Protocol summary

Summary
The purpose of this semi experimental intervention study is women's empowerment in improving eating behaviors. period of intervention is 2 months, 90 women are randomly divided to the intervention and control groups. The study begins with conducting pretest. The control group do not receive any intervention. The intervention is training sessions based on family-centered empowerment model steps: 1- Increasing the perceived threat (sensitivity and perceived severity of the problem in the test group increase in three 45-minute sessions of group discussion) 2- Problem solving (women become practically familiar with the problem and its solving process during three 45-minute sessions of group discussion in small groups) 3- Education Partnership (educational materials in the form of pamphlets and booklet are transferred through the women to the active family member ( husbands) 4- Process evaluation are done with oral questions at the beginning and after the end of each session and final evaluation are conducted with post-test. Inclusion criteria: age between 18 and 60 years old; married; having BMI above 25; not pregnant at the time of project; can read and write; ability to participate in the empowerment program; willingness to participate in project Exclusion criteria: Unwillingness or impossibility to continue to participate in the study; unwillingness to complete research tools; not participate in problem-solving sessions and in the training program. outcome measures include empowerment of women in the prevention and control of obesity through improved eating some unhealthy behaviors and reduce the economic burden on society in the future, and reduce the incidence of obesity-related diseases and disorders.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201209127352N7
Registration date: 2012-09-30, 1391/07/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-30, 1391/07/09
Registrant information
Name
Mohammad Hossein Taghdisi
Name of organization / entity
Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 7674
Email address
m-taghdisi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Center for community based participatory research, Tehran university of medical sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of training based on family centered empowerment model on modifying some of obesity-related eating behaviors among women in Urmia
Public title
modification of obesity-related eating behaviors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 60 years old; married; having BMI above 25; not pregnant at the time of project; can read and write; ability to participate in the empowerment program; willingness to participate in project Exclusion criteria: Unwillingness or impossibility to continue to participate in the study; unwillingness to complete research tools; not participate in problem-solving sessions and in the training program.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
center for community based participatory research, Tehran university of medical sciences
Street address
Unit 9, floor 7, Gol complex, by Keshavarz Blvd.., Northern Kargar
City
Tehran
Postal code
Approval date
2012-09-11, 1391/06/21
Ethics committee reference number
91-02-62-16975-63822

Health conditions studied

1

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

Primary outcomes

1

Description
food behavior
Timepoint
Before the intervention, two months after the intervention
Method of measurement
food behaviors checklist

Secondary outcomes

1

Description
Food behavior self efficacy
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Food behavior self efficacy questionnaire

2

Description
Knowledge
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Knowledge Questionnaire

3

Description
Attitude
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Attitude questionnaire

4

Description
Self- Steem
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Rosenberg Self-Esteem Scale

Intervention groups

1

Description
Education based on family centered empowerment model steps will be implemented as following: Step one: The first step in family centered empowerment model is, increasing the perceived threat (perceived severity and perceived susceptibility) in the test group. Here perceived severity means to understand the risk as the absence of proper eating behavior and perceived susceptibility means to understand how a person is at risk for the diseases resulting from lack of proper eating behavior. Thus, by holding three group discussions and question and answer of participants about right and wrong eating behavior and unhealthy eating behaviors that will lead to complications and problems, we will try to improve the perceived threat (severity and perceived susceptibility). The second step in the empowerment model of family-centered, is problem solving: Problem solving will be conducted via group discussions in a manner that promotes self-esteem and self-control in the test group. The goal of this step is, understanding the problem by women and providing its solution. Hence problem-solving sessions, will hold in three 45-minute group discussions in small group of women, with together, under supervision of the researcher, with an objective example of their situation and expressing their experiences and also will discuss in what they have done so far in order to modify their wrong food behavior and so at this stage, women get practically familiar with their problems and their solving process. and this issue will enhance their efficacy. The third step in the family-centered empowerment model, is participation in training: in this step, discussed topics in previous meetings, on educational participation, transferred by the pamphlets and booklet to the active member of the family, to their husbands in this research, by women, in order to participate and support of their wives to modify the improper eating behavior. The fourth step in family centered empowerment model is evaluation that includes two stages: process evaluation and final evaluation
Category
Prevention

2

Description
no intervention in the control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Care Center no 14
Full name of responsible person
Ms. Nemati
Street address
Imam Reza end street
City
urmia

2

Recruitment center
Name of recruitment center
Shahid Nikkhah Health Care Center
Full name of responsible person
Dr. Behzad
Street address
Mirza Shirazi Street, in front of Dokhaniyat
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
center for community based participatory research, Tehran university of medical sciences
Full name of responsible person
Mrs. E. Karimi
Street address
Unit 9, floor 7, Gol complex, by Keshavarz Blvd.., Northern Kargar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
center for community based participatory research, Tehran 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
Tehran University of Medical Sciences - Department of Health (Campus Alvand)
Full name of responsible person
Maryam Mataji Amirroud
Position
Master of Health Education
Other areas of specialty/work
Street address
no.23, 1st alley, 1st ave, 9 ave, Ammar st.
City
Tehran
Postal code
Iran
Phone
+98 44 1345 5169
Fax
Email
m.mataji2009@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Taghdisi
Position
Associate Professor ,Faculty of Health, Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Tehran Faculty of Medical Sciences, St.Alvand, Argentina's Square
City
Tehran
Postal code
Iran
Phone
+98 218777674
Fax
Email
taghdisi.mh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences - Department of Health (Campus Alvand)
Full name of responsible person
Maryam Mataji Amirroud
Position
Master of Health Education
Other areas of specialty/work
Street address
no.23, 1st alley, 1st ave, 9 ave, Ammar st.
City
Urmia
Postal code
Iran
Phone
+98 44 1345 5169
Fax
Email
m.mataji2009@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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