The effect of lifestyle based educational package on physical activity and nutritional status in obese and overweight pregnant women: a randomized controlled clinical trial
Objectives: To determine the effect of lifestyle based on physical activity and nutritional status of obese and overweight pregnant women.
Design: Two-armed randomized controlled trial.
Conduct: This study will be conducted on 140 pregnant women referring to heath centers of Tehran. Two centers that have at least 12 eligible women were selected from each region of Tehran. The researcher will attend in health centers and will select eligible women by convenience method. Participants will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4 and 6. A person not involved in the sampling will generate allocation sequence.
Participants: Obese and overweight pregnant women at 16-20 weeks of gestation.
Intervention: The intervention group will receive a single group education session at 16-20 weeks of pregnancy about lifestyle aspects including nutrition and physical activity and also a booklet about nutrition and physical activity will given to them. The control group will receive the routine prenatal cares.
The main outcome variables include physical activity and nutrition that will be assessed before, 4 and 8 weeks after the intervention by International Physical Activity Questionnaire (IPAQ) and Food Frequency Questionnaire (FFQ), respectively. The secondary outcome variables include weight gain rate and frequency of gestational diabetes that will be assessed 8 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041210324N31
Registration date:2016-06-01, 1395/03/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-01, 1395/03/12
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lifestyle based educational package on physical activity and nutritional status in obese and overweight pregnant women: a randomized controlled clinical trial
Public title
The effect of lifestyle based educational package on physical activity and nutritional status in obese and overweight pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with gestational age of 16-20 weeks; Having evidence regarding singleton and non-problematic pregnancy; Women with first, second and third pregnancy; Having health record in health center; Having at least secondary school education; Body mass index higher than 25 in preconception care or first trimester of pregnancy; Not participation in other similar studies; Being interested in participating in the study; Women ages 18 years old and higher.
Exclusion criteria: Having any diagnosed mental and physical diseases in mother; Following of special diet (according to mother’s expression); Having hospitalization history at present pregnancy; Change of living place during study implementation; Separation from husband; Addiction or habitual use of alcohol or addictive drugs; Having infertility history and using of assisted reproductive technologies; Having history of relatives death, divorce and acute emotional problems in the last month.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
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 Tabriz Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan
City
Tabriz
Postal code
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
IR.TBZMED.1385.70
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
Physical activity score
Timepoint
4 and 8 weeks after intervention
Method of measurement
International Physical Activity Questionnaire (IPAQ)
2
Description
Food subgroups score
Timepoint
4 and 8 weeks after intervention
Method of measurement
Food Frequency Questionnaire (FFQ)
Secondary outcomes
1
Description
Weight gain rate
Timepoint
8 weeks after intervention
Method of measurement
Scale (Model: Seca, Germany)
2
Description
Frequency of gestational diabetes
Timepoint
8 weeks after intervention
Method of measurement
Two-hour Oral Glucose Tolerance Test (OGTT) in 26 to 30 weeks
Intervention groups
1
Description
The intervention group will receive a single group education session at 16-20 weeks of pregnancy about lifestyle aspects including nutrition and physical activity and also a booklet about nutrition and physical activity will given to them.
Category
Lifestyle
2
Description
The control group will receive the routine prenatal cares.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tehran city
Full name of responsible person
Elham Eslami
Street address
Health centers, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Elham Eslami
Position
MSC student in Midwifery
Other areas of specialty/work
Street address
South shariati Street, Nursing & Midwifery Faculty
City
Tabriz
Postal code
5451796499
Phone
+98 41 3233 8041
Fax
Email
mid.eslami@gmail.comesmahmadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Assistant Professor, PhD of reproductive health
Other areas of specialty/work
Street address
South shariati, Nursing & Midwifery Faculty
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.irmirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Elham Eslami
Position
MSC student in Midwifery
Other areas of specialty/work
Street address
South shariati Street, Nursing & Midwifery Faculty
City
Tabriz
Postal code
5451796499
Phone
+98 41 3233 8041
Fax
Email
mid.eslami@gmail.comesmahmadi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)