NCT05577325

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

April 25, 2022

Last Update Submit

October 9, 2022

Conditions

OBESITY

Outcome Measures

Primary Outcomes (4)

  • nutritional self-efficacy

    increase in nutritional self-efficacy scores

    12 weeks

  • physical activity

    increased physical activity scores

    12 weeks

  • lifestyle behavior

    increase in lifestyle behavior scores

    24 weeks

  • percentile-BMI values

    normal percentile-BMI values

    18 weeks

Study Arms (2)

PLANNED EDUCATION BASED ON THE HEALTH IMPROVEMENT MODEL

EXPERIMENTAL

Educational 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.

Behavioral: control group will be followed without health education

follow without interference

EXPERIMENTAL

follow up without any education

Behavioral: control group will be followed without health education

Interventions

control group will be followed without health educationBEHAVIORAL

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.

Also known as: Follow up without planned education
PLANNED EDUCATION BASED ON THE HEALTH IMPROVEMENT MODELfollow without interference

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mevlana Vali Zubeyir Kemelek Secondary School

Sivas, Turkey (Türkiye)

Location

Selcuk Secondary School

Sivas, Turkey (Türkiye)

Location

Related Publications (18)

  • Alıcı, M., Pınar, R. (2008). Obez hastalara verilen eğitimin etkinliğinin değerlendirilmesi. Hemşirelikte Araştırma Geliştirme Dergisi, 2: 32-47.

    BACKGROUND

  • 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.

    PMID: 28728473BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 21886292BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 20179126BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 12799128BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • Martinez Vizcaino V, Salcedo Aguilar F, Franquelo Gutierrez R, Solera Martinez M, Sanchez Lopez M, Serrano Martinez S, Lopez Garcia E, Rodriguez 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. doi: 10.1038/sj.ijo.0803738. Epub 2007 Sep 25.

    PMID: 17895883BACKGROUND

  • Yabancı N. (2011) Okul sağlığı ve beslenme programları. TAF Preventive Medicine Bulltein;10(3):361-368.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşe Yilmaz

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

  • Semra Zorlu

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer/PhD student

Study Record Dates

First Submitted

April 25, 2022

First Posted

October 13, 2022

Study Start

January 13, 2022

Primary Completion

October 1, 2022

Study Completion

April 1, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

TU(2)