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Study on the Effect of Nutrition Education and Physical Activity intervention using Social Cognitive Theory for Overweight and Obese Student Girls of Middle School of Shahinshahr.

Protocol summary

Summary
This study aimed to correct two important criteria of lifestyle, nutrition and physical activity, and ultimately reduce the prevalence of overweight and obesity and promoting level of health among adolescents, will be implemented among girl students by using nutrition and physical activity education according to SCT. For this study, a total 150 students who are 12 to 16 years old and do not received and followed any diet for losing weight before study, and do not have any metabolic diseases, will be randomly selected and then will be randomly divided into two groups (intervention and control, each group comprise 75 students). In the intervention group, students and their parents will be taught about nutrition and physical activity with participating in theory and practical seminars, conferences and workshops. Other parts of education are, sending messages for students and their parents, educational CD and holding practical exercise classes. Students in both groups before the study will complete questionnaires about their nutritional and physical activity behaviors. In addition, they will complete questionnaires about self-efficacy, perceived social support and perceived outcome expectation in nutrition and physical activity. After six month intervention questionnaires will be completed again. Weight, height and waist circumference of students, will be measured and recorded before and after study. Finally, data will be analyzed.

General information

Acronym
SCT: Social cognitive theory
IRCT registration information
IRCT registration number: IRCT2013103115211N1
Registration date: 2013-11-27, 1392/09/06
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-11-27, 1392/09/06
Registrant information
Name
Mohammad Bagherniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
m_bagherniya@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences, Shhinshahr city department of education
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2014-05-31, 1393/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the Effect of Nutrition Education and Physical Activity intervention using Social Cognitive Theory for Overweight and Obese Student Girls of Middle School of Shahinshahr.
Public title
The effect of of nutrition and physical activity education on nutrition and exercise behaviors weight in overweight and obese adolescents.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Second and third grade female students in middle schools who according to the WHO 2007 Tables have Body Math Index above the 85th percentile; Student's age are between 12 to 16 years; Students do not have any of the exclusion criteria.  Exclusion criteria: Using drugs which associated with overweight and obesity, such as nerve drugs, corticosteroids and so on; Received and followed any diet by students for losing weight before the study; Students who have any Metabolic diseases such as endocrine disorders, thyroid disease, diabetes and so on.
Age
From 12 years old to 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
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
Vice-Chancellor for Research, Tehran University of Medical Sciences
Street address
4th fl, Main Organization of Tehran University of Medical Sciences, Qods corner, Keshavarz Blv, Tehran
City
Tehran
Postal code
Approval date
2013-11-19, 1392/08/28
Ethics committee reference number
92-02-161-23509-98943

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
weight
Timepoint
Before intervention, three months after starting intervention, at the end, after intervention
Method of measurement
digital scale

2

Description
height
Timepoint
Before intervention, three months after starting intervention, at the end, after intervention
Method of measurement
height gauge

3

Description
Body Math Index
Timepoint
Before intervention, three months after starting intervention, at the end, after intervention
Method of measurement
wieght/height2

4

Description
waist circumference
Timepoint
Before intervention, three months after starting intervention, at the end, after intervention
Method of measurement
non-elastic flexible tape

5

Description
nutritional behavior
Timepoint
Before intervention and after intervention
Method of measurement
questionnaire

6

Description
physical activity behavior
Timepoint
Before intervention and after intervention
Method of measurement
questionnaire

7

Description
nutrition self efficacy
Timepoint
Before intervention and after intervention
Method of measurement
questionnaire

8

Description
physical activity self efficacy
Timepoint
Before intervention and after intervention
Method of measurement
questionnaire

9

Description
perceived social support in nutrition
Timepoint
Before intervention and after intervention
Method of measurement
questionnaire

10

Description
perceived social support in physical activity
Timepoint
Before intervention and after intervention
Method of measurement
questionnaire

11

Description
outcome expectation in nutrition
Timepoint
Before intervention and after intervention
Method of measurement
questionnaire

12

Description
outcome expectation in physical activity
Timepoint
Before intervention and after intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: students and their parents will be taught about nutrition and physical activity with participating in theory and practical seminars, conferences and workshops (12 sessions and each session 60 minutes). In addition, 6 sessions will be held for Individual Counseling about nutrition and physical activity for students (each session 60 minutes). Other parts of education are comprised from sending 48 messages for students and their parents, educational CD and holding practical exercise classes for students (40 sessions and each session 90 minutes). All interventions will be done in 6 months.
Category
Behavior

2

Description
Control group: During study no intervention will be done in control group. but after that, four education sessions will be held in control group for students and their parents. (each session will be 90 minutes )
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Network of Shahinshahr and meime city
Full name of responsible person
Ramesh Allipour Birgani
Street address
9 west street, Taleghani Boulevard, Shahinshahr city
City
Shahinshahr

2

Recruitment center
Name of recruitment center
Department of Education of Shahinshahr city
Full name of responsible person
Sadegh Shenavaie
Street address
Next to the Fatemieh square, Imam Khomeini Boulevard
City
Shahinshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sceineces
Full name of responsible person
Vice-chancellor for research, Dr Masoud Younesian
Street address
4th fl, Main Organization of Tehran University of Medical Sciences, Qods corner, Keshavarz Blv, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sceineces
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Department of Education of Shahinshahr city
Full name of responsible person
Sadegh Shenavaie
Street address
Next to the Fatemieh square, Imam Khomeini Boulevard
City
Shahinshahr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Education of Shahinshahr city
Proportion provided by this source
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
Tehran University of Medical Sceineces
Full name of responsible person
Mohamad Bagherniya
Position
MSc student of public health in nutrition
Other areas of specialty/work
Street address
No6, Poursina St, 16th-azar St, Keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4463
Fax
Email
m_bagherniya@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Keshavarz
Position
PhD/ full Professor of Nutrition
Other areas of specialty/work
Street address
No6, Poursina St, 16th-azar St, Keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4463
Fax
Email
s_akeshavarz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Bagherniya
Position
MSc student of public health in nutrition
Other areas of specialty/work
Street address
No6, Poursina St, 16th-azar St, Keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 8897 4463
Fax
Email
m_bagherniya@razi.tums.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
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