Type 2 Diabetes Mellitus (T2DM)NCT06721546
The Effect of Healthy Nutrition and Functional Foods Education Based on the Health Promotion Model for Individuals With Type 2 Diabetes on Healthy Lifestyle Behaviors and Self-Efficacy in Diabetes: Randomized Controlled Study
A study testing Nursing interventions, reminder messages and Telephone counseling in people with Type 2 Diabetes Mellitus (T2DM), run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Non-communicable diseases (NCDs) are defined by the World Health Organization (WHO) as "slowly progressing and long-lasting diseases, health problems that require continuous care due to the combination of genetic, physiological, environmental, and behavioral factors." (WHO 2023). Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Nursing interventions, reminder messages and Telephone counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 30 Nov 2024
- 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 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant aged 30-64 years
- Those diagnosed with Type 2 Diabetes for at least 6 months
- Not diagnosed with psychiatric and neurological diseases diagnosed by a doctor,
- Having basic diabetes knowledge,
- At least primary school graduate
- Individuals who volunteered to participate in the research,
- Smartphone and internet access,
Who cannot join
- Those who do not meet the inclusion criteria,
- Those who have a condition that prevents them from receiving education (physical, mental, vision and hearing, etc.)
- Those who have previously received functional food education,
- Those who are pregnant,
- Those with cancer,
- Those with acute or chronic kidney disease,
- Those with known food allergies.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman education and research hospital
Karaman, Merkez
About this study
Non-communicable diseases (NCDs) are defined by the World Health Organization (WHO) as "slowly progressing and long-lasting diseases, health problems that require continuous care due to the combination of genetic, physiological, environmental, and behavioral factors." (WHO 2023). One of these health issues, Diabetes Mellitus (DM), is one of the chronic and universal health problems affecting many people worldwide (Ministry of Health 2021). When diabetes is not controlled, many acute or chronic complications arise that significantly affect both the individual and society (Üstündağ and Dayapoğlu, 2021). As a result of the complications caused by diabetes, various organ and function losses occur in the individual. As a result, the individual's lifespan and quality of life are negatively affected, and social and economic losses that impact the entire society also occur. (Olgun ve ark. 2017). Therefore, healthy lifestyle behaviors influence minimizing the risk of diabetes and controlling the diabetes that has developed. These include healthy eating, regular medication use, regular exercise, weight maintenance, stress management, quitting smoking/alcohol, and patient education. Coordinating all of these ensures successful diabetes management (Üren and Karabulutlu 2018). Functional foods encompass certain minerals, fatty acids, dietary fibers (such as vegetables, fruits, whole grains, and legumes), antioxidants, or prebiotics that contain biologically active extracts and have beneficial effects on life. (Granato ve ark 2020). For example, foods that contain bioactive substances such as dietary fiber, polyphenols, saponins, and peptides, and have a low glycemic index, help diabetic patients in regulating their blood sugar levels. (Kazeem \& Davies, 2016). Under the guise of nutrition education, natural functional foods that balance blood sugar in our daily lives can create awareness among individuals with type 2 diabetes, making diabetes management easier alongside medication treatment. To create a healthy society, ensuring that individuals and communities use healthy nutrition and functional foods in accordance with nutritional principles, based on their economic situations, will benefit the national economy and also improve the quality of life for individuals. Education conducted using a nursing model can further facilitate the adaptation process to chronic diseases. This study aims to examine the effects of nursing interventions, including group training, reminder messages, and telephone counseling, based on a health promotion model, on healthy lifestyle behaviors related to the daily use of functional foods and diabetes self-efficacy among individuals aged 30-64 with Type 2 diabetes. The interventions were implemented through a researcher-prepared healthy nutrition and functional foods education booklet. The study employs a randomized pre-test-post-test controlled experimental design. Before the random assignments of the 86 individuals who met the sample selection criteria and agreed to participate in the study into intervention and control groups, the Informed Consent Form, Personal Information Form, General Information Form on Eating Habits and Functional Foods, Functional Foods Consumption Form, Diabetes Self-Efficacy Scale, and Healthy Lifestyle Behaviors II Scale Form were completed. At the end of the 12th week after each group's training, the final tests will be conducted by the researcher via phone interview for the intervention and control groups. In the final test, the individuals in the intervention and control groups will be administered the General Information Form on Functional Foods, the Functional Food Consumption Form, the Healthy Lifestyle Behavior Scale-II, and the Self-Efficacy Scale for Diabetes Management in Diabetic Patients.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Nursing interventions, reminder messages, Telephone counseling
- Keywords
- type 2 diabetes, functional food, diabetes management, healthy eating
- 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.
