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ObesityNCT02297919

Evaluation of the Effectiveness of Internet Based Nutrition and Physical Activity Education Programme in Adolescents

A study of Obesity, run by Eskisehir Osmangazi University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The purpose of this study to create an educational portal "Genç (e) sağlık" in an attempt to develop a healthy eating habit, increase physical activity and reduce sedentary behavior in order to prevent to overweight gain which is school-based approach in adolescents and there with also test the level of program… Read more about this study

Who is it for?
Ages 13 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteTurkey (Türkiye)
Study dates
Jan 2014to Sep 2015
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 13 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All students who accept to participate in the study

Who cannot join

  • Students who refused to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eskisehir Osmangazi University Medicine Faculty Department of Public Health

    Eskişehir, 26000

Other trials in Turkey (Türkiye)

About this study

Official title: Eskisehir Osmangazi University- Scientific Research Projects

The purpose of this study to create an educational portal "Genç (e) sağlık" in an attempt to develop a healthy eating habit, increase physical activity and reduce sedentary behavior in order to prevent to overweight gain which is school-based approach in adolescents and there with also test the level of program information and the behavioral alterations of effectiveness.

Read the detailed description

This interventional study was planned to be conducted on high school class 1 students from the city center of Eskisehir. With considering a method success of 40%, thenew approach is expected to increase the success rate to 55%. In this study that will be carried out on two sets of methods, the sample size needed is estimated to be 175 individual with 95% confidence and 80% power.

Because of the three-stage nature of the study and characteristics of study population, it was planned to include approximately 250 students in each group with raising the estimated sample size by 50%. There are 3 high schools (Ahmet Kanatli Anatolian High school, Kilicoglu Anatolian High school and Ahmet Yesevi Anatolian High school) with an established internet infrastructure which were included in the Fatih Project implemented by the Ministry of Education and tablet PCs were provided to the students studying these three schools in Eskisehir.

Tablet PCs were only provided to the class 1 students. A total of 550 students getting education and training in these 18 class 1 classrooms in these three school were planned to be included in the study. Of the classrooms, 9 were considered to be randomized as interventional group and other 9 were as control groups.

After obtaining the necessary permissions to perform the study, measured body weights and heights of all students and calculated body mass index and physical activiti evaluated by pedometre. Number of steps will be measured with the pedometer at the beginning and at the end of the week all students. Conduct a questionnaire, which is accepted in the international literature, the School Physical Activity and Nutrition(SPAN) has been modified and validated Turkish version of questionnaire will be applied.

Students will have access to the educational content through the learning management system on the web site (genç-e-saglık) created for this project. The images and links appropriate to the age of the students will be present in the home page. There will be 4 parts consisting of a Myself assessments (to provide individual feedback to the user), a communication channel through which students can ask relevant questions, a media offering the weekly content of the courses, as well as another part including a variety of interactions and fun games. Weekly courses will include a total of 4 lessons, with 2 lessons on nutrition and one each lessons on obesity and physical activity. Each lesson was planned to take approximately 15 minutes. A short assessment form including 5 questions will be included at the end of each course and it will be designed to inform the students how many right answers they gave at the end of the test. The program is scheduled to continue for 4 months. During the each training period, will be send a letter for family and a CD which is recorded the training program. Besides that submit a claim to sign and send back a document that they have committed to participate in the program and time spent towatch CD. Training at the control group,lectures will be presented on the basis of the classic preprepared lesson by educatorand at the end of the training, will be answered student's questions. Before and after the training, will be considered to survey the level of knowledge by questions. After the completion of the four monthly training program, at the sixth month of study, will be evaluated to the height and weight measurement, determination of the number of steps and the latest state of students by SPAN questionnaire physical activiti evaluated by pedometre. At the end of the study, an assembly will be arranged to given gifts to participating schools, students which is participating in all phases of the study and who achieved success evaluation of the level of knowledge more over presented the results of the project.

Conditions
Obesity
Being tested
Effectiveness of Internet Based Obesity Control Programme
Keywords
Web-based education, Adolescent, Obesity
Medical subject headings
Obesity

What participants receive

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

  • Effectiveness of Internet Based Obesity Control ProgrammeBehavioural

Study groups in NCT02297919
Study groupRoleWhat they receive
web based interventionExperimentalWeb based intervention: Students will have access to the educational content through the learning management system on the web site (genc-e-saglik) created for this project.
Receives: Behavioral: Effectiveness of Internet Based Obesity Control Programme
classic preprepared lessonActive comparatorTraining at the control group,lectures will be presented on the basis of the classic preprepared lesson by educator and at the end of the training, will be answered student's questions.
Receives: Behavioral: Effectiveness of Internet Based Obesity Control Programme

What is being measured

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

  1. Eating habit and behaviour will assess. The height and weight of student's will measure.

    Measured: four months

Timeline

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

  1. First posted21 Nov 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2015 (estimated)
  4. Study completionSep 2015 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297919
Sponsor's protocol ID
80558721/244
Status last verified
Aug 2015
First submitted
6 Nov 2014
Last updated
26 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study of Obesity, run by Eskisehir Osmangazi University at 1 site 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 1 inclusion and 1 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 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Eating habit and behaviour will assess. The height and weight of student's will measure. (time frame: four months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Aug 2015.

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