AzTrials
AzTrials

OBESITYNCT05577325

The Effect Of Planned Educatıon Based On The Health Improvement Model

A study of OBESITY, run by Ayse Yilmaz at 2 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 10 to 13 years
Conditions the study is for
OBESITY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
2 sitesTurkey (Türkiye)
Study dates
13 Jan 2022to Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

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 10 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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,

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Mevlana Vali Zubeyir Kemelek Secondary School

    Sivas

  • Selcuk Secondary School

    Sivas

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Planned Educatıon Based On The Health Improvement Model On Lıfe Style Behavıors And Weıght Management In Obese Secondary School Students

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.

Read the detailed 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.

Conditions
OBESITY
Being tested
control group will be followed without health education
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • control group will be followed without health educationBehavioural

    Also called Follow up without planned 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.

Study groups in NCT05577325
Study groupRoleWhat they receive
PLANNED EDUCATION BASED ON THE HEALTH IMPROVEMENT MODELExperimentalEducational content based on the health promotion model, including nutrition and physical activity, will be created by the researcher by scanning the literature and considering the needs of the students. For the nutrition and physical activity plans included in the training, a diet specialist and a sports specialist will be consulted on the subject. The created training content and the booklet will be submitted to the opinion of at least three experts who are suitable for the subject area. Educational content deemed appropriate will be shared with students for 1 lesson per week for 10 weeks.
Receives: Behavioral: control group will be followed without health education
follow without interferenceExperimentalfollow up without any education
Receives: Behavioral: control group will be followed without health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. nutritional self-efficacy

    increase in nutritional self-efficacy scores

    Measured: 12 weeks

  2. physical activity

    increased physical activity scores

    Measured: 12 weeks

  3. lifestyle behavior

    increase in lifestyle behavior scores

    Measured: 24 weeks

  4. percentile-BMI values

    normal percentile-BMI values

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start13 Jan 2022
  3. Primary completionOct 2022 (estimated)
  4. Study completionApr 2023 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05577325
Sponsor's protocol ID
Ayse Yilmaz
Status last verified
Oct 2022
First submitted
25 Apr 2022
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Alıcı, M., Pınar, R. (2008). Obez hastalara verilen eğitimin etkinliğinin değerlendirilmesi. Hemşirelikte Araştırma Geliştirme 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.

    PubMed 28728473
  • Bahar, Z. (2010). Okul Sağlığı Hemşireliği. Dokuz Eylül Üniversitesi Hemşirelik Yüksekokulu Elektronik Dergisi, 3 (4):195-200.

  • Bahar. Z., Açıl. D. (2014) Sağlığı Geliştirme Modeli: Kavramsal Yapı. Dokuz Eylül Üniversitesi Hemşirelik Yüksekokulu Elektronik Dergisi 7 (1).ss: 59-67

  • Bayazıt Hayta, A., Şanlıer, N.(2007). İlköğretim 6. 7. 8. Sınıf Öğrencilerinin Beslenme Davranışları Ve Sosyal Onaylanma İsteği. Milli Eğitim Dergisi, 174.

  • Berberoğlu M. (2008). Adölesanlarda obezite. İ. Ü. Cerrahpaşa Tıp Fakültesi Sürekli Tıp Eğitimi Etkinlikleri Adolesan Sağlığı II Sempozyum Dizisi, 63: 79- 80.

  • Bilici, S., Köksal, E.(2013). Okul Öncesi ve Okul Çağı Çocuklara Yönelik Beslenme Önerileri ve Menü Programları. Şanlıer, N.(Ed). Sağlık Bakanlığı Yayınları, Ankara.

  • COSI-TUR (2017). Türkiye Çocukluk Çağı (İlkokul 2. Sınıf Öğrencilerde) Şişmanlık Araştırması Cosı-Tur 2016. Sağlık Bakanlığı Yayın No:1080, Ankara.

  • 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.

    PubMed 21886292
  • Ergül, Ş., Kalkım, A. (2011). Önemli Bir Kronik Hastalık: Çocukluk ve Ergenlik Döneminde Obezite. TAF Preventive Medicine Bulletin, 10(2): 223-230.

  • 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.

    PubMed 20179126
  • Meydanlıoğlu A. (2013) Hemşire Liderli Sağlik İçin Beslenme ve Fiziksel Aktivite Programi'nın Çocuklarin Beslenme ve Fiziksel Aktivite Düzeylerine Etkisi. Yayınlanmış Doktora Tezi, Marmara Ü. SBE, Halk Sağlığı Hemşireliği 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. doi: 10.1016/s0091-7435(03)00057-4.

    PubMed 12799128
  • 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., Felıx,E., Furlong, Mj.(2006). Fıghtıng An Epıdemıc: The Role Of Schools In Reducıng Chıldhood Obesıty. Psychology in the Schools, 43(3): 361-376.

Questions about this trial

What is this clinical trial studying?

A study of OBESITY, run by Ayse Yilmaz at 2 sites 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

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?

nutritional self-efficacy (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05577325, which also lists 18 linked publications.

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 13 Oct 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in