Nursing interventionsOther
The data collection process took place between March and June 2024. The implementation process took place between July 9 and October 24, 2024. In this process, education, reminder messages and telephone counseling for individuals with type 2 diabetes continued for 12 weeks.
Introduction and Preliminary Preparation: Before randomization, both oral and written informed consent form and pretest forms (Personal Information Form, Nutrition Habits, Functional Foods Information Form, Functional Foods Consumption Form, Diabetes Self-Efficacy Scale, Healthy Lifestyle Behaviors II Scale Application) were administered by the researcher to individuals with type 2 diabetes who agreed to participate in the study between March and June 2024. After reaching the sample size (n=86), randomization was performed. Appointments were made for the intervention group for training at KEAH via telephone on Tuesday-Thursday of the week in groups.
reminder messagesOther
Reminder messages: Address and telephone numbers of individuals with Type 2 diabetes in the intervention group were obtained after obtaining their informed consent at the first meeting. After the group training, the messages were sent to the groups (groups A, B, C and D) on Tuesdays and Thursdays during daylight hours every week on the 2nd (July 23-August 15) and 6th (August 20-September 12) weeks. The message was a reminder to the participants about healthy nutrition and consumption of functional foods.
Telephone counselingOther
Telephone counseling: After the group trainings applied to the intervention group, in the 4th (August 6-August 29) and 8th (September 3-September 26) weeks of each week on Tuesdays and Thursdays during daylight hours, individuals with diabetes mellitus were questioned about 'the obstacles they encounter during healthy eating and functional food consumption and whether they have the belief that they can overcome these obstacles and whether there is a change in their healthy eating and functional food consumption behaviors'. Reinforcement was made with reminder questions. In this process, the importance of functional food consumption was emphasized. The first telephone interview with 43 individuals with type 2 diabetes lasted 575 minutes in total and the second telephone interview lasted 495 minutes in total.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Other | The intervention group was provided with group education on healthy nutrition and functional foods based on the health promotion model, the provision of booklets, sending reminder messages and nursing interventions aimed at increasing motivation by providing telephone counseling. The intervention group was given an appointment for Tuesday-Thursday of the week for training at KEAH via telephone. After the training given to the intervention group, 2 reminder messages were given at two-week intervals and 3 telephone consultations were given, including the post-test application. 12 weeks after the training developed and applied according to the health promotion model given to the intervention group, post-test data were collected in both groups. In the post-test, the "Eating Habits and Functional Foods Information Form, Functional Food Consumption Form, Self-Efficacy Scale for Diabetes Management and Healthy Lifestyle Behaviors II" were applied as measurement tools. Receives: Other: Nursing interventions; Other: reminder messages; Other: Telephone counseling |
| control | No intervention | In this group, type 2 diabetics were given pre-tests and post-tests (Functional Food Consumption Form, Diabetes Self-Efficacy Scale, Healthy Lifestyle Behaviors II Scale) during the pre-randomization phase during the familiarization phase between October 1 and October 30, 2024 during weekday daytime hours. No intervention was made to the control group. After the study was completed, the participants in the control group were given the right to be informed from an ethical perspective and a day was set for them to come to the hospital for 'healthy nutrition and functional food education' and education was started. The education is also provided in the booklet after the training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Lifestyle Behavior Scale-II
H0a: There is no difference between the mean scores of the healthy lifestyle behaviors assessment scale.
H1a: There is a difference between the mean scores of the healthy lifestyle behaviors assessment scale.
Measured: before randomization, at the time 12 weeks after education
Self-Efficacy Scale for Diabetes Management in Diabetes Patients
H0b: There is no difference between the mean scores of the self-efficacy in diabetes scale evaluation scale.
H1b: There is a difference between the mean scores of the evaluation scale of the self-efficacy scale in diabetes.
Measured: before randomization, at the time 12 weeks after education
Secondary outcomes (1)
functional foods consumption form
Measured: before randomization, at the time 12 weeks after education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 Mar 2024
- Primary completion9 Jul 2024
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- This study aims to examine the effects of nursing interventions, including group training, reminder messages, and telephone counseling, based on a health promotion model, on healthy lifestyle behaviors related to the daily use of functional foods and diabetes self-efficacy among individuals aged 30-64 with Type 2 diabetes. The interventions were implemented through a researcher-prepared healthy nutrition and functional foods education booklet. The study employs a randomized pre-test-post-test controlled experimental design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oznur Gungor, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721546
- Sponsor's protocol ID
- NecmettinEU/GÜNGÖR_001
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Healthy Nutrition and Functional Foods Education Based on the Health Promotion Model for Individuals With Type 2 Diabetes on Healthy Lifestyle Behaviors and Self-Efficacy in Diabetes: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06721546
- Acronym / sponsor ID
- NecmettinEU/GÜNGÖR_001
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- type 2 diabetes, functional food, diabetes management, healthy eating
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 6 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.
