Protocol summary

Study aim
Reviewing the effect of self-care training through social media -WhatsApp- on self-care of diabetic pregnant women with obesity and overweight
Design
A clinical trial with a control group and an intervention group. Blocked randomization of 4 in a group of 30 blocks on 120 diabetic pregnant women who suffer obesity and overweight to investigate the effect of self-care training through WhatsApp.
Settings and conduct
After explaining the reasons and methods of the research, diabetic pregnant women will be invited to have the research done. Women, after obtaining informed satisfaction and ensuring of confidentiality of their personal information, would enter the study as intervention and control group. Then, the intervention group members will enter the WhatsApp messenger group and receive the educational content on line on even days in forms of video, photo or written text for 10 weeks from the 28th to the 38th week of pregnancy .Women in the control group only receive routine care.
Participants/Inclusion and exclusion criteria
The terms of entering the study: 1. 24-28-week pregnant women whose gestational diabetes has been confirmed by blood sugar test Two hours after taking 75 grams of glucose 2- being literate 3- having a private mobile phone 4- having WhatsApp installed and being able to use it 5- having the ability to attend In face-to-face .meetings and answering questions The terms of NOT entering the study: 1-Mother suffering from chronic diseases and medical conditions requiring taking medicine 2-Existence of high-risk pregnancy in the mother (pregnancy poisoning, twins...) 3-Mother’s history of depression and drug addiction (psychoactive drugs, stimulants, alcoholic drinks...).
Intervention groups
Intervention group: self-care training through WhatsApp social network Control group: only routine care
Main outcome variables
Self-care promoting behaviors score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220909055918N1
Registration date: 2022-11-07, 1401/08/16
Registration timing: registered_while_recruiting

Last update: 2022-11-07, 1401/08/16
Update count: 0
Registration date
2022-11-07, 1401/08/16
Registrant information
Name
Fatemeh Salarkarimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4336 6681
Email address
f.salar.7172@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Reviewing the effect of self-care education through social media on self-care of overweight and obese pregnant women
Public title
Investigating the effect of self-care training through WhatsApp on self-care criteria of diabetic pregnant women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. 24-28-week pregnant women whose gestational diabetes has been confirmed by blood sugar test Two hours after taking 75 grams of glucose. 2. Being literate.3. Having a private mobile phone.4. Having WhatsApp installed and being able to use it.5. Having the ability to attend in face-to-face .meetings and answering questions
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The size of sample group is estimated to be 120 people. Sampling is done by using the Block Design Randomization method (30 blocks of 4) and using the table of random numbers. . In general, the samples are devided in a virtual training group and a control group. In total, 60 people are in the intervention group and 60 people are in the control group. Thus, the samples were randomly divided into the intervention group (training through WhatsApp + routine care)and the control group (only routine care). In this way, all possible modes of placement including A: Training via WhatsApp and B: Routine care were considered in blocks of 4 with an allocation ratio of 1:1, and the number of required blocks was determined based on the number of samples. After that, according to the required number of blocks and based on the table of random numbers, the blocks corresponding to each table were listed in order. Finally, as the samples entered the study, each person got a certain letter according to the obtained order .In order to hide the random allocation, the sealed non-transparent envelopes method with random sequence was used. In this method, first, a random sequence is created using a random number table, and based on the sample size of the research(120), 120 matte envelopes (in order to make the content of the envelope unclear) were prepared. Each of the created random sequences was recorded on a card by a person who was unaware of the goals and topic of the study and the cards were placed in the envelopes, and finally the envelopes were sealed and placed in a box in order. At the time of sampling, the researcher, according to the order in which the qualified participants entered, opened one of the envelopes and the group of that participant was revealed.
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 Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan Ave,Golestan Blvd,Ahvaz,KHuzestan province,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2022-09-03, 1401/06/12
Ethics committee reference number
IR.AJUMS.REC.1401.232

Health conditions studied

1

Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy

Primary outcomes

1

Description
Score of self-care
Timepoint
Before and after the intervention
Method of measurement
Diabetes self-care questionnaire

2

Description
Blood sugar
Timepoint
Before and after the intervention
Method of measurement
blood sugar test 2 hours after consuming 75 grams of glucose and fasting blood sugar test

Secondary outcomes

1

Description
Physical activity
Timepoint
Before and after the intervention
Method of measurement
Physical activity questionnaire

2

Description
life style
Timepoint
Before and after the intervention
Method of measurement
Lifestyle questionnaire

3

Description
Weight changes
Timepoint
Before and after the intervention
Method of measurement
Recording weight changes with a scale.

