Objectives: The aim of this study is to determine the effect of education on postpartum lifestyle in primiparous mothers.
Design: Two parallel arm Randomized Controlled Trial.
Setting and conduct: This study will be conducted in postpartum wards of four hospitals in Tabriz (2 educational hospitals and 2 private hospitals that will be selected randomly). Eligible women will be randomly assigned into 2 groups of 110 subjects with block sizes of 4 and 6, stratified by hospital type. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants: Hospitalized primiparous mothers in the postpartum ward.
Intervention: The intervention group will receive education about postpartum lifestyle and control group will receive no intervention. