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临床试验/NCT06721546
NCT06721546进行中(未招募)不适用

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

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
86
试验地点
1
主要终点
Healthy Lifestyle Behavior Scale-II

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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,

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Nursing interventions (Other)

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.

干预措施: reminder messages (Other)

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.

干预措施: Telephone counseling (Other)

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.

结局指标

主要结局

Healthy Lifestyle Behavior Scale-II

时间窗: 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

时间窗: 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.

次要结局

  • functional foods consumption form(before randomization, at the time 12 weeks after education)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oznur Gungor

nursing

Necmettin Erbakan University

研究点 (1)

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