This study goal is to affect of education and counseling on health promotion with the focus of regulating physical activity and balanced diet on weight gain in pregnant women with overweight.
Design
Two parallel group randomized of pregnant women with overweight were selected to participate in this study (33 in intervention group and 33 in control group). This study was not blind.
Settings and conduct
This randomized study was conducted on 66 pregnant women with overweight referring to health centers of Tabriz. The data collection tool was standard questionnaires of physical activity and Food frequency. At first, the primary test was performed in two groups (intervention and control) and then again, the test was performed in weeks 24- 28, 30-34 and 36-40 of pregnancy with the same questionnaire in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranians, Body mass index between 29.9-25, First pregnancy, single pregnancy, Being in weeks 16 to 20 of pregnancy, Lack of specific physical and mental illness, lack of midwifery risk factors and 18 to 40 years . Exclusion criteria: Non-cooperation
Intervention groups
The intervention group received 4 sessions of educational intervention and counseling for 90 minutes using lecturing method, question answer method, focus group discussion, slideshows and pamphlet in in weeks 16-20 pregnancy. The control group received only routine prenatal care.
Main outcome variables
The weight, physical activity, calories
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161122031023N2
Registration date:2018-10-15, 1397/07/23
Registration timing:registered_while_recruiting
Last update:2018-10-15, 1397/07/23
Update count:0
Registration date
2018-10-15, 1397/07/23
Registrant information
Name
Azita Fathnezhad Kazemi
Name of organization / entity
Sahid Beheshti Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 8073
Email address
a_kazemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of health promoting interventions on pregnancy outcomes in overweight women in Tabriz
Public title
Effectiveness of health promotion interventions on outcomes of pregnancy and childbirth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Iranians
Body mass index between 29.9-25
First pregnancy
single pregnancy
Being in weeks 16 to 20 of pregnancy
Lack of specific physical and mental illness
lack of midwifery risk factors
18 to 40 years
Exclusion criteria:
Non-cooperation
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In the random sampling process of pregnant women in two groups of intervention and control, random allocation software for clinical trails was used. Using this software, data about the number of samples, the number and names of the groups were given to Excel software, and the output was taken from the random list of the groups.
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 Shahid Beheshti University of Medical Sciences
Street address
Nursing and Midwifery School, Crossroads Valieaser with Niaiesh, Valieaser St.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-07-15, 1395/04/25
Ethics committee reference number
IR.SBMU.PHNM.1395.498
Health conditions studied
1
Description of health condition studied
Overweight
ICD-10 code
Z68.54
ICD-10 code description
Body mass index (BMI) pediatric, greater than or equal to 95th percentile for age
2
Description of health condition studied
Pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
weight gain
Timepoint
Weeks 16 to 20, 24 to 28, 30 to 34, and 36 to 40 pregnancies
Method of measurement
Scale
2
Description
Physical activity
Timepoint
Weeks 16 to 20, 24 to 28, 30 to 34, and 36 to 40 pregnancies
Method of measurement
International Physical Activity Questionnaire
3
Description
Amount of calories
Timepoint
Weeks 16 to 20, 24 to 28, 30 to 34, and 36 to 40 pregnancies
Method of measurement
Food Frequency Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received 4 sessions of training and counseling for regulating physical activity and balanced diet In weeks 16 to 20 of pregnancy.
Category
Lifestyle
2
Description
Control group: The control group received only routine prenatal care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Tabriz
Full name of responsible person
Azita Fathnezhad Kazemi
Street address
No. 58, second Ave., Azari Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167635361
Phone
+98 41 3327 1080
Email
a_kazemi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, beside the Taleqani hospital, Yaman St, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 8820 2512
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for research Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Fathnezhad Kazemi
Position
student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
No. 58, second Ave, Azari Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167635361
Phone
+98 41 3327 1080
Fax
Email
afnkazemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Hajian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery School, Crossroads Valieaser with Niaiesh, Valieaser St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
Email
hajian74@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Fathnezhad Kazemi
Position
PhD.student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
No.58, Second Ave, Azari Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167635361
Phone
+98 41 3327 1080
Fax
Email
afnkazemi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available