Non-communicable diseases (NCDs) are defined by the World Health Organization (WHO) as "slowly progressing and long-lasting diseases, health problems that require continuous care due to the combination of genetic, physiological, environmental, and behavioral factors." (WHO 2023). One of these health issues, Diabetes Mellitus (DM), is one of the chronic and universal health problems affecting many people worldwide (Ministry of Health 2021). When diabetes is not controlled, many acute or chronic complications arise that significantly affect both the individual and society (Üstündağ and Dayapoğlu, 2021). As a result of the complications caused by diabetes, various organ and function losses occur in the individual. As a result, the individual's lifespan and quality of life are negatively affected, and social and economic losses that impact the entire society also occur. (Olgun ve ark. 2017). Therefore, healthy lifestyle behaviors influence minimizing the risk of diabetes and controlling the diabetes that has developed. These include healthy eating, regular medication use, regular exercise, weight maintenance, stress management, quitting smoking/alcohol, and patient education. Coordinating all of these ensures successful diabetes management (Üren and Karabulutlu 2018). Functional foods encompass certain minerals, fatty acids, dietary fibers (such as vegetables, fruits, whole grains, and legumes), antioxidants, or prebiotics that contain biologically active extracts and have beneficial effects on life. (Granato ve ark 2020). For example, foods that contain bioactive substances such as dietary fiber, polyphenols, saponins, and peptides, and have a low glycemic index, help diabetic patients in regulating their blood sugar levels. (Kazeem \& Davies, 2016). Under the guise of nutrition education, natural functional foods that balance blood sugar in our daily lives can create awareness among individuals with type 2 diabetes, making diabetes management easier alongside medication treatment. To create a healthy society, ensuring that individuals and communities use healthy nutrition and functional foods in accordance with nutritional principles, based on their economic situations, will benefit the national economy and also improve the quality of life for individuals. Education conducted using a nursing model can further facilitate the adaptation process to chronic diseases. This study aims to examine the effects of nursing interventions, including group training, reminder messages, and telephone counseling, based on a health promotion model, on healthy lifestyle behaviors related to the daily use of functional foods and diabetes self-efficacy among individuals aged 30-64 with Type 2 diabetes. The interventions were implemented through a researcher-prepared healthy nutrition and functional foods education booklet. The study employs a randomized pre-test-post-test controlled experimental design. Before the random assignments of the 86 individuals who met the sample selection criteria and agreed to participate in the study into intervention and control groups, the Informed Consent Form, Personal Information Form, General Information Form on Eating Habits and Functional Foods, Functional Foods Consumption Form, Diabetes Self-Efficacy Scale, and Healthy Lifestyle Behaviors II Scale Form were completed. At the end of the 12th week after each group's training, the final tests will be conducted by the researcher via phone interview for the intervention and control groups. In the final test, the individuals in the intervention and control groups will be administered the General Information Form on Functional Foods, the Functional Food Consumption Form, the Healthy Lifestyle Behavior Scale-II, and the Self-Efficacy Scale for Diabetes Management in Diabetic Patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study aims to examine the effects of nursing interventions, including group training, reminder messages, and telephone counseling, based on a health promotion model, on healthy lifestyle behaviors related to the daily use of functional foods and diabetes self-efficacy among individuals aged 30-64 with Type 2 diabetes. The interventions were implemented through a researcher-prepared healthy nutrition and functional foods education booklet. The study employs a randomized pre-test-post-test controlled experimental design.
