Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000612819
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
7/06/2012
Date last updated
7/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Educational intervention on health related lifestyle changes among Iranian adolescents
Scientific title
Educational intervention on health related lifestyle changes among Iranian adolescents
Secondary ID [1] 280625 0
Nil
Universal Trial Number (UTN)
U1111-1131-4907
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health related lifestyle changes among Iranian adolescents 286636 0
Condition category
Condition code
Public Health 286920 286920 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The classroom-based lecture method was adopted for imparting lifestyle education. This educational intervention consisted of six ninety minute sessions over a three week time frame. The lectures were targeted to the group based on the baseline data. Lectures were conducted using age appropriate power-point presentations, which included pictorial graphics and educative statements. Each lecture was followed by interactive discussions, where the educator addressed all related queries from the participants.
All lectures were administered by a trained nutritional health educator.
After each session an informative pamphlet was distributed to study at home to reinforce and attain the information gained through lectures and group discussions.
Standard educational content about healthy lifestyles was provided by Iran's Ministry of Health and used for the education component of the intervention. Overall the content included five axes (i.e. nutrition, physical activity, mental health, communication, and safety). The information included the food pyramid, vigorous physical activity, stress management techniques, and information about safety points such as seat belt usage and preventing accidents.
Different educational materials such as charts and posters were developed and pre-tested for use as teaching aids by the lecturers. Charts and posters contained basic information related to healthy lifestyles. Two weeks and Three months after the intervention both groups were readministered the survey and data were compared to the baseline data.
Intervention code [1] 285023 0
Lifestyle
Comparator / control treatment
No treatment. i.e, the control group for this study did not receive any additional intervention, but just continued their usual school classes and schedules.
Control group
Active

Outcomes
Primary outcome [1] 287277 0
Lifestyle modification>20%
This was assessed by Adolescent Lifestyle questionnaire (ALQ).
Timepoint [1] 287277 0
at baseline and at 2 weeks, 3 months, after intervention commencement
Secondary outcome [1] 297808 0
Nil
Timepoint [1] 297808 0
Nil

Eligibility
Key inclusion criteria
signing consent form by a parent or legal guardian, voluntary participation
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
planning to leave the geographic area, having a friend or relative enrolled in the trial

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A clustered multistage sampling method was used to select students. For this, we first obtained the list of governmental high schools that placed on 4 southern zones of Tehran. The reasons for choosing these zones were to facilitate accessibility and to speed the agreements to school`s officials for administration of the intervention and data collection. Then we selected 2 high schools (one for girls and another for boys) in each zone by simple random allocation. Next, from each school two classes as intact groups has been recruited for participation. To avoid diffusion effect 4 high schools have been assigned to intervention and the rest to control randomly.
We used numbered containers for allocation concealment procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
365
Accrual to date
Final
Recruitment outside Australia
Country [1] 4347 0
Iran, Islamic Republic Of
State/province [1] 4347 0
Tehran

Funding & Sponsors
Funding source category [1] 285393 0
University
Name [1] 285393 0
Tehran University of Medical Sciences
Country [1] 285393 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical Sciences
Address
Keshavarz Blvd., next to Ghods street, Tehran, Iran.
postcode: 1417653761
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 284247 0
University
Name [1] 284247 0
Baqiyatallah university of medical sciences
Address [1] 284247 0
Shekhbahaei street, Tehran, Iran.
postcode: 1435814783
Country [1] 284247 0
Iran, Islamic Republic Of
Other collaborator category [1] 276849 0
Individual
Name [1] 276849 0
Hasan Eftekhar
Address [1] 276849 0
Department of health education and promotion, Tehran University of Medical Sciences, Tehran, Iran.
postcode: 1417653761
Country [1] 276849 0
Iran, Islamic Republic Of
Other collaborator category [2] 276850 0
Individual
Name [2] 276850 0
Mahmoud Mahmoudi
Address [2] 276850 0
Department of Epidemiology & Biostatistics, Tehran University of Medical Sciences, Tehran, Iran.
postcode: 1417653761
Country [2] 276850 0
Iran, Islamic Republic Of
Other collaborator category [3] 276851 0
Individual
Name [3] 276851 0
Najmemolouk Amini
Address [3] 276851 0
Department of health education and promotion, Tehran University of Medical Sciences, Tehran, Iran.
postcode: 1417653761
Country [3] 276851 0
Iran, Islamic Republic Of
Other collaborator category [4] 276852 0
Individual
Name [4] 276852 0
Hormoz Sanaeinasab
Address [4] 276852 0
Health Education Department, school of health, Baqiyatallah University of Medical Sciences, Tehran, Iran.
postcode: 1435814783
Country [4] 276852 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287406 0
Tehran University of Medical Sciences
Ethics committee address [1] 287406 0
Ethics committee country [1] 287406 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 287406 0
12/07/2010
Approval date [1] 287406 0
25/08/2010
Ethics approval number [1] 287406 0
9256

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34273 0
Address 34273 0
Country 34273 0
Phone 34273 0
Fax 34273 0
Email 34273 0
Contact person for public queries
Name 17520 0
Mohsen Saffari
Address 17520 0
Health Education Department, school of health, Baqiyatallah University of Medical Sciences, Tehran, Iran.
postcode: 1435814783
Country 17520 0
Iran, Islamic Republic Of
Phone 17520 0
+98 21 88040153
Fax 17520 0
Email 17520 0
[email protected]
Contact person for scientific queries
Name 8448 0
Mohsen Saffari
Address 8448 0
Health Education Department, school of health, Baqiyatallah University of Medical Sciences, Tehran, Iran.
postcode: 1435814783
Country 8448 0
Iran, Islamic Republic Of
Phone 8448 0
+98 21 88040153
Fax 8448 0
Email 8448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.