This study is a quasi-experimental study. The objective of the study is to evaluate The effect of the Individualized Education Program on the prevalence of gestational diabetes mellitus in pregnant by In Vitro Fertilization. Participants will include 170 pregnant women through In Vitro Fertilization (IVF). They will be divided into two groups (85 people in intervention group and 85 people in control group). Before the intervention, they will complete questionnaire of lifestyle for nutrition and eating habits, 24-hour dietary recall questionnaire for three days and Physical Activity Questionnaire by individuals in both groups. Height and weight will be measured and body mass index will be calculated. Samples will receive education about Diet, weight control, exercise and physical activity in 6 sessions in intervention group and controls will receive clinic Routine care. Participants of intervention and control groups will be checked by glucose tolerance test (GTT) at week 24 to 28 of pregnancy and again in 34 week for final diagnosis of gestational diabetes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020228847N2
Registration date:2017-04-12, 1396/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
leila Neisani
Name of organization / entity
Iran University Medical of Science
Country
Iran (Islamic Republic of)
Phone
+98 88006990
Email address
neisani89@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the Individualized Education Program on the prevalence of gestational diabetes mellitus in pregnants by In Vitro Fertilization
Public title
The effect of the Individualized Education Program on the prevalence of gestational diabetes mellitus in pregnants by In Vitro Fertilization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pre-pregnancy body mass index of 19 to 25; gestational age 12 to 16 weeks with LMP or ultrasound in the first trimester; In Vitro Fertiliaztion is not due to PCOs factor; no history of diabetes in first-degree relatives (father, mother, sister, brother); no history of previous neonatal mortality in pregnancy; no history of previous pregnancy with malformed infant or fetus; lack of macrosomia (birth weight more than 4000 grams); no history of gestational diabetes and preeclampsia in a previous pregnancy; No more than three times repeated abortions; the absence of chronic diseases (hypertension, cardiovascular disease, kidney disease, anemia, autoimmune); Lack of mental disease; Lack of education in the Department of Medical Sciences (Nursing, Nursing, Medical, Nutritional Science); normal FBS (less than 126) in the first quarter (of the case)
Exclusion criteria: smoking and drug abuse
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway,Tehran
City
Tehran
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.IUMS.REC 1395.9311373013
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24
ICD-10 code description
Diabetes mellitus in pregnancy
Primary outcomes
1
Description
Gestational Diabetes
Timepoint
In 24-28 weeks and again in 34 week
Method of measurement
Screening test for gestational diabetes and GTT test
Secondary outcomes
empty
Intervention groups
1
Description
ٍEducation about Nutrition , weight control, physical activity during the sixth session since the arrival of up to 34 weeks of gestation for 15 to 20 minutes per session, coinciding with the visit of prenatal in intervention group
Category
Lifestyle
2
Description
routine care Of Clinics in control group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Dr. Tehrani Nejad
Full name of responsible person
Leila Neisani
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Clinic of Dr. Ashrafi
Full name of responsible person
Leila Neisani
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Infertility clinic of Akbar Abadi Hospital
Full name of responsible person
Simin Jafari
Street address
Molavi Street
City
Tehran
4
Recruitment center
Name of recruitment center
Infertility clinic Of Firoozgar Hospital
Full name of responsible person
Street address
Karim Khan Street, Be Afarin Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research Of Nursing and Midwifery Faculty of Iran University Of Medical Sciences
Full name of responsible person
Dr. Nahid Akbari
Street address
Nursing and Midwifery Faculty of Iran University Of Medical Sciences, Rashid yasemi Street, Valiasr street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research Of Nursing and Midwifery Faculty of Iran University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University Of Medical Science
Full name of responsible person
Laila Neisani Samani
Position
teacher
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University Of Medical Sciences, Rashid Yassami Street, Vali Asr Street
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
neisani89@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty of Iran University Of Medical Science
Full name of responsible person
Leila Neisani
Position
Teacher
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Iran University Of Medical Sciences, Rashid Yassami Street, Vali Asr Street
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
neisani89@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)