Protocol summary

Summary
This double-blind clinical trial aims to determine the effect of physical activity and diet on the outcome of pregnancy among 122 pregnant women with metabolic syndrome who are referred to Ayatullah Rouhani Center for pregnancy care in the first trimester of pregnancy. The IDF scale is used to diagnose metabolic syndrome. Women with 3 out of 5 signs (based on BP, weight, height, W.C., HDL, TG, FBS before intervention) will be included in the study. Also written consent should be obtained from patients. Patients will be randomly divided into two groups using a computerized program. The intervention group receives the physical activity program three one-hour sessions a week in combination with Mediterranean diet with key components including high intake of fruit and vegetables, non-refined grains, legumes, moderate to high consumption of fish, small to moderate intake of poultry and dairy products such as yoghurt and cheese, low consumption of red meat and processed meat and avoidance of sugary drinks, fast food and food rich in animal fat until the end of pregnancy. The control group will receive routine pregnancy care until the end of pregnancy. After the end of pregnancy, The maternal ( pre-eclampsia,Gestational Diabetes,Extreme weight gain during pregnancy,Pregnancy-induced hypertension) and neonatal (Preterm labor,Apgar Score,IUGR, LGA) outcomes of pregnancy will be measured among two groups using a questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017042333070N1
Registration date: 2017-10-04, 1396/07/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-04, 1396/07/12
Registrant information
Name
Farideh Mohsenzadeh - ledari
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
f.ledari@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Sharoud University of Medical Sciences
Expected recruitment start date
2017-09-21, 1396/06/30
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of interventional plan of care diet and physical activities on pregnancy outcomes in pregnant women with metabolic syndrome
Public title
The Effect of Diet and Physical Activities on Pregnancy Complications in Metabolic Syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Women with metabolic disorders; gestational age less than 14 weeks; able to read and write in Persian; respond to questionnaire without the help of another person; signing the consent to participate in the research project; have no visual or auditory disorder; mental illness does not require medication or continuous psychiatrist's care; not having any underlying diseases. Exclusion criteria: pregnant women who do not wish to participate in the study.
Age
From 14 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square,Shahroud
City
Shahroud
Postal code
36147-73947
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.SHMU.REC.1395.123

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Pre-eclampsia
Timepoint
The end of intervention
Method of measurement
Checklist;Clinical signs;test;Measuring Blood Pressure

2

Description
Gestational Diabetes
Timepoint
The end of intervention
Method of measurement
Fasting Blood Sugar;blood sugar 2 hours after eating

3

Description
Pregnancy-induced hypertension (PIH)
Timepoint
The end of intervention
Method of measurement
Measuring Blood Pressure

4

Description
Excessive Weight Gain During Pregnancy
Timepoint
During and at the end of the intervention
Method of measurement
Weight Measurement

Secondary outcomes

1

Description
Preterm labor
Timepoint
During and at the end of the intervention
Method of measurement
Gestational age by obstetric ultrasonography.

2

Description
Macrosomia
Timepoint
During and at the end of the intervention
Method of measurement
Measure of weight Infant

3

Description
Intra uterine growth restriction
Timepoint
During and at the end of the intervention
Method of measurement
Evaluation of gestational age based on ultrasound fetal growth measurements

4

Description
Apgar score
Timepoint
End of intervention
Method of measurement
Determination of Apgar score at five scale Apgar

Intervention groups

1

Description
The intervention group will receive a designed care plan including one-hour Physical activity sessions, three times a week and Mediterranean diet after the 14th week of pregnancy. The key components of the diet will include high intake of fruit and vegetables, non-refined grains, legumes, moderate to high fish consumption, low to moderate intake of poultry and dairy products such as yoghurt and cheese, low consumption of red meat and processed meat and avoidance of sugary drinks, fast food and food rich in animal fat which are delivered to the patients through brochures and training CD in addition to standard care during pregnancy.
Category
Lifestyle

2

Description
The control group received the standard prenatal
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Farideh Mohsenzadeh Ledari
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Emamiyan
Street address
Shahroud University of Medical Sciences,Hafte-Tir Square,Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Mottaghi
Position
PhD reproductive health
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences,Hafte-Tir Square,Shahroud.
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
zhrmotaghi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Nursing and Midwifery Care Research Center, Iran University of Medi
Full name of responsible person
Ziba Taghizadeh
Position
PhD reproductive health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Vali Asr street,Tehran
City
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
Email
zibataghizadeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Farideh Mohsenzadeh Ledari
Position
PhD candidate in reproductive health
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square,Shahroud
City
Shahroud
Postal code
36147-73947
Phone
+98 23 3239 5054
Fax
+98 911 119 2989
Email
Mohsenzadh2008@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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