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Effect of preconception counseling on health promoting behaviors of reproductive age women

Protocol summary

Summary
This study aimed to investigate the effect of educational intervention on promoting healthy behaviors of reproductive age women in Sari city. Methods: This study is a randomized controlled trial, that 104 women in childbearing age that randomly selected in SARI city and assigned to intervention and control groups (n=52). Inclusion criteria was women who willing childbearing at age 18-40, physical and mental wellness, lack of the history of mental illness, lack of addiction, residence in the city of Sari and exclusion criteria was not wanting to continue participation in the study and relocation and migration from Sari city. The data collection tool was social demographic questionnaire (has 15 questions: demographic data and history of pregnancy) and health promoting life style ॥ (HPLP-II) questionnaire, Including 6 dimension: health responsibility, physical activity, nutritional status, spiritual growth, stress management and interpersonal relationship. According to information obtained from the pre-test stage, educational intervention about the dimension of health promoting behaviors were conducted for intervention group. To intervention group, was used of pamphlets and training package prepared by the researcher. Intervention program was including educational sessions and once a week. A month after the intervention, data (Scores of dimension of health promoting behaviors) collected using the same basic questionnaire in two groups, and were analyzed with parametric and non parametric tests. Keywords: Preconception counseling, health promotion, reproductive age, health promoting behaviors

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016030226879N1
Registration date: 2016-04-04, 1395/01/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-04, 1395/01/16
Registrant information
Name
marzieh shabani chepi
Name of organization / entity
health school of guilan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 11 4203 8293
Email address
mshabani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preconception counseling on health promoting behaviors of reproductive age women
Public title
Effect of Preconception Counseling on Health Promoting Behaviors
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 and 40 years; being physically and mentally healthy; lack of addiction; have at least read and write; fill informed consent to participate in the study; residence in the city of Sari. Exclusion criteria: Not wanting to continue participation in the study; relocation and migration from the city of Sari.
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: 104
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
Guilan University of Medical Sciences
Street address
School of Health, Guilan University of Medical Sciences, Resalat street, Rasht, Iran.
City
Rasht
Postal code
-
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
1930596722

Health conditions studied

1

Description of health condition studied
Relationship of preconception counseling on health promoting behaviors of reproductive age women
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Health responsibility
Timepoint
Before and one month after the intervention
Method of measurement
Health-promoting lifestyle questionnaire score

2

Description
physical activity
Timepoint
Before and one month after the intervention
Method of measurement
Health-promoting lifestyle questionnaire score

3

Description
nutrition status
Timepoint
Before and one month after the intervention
Method of measurement
Health-promoting lifestyle questionnaire score

4

Description
spiritual growth
Timepoint
Before and one month after the intervention
Method of measurement
Health-promoting lifestyle questionnaire score

5

Description
interpersonal relationships
Timepoint
Before and one month after the intervention
Method of measurement
Health-promoting lifestyle questionnaire score

6

Description
stress management
Timepoint
Before and one month after the intervention
Method of measurement
Health-promoting lifestyle questionnaire score

7

Description
total score of health promoting behaviors
Timepoint
Before and one month after the intervention
Method of measurement
Health-promoting lifestyle questionnaire score

Secondary outcomes

empty

Intervention groups

1

Description
interventional group: after selecting the desired samples according to the criteria, questionnaires will be distributed and completed. According to information obtained from the pre-test stage, educational needs of research units determined and educational intervention conducted for intervention group. For test groups used the training package prepared by the researcher. Intervention program including educational sessions and once a week. A month after the intervention, data collected using the same basic questionnaire in two groups.
Category
Lifestyle

2

Description
Control group: for control group, like the clients of other health centers is used of booklet,s Safe Motherhood national program: integrated maternal health care the Ministry of Health". Preconception counseling be done in 1-2 sessions Individually.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No. 8 and 5 Sari
Full name of responsible person
Marzieh Shabani Chepi, master of health education
Street address
Health Center No. 8 and 5, Sari, Mazandaran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Azari, Research Assistant
Street address
School of Health, Guilan University of Medical Sciences, Resalat street, Rasht, Iran.
City
Rasht
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
School of Health, Guilan University of Medical Sciences
Full name of responsible person
Marzieh Shabani Chepi
Position
Student - MA
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences, Resalat street, Rasht, Iran.
City
Rasht
Postal code
-
Phone
+98 13 3384 9411
Fax
-
Email
mshabani_2007@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health, Guilan University of Medical Sciences
Full name of responsible person
Marzieh Shabani Chepi
Position
Student, Master of Science
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences, Resalat street, Rasht, Iran.
City
Rasht
Postal code
Phone
+98 13 3384 9411
Fax
Email
mshabani_2007@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Health, Guilan University of Medical Sciences
Full name of responsible person
Marzieh Shabani Chepi
Position
Student, master of health education
Other areas of specialty/work
Street address
School of Health, Guilan University of Medical Sciences, Resalat street, Rasht, Iran.
City
Rasht
Postal code
-
Phone
+98 13 3384 9411
Fax
-
Email
mshabani_2007@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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