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

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06721546
• Lead Sponsor: Necmettin Erbakan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Primary Completion: 2024-07-09
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Healthy Lifestyle Behavior Scale-II	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	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.

Secondary Outcome Measures

Name	Time	Method
functional foods consumption form	before randomization, at the time 12 weeks after education

Trial Locations

Locations (1)

Karaman education and research hospital; 🇹🇷 Karaman, Merkez, Turkey