The effectiveness of a text message intervention on obesity-related parameters in obese or overweight women with polycystic ovarian syndrome: a randomized controlled clinical trial
This study aims to investigate the effectiveness of a short massage intervention on diet, physical activity level and anthropometric measurements in obese or overweight women with polycystic ovarian syndrome
This study will be conducted on women with polycystic ovary syndrome referring to Alzahra Hospital in Tabriz. After obtaining informed consent, educational brochures will be provided to patients and the intervention group will receive educational text messages for 6 months. Baseline characteristics and study outcomes will be assessed.
Participants/Inclusion and exclusion criteria
Women with polycystic ovary syndrome confirmed by a gynecologist according to the Rotterdam criteria, who have a BMI higher than 25, and are willing to lose weight, will be included in the study. women who use weight loss medication or have other metabolic diseases including diabetes and thyroid disorders will not be included in the study.
Intervention groups
The intervention group will recieve educational text messages about the importance of weight loss on the clinical symptoms of polycystic ovary syndrome, recommendations about healthier food choices and physical activity. both control and intervention group will recieve educational brochures.
Main outcome variables
Anthropometric measurements including weight, height, BMI, waist and hip circumference and their ratio; appetite; food records; Average physical activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220222054091N1
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Anis Sani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3326 6351
Email address
anissani105@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-26, 1401/10/05
Expected recruitment end date
2023-12-26, 1402/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a text message intervention on obesity-related parameters in obese or overweight women with polycystic ovarian syndrome: a randomized controlled clinical trial
Public title
The effectiveness of a text message intervention on obesity in women with polycystic ovarian syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
women with polycystic ovarian syndrome
BMI more than 25
fertility age
a desire to lose weight
Exclusion criteria:
Not having a mobile phone
Use of weight loss medication
Having other metabolic diseases such as diabetes or thyroid disorders
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are assigned to the intervention and control groups by block randomization with a block size of 4 and 6 and with 1:1 allocation. For Allocation Concealment, the group name will be written on paper and placed inside numbered opaque envelopes. The envelopes will be opened in the order of participants entering the study and the group of participants will be determined. The randomization and preparation of envelopes will be done by someone who is not involved in sampling and data collection.
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 Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building Number 2, Golgasht Street
City
tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
IR.TBZMED.REC.1401.707
Health conditions studied
1
Description of health condition studied
obesity or overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
2
Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
body weight
Timepoint
At the beginning of the study, after 3 months and 6 months of intervention
Method of measurement
Weighing scale
2
Description
waist circumference
Timepoint
At the beginning of the study, after 3 months and 6 months of intervention
Method of measurement
tape measure
Secondary outcomes
1
Description
Average physical activity
Timepoint
At the beginning of the study, after 3 months and 6 months of intervention
Method of measurement
International Physical Activity Questionnaire
2
Description
diet
Timepoint
At the beginning of the study, after 3 months and 6 months of intervention
Method of measurement
3-day food records questionnaire
3
Description
appetite
Timepoint
At the beginning of the study, after 3 months and 6 months of intervention
Method of measurement
appetite questionnaire
4
Description
hip circumference
Timepoint
At the beginning of the study, after 3 months and 6 months of intervention
Method of measurement
tape measure
5
Description
body mass index
Timepoint
At the beginning of the study, after 3 months and 6 months of intervention
Method of measurement
weight in kilograms divided by height in meters squared
Intervention groups
1
Description
Intervention group: Educational brochures at the begining of study and educational text messages about the importance of weight loss on the clinical symptoms of polycystic ovary syndrome, recommendations about healthier food choices and physical activity. The brochures are provided to all participants at the beginning of the study and include general information about polycystic ovary syndrome and the importance of weight loss in this disease. text messages are sent twice a week for 6 months to the study group, and participants will be asked to pay attention to these texts, read and follow them if possible. The content of the messages will be written using scientific papers, physical activity and healthy diet guidelines published by the World Health Organization and other standard sources. The content of the messages will be reviewed and approved by specialists in nutrition, sports medicine, gynecologist, social physician and psychologist.
Category
Lifestyle
2
Description
Control group: Educational brochures about the importance of weight loss on the clinical symptoms of polycystic ovary syndrome, recommendations about healthier food choices and physical activity. The brochures are provided to all participants at the beginning of the study and include general information about polycystic ovary syndrome and the importance of weight loss in this disease.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital of Tabriz
Full name of responsible person
mahasti alizadeh mizani
Street address
Alzahra Hospital , Artesh Street, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 1553 9161
Email
anissani105@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
parviz shahabi
Street address
Central Building Number 2, Golgasht Street
City
tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
mahasti alizadeh mizani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
2nd Floor, Social Determinants of Health Research Center, Central Library of Tabriz University of Medical Sciences, University of Tabriz Campus, Daneshgah St., Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3177 2334
Email
alizadm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mahasti alizadeh mizani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
2nd Floor, Social Determinants of Health Research Center, Central Library of Tabriz University of Medical Sciences, University of Tabriz Campus, Daneshgah St., Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3177 2334
Email
alizadm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mahasti alizadeh mizani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
2nd Floor, Social Determinants of Health Research Center, Central Library of Tabriz University of Medical Sciences, University of Tabriz Campus, Daneshgah St., Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3177 2334
Email
alizadm@yahoo.com
Sharing plan
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after making individuals unidentifiable
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
By observing the principle of intellectual property and without making any changes or misapplication
From where data/document is obtainable
Scientific respondent to the study E-mail :alizadm@yahoo.com Dr. Mahasti Alizadeh mizani
What processes are involved for a request to access data/document