Protocol summary

Summary
Study objective : Survey effect of educational program by BASNEF model on nutritional supplements use during pregnancy among pregnant women referred to health centers in Hamadan city . Study design : The study is a randomized study . The study population will be in the third month of pregnancy , pregnant women referred to health centers in north region of Hamadan. 88 cases of pregnant women assigned randomly groups will be placed in the intervention and control. Important inclusion criteria: Being in the third month of pregnancy , Written informed consent & important exclusion criteria: Termination of pregnancy during the study for any reason, Diagnosed ban for taking supplements & Refusing to participate in workshop two sessions and more. Mothers in the intervention group will participate in 4 sessions during one month in educational program based on BASNEF model also a follow-up meeting will be held a month after the interventional education. Before the intervention, immediately after the intervention and 2 months after the intervention , both the intervention and control groups , will be completed a questionnaire; main outcome of this study is predicted to be increase the behavior supplementation use during pregnancy in the intervention group .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014022316701N1
Registration date: 2014-03-31, 1393/01/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-03-31, 1393/01/11
Registrant information
Name
Tahere Etesamifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0755
Email address
taherehealth@gmail.com
Recruitment status
Recruitment complete
Funding source
Funding source for this study is the Vice President for Research and Technological University of Hamadan Medical Sciences.
Expected recruitment start date
2014-04-12, 1393/01/23
Expected recruitment end date
2014-05-13, 1393/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey effect of educational program by BASNEF model on nutritional supplements use during pregnancy among pregnant women referred to health centers in Hamadan city
Public title
The effect of education on prenatal supplements
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Third trimester pregnant women referred to health centers in north of Hamadan; Written informed consent by the pregnant women under study; Lack of a ban on pregnancy supplements use.Exclusion criteria: Pregnant women who do not wish to continue participating in the study; Ban the use of one or all three supplements during pregnancy, in terms of doctor or midwife; Termination of pregnancy during the study for any reason (including abortion, and the doctor's advice, ...); Change the location so that they will be removed from the covered population; Refusing to participate in workshop two sessions and more.
Age
No age limit
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Hamadan - Fahmideh strett - opposit Mardom Park
City
Hamadan
Postal code
Approval date
2013-04-08, 1392/01/19
Ethics committee reference number
d/p/16/35/9/24

Health conditions studied

1

Description of health condition studied
nutritional supplements use during pregnancy
ICD-10 code
E50
ICD-10 code description
Vitamin A deficiency

2

Description of health condition studied
nutritional supplements use during pregnancy
ICD-10 code
E51
ICD-10 code description
Thiamine deficiency

3

Description of health condition studied
nutritional supplements use during pregnancy
ICD-10 code
E53
ICD-10 code description
Deficiency of other B group vitamins

4

Description of health condition studied
nutritional supplements use during pregnancy
ICD-10 code
E54
ICD-10 code description
Ascorbic acid deficiency

5

Description of health condition studied
nutritional supplements use during pregnancy
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency

6

Description of health condition studied
nutritional supplements use during pregnancy
ICD-10 code
E56
ICD-10 code description
Other vitamin deficiencies

7

Description of health condition studied
nutritional supplements use during pregnancy
ICD-10 code
E58
ICD-10 code description
Dietary calcium deficiency

8

Description of health condition studied
nutritional supplements use during pregnancy
ICD-10 code
E61
ICD-10 code description
Deficiency of other nutrient elements

Primary outcomes

1

Description
nutritional supplements use during pregnancy
Timepoint
Before the intervention, immediately after intervention, and two months after the end of intervention
Method of measurement
Made questionnaire

Secondary outcomes

1

Description
knowledge
Timepoint
Before the intervention, immediately after intervention, and two months after the end of intervention
Method of measurement
Made questionnaire

2

Description
belifes & evaluational of behavioral outcome
Timepoint
Before the intervention, immediately after intervention, and two months after the end of intervention
Method of measurement
Made questionnaire

3

Description
attitude toward the behavior
Timepoint
Before the intervention, immediately after intervention, and two months after the end of intervention
Method of measurement
Made questionnaire

4

Description
normative beliefs
Timepoint
Before the intervention, immediately after intervention, and two months after the end of intervention
Method of measurement
Made questionnaire

5

Description
subjective norms
Timepoint
Before the intervention, immediately after intervention, and two months after the end of intervention
Method of measurement
Made questionnaire

6

Description
behavioral intention
Timepoint
Before the intervention, immediately after intervention, and two months after the end of intervention
Method of measurement
Made questionnaire

7

Description
enabling factors
Timepoint
Before the intervention, immediately after intervention, and two months after the end of intervention
Method of measurement
Made questionnaire

Intervention groups

1

Description
A training manual utilizes the scientific literature by the researcher will be provided after confirmation of its validity and reliability will be held in 4 sessions (one session per week) and about 60 minutes for each session for the third month pregnant women in the intervention group. Teaching methods will include lectures, group discussions and questions and answers.
Category
Prevention

2

Description
For the control group, there will be no educational intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza health center
Full name of responsible person
Tahere Etesamifard - student of Msc of health education
Street address
City
Hamadan

2

Recruitment center
Name of recruitment center
Ghods health center
Full name of responsible person
Tahere Etesamifard - student of Msc of health education
Street address
City
Hamadan

3

Recruitment center
Name of recruitment center
Eslamshahr health center
Full name of responsible person
Tahere Etesamifard - student of Msc of health education
Street address
City
Hamadan

4

Recruitment center
Name of recruitment center
Khezr health center
Full name of responsible person
Tahere Etesamifard - student of Msc of health education
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences - Vice chanellor for Research and Technology
Full name of responsible person
Dr. Alikhani
Street address
Hamadan - opposit of Mardom Park - Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences - Vice chanellor for Research and Technology
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
Hamadan University of Medical Sciences
Full name of responsible person
Tahere etesamifard
Position
student of Msc of health education
Other areas of specialty/work
Street address
Hamadan - opposite of Mardom Park - Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 1838 0574
Fax
Email
ICT@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Tahere Etesamifard
Position
student of Msc of health education
Other areas of specialty/work
Street address
Hamadan - opposite of Mardom Park - Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 1838 0574
Fax
Email
ICT@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Tahere Etesamifard
Position
student of Msc of health education
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
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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