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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05577325
Other study ID # Ayse Yilmaz
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 13, 2022
Est. completion date April 2023

Study information

Verified date October 2022
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effect of planned education based on the health promotion model on lifestyle behaviors and weight management in obese secondary school students.


Description:

Obesity is a chronic disease that is explained by the increase in body fat mass compared to lean body mass, as a result of the fact that the energy taken into the body is more than the energy spent. Obesity, which is accepted as a complex and multifactorial disease that negatively affects health, is the second most important cause of preventable deaths after smoking. Obesity, cardiovascular diseases, especially type 2 diabetes and prediabetes, hypertension (HT), hyperlipidemia (HL), cerebrovascular disease, various cancers, obstructive sleep-apnea syndrome, non-alcoholic fatty liver disease, gastroesophageal reflux, biliary tract disease, It increases health expenditures by causing many health problems such as polycystic ovary syndrome, infertility, osteoarthrosis and depression. Obesity is defined by the World Health Organization (2020) as "abnormal or excessive fat accumulation in the body to the extent that it impairs health". WHO (2020) reported that as of 2019, 38 million children under the age of 5 were overweight or obese in the world, and according to 2016 data, more than 340 million children and adolescents between the ages of 5-19 were overweight or obese. According to the results of Turkey Childhood Obesity Survey-2016, COSI-TUR (Childhood Obesity Surveillance Initiative), the rate of overweight in children aged 6-9 years was 14.6% and obesity rate was 9.9%. WHO (2016) reported that childhood obesity is one of the most serious public health problems of the 21st century, affecting many low- and middle-income countries, especially in urban environments, and that the problem is global. With education becoming compulsory, schools are important places where children spend most of their lives independent of their families. In order for children to fully benefit from education, they must first be healthy. The age range of 6-12, also called school age, is stated as the period in which children's biopsychosocial development and growth is rapid, and they are most suitable for acquiring knowledge and gaining habits by gaining lifelong behaviors. Although healthy, adequate and balanced nutrition is very important especially for children, as in all ages, it is known that nutritional problems are very common in this period. School-age children are among the groups most affected by inadequate and unbalanced nutrition. Another important problem accompanying the risk of unhealthy nutrition is the sedentary lifestyle. Technological factors (TV, internet), mostly driving to and from school, long working hours for exams, and unnecessary skipping of physical education classes lead children to a sedentary life. Children's adopting a more active lifestyle, increasing their physical activity levels and supporting them in this regard will make significant contributions to the social, mental and physical development of children. The fact that childhood obesity is a global problem that seriously threatens public health brings forward initiatives to protect, which is the basis of the fight against obesity. Health professionals should ensure that children develop positive health behaviors and maintain these behaviors in adulthood by intervening on changeable factors such as lifestyle, nutritional behaviors and physical activity to prevent obesity. In order for the interventions to be successful, it is very important for health professionals to carry out their work in cooperation with parents, family and school. Lifestyle changes and medical treatment are used in the treatment of obesity. In cases where lifestyle changes are unsuccessful, it is recommended to switch to medical treatment. On the other hand, it is stated that non-drug methods are very successful in improving mental health, quality of life and health, and are cost-effective in terms of not carrying risks and being inexpensive. With the development of the nursing profession, the increase in its authority and responsibilities is closely related to the increase in its independent roles. One of the basic roles of the nurse is to provide education in a planned manner to protect and improve the health of the individual, family and society, to heal in case of illness and to gain the right health behaviors. Nursing knowledge is formed by nursing theories and conceptual models of nursing, and the new roles that have emerged in the nursing profession, nurses' other disciplines. Unlike others, it requires the use of theories and models to improve care. Using nursing theoretical models in nursing practice provides a systematic approach to care and provides a scientific basis for practice-related concepts and principles. One of the most used models in the acquisition