Protocol summary

Summary
Objectives: In this research, level of physical activity in both control and intervention group will be measured. By comparing the result of the two groups, effectiveness of the educational method is determined. If the method turns out to be effective, it can be used for future health educations and researches. Design: The study will be on the student of elementary school of the west of Tehran, with overweight or obesity. One school as the control group, and another as the intervention group will be determined with randomization. Setting and conduct : Sample size is specified to be 50 students at each school. At first, region 5 in the west of Tehran is chosen randomly then from all schools 2 school randomly selected. 5 educational sessions are held for the intervention group Participants: in the schools specified student with obesity and overweight are determined from the health files of students of the schools and their height and weight will be measured and those who are willing to participate in the research are studied. main outcome : All students in both groups will be pretested, then the intervention group will be thought for 5 sessions. Finally, one week after the last session all students will be post tested. Variable: independent variable is educational intervention based on planned behavioral theory and dependent variable is level of physical activity, using the questionnaire, level of physical activity of each person during the last week will be measured.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015061722790N1
Registration date: 2015-08-12, 1394/05/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-08-12, 1394/05/21
Registrant information
Name
Zahra Rahmaty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3612 6412
Email address
ekhterachian@physics.sharif.edu
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-09-25, 1394/07/03
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating effect of a physical activity education based on planned behavior theory on physical activity among 7-12 years old girls with obesity
Public title
Investigating effect of a physical activity education based on planned behavior theory on physical activity among 7-12 years old girls with obesity
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Being girl;Being in Tehran west region schools;7 to 12 years old; Being obese or overweight based on WHO references; Willing to participate from child and her family; Without any disability exclution criteria: more than one session absence
Age
From 8 years old to 13 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
random number generation using calculator

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University Of Medical Sceinces, between Sheikh Fazlollah and Chamran street, Shahid Hemmat highway
City
Tehran
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
ir.iums.rec.1394.9211196248

Health conditions studied

1

Description of health condition studied
Obesity and Overweight
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS

Primary outcomes

1

Description
Physical Activity
Timepoint
before intervention and 2 months after
Method of measurement
questionnaire

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
intervention group, five session education based on planned behavioral theory with PowerPoint and videos,time of each session is 45 minutes, sessions are designed based on the theory and have been approved by 10 professors.
Category
Lifestyle

2

Description
control group, in this group no intervention will be occur
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Girls' elementary schools of the west region of Tehran
Full name of responsible person
Zahra Rahmaty
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr. Khanjary
Street address
School of Nursing, Rashid Yasemi Street, Valiasr street, Tehran, Iran
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 for research of Iran University of Medical Sciences
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
Nursing school of Iran University Of Medical Science
Full name of responsible person
Zahra Rahmaty
Position
Master Of Science Student in Nursing
Other areas of specialty/work
Street address
School of Nursing, Rashid Yasemi Street, Valiasr street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4498 2764
Fax
Email
z.rahmaty1368@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing School of Iran University Of Medical Science
Full name of responsible person
Zahra Rahmaty
Position
Master of science student in nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasemi Street, Valiasr street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4498 2764
Fax
Email
z.rahmaty1368@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing Faculty of Iran University of Medical Science
Full name of responsible person
Zahra Rahmaty
Position
student of master of science in nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasemi Street, Valiasr street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 43651000
Fax
Email
z.rahmaty1368@gmail.com
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
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