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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| web based intervention | Experimental | Web 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 lesson | Active comparator | Training 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.
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.
- First posted21 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Oz, Eskisehir Osmangazi University
- Investigators
- Selma Metintas, Study director, Eskisehir Osmangazi University Medicine Faculty Department of Public Health
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eskisehir Osmangazi University- Scientific Research Projects
- ClinicalTrials.gov ID
- NCT02297919
- Acronym / sponsor ID
- 80558721/244
- Conditions
- Obesity
- Keywords
- Web-based education, Adolescent, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| web based intervention | Experimental | Behavioral: Effectiveness of Internet Based Obesity Control ProgrammeWeb 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. |
| classic preprepared lesson | Active comparator | Behavioral: Effectiveness of Internet Based Obesity Control ProgrammeTraining 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All students who accept to participate in the study
Key exclusion criteria (1 listed)
- Students who refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effectiveness of Internet Based Obesity Control Programme | Behavioural | classic preprepared lesson, web based intervention |
Primary outcome
Eating habit and behaviour will assess. The height and weight of student's will measure.
Time frame: four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selma Metintas study director
Eskisehir Osmangazi University Medicine Faculty Department of Public Health
1 site in 1 country: see every site and its status.
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.