Intervention groups

1

Description
Intervention group: In the beginning, the people who meet the criteria for entering the study will be identified and by using the block randomization method, divided into two groups of 60 people, the control group (face-to-face training) and 60 people in the intervention group (face-to-face training and training through software. Data collection tools in this research includes: demographic information form, blood sugar test checklist, measuring mothers' weight and recording weight changes, international physical activity questionnaire, lifestyle questionnaire and diabetes self-care questionnaire. At the beginning (between 24 and 28 weeks of pregnancy) for the samples of both groups, a checklist of blood sugar tests two hours of taking 75grams glucose and fast blood sugar test will be completed by the researcher. Then, the demographic information form and Physical activity, lifestyle and self-care questionnaires will be provided to people to complete. Then the total samples, all 120 people, the intervention group (60 people) and the control group (60 people), will receive face-to-face training, which is actually the same routine pregnancy care through health centers until delivery. In addition to face-to-face training provided by health center midwives for the intervention group training will also be provided through the software. A group will be created on the WhatsApp social network and all the intervention group members will be joined to this group, and within 10 weeks (28-38 weeks) on even days, two educational messages will be sent in the form of written text or photos or educational videos into the group. The content provided in the educational messages will be similar to the content of face-to-face training. The content of face-to-face training sessions (routine pregnancy care) and educational messages of the software includes: “training about gestational diabetes and its effects on the mother and the fetus, explanation of self-care methods, nutrition education including foods that a pregnant person should not consume, portion of food and having regular physical activity, benefits of exercise and physical activity during pregnancy, Regular walking, recommended exercises for pregnant women (balanced movements, stretching exercise, Pilates and special classes for pregnancy), how to eat healthily, how to use insulin correctly’. After the completion of the training in two groups (38 weeks of pregnancy), the samples will be asked to perform the fasting blood sugar test and the blood sugar test after two hours of taking 75 grams of glucose and provide the results to the sampling centers. After reviewing the tests, As mentioned, the results will be recorded in the blood sugar test registration checklist by the researcher, and then the questionnaires (physical activity, lifestyle and self-care) will be completed again by both groups and the amount of weight changes will be estimated.
Category
Lifestyle

2

Description
Control group: Routine care of pregnancy
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Health Centers
Full name of responsible person
Ftamah salarkarimi
Street address
Ahvaz Jondishapur University of Medical Sciences ,Golestan Ave, Golestan Blvd ,Ahvaz, KHuzestan province ,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
f.salar.7172@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Street address
Ahvaz Jondishapur University of Medical Sciences ,Golestan Ave, Golestan Blvd ,Ahvaz, KHuzestan province ,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
f.salar.7172@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jondishapur University of Medical Sciences ,Golestan Ave, Golestan Blvd ,Ahvaz, KHuzestan province ,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
abbaspoor-z@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jondishapur University of Medical Sciences ,Golestan Ave, Golestan Blvd ,Ahvaz, KHuzestan province ,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
abbaspoor-z@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jondishapur University of Medical Sciences ,Golestan Ave, Golestan Blvd ,Ahvaz, KHuzestan province ,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
abbaspoor-z@ajums.ac.ir

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
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
Title and more details about the data/document
Use of data for research purposes only
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Everyone has access to published data
Under which criteria data/document could be used
Raw statistical data will not be published, but statistical analysis will be available
From where data/document is obtainable
Responsible for clinical trial registration
What processes are involved for a request to access data/document
It will be possible with the permission of the Ethics Committee and Research Vice-Chancellor of Jundishapur University of Medical Sciences, Ahwaz
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