Determining the effect of telemedicine training on eating behavior and weight gain of pregnant women with higher than normal body mass index
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, on 102 mothers. Random permutation blocks were used for randomization.
Settings and conduct
samples are selected from pregnant mothers referring to health centers.
Participants/Inclusion and exclusion criteria
Pregnancy
Body mass index 25 to 29.9 kg / m2 at the beginning or before of pregnancy
Gestational age 12 to 14 weeks by ultrasound
Single pregnancy
Mother age between 18 -35
Ability of read and write in Persian
Having a smart phone
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Maternal disease and medical conditions require medical intervention
Existence of risk factor for high risk pregnancy in mother (Preeclampsia, gestational diabetes, placenta previa and twin pregnancy)
History of depression
Addiction to drugs such as stimulants, alcohol, cigarettes and hookah Women who are on a diet or exercising regularly
Intervention groups
for intervention group, in addition to the routine care of health centers, training is provided using the WhatsApp messenger. To this end, a Group will be formed in WhatsApp messenger and they will receive two weekly educational messages containing nutrition and physical activity recommendations and a motivational message with images and videos From the 14st to the 36rd week of pregnancy . control group only receive routine care at health centers during the entire intervention period.
Main outcome variables
maternal weight gain is calculated and compared as the difference between the mother's weight before the intervention, and after the end of 28 and 36 weeks of pregnancy in the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220130053884N1
Registration date:2022-07-10, 1401/04/19
Registration timing:retrospective
Last update:2022-07-10, 1401/04/19
Update count:0
Registration date
2022-07-10, 1401/04/19
Registrant information
Name
Saeedeh Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3262 2833
Email address
esmaeili.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-27, 1401/02/07
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nutrition education through a Smartphone on eating behavior and gestational weight gain in overweight pregnant women
Public title
The effect of nutrition education through a Smartphone on eating behavior and gestational weight gain in overweight pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy
Body mass index 25 to 29.9 kg / m2 at the beginning or before of pregnancy
Single pregnancy
Gestational age 12 to 14 weeks by ultrasound
Mother age between 18 -35
Ability of read and write in Persian
Having a smart phone
Exclusion criteria:
Maternal disease and medical conditions require medical intervention
Existence of risk factor for high risk pregnancy in mother (Preeclampsia, gestational diabetes, placenta previa and twin pregnancy)
History of depression
Addiction to drugs such as stimulants, alcohol, cigarettes and hookah
Women who are on a diet or exercising regularly
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Research samples had selected from available mothers who refer to health centers that have had criteria for enter the study. The method of assay is included the intervention on participants that are selected random and by the method of random permutation blocks with block size 1 (using the table related to random permutations) and the percentage of appointment is 2:2. The randomization list is prepared by a statistician. Each mother is reviwed for entering study condions and if she is eligible, she will enter one of the two study groups (control, intervention) based on randomization list.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, Ahvaz Jundishapur University of Medical Sciences and Health Services, , Vice Chancellor for Research and Technology, University City,Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.AJUMS.REC.1400.243
Health conditions studied
1
Description of health condition studied
Body mass index higher than normal
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
gestational weight gain
Timepoint
28،36 week of pregnancy
Method of measurement
Weight Scale
Secondary outcomes
1
Description
Eating behavior
Timepoint
28،36 week of pregnancy
Method of measurement
Three Factor Eating Questionnaire
Intervention groups
1
Description
Intervention group:for intervention group, in addition to the routine care of health centers, training is provided using the WhatsApp messenger. To this end, a Group will be formed in WhatsApp messenger and they will receive two weekly educational messages containing nutrition and physical activity recommendations and a motivational message with images and videos From the 14st to the 36rd week of pregnancy (for 23weeks).
Category
N/A
2
Description
Control group: . control group only receive routine care at health centers during the entire intervention period.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
East Ahwaz Health Center; West Ahwaz Health Center
Full name of responsible person
Amrollah Mardani. Mehran Ahmadi Baloutaki
Street address
Kianabad between 15th and 16th East streets, in front of Haft Tir Park, Shahid Rastegari Street, Ayatollah Behbahani Highway.
City
Ahvaz
Province
Khouzestan
Postal code
6155745477؛157946135
Phone
+98 61 2215 6336
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ground Floor, Ahvaz Jundishapur University of Medical Sciences and Health Services, , Vice Chancellor for Research and Technology, University City,Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
zakerkish-m@ajums.ac.ir
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
Saeedeh Esmaeili
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan, Ahvaz town
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3373 8331
Email
esmaili.saeede@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan, Ahvaz town
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3338 6457
Email
javadifar-n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saeedeh Esmaeili
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan, Ahvaz town
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3373 8331
Email
esmaili.saeede@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
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic information and outcome information will be shared without naming individuals.
When the data will become available and for how long
Start access 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in review studies and by researchers working in academic institutions whose field of work is midwifery.
From where data/document is obtainable
Correspond Author
javadifar-n@ajums.ac.ir
Contact number 09166121693
What processes are involved for a request to access data/document
The applicant emailed the responsible author and explained the reason for his request, and if the reasons are justified, the data will be provided to the person within a maximum of 7 working days.