Protocol summary

Summary
The purpose of this study is to the comparison of the effect of training to group discussion method with the multimedia package on the learning and nutritional status in pregnant women. Inclusion criteria: gestational age between 6 to 10 weeks; having the possibilities of using multimedia package in the home and lack of experience a stressful event during 2 recent months. Exclusion criteria: no follow up and request to withdraw from the study at any stage; lack of participation regularly and according to designed training Program and the incidence of stressful event for the samples during the study. For this clinical trial 180 pregnant women will be selected by using quota sampling technique from Gonabad and Mashhad cities. Participants randomly into three groups multimedia package, group discussion and control will be assigned. After obtaining informed consent, the questionnaires will be completed in three groups. For mothers in multimedia group will be loaned a DVD about nutrition during pregnancy for 2 weeks. People in group discussion were divided into 8 groups of 8 to 12 members and will be taught by group discussion method over three 90 minute sessions. During the study, all three groups will be received routine prenatal cares, with this difference that educational intervention will be done only in groups of multimedia package and group discussion. One month after the intervention, the questionnaires will be completed in three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016091117800N3
Registration date: 2016-10-11, 1395/07/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-10-11, 1395/07/20
Registrant information
Name
Samane Najafi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 5027
Email address
najafi.s@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad university of medical sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of training to group discussion method with the multimedia package on the learning and nutritional status in pregnant women
Public title
The comparison of training to group discussion method with the multimedia package
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: gestational age between 6 to 10 weeks; do not receive other training or caring plan associated with the nutrition in pregnancy during the study; having the possibilities of using multimedia package in the home; having ability to read and write; lack of experience a stressful event during 2 recent months. Exclusion criteria: having the severe pica for a particular food; certain diseases with than once from educational session’s special medical regimen, no follow up and request to withdraw from the study at any stage; lack of participation regularly and according to designed training Program; the incidence of stressful event for the samples during the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
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 Gonabad university of medical sciences
Street address
Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Approval date
2013-08-06, 1392/05/15
Ethics committee reference number
1145/ص/92

Health conditions studied

1

Description of health condition studied
The comparison of the training to group discussion method with the multimedia package on the learning and nutritional status in pregnant women
ICD-10 code
Z34.0
ICD-10 code description
Supervision of normal first pregnancy

Primary outcomes

1

Description
The learning
Timepoint
Immediately before intervention and one month after intervention
Method of measurement
The researcher made questionnaire for the survey of the learning in three cognitive, affective and psychomotor domains and "Kolb" learning style questionnaire.

Secondary outcomes

1

Description
Nutritional status
Timepoint
Immediately before intervention and one month after intervention
Method of measurement
Food frequency instrument

Intervention groups

1

Description
The intervention group consisted of two groups multimedia package and discussion groups. For mothers in multimedia group will be loaned a DVD about nutrition during pregnancy for 2 weeks. People in group discussion were divided into 8 groups of 8-12 members and will be taught by group discussion method over three 90-minute sessions.
Category
Lifestyle

2

Description
In control group only routine prenatal cares will be provided and will not receive any intervention.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health care centers of Gonabad and Mashhad cities
Full name of responsible person
Samane Najafi
Street address
Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad university of medical sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
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, Gonabad 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
Gonabad university of medical sciences
Full name of responsible person
Samane Najafi
Position
MSc in nursing education
Other areas of specialty/work
Street address
Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
S.Najafi2012@yahoo.com; Najafi.S@gmu.ac.ir; SamanehNajafi79@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad university of medical sciences
Full name of responsible person
Samane Najafi
Position
MSc in nursing education
Other areas of specialty/work
Street address
Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
S.Najafi2012@yahoo.com; Najafi.S@gmu.ac.ir; SamanehNajafi79@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gonabad university of medical sciences
Full name of responsible person
Samane Najafi
Position
MSc in nursing education
Other areas of specialty/work
Street address
Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
S.Najafi2012@yahoo.com; Najafi.S@gmu.ac.ir;SamanehNajafi79@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
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