Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: type 2 diabetes, functional food, diabetes management, healthy eating
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 86
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Healthy Lifestyle Behavior Scale-II
timeFrame: before randomization, at the time 12 weeks after education
measure: Self-Efficacy Scale for Diabetes Management in Diabetes Patients
timeFrame: before randomization, at the time 12 weeks after education
Secondary outcomes:
measure: functional foods consumption form
timeFrame: before randomization, at the time 12 weeks after education
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman education and research hospital
state: Merkez
Study officials:
References: