Evaluation of the Effect of Education Based on Theory of Planned Behavior on Eating Behaviors In Adolescent Girls with Polycystic Ovarian Syndrome (PCOS)
Determination of the effect of education based on the theory of planned behavior on eating behaviors In adolescent girls with polycystic ovarian syndrome(PCOS)
Design
This clinical trial has an intervention group and a control group. Each group will be selected randomly based on their admission to the clinic from 4 gynecologic clinics. Sample size for each group is 32 persons but considering the chance of sample loss, sample size will be increased to72.
Settings and conduct
In this study the research environment is 4 selected educational clinics affiliated to Shiraz University of Medical Sciences. Initially, through health records, the list of adolescent girls aged 15 to 21 with polycystic ovary syndrome is extracted and invite them to participate in the research by telephone. Training for intervention group is conducted in 4 sessions of 60 to 90 minutes during two weeks (two sessions a week). Also, in the intervention group, follow-up training and sharing experiences of adolescent girls with PCOS will be conducted through the social media messaging network .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Overweight, obese and single adolescent girls with PCOS, Not having any chronic diseases which requires special diet.
Exclusion criteria: Absence of more than 2 sessions of training course
Intervention groups
This study is a clinical trial that will be conducted on two groups. In the intervention group education will be done by lecture, group discussion and role playing. The control group will not receive training, .
Main outcome variables
Knowledge; attitude; subjective norms; perceived behavioral control; Intention and eating practice in 2 groups will be measured before and 3 months after the intervention through researcher-made questionnaires.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160224026756N6
Registration date:2018-08-18, 1397/05/27
Registration timing:prospective
Last update:2018-08-18, 1397/05/27
Update count:0
Registration date
2018-08-18, 1397/05/27
Registrant information
Name
Mahnaz Noroozi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3441 1421
Email address
noroozi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Education Based on Theory of Planned Behavior on Eating Behaviors In Adolescent Girls with Polycystic Ovarian Syndrome (PCOS)
Public title
Effect of education on eating behaviors In adolescent girls with polycystic ovarian syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and obtaining informed consent from the adolescent and her parents (in cases of younger than 18 years old)
Overweight, obese, and single adolescent girls with PCOS
Diagnosis of PCOS has been confirmed by a gynecologist
Not having a history of diagnosed major mental problems undergoing drug treatments
Not having any chronic diseases (cardiovascular diseases, diabetes, renal diseases etc.), which requires special diet prescribed by a physician
Not attending a clinical trial simultaneously
Possibility of participation in training course
Exclusion criteria:
Use of certain dietary patterns during study
Absence of more than 2 sessions of training course
Age
From 15 years old to 21 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not 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
Ethics committee of Isfahan University of Medical Sciences
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-12-19, 1395/09/29
Ethics committee reference number
IR.MUI.Rec.1395.3.885
Health conditions studied
1
Description of health condition studied
Eating behaviors in adolescent girls with polycystic ovarian syndrome
ICD-10 code
E00-E90
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Knowledge
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Knowledge Questionnaire
2
Description
Attitude
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Attitude Questionnaire
3
Description
Subjective norms
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Subjective norms Questionnaire
4
Description
Perceived behavioral control
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Perceived behavioral control Questionnaire
5
Description
Behavioral intention
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Behavioral intention Questionnaire
6
Description
Eating practice
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Food frequency Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group training (groups of 12 people) will be conducted in four sessions of 60 to 90 minutes during two weeks.
Category
Other
2
Description
Control group: No intervention will be received
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Dr Hossein Jamali
Street address
Shahid Motahari Clinic, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
71348714658
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir
2
Recruitment center
Name of recruitment center
Hazrat Zeynab Medical and Training Center
Full name of responsible person
Dr Navid Omidifar
Street address
Hazrat Zeynab Medical and Training Center, Holy Defense Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3726 6811
Email
zeinabhp@sums.ac.ir
3
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Dr Mohammad Rafati
Street address
Hafez Hospital, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
3478671946
Phone
+98 71 3647 9531
Email
hafezhospt@sums.ac.ir
4
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Dr Hossein Jamali
Street address
Imam Reza Clinic, West Blood Transfusion, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7000
Email
emamreza@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjouy Javanmard
Street address
Research & Technology Dept, Isfahan University of Medical Sciences, St Hezar Jarib, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
319-81745
Phone
+98 31 3668 8138
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Research Department, Seven Floor, Central Construction of Shiraz University of Medical Sciences, Zand Avenue ,Shiraz
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
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
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Noroozi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, St. thousand acres, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7532
Email
noroozi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Noroozi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences,St. Thousand acres street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7532
Email
noroozi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Hajivandi
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, St.Thousand acres, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7532
Email
leila.hajivandi@gmail.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
Data of participants are privacy
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of clinical study will be published as article.
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Email: noroozi@nm.mui.ac.ir
What processes are involved for a request to access data/document