Protocol summary

Summary
This study is a experimental study with two experimental and one control groups. Main aim of study: determining the impact of direct and indirect education on knowledge and preventive behaviors. Inclusion criteria: age 12-13؛Previously have not participated in osteoporosis classes. Exclusion criteria: students absence؛ disease؛ and unwillingness. The study population: seventh grade girl students who are studying in Andishe city. Sample size: The required sample for each group is 68، and totally 194 students. convenience sampling .Study intervention: students in first experimental group will participate in osteoporosis classes (lecture), One day and for 60 minutes. participants in second experimental group (pamphlet)،will receive a pamphlet about osteoporosis. student will complete post test after two months. The intervention will be done 7th and 8th of February. Primitive outcome: Effectiveness of osteoporosis educational classes (lecture) and pamphlet on students' knowledge and preventive behaviors about osteoporosis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112231014N1
Registration date: 2017-06-09, 1396/03/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-09, 1396/03/19
Registrant information
Name
Leila Darabi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6534 9406
Email address
l.darabi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2015-12-20, 1394/09/29
Expected recruitment end date
2015-12-24, 1394/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of direct and indirect teaching methods on preventive behaviors of osteoporosis: Acomparison study.
Public title
The effect of direct and indirect teaching methods on preventive behaviors of osteoporosis: Acomparison study.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 12-13؛ Previously have not participated in osteoporosis classes؛ Exclusion criteria:students absence؛ disease؛ and unwillingness.
Age
From 12 years old to 13 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 205
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Crossing highway jalal al ahmad and chamran؛ Tehran
City
Tehran
Postal code
141554838
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
6584/د52

Health conditions studied

1

Description of health condition studied
Osteoporosis
ICD-10 code
m81
ICD-10 code description
Osteoporosis without pathological fracture

2

Description of health condition studied
Osteoporosis
ICD-10 code
m80
ICD-10 code description
Osteoporosis with pathological fracture

Primary outcomes

1

Description
Physical activity
Timepoint
Before and two months after the intervention
Method of measurement
Physical Activity Questionnaire

2

Description
Calcium intake
Timepoint
Before and 2 month after the intervention
Method of measurement
Food frequency questionnaire FFQ

Secondary outcomes

empty

Intervention groups

1

Description
Control group will not receive any education about osteoporosis
Category
Lifestyle

2

Description
First experiment group (lecture) will participate in osteoporosis class. One day and for 60 minute. The contents of lecture is about osteoporosis and its prevention.
Category
Lifestyle

3

Description
Second experiment group ( pamphlet) will recieve a pamphlet. The contents of pamphlet is about osteoporosis and its prevention.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Atiee school
Full name of responsible person
Leila Darabi student
Street address
Plaque 10؛ Third Alley؛ Valieasr street؛ Andishe؛ Tehran.
City
Andishe

2

Recruitment center
Name of recruitment center
Armaghan school
Full name of responsible person
Leila Darabi student
Street address
Plaque 23؛ kharazi Alley؛ Shohada street؛ Andishe؛ Tehran.
City
Andishe

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Research of Tarbiat Modares University
Full name of responsible person
Yaeghob Fatholahi
Street address
Crossing highway Jalal Al-e Ahmad and Chamran؛ Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research of Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Leila Darabi
Position
post graduat / student
Other areas of specialty/work
Street address
Crossing highway Jalal Al-e Ahmad and Chamran؛ Tehran.
City
Tehran
Postal code
Phone
+98 216535695
Fax
Email
L.darabi@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farkhonde Amin Shokravi
Position
Phd public health
Other areas of specialty/work
Street address
Crossing highway Jalal Al-e Ahmad and Chamran؛ Tehran.
City
Tehran
Postal code
009821631745
Phone
+98 21631745
Fax
Email
F_aminsh@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Leila Darabi
Position
Post graduat/ student
Other areas of specialty/work
Street address
Crossing Jalal Al-e Ahmad and Chamran؛ Tehran.
City
Tehran
Postal code
Phone
+98 216535985
Fax
Email
L.darabi@modares.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...