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Effect of educational package on nutritional knowledge, beliefs and behaviors in pregnant women :A randomized controlled trial

Protocol summary

Summary
The aim of this randomized controlled trial is to determine the effect of an educational package on nutritional knowledge, beliefs and behaviors in pregnant women. We will recruit 88 women of the 8 to 14 weeks of pregnancy from the four selected public health centers in Karaj, Iran (22 from each center, 11 for each intervention and contol groups). After getting written informed consent, participants will complete the pre-test questionnaire including demographic characteristics and items about nutritional knowledge, beliefs and behavior. Then we will randomly allocate them into intervention and control groups using permuted block randomization with block sizes of 4 and 6 concealed in sequentially numbered, sealed, opaque envelopes. Intervention group will be educated about nutrition and control group about sex during pregnancy. The groups will be educated in two sessions, approximately sixty minutes each session, once per week for two consecutive weeks. Number of participants in each class will be 5-15 persons. One of the research team members, a midwife with special short education in nurition in pregnancy, will teach at the interventional group sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The subjects in the interventional group can also get telephone counseling about nutrition. The participants will complete post -test questionnaires in three time points, 4 weeks after intervention, 24-28 weeks gestational age, and 36-40 weeks gestational age. The research assistant (assessor) will be blind.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105183706N8
Registration date: 2011-07-31, 1390/05/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-31, 1390/05/09
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-07-30, 1390/05/08
Expected recruitment end date
2011-09-30, 1390/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational package on nutritional knowledge, beliefs and behaviors in pregnant women :A randomized controlled trial
Public title
Effect of an educational package on nutritional knowledge, beliefs and behaviors in pregnant women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women in 8-14 weeks of pregnancy; having health records in Karaj city health centers; willing to stay in Karaj, Iran during pregnancy; no history of known chronic disorders such as: cardiovascular, renal, respiratory, gastrointestinal, blood, autoimmune, diabetes, lupus, thyroid, epilepsy, chronic hypertension, cancer; no history of bleeding and threatened abortion, multiple pregnancy, PROM and preterm delivery, severe nausea and vomiting in pregnancy, intrauterine growth retardation, preclampsia, gestational diabetes and infertility; not being smoker, alcohol and drug user and having six years or more school education Exclusion criteria: termination of pregnancy for any reason within 6 weeks after the second educational session.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research deputy, Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
51665118
Approval date
2011-05-26, 1390/03/05
Ethics committee reference number
910

Health conditions studied

1

Description of health condition studied
Nutrition during pregnancy
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy

Primary outcomes

1

Description
Knowledge, bliefs and behaviors of nutrition on pregnant women
Timepoint
Before intervention, one month after intervention,in 24-28 weeks of pregnancy,in 36-40 weeks of pregnancy
Method of measurement
Through self-made questionnaire

Secondary outcomes

1

Description
Weight gain of mother
Timepoint
Before intervention, one month after intervention,in 24-28 weeks of pregnancy,in 36-40 weeks of pregnancy
Method of measurement
Recorded weight gain in the health record

2

Description
Child birth weight
Timepoint
Within the 12 hours after birth
Method of measurement
Weight recorded in the summary birth record

Intervention groups

1

Description
Intervention group: implementation of a nutritional education package, i.e. at first, group education will be conducted in groups with 5-11 women in the selected health centers in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife, will teach at the sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The women will be asked to study the book (themselves and their husbands) till the second educational session and ask their questions in the session. The subjects can also get telephone counseling about nutrition.
Category
Lifestyle

2

Description
Control group: implementation of a sex education package, i.e. at first, group education will be conducted in groups with 5-11 women in the selected health centers in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife with special short education in sexual health in pregnancy, will teach at the sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The women will be asked to study the book (themselves and their husbands) till the second educational session and ask their questions in the session. The subjects and their husbands can also get telephone counseling about sexual health.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Fardis shohada
Full name of responsible person
Fateme Omidi
Street address
Fardis Sq. West Canal
City
Karaj

2

Recruitment center
Name of recruitment center
Valyasr Fardis
Full name of responsible person
Fateme Omidi
Street address
Anbar Naft square
City
Karaj

3

Recruitment center
Name of recruitment center
Tabatabaie
Full name of responsible person
Fateme Omidi
Street address
Mohammad Shahr
City
Karaj

4

Recruitment center
Name of recruitment center
Meshkin Dasht
Full name of responsible person
Fateme Omidi
Street address
Shahid Hemmatkar Street
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Science
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Golgasht street
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 Science
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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Omidi
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South shariati
City
Tabriz
Postal code
44931-83648
Phone
+98 14 2762 1281
Fax
Email
fatemeomidi45@yahoo.com; omidi_f90@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing And Midwifery, Tabriz University of Medical sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-charandabi
Position
Assistant Professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
Email
alizades@tbzmed.ac.ir
Web page address
http://ravand.tbzmed.ac.ir; users/mohammadalizadeh/index.php

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Omidi
Position
Master of sciences student in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
44931-83648
Phone
+98 14 2762 1281
Fax
Email
fatemeomidi45@yahoo.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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