Determining the effect of a mobile phone-based application in controlling the weight gain of pregnant women during pregnancy
Design
In this randomized controlled trial study, all pregnant women (overweight and non-overweight) are divided into two intervention (50 people) and control (50 people) groups. Randomization is done by block method and using a table of random numbers.
Settings and conduct
When pregnant women in the 13th week of pregnancy go to the specialized gynecology office and clinic implementing the project, first, an introduction regarding the goals of the project will be given to the study subjects by the researcher in simple language, and then written informed consent will be obtained from the participants. Then the basic evaluations including weight, height, diet and physical activity are performed according to the criteria used in the application program. After allocating the participants to the intervention and control groups, the application program is installed and described by the researcher on the mobile phones of the people in the intervention group. The doctor will provide them with a full explanation of how to use the program.
Participants/Inclusion and exclusion criteria
Pregnant women who are overweight (body mass index above 25) and not overweight (body mass index below 25) with a gestational age of 13 weeks, with a smart phone with a singleton pregnancy, with at least elementary education, age above 18 years
Intervention groups
The control group includes pregnant women who receive their standard and usual care, and the intervention group includes pregnant women who, in addition to standard and usual care, use a designed smartphone-based application.
Main outcome variables
weight gain, food intake, physical activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221025056295N1
Registration date:2022-10-31, 1401/08/09
Registration timing:prospective
Last update:2022-10-31, 1401/08/09
Update count:0
Registration date
2022-10-31, 1401/08/09
Registrant information
Name
Safoora Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3529 0494
Email address
ramezani-s@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of a mobile-based application on weight gain control of pregnant women during pregnancy
Public title
Effect of a mobile application on weight gain control of pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with overweight (body mass index above 25) and without overweight (body mass index below 25) with a gestational age of 13 weeks.
Have a smart mobile phone with an Android operating system that has the ability to install an application.
Have documents of singleton pregnancy.
Have a minimum level of primary education.
Age above 18 years.
Exclusion criteria:
Addiction or use of alcohol and drugs.
Change of living place during the study period.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized controlled trial study, all pregnant women (overweight and non-overweight) are divided into two intervention (50 people) and control (50 people) groups by block randomization method. Randomization is done by the block method in such a way that first all the 4 blocks containing two codes A and B are prepared (6 blocks), then the numbers one to six are selected using the table of random numbers (20 numbers). ) and the corresponding block will be written based on the randomly selected number. With this, a sequence of 80 letters A and B will be obtained. Each of the sample will have a number from 1 to 80 (20 people to take into account attrition) and will receive an A or B code based on the list of letters based on the number of each person. Both groups will be almost the same. It should be mentioned that the effect of confounding variables will be controlled by the block randomization method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study has two groups. The control group includes pregnant women who receive standard and usual care, and the intervention group includes pregnant women who, in addition to standard and usual care, use a smartphone-based application.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Nursing and Midwifery, Health and Paramedicine - Kashan Univ
Street address
Qutb Rawandi Blvd
City
kashan
Province
Isfehan
Postal code
8715973474
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1401.053
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Weight gain
Timepoint
From the 13th week of pregnancy monthly until the last week of pregnancy
Method of measurement
In order to measure the weight, all subjects of the monthly study are weighed without shoes and with as little clothing as possible. To weigh pregnant women, the scale (seca) available in the specialized obstetrics and gynecology office and clinic of the project executive will be used, and the correct performance of the scale will be evaluated by weighing a 500-gram weight at each weighing session.
2
Description
Food intake
Timepoint
From the 13th week of pregnancy weekly until the last week of pregnancy
Method of measurement
To measure food intake, the food frequency questionnaire, which is a standard questionnaire, will be used.
3
Description
Physical activity
Timepoint
From the 13th week of pregnancy weekly until the last week of pregnancy
Method of measurement
In order to measure physical activity, the International Physical Activity Questionnaire, which is a standard questionnaire, will be used.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: includes pregnant women who use intervention in addition to standard and usual care. The intervention includes an application that was designed in a previous study by a team of health information management specialists and gynecologists using Adobe Air software under the Android operating system. It is an application with various capabilities, including providing educational information, recording information, calculating gestational age, birth date and body mass index, setting reminders and communicating with the doctor, which helps pregnant women to control weight gain during pregnancy. In this study, the capabilities of providing educational information, recording information and calculating gestational age, birth date and body mass index are used to measure the results of the study.
Category
Behavior
2
Description
Control group: includes pregnant women who are under their standard and usual care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi hospital
Full name of responsible person
Zahra Vahedpoor
Street address
Rajaei street
City
Kashan
Province
Isfehan
Postal code
8713743444
Phone
+98 31 5545 1515
Email
zahravahedpoor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Farzandipour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Information Management
Street address
Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973449
Phone
0098 31 55540021-25
Email
farzandipour_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Vehedpoor
Position
Specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0026
Email
zahravehedpoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Safoora Ramezani
Position
MSc student of health information technology
Latest degree
Bachelor
Other areas of specialty/work
Health Information Technology
Street address
Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8157993411
Phone
+98 31 3529 0404
Email
safoora.ramezani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data file of participants and statistical analysis in SPSS file format
will be available. Clinical study data in article format
It will be published.
When the data will become available and for how long
6 months after the publication of the final results of the study.
To whom data/document is available
The final results of the study for the public and the data file and statistical analysis if requested by scientific institutions.
Under which criteria data/document could be used
Only scientific and academic institutions can send data access requests for scientific analysis.
From where data/document is obtainable
Kashan University of Medical Sciences, Department of Health Information Technology and Management, Safoora Ramezani.
What processes are involved for a request to access data/document
The application should be sent by post to the Health Information Technology and Management Department of Kashan University of Medical Sciences or to the following email:
Ramezani-s@kaums.ac.ir