.gov ID
- NCT05545722
- Acronym / sponsor ID
- 2021-20
- Conditions
- Diabetes Mellitus, Nurse-Patient Relations, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Tuğba BilgehanUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Sep 2022 (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 Mellitus (DM) is an endocrine and metabolic disease that is characterized by hyperglycemia, develops microvascular and macrovascular complications, and requires chronic and continuous care. is a disease. According to IDF 2019 data, it is predicted that the number of diabetics in the world, which was 463 million in 2019, will reach 700 million in 2045 with an increase of 51%. The global prevalence of diabetes between the ages of 20-79 in 2019 is 9.3%, and it is estimated to increase to 10.2% in 2030 and 10.9% in 2045. Our country, on the other hand, has the highest prevalence with a rate of 11.1% among European countries. According to the IDF 2019 Diabetes Atlas data, 6.6 million people with diabetes live in our country as of 2019, and it is estimated that this rate will reach 10 million by 2045.
American Diabetes Association (American Diabetes Association) and American Association of Clinical Endocrinologists (American Association of Clinical Endocrinologists) to achieve the goals of treatment and care in individuals with diabetes; emphasizes the need for regulation of nutrition, regulation of physical activity, regulation of pharmacological treatment, diabetes education, continuous monitoring and health controls. Individuals with diabetes should receive diabetes self-management education and support when necessary. Diabetes self-management is defined as the process of facilitating the knowledge, skills and abilities necessary for the individual's self-care. Individuals with diabetes who are competent and skilled in self-management can improve their health outcomes. The American Diabetes Association (ADA) defines diabetes self-management education as a process that begins at the diagnosis stage and continues, based on an individual-centered approach and making joint decisions to facilitate the knowledge, skills and abilities necessary for the self-care of diabetes patients.
The purpose of diabetes self-management is for diabetics to develop new skills and behaviors that support self-management goals, and to form habits. The general goals of diabetes self-management education are to support individuals diagnosed with diabetes to make conscious decisions, solve problems, perform self-care behaviors, and improve their metabolic results, health status and quality of life. Diabetes patients need knowledge, skills and motivation to strengthen their diabetes by providing self-management. The nurse helps the patient to adapt to the disease and achieve the ability to perform self-care by counseling and training individuals. Coaching sessions are used to strengthen self-management and diabetes in diabetes. The coach is the person who provides the necessary motivation to maximize the strengths of the client, to ensure that the potentials are fully used through continuous education, to develop new skills and activities to be more effective, to be ready for new responsibilities and to manage himself. Life Coaching with Diabetes is based on the basic principles and principles of professional life coaching practices (ICF-International Coaching Federation), aiming at behavioral change in approaches related to diabetes lifestyle. Life coaching with diabetes is to give practical applications to people who have been diagnosed with diabetes in order to gain necessary changes in life through coaching.
- Problem and Sub-Problems H0: Diabetes life coaching given to individuals with Type 2 Diabetes has no effect on glycemic control, diabetes strengthening and self-management.
H1: Diabetes life coaching given to individuals with Type 2 Diabetes has an effect on glycemic control, strengthening diabetes and self-management.
- Aims and Expected Benefits of the Research This study was planned as a control group intervention study to determine the effect of diabetes coaching on glycemic control, diabetes strengthening and self-management in individuals with Type 2 Diabetes.
Expected benefits:
- Developing appropriate self-care activities (physical activity, medical nutrition, drug management, avoiding risky behaviors, etc.) by improving the self-management skills of the individual with diabetes,
- Individuals with diabetes become self-managed in their self-care practices,
- Ensuring metabolic control of the diabetic individual
- Developing decision-making and problem-solving skills of individuals with diabetes,
- Promoting diabetes coaching in the nursing profession and increasing its visibility and spreading diabetes coaching.
Detailed description
Research Method In the study, data will be collected by means of the data collection form, the diabetes strengthening scale, the diabetes self-management scale in people with type 2 diabetes, and based on the researcher's experiences and literature.
- Data collection form: It will be created by the researcher based on the literature. (such as age, gender, how many years have had diabetes).
- Diabetes strengthening scale: It has 3 sub-dimensions: management of psychosocial aspects in diabetes, level of dissatisfaction and readiness for change, setting and achieving diabetes goals.
- Diabetes self-management scale for people with type 2 diabetes: The scale developed by has 3 sub-dimensions: healthy lifestyle, blood sugar management, and use of health services. High scores on the scale indicate good self-management, and low scores indicate poor self-management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| life coaching group with diabetes | Experimental | Behavioral: life coaching group with diabetesIndividuals with diabetes in the intervention 1 group will be interviewed for 'life coaching with diabetes'. Coaching is a set of systems that make people think deeply and reveal their own awareness and potential. A coach is a person who deliberately applies all these systems with awareness. Life coaching sessions with diabetes are based on the philosophy of coaching. Sessions are continued with questions that will enable the individual to realize the deficiencies in diabetes self-management. It helps the person with diabetes to discover solutions.This training will last for 3 months, once in 10 days. A total of 9 interviews will be provided. |
| Standard diabetes education | Experimental | Behavioral: life coaching group with diabetesStandard diabetes education will be given to individuals with diabetes in this group. This training will last for 3 months, once in 10 days. A total of 9 interviews will be provided. |
| control group | No intervention | –only pre-test and post-test were applied to this group. The patients in this group are the patient group who received training from the diabetes nurse of the hospital. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient;
Key exclusion criteria (6 listed)
- • The patient's desire to leave the study,
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 |
|---|---|---|
| life coaching group with diabetesEach patient was interviewed once a week. Coaching interviews were conducted one-on-one and in accordance with coaching principles. | Behavioural | Standard diabetes education, life coaching group with diabetes |
Primary outcome
diabetes self-management skill scale
Time frame: 12 weeks
Diabetes self-management scale in people with type 2 diabetes: The score that can be obtained from the scale is between 95-19. A high score from the scale indicates good self-management, and a low score indicates poor self-management.
1 secondary outcome
Diabetes strengthening scale
Time frame: 12 weeks
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 19 Sep 2022.
- Derived from this study: PubMed 40457333Bilgehan T, Vardar Inkaya B. The effect of a holistic nurse coaching intervention on glycemic control, diabetes self-management, and empowerment: a randomized controlled trial. BMC Nurs. 2025 Jun 2;24(1):627. doi: 10.1186/s12912-025-03252-0.
- Individual participant dataSharing planned: Undecided
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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 life coaching group with diabetes in people with Diabetes Mellitus and Nurse-Patient Relations, run by Tuğba Bilgehan 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 10 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 19 Sep 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?
diabetes self-management skill scale (time frame: 12 weeks). 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 NCT05545722, 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 19 Sep 2022.