Investigating the effect of motivational interviewing on lifestyle affecting weight, body mass index and weight changes in overweight and obese women with polycystic ovary syndrome
Determining the effect of motivational interviewing on lifestyle changes and body mass index in overweight and obese women with polycystic ovary syndrome
Design
A clinical trial with a control group, with parallel groups, randomized by simple random method, sample size:60 patients.
Settings and conduct
The study is conducted on two groups of patients with polycystic ovary syndrome, one group receives an intervention (motivational interview) in five weekly sessions, and the control group receives a lifestyle booklet. The place of the study is Shahid Rezaei specialized clinic in Lande city, located in Kohgiluyeh and Boyer Ahmad province
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with polycystic ovary syndrome according to the diagnosis of the attending physician based on the Rotterdam criteria, having the desire and informed consent to participate in the research.
Exclusion criteria: being pregnant or undergoing fertility treatment, the presence of chronic diseases such as diabetes, cardiovascular, smoking, drugs and alcohol according to the patient
Intervention groups
Intervention group: overweight and obese women with polycystic ovary syndrome who will be given a motivational interview and the control group will receive a healthy lifestyle booklet.
Main outcome variables
Average body mass index; Average lifestyle score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231121060125N1
Registration date:2023-12-25, 1402/10/04
Registration timing:prospective
Last update:2023-12-25, 1402/10/04
Update count:0
Registration date
2023-12-25, 1402/10/04
Registrant information
Name
Fereshteh Khaleghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3246 3133
Email address
f.khaleghi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of motivational interviewing on lifestyle affecting weight, body mass index and weight changes in overweight and obese women with polycystic ovary syndrome
Public title
Investigating the effect of motivational interviewing on lifestyle affecting weight, body mass index and weight changes in overweight and obese women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovary syndrome according to the rotterdam criteria
Informed concept
Body mass index more than 25 Kg/m2
At least literate in reading and writing and speaking Persian language
Iranian and resident of Lande city
Ages 15 to 45 years
Having a mobile phone
Exclusion criteria:
Being pregnant or undergoing fertility treatment
Having chronic diseases such as diabetes, cardiovascular disease, etc.
The presence of various types of severe mental disorders (psychosis, etc.)
Restrictions on physical activity
Having diseases that require following a special diet
Existence of stressful events during the past 6 months, such as migration, divorce, financial problems, etc.
Smoking, drugs and alcohol
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done individually using a table of random numbers, and the participants are assigned to two intervention and control groups. After dividing, people will complete the study questions (demographic information questionnaire and lifestyle questionnaire). The intervention group will conduct 5 motivational interview sessions at the gynecology clinic affiliated to Yasouj University of Medical Sciences, and the control group will receive lifestyle modification booklets in polycystic ovary syndrome.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadougi University of Medical Sciences, Yazd
Street address
Shahid Bahonar square
City
Yazd
Province
Yazd
Postal code
8915818411
Approval date
2023-11-04, 1402/08/13
Ethics committee reference number
IR.SSU.REC.1402.062
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Average body mass index of obese women with polycystic ovary syndrome
Timepoint
The time of starting the study and one month after the intervention
Method of measurement
kg/m2
2
Description
Average lifestyle score of obese women with polycystic ovary syndrome
Timepoint
At the beginning of the study, two months later
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Quality life
Timepoint
Two months after starting the study
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: overweight and obese women with polycystic ovary syndrome
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rezaei specialized clinic in Lende city
Full name of responsible person
Afsaneh Azadeh
Street address
Shahid Motahari
City
Lendeh
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7574144798
Phone
+98 74 3246 3064
Email
a.azadeh.1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi
Street address
Shahid Bahonar
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3628 8114
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9137
Email
Behnaz.enjezab@email.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9137
Email
Behnaz.enjezab@email.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9137
Email
Behnaz.enjezab@email.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available