1) Objectives:The aim of this study is to assess the efficacy of Reproductive Life Plan (RLP)-based counseling in improving women’s knowledge and attitudes towards healthy reproduction. 2) Design: This is a randomized-controlled trial. 3) Setting and conduct: A health care services centre no. 7 in Sari city, Mazandaran. 183 women will be randomly allocated in three groups of intervention (n=61) and two control groups of each 61 women. 4) The study population will consist of reproductive-aged women (15-44 year) who will attend a primary health care center to receive health care services including pap smear, vaccination and routine health check-up. The study exclusion criterion is having permanent contraceptive methods. 5) At baseline, the intervention group will receive an RLP-based information session of 5-15 minutes duration plus an informative brochure regarding health reproduction. Intervention and two control groups all will receive routine care. The study tool is a questionnaire developed by the investigators using a literature search. Its validity and reliability were confirmed. The study questionnaire includes questions about demographic, reproductive history, knowledge and attitudes towards reproduction. At the follow-up visit, which is two months after the baseline visit, all participants in the three groups will fill in the study questionnaire. The intervention group will receive additional questions on their views and opinion about the intervention. 6) main outcome measures: Knowledge about folic acid intake prior to pregnancy and healthy reproduction
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091929880N1
Registration date:2016-11-14, 1395/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
Ensieh Fooladi
Name of organization / entity
Mazandaran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
ensieh.fooladi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
Expected recruitment start date
2016-10-03, 1395/07/12
Expected recruitment end date
2017-04-03, 1396/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Reproductive Life Plan-based counselling in improving knowledge and attitudes of women towards healthy reproduction
Public title
The efficacy of Reproductive Life Plan-based counselling in improving knowledge and attitudes of women towards healthy reproduction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 15-44 year-old women referred to a health care services center no. 7 in Sari.
Exclusion criteria: Having used a permanent method of contraception such vasectomy or tubal ligation
Age
From 15 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
183
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 Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research, Moallem Street, Sari, Mazandaran University of Medical Sciences
City
Sari
Postal code
4816715793
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
IR.MAZUMS.REC.95.2535
Health conditions studied
1
Description of health condition studied
Contraceptive Counselling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Knowledge of women towards taking folic acid before pregnancy and healthy reproduction
Timepoint
Before and two months after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Attitude towards reproductive health and evaluation of the intervention by participants
Timepoint
2 months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
After filling the questionnaire at baseline and receiving the routine health care, the intervention group will receive an RLP-based information session of 5-15 minutes duration plus an informative brochure regarding healthy reproduction.
Category
Prevention
2
Description
Two control groups all will receive routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
A Health Care Center in Sari, No. 7
Full name of responsible person
Dr .Ensieh Fooladi
Street address
Nasibeh Nursing and Midwifery School, Vesal Street, Sari, Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice Chancellor for Research building, Moallem Street, Sari, Mazandaran University of Medical Sciences
City
Sari
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, Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr. Ensieh Fooladi
Position
PhD
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Street, Sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
Email
ensieh.fooladi5@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr.Ensieh Fooladi
Position
PhD
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
Email
ensieh.fooladi5@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr.Ensieh Fooladi
Position
PhD
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
Email
ensieh.fooladi5@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)