Protocol summary

Study aim
Effect of lifestyle changes on eating behavior and its components in overweight women
Design
In this research, 50 overweight students were chosen purposefully.and a code was allocated to each one of them.Then, participants were randomly divided into two control and intervention groups.
Settings and conduct
Intervention in college was done and the interventions designs so that the subjects under study are not aware of the allocation of the study group.
Participants/Inclusion and exclusion criteria
BMI higher than 25 Written consent for participation in the research Do some medical tests (thyroid and diabetes) Do not take anti-obesity drugs The lack of borderline personality disorders
Intervention groups
The two experimental and control groups were subjected to lifestyle intervention interventions, respectively.
Main outcome variables
Modify eating behavior and its components

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171014036760N1
Registration date: 2017-12-11, 1396/09/20
Registration timing: prospective

Last update: 2017-12-11, 1396/09/20
Update count: 0
Registration date
2017-12-11, 1396/09/20
Registrant information
Name
Fariba Parsamanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3418 2727
Email address
f.parsamanesh@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2017-12-30, 1396/10/09
Actual recruitment start date
2017-12-21, 1396/09/30
Actual recruitment end date
2017-12-30, 1396/10/09
Trial completion date
empty
Scientific title
The Effect of Lifestyle Change on Eating Behavior of Overweight Women
Public title
Effect of lifestyle changes in treatment of obesity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
BMI higher than 25 Written consent for participation in the research Do some medical tests (thyroid and diabetes) Do not take anti-obesity drugs The lack of borderline personality disorders
Exclusion criteria:
BMI less than 25 thyroid and diabetes diseases take anti-obesity drugs borderline personality disorders Missing more than three times in intervention sessions
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Statistical sample In this study, 40 female students of Psychology of Islamic Azad University of Karaj, by controlling entry and exit criteria and available sampling methods, selected and randomly assigned into two groups of 20 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher designs the interventions so that the subjects under study are not aware of the allocation of the study group.
Placebo
Not used
Assignment
Factorial
Other design features
Change the lifestyle based on the Islamic approach

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Karaj Azad University
Street address
Unit 1, No.320, Maryam St, Azadegan Square, Taleghani Blvd.,Karaj,
City
Karaj
Province
Alborz
Postal code
3155617371
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.IAU.K.REC.1396,53

Health conditions studied

1

Description of health condition studied
Metabolic diseases
ICD-10 code
E00-E90
ICD-10 code description
مشکلات وزن بدن (چاقی)

Primary outcomes

1

Description
Modify of eating behavior
Timepoint
Eating behavior evaluation before and after the intervention
Method of measurement
Diet eating behavior questionnaire

Secondary outcomes

1

Description
Types of eating behavior(emotion, externality and inhibition)
Timepoint
Eating behavior evaluation before and after the intervention
Method of measurement
Diet eating behavior questionnaire

Intervention groups

1

Description
Intervention group: The Islamic lifestyle protocol is grouped for 10 sessions per week for the intervention group
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Karaj Azad University
Full name of responsible person
Fariba Parsamanesh
Street address
Karaj Azad University
City
Karaj
Province
Alborz
Postal code
3148635731
Phone
+98 26 3418 2727
Fax
+98 26 3418 2727
Email
f.parsamanesh@kiau.ac.ir
Web page address
http://www.kiau.ac.ir/fa/contactus

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fariba Parsamanes
Street address
Karaj Azad University
City
Karaj
Province
Alborz
Postal code
3148635731
Phone
+98 26 3254 2133
Fax
Email
fparsamanesh@yahoo.com
Web page address
http://www.kiau.ac.ir/fa/contactus
Grant name
9
Grant code / Reference number
999
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fariba Parsamanesh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Karaj Azad University
City
Karaj
Province
Alborz
Postal code
3148635731
Phone
+98 26 3254 2133
Email
fparsamanesh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fariba Parsamanesh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Karaj Azad University
City
Karaj
Province
Alborz
Postal code
3148635731
Phone
+98 26 3254 2133
Email
fparsamanesh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fariba Parsamanesh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Karaj Azad University
City
Karaj
Province
Alborz
Postal code
3148635731
Phone
+98 26 3254 2133
Fax
+98 26 3254 2133
Email
fparsamanesh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Ethical reasons
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data can be shared after unidentifiable people.
When the data will become available and for how long
Farvardin 1397
To whom data/document is available
Professors
Under which criteria data/document could be used
Non-reuse
From where data/document is obtainable
fparsamanesh@yahoo.com
What processes are involved for a request to access data/document
Identification of the requesting person
Comments
I have no explanation
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