| Arm | Type | Receives |
|---|---|---|
| intervention | Other | Other: Nursing interventions, Other: reminder messages, Other: Telephone counselingThe intervention group was provided with group education on healthy nutrition and functional foods based on the health promotion model, the provision of booklets, sending reminder messages and nursing interventions aimed at increasing motivation by providing telephone counseling. The intervention group was given an appointment for Tuesday-Thursday of the week for training at KEAH via telephone. After the training given to the intervention group, 2 reminder messages were given at two-week intervals and 3 telephone consultations were given, including the post-test application. 12 weeks after the training developed and applied according to the health promotion model given to the intervention group, post-test data were collected in both groups. In the post-test, the "Eating Habits and Functional Foods Information Form, Functional Food Consumption Form, Self-Efficacy Scale for Diabetes Management and Healthy Lifestyle Behaviors II" were applied as measurement tools. |
| control | No intervention | –In this group, type 2 diabetics were given pre-tests and post-tests (Functional Food Consumption Form, Diabetes Self-Efficacy Scale, Healthy Lifestyle Behaviors II Scale) during the pre-randomization phase during the familiarization phase between October 1 and October 30, 2024 during weekday daytime hours. No intervention was made to the control group. After the study was completed, the participants in the control group were given the right to be informed from an ethical perspective and a day was set for them to come to the hospital for 'healthy nutrition and functional food education' and education was started. The education is also provided in the booklet after the training. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant aged 30-64 years
- Those diagnosed with Type 2 Diabetes for at least 6 months
- Not diagnosed with psychiatric and neurological diseases diagnosed by a doctor,
- Having basic diabetes knowledge,
- At least primary school graduate
Key exclusion criteria (7 listed)
- Those who do not meet the inclusion criteria,
- Those who have a condition that prevents them from receiving education (physical, mental, vision and hearing, etc.)
- Those who have previously received functional food education,
- Those who are pregnant,
- Those with cancer,
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 |
|---|---|---|
| Nursing interventionsThe data collection process took place between March and June 2024. The implementation process took place between July 9 and October 24, 2024. In this process, education, reminder messages and telephone counseling for individuals with type 2 diabetes continued for 12 weeks. Introduction and Preliminary Preparation: Before randomization, both oral and written informed consent form and pretest forms (Personal Information Form, Nutrition Habits, Functional Foods Information Form, Functional Foods Consumption Form, Diabetes Self-Efficacy Scale, Healthy Lifestyle Behaviors II Scale Application) were administered by the researcher to individuals with type 2 diabetes who agreed to participate in the study between March and June 2024. After reaching the sample size (n=86), randomization was performed. Appointments were made for the intervention group for training at KEAH via telephone on Tuesday-Thursday of the week in groups. | Other | intervention |
| reminder messagesReminder messages: Address and telephone numbers of individuals with Type 2 diabetes in the intervention group were obtained after obtaining their informed consent at the first meeting. After the group training, the messages were sent to the groups (groups A, B, C and D) on Tuesdays and Thursdays during daylight hours every week on the 2nd (July 23-August 15) and 6th (August 20-September 12) weeks. The message was a reminder to the participants about healthy nutrition and consumption of functional foods. | Other | intervention |
| Telephone counselingTelephone counseling: After the group trainings applied to the intervention group, in the 4th (August 6-August 29) and 8th (September 3-September 26) weeks of each week on Tuesdays and Thursdays during daylight hours, individuals with diabetes mellitus were questioned about 'the obstacles they encounter during healthy eating and functional food consumption and whether they have the belief that they can overcome these obstacles and whether there is a change in their healthy eating and functional food consumption behaviors'. Reinforcement was made with reminder questions. In this process, the importance of functional food consumption was emphasized. The first telephone interview with 43 individuals with type 2 diabetes lasted 575 minutes in total and the second telephone interview lasted 495 minutes in total. | Other | intervention |
Primary outcome
Healthy Lifestyle Behavior Scale-II
Time frame: before randomization, at the time 12 weeks after education
H0a: There is no difference between the mean scores of the healthy lifestyle behaviors assessment scale. H1a: There is a difference between the mean scores of the healthy lifestyle behaviors assessment scale.
Self-Efficacy Scale for Diabetes Management in Diabetes Patients
Time frame: before randomization, at the time 12 weeks after education
H0b: There is no difference between the mean scores of the self-efficacy in diabetes scale evaluation scale. H1b: There is a difference between the mean scores of the evaluation scale of the self-efficacy scale in diabetes.
1 secondary outcome
functional foods consumption form
Time frame: before randomization, at the time 12 weeks after education
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 6 Dec 2024.
- Related InfoLink provided by the sponsor.
- 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 Nursing interventions, reminder messages and Telephone counseling in people with Type 2 Diabetes Mellitus (T2DM), run by Necmettin Erbakan 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 6 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?
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?
Healthy Lifestyle Behavior Scale-II (time frame: before randomization, at the time 12 weeks after education). 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 6 Dec 2024.