of health behaviors is the Health Promotion Model (SGM). SGM was developed by Pender between 1982-1984. The Health Promotion Model, which has features that will guide the practices related to health promotion, explains the factors that promote health and the factors that hinder it. In the model, factors that have direct and indirect effects on the health behavior of the individual are defined. According to Pender (1992), healthy lifestyle behaviors include spiritual development, health responsibility, exercise, nutrition, interpersonal relationships and stress management. The purpose of the model is to create a multivariate paradigm to explain and predict the components of lifestyle-related health promotion behaviors, to help nurses understand the determinants of healthy lifestyle behaviors, and to evaluate the individual's past life and other factors that may affect their perceptions of health behavior. Eating healthy, maintaining a normal body weight, and coping with stress appropriately are stated as the key to achieving a healthy lifestyle for the individual. Obesity is closely related to the sub-dimensions of healthy lifestyle behaviors. Nutrition, physical activity and psychological factors are risk factors for obesity. Bad eating habits, sedentary life, increase in harmful habits cause the prevalence of obesity to increase day by day. Therefore, there is a strong relationship between the lifestyle habits of individuals and obesity. For this reason, it is recommended to monitor individuals with one or more risk factors for primary prevention, early detection of risks related to their lifestyle, and gaining healthy lifestyle behaviors to individuals. At this point, primary health care providers have important roles and responsibilities, and nurses are expected to support individuals in gaining healthy lifestyle behaviors. The general goal in obesity management is to maintain or achieve normal BMI. The methods applied in the treatment of obesity can be grouped into five groups as Physical Activity, Behavioral Therapy, Nutritional Therapy, Medication, and Surgical Treatment. However, it is reported that it is inconvenient to apply drug therapy and surgical treatment in childhood, except in very compulsory situations. Studies on obesity indicate that nutritional therapy alone is not successful, that physical activity and nutrition therapy together provide more effective and long-term weight loss, and that lifestyle regulation and regular physical activity are essential to maintain weight loss. From this point of view, most of the programs to prevent obesity in children are about nutrition and physical activity. Changing individual behavior has been the main approach to prevent obesity. Schools are excellent learning environments for children. Most intervention studies on lifestyle and behavioral changes in children are school-based. School-based dietary and physical activity changes reduce the risk of obesity and chronic diseases and health expenditures . There are many examples of school-based nutrition and physical activity programs implemented in the world and in our country. School health services carried out by the school health team are important in preventing obesity in children and protecting school children from obesity. Within the team that carries out school health services, the school health nurse has a key role in protecting and improving the health of students. Considering the role and responsibilities of the school nurse in eliminating the risk of obesity in school children; To prevent obesity, especially health education, to take health-promoting approaches, to determine risk groups by early diagnosis of overweight or obese children, to prevent the development of obesity in overweight children, to prevent the progression of obesity and the development of obesity-related complications in children who are determined to be obese. find it is clear that it is necessary. When nurses apply the necessary protection measures when they encounter children and families, the obesity rate and all risks that may develop due to obesity will be reduced. The purpose of this research; The aim of this study is to determine the effect of planned education based on the health promotion model on lifestyle behaviors and weight management in obese secondary school students.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 112
Est. completion date April 2023
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 10 Years to 13 Years
Eligibility Inclusion Criteria: - Being a middle school 6th and 7th grade student, - Being =95 percentile according to percentile curves, - Not having a chronic disease (metabolic syndrome, eating disorder, etc.) associated with obesity, - Not using drugs continuously - Not having a physical disability to be able to do physical activity, - Not having a mental disability. Exclusion Criteria: - Although they have accepted to participate in the research those who want to quit the study voluntarily during the research process, - Do not participate in the trainings and counseling programs given within the specified time period, - And are diagnosed with any health problem,

