Objectives: To determine the effect of preconception counseling on women lifestyle.
Design: A randomized controlled trial.
Conduct: This study will be conducted on healthy women and having plan to become pregnant in the next one year. The researcher will attended in health centers of Bonab and will provide a list of women ages 18-35 years old then will call them and if they comply with the inclusion criteria and have tendency to participate in study, they will be invited to be present at the health center. Pre-test questionnaires will be completed and preconception lifestyle questionnaire will be analyzed and women with low and middle lifestyle score will be included in the study. Then women will be randomly assigned to two groups (one group receiving counseling and other group receiving routine care or no care) using block randomization stratified by history of pregnancy. A person from research team not involved in the sampling will generate allocation sequence.
Participants: 152 women ages 18 - 35 and having plan to become pregnant.
Intervention: Group counseling will be provided to intervention group at six sessions twice a week in three consecutive weeks about topics of nutrition and acid folic use, physical activity, stress management, smoking and second hand smoking, alcohol, medication, dental care and safety observation.
The main outcome variable is preconception lifestyle and secondary outcomes are perceived stress, preconception lifestyle knowledge and Locus of control that will be assessed before, 4 and 8 weeks after the intervention by questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012610324N28
Registration date:2016-04-10, 1395/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-10, 1395/01/22
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
2016-04-10, 1395/01/22
Expected recruitment end date
2016-10-10, 1395/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preconception counseling on women lifestyle: a single-blind randomized controlled trial
Public title
The effect of preconception counseling on women lifestyle
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Non pregnant women ages 18-35 years old; Having secondary school and higher education level; Having ability to becoming pregnant (no history of hysterectomy, tubectomy and other reasons of infertility); Having plan to become pregnant in the next one year; Having health record in health center; Being interested in participating in the study; Having a contact number for follow-up.
Exclusion criteria: Having any diseases including cardio-vascular, hypertension, diabetes and mental diseases according to the woman expression.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Stratified by existence of prior pregnancy
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz,
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
TBZMED.REC.1394.1057
Health conditions studied
1
Description of health condition studied
Lifestyle
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
Preconception lifestyle
Timepoint
Before, 4 and 8 week after intervention
Method of measurement
Preconception lifestyle questionnaire
Secondary outcomes
1
Description
Perceived Stress
Timepoint
Before, 4 and 8 week after intervention
Method of measurement
Perceived Stress Scale (PSS)
2
Description
Preconception lifestyle knowledge
Timepoint
Before, 4 and 8 week after intervention
Method of measurement
Preconception lifestyle knowledge questionnaire
3
Description
Locus of control
Timepoint
Before, 4 and 8 week after intervention
Method of measurement
Multidimensional health locus of control scale B (MHLC)
Intervention groups
1
Description
The intervention group will receive group counseling at six sessions twice a week in three consecutive weeks about topics of nutrition and acid folic use, physical activity, stress management, smoking and second hand smoking, alcohol, medication, dental care and safety observation.
Category
Lifestyle
2
Description
گروه کنترل مداخله ای دریافت نخواهد کرد
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Bonab city
Full name of responsible person
Sakineh Ghasemi
Street address
Bonab city, East Azerbaijan
City
Bonab
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
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
Nursing & Midwifery Faculty,Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Ghasemi
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
6615615733
Phone
+98 41 3776 9310
Fax
Email
ghasemisa9727@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
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
6615615733
Phone
+98 41 3335 7582
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
Phone
+98 413335758
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)