Determining the effect of eating and body image improvement program on psychological well-being of obese and overweight women referring to hypertension clinic
Design
Clinical trials with control group, with parallel groups, randomized,Sample size 72 people
Settings and conduct
By holding 8 sessions on the program for improving eating behavior and body image on psychological well-being of overweight and obese women referred to the hypertension clinic at the Chamran Heart Rehabilitation Center
Participants/Inclusion and exclusion criteria
Entry requirements: Having a medical record at the center of the Chamran heart research center, willingness to participate in the study, ability to read and write, and people of the informed form have filled in; Conditions of absence: no overweight and obesity
Intervention groups
n intervention group: Eight 90 minute sessions on eating and body image improvement programs on psychological well-being of obese and overweight women
In control group: holding two sessions on common topics
Main outcome variables
Psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180818040826N1
Registration date:2018-11-09, 1397/08/18
Registration timing:registered_while_recruiting
Last update:2018-11-09, 1397/08/18
Update count:0
Registration date
2018-11-09, 1397/08/18
Registrant information
Name
Masoomeh Mahmoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7576
Email address
masoomeh.mahmoudi61@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the program on improving eating behavior and body image on psychological well-being of obese and overweight women
Public title
Evaluating the effect of improving eating habits in obese women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have a medical record at Chamran Heart Center
The desire to participate in the study
People have filled in the form
Ability to read and write
Exclusion criteria:
The presence of chronic diseases
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the samples will be selected using the random number table method, so that all individuals who come to the Chamran Heart Rehabilitation Center who will accept acceptable conditions for entering the research will be selected according to a random number table. And are randomly assigned to two groups of test and control.
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
A thousand jeribs, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.MUI.REC.1396.3.842
Health conditions studied
1
Description of health condition studied
Psychological well-being
ICD-10 code
F54
ICD-10 code description
Psychological and behavioural factors associated with disorders or diseases classified elsewhere
Primary outcomes
1
Description
Psychological well-being
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
Reef Psychological Well-Being Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The researcher already develops the content of the training based on the texts, books and articles available and according to the approval of the experts in this field. Eating behavior improvement program in 8 sessions of 90 minutes over a period of 8 weeks (one week each week) in groups of 17 to 18, using lecture, group discussion and role play in the educational class of the Chamran Heart Institute The training program will begin with a briefing session in order to acquaint the members with each other, how to hold meetings, how to participate in the research process, to be accountable and to be active in the group, and the importance of research. The content of the sessions is the same for all groups and all study groups provide an educational pamphlet based on the subject of each session, and they are asked to practice the homework daily until the next session, and at the beginning of the next meeting, the discussion They will be posted
Category
Behavior
2
Description
Holding two sessions on topics such as the recent lifestyle program,
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Heart Rehab center
Full name of responsible person
Masoumeh Sadeghi
Street address
Postcode: Isfahan, Mashhagh Third, after the city bridge, next to Shahid Chamran Heart Center, Shahid Rahmani Alley, Isfahan Cardiovascular Research Center
City
Esfahan
Province
Isfehan
Postal code
۱۱۴۸-۸۱۴۶۵
Phone
+98 31 3611 5313
Email
sadeghimasoumeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Haghjoy Shaghayegh
Street address
A thousand Jebra, Isfahan University of Medical Sciences, Nursing and Midwifery Faculty
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7580
Email
taleghani@nm.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
100
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
zahra ghazavi/masoomeh mahmoudi
Position
Faculty Member of Isfahan University of Medical Sciences / MSc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
A thousand Jebra, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery, Psychiatric Nursing
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7580
Email
masoomeh.mahmoudi61@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ghazavi Zahra
Position
Instrutor, Accademic Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar jerib Ave.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Thesis
When the data will become available and for how long
"Starting the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia and academia will be available
Under which criteria data/document could be used
Impact on psychological well-being
From where data/document is obtainable
Zahra Ghazavi / Masoomeh Mahmoudi
Faculty Member of Isfahan University of Medical Sciences / MSc
MA
Nursing
Department of Psychiatric Nursing, Isfahan University of Medical Sciences, Isfahan, Iran
8174673461
What processes are involved for a request to access data/document