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
control group will be followed without health education
After the whole universe is evaluated in terms of percentile value, students with a percentile value of =95 will be filled with a pre-application form in terms of inclusion criteria in the research. Randomization will be made by drawing lots from the closed envelope in a way that will be homogeneously distributed between the classes and genders of the students who accept to participate in the research. Pre-tests will be given to those who accept to participate in the research. In the first week of the training, pedometers will be distributed and their use will be explained. This group is follow up without planned education. At the end of the sixth month of the study, the post-test data collection forms, excluding the personal information form, will be applied to the intervention group and anthropometric measurements will be made again.

Locations

Country Name City State
Turkey Mevlana Vali Zubeyir Kemelek Secondary School Sivas
Turkey Selcuk Secondary School Sivas

Sponsors (1)

Lead Sponsor Collaborator
Ayse Yilmaz

Country where clinical trial is conducted

Turkey, 

References & Publications (18)

Alici, M., Pinar, R. (2008). Obez hastalara verilen egitimin etkinliginin degerlendirilmesi. Hemsirelikte Arastirma Gelistirme Dergisi, 2: 32-47.

Appleton J, Fowler C, Brown N. Parents' views on childhood obesity: qualitative analysis of discussion board postings. Contemp Nurse. 2017 Aug;53(4):410-420. doi: 10.1080/10376178.2017.1358650. Epub 2017 Aug 1. — View Citation

Bahar, Z. (2010). Okul Sagligi Hemsireligi. Dokuz Eylül Üniversitesi Hemsirelik Yüksekokulu Elektronik Dergisi, 3 (4):195-200.

Bahar. Z., Açil. D. (2014) Sagligi Gelistirme Modeli: Kavramsal Yapi. Dokuz Eylül Üniversitesi Hemsirelik Yüksekokulu Elektronik Dergisi 7 (1).ss: 59-67

Bayazit Hayta, A., Sanlier, N.(2007). Ilkögretim 6. 7. 8. Sinif Ögrencilerinin Beslenme Davranislari Ve Sosyal Onaylanma Istegi. Milli Egitim Dergisi, 174.

Berberoglu M. (2008). Adölesanlarda obezite. I. Ü. Cerrahpasa Tip Fakültesi Sürekli Tip Egitimi Etkinlikleri Adolesan Sagligi II Sempozyum Dizisi, 63: 79- 80.

Bilici, S., Köksal, E.(2013). Okul Öncesi ve Okul Çagi Çocuklara Yönelik Beslenme Önerileri ve Menü Programlari. Sanlier, N.(Ed). Saglik Bakanligi Yayinlari, Ankara.

COSI-TUR (2017). Türkiye Çocukluk Çagi (Ilkokul 2. Sinif Ögrencilerde) Sismanlik Arastirmasi Cosi-Tur 2016. Saglik Bakanligi Yayin No:1080, Ankara.

Ergül, S., Kalkim, A. (2011). Önemli Bir Kronik Hastalik: Çocukluk ve Ergenlik Döneminde Obezite. TAF Preventive Medicine Bulletin, 10(2): 223-230.

Iversen CS, Nigg C, Titchenal CA. The impact of an elementary after-school nutrition and physical activity program on children's fruit and vegetable intake, physical activity, and body mass index: Fun 5. Hawaii Med J. 2011 Jul;70(7 Suppl 1):37-41. — View Citation

Kriemler S, Zahner L, Schindler C, Meyer U, Hartmann T, Hebestreit H, Brunner-La Rocca HP, van Mechelen W, Puder JJ. Effect of school based physical activity programme (KISS) on fitness and adiposity in primary schoolchildren: cluster randomised controlled trial. BMJ. 2010 Feb 23;340:c785. doi: 10.1136/bmj.c785. — View Citation

Martínez Vizcaíno V, Salcedo Aguilar F, Franquelo Gutiérrez R, Solera Martínez M, Sánchez López M, Serrano Martínez S, López García E, Rodríguez Artalejo F. Assessment of an after-school physical activity program to prevent obesity among 9- to 10-year-old children: a cluster randomized trial. Int J Obes (Lond). 2008 Jan;32(1):12-22. Epub 2007 Sep 25. — View Citation

Meydanlioglu A. (2013) Hemsire Liderli Saglik Için Beslenme ve Fiziksel Aktivite Programi'nin Çocuklarin Beslenme ve Fiziksel Aktivite Düzeylerine Etkisi. Yayinlanmis Doktora Tezi, Marmara Ü. SBE, Halk Sagligi Hemsireligi ABD.

Neumark-Sztainer D, Story M, Hannan PJ, Rex J. New Moves: a school-based obesity prevention program for adolescent girls. Prev Med. 2003 Jul;37(1):41-51. — View Citation

Pender, N.J., Murdaugh, C.L. ve Parsons, M.A. (2002) Health Promotion in Nursing Practice, Fourth Edition, New Jersey, 13-209.

Pyle, S., Sharkey, J., Yetter, G., Felix,E., Furlong, Mj.(2006). Fighting An Epidemic: The Role Of Schools In Reducing Childhood Obesity. Psychology in the Schools, 43(3): 361-376.

Udemgba C, Sharma M. (2015). ChildhoodObesity: A QualitativeReview of School-BasedInterventions. Austin J Obes&MetabSynd. 1(1): 1004.

Yabanci N. (2011) Okul sagligi ve beslenme programlari. TAF Preventive Medicine Bulltein;10(3):361-368.

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary nutritional self-efficacy increase in nutritional self-efficacy scores 12 weeks
Primary physical activity increased physical activity scores 12 weeks
Primary lifestyle behavior increase in lifestyle behavior scores 24 weeks
Primary percentile-BMI values normal percentile-BMI values 18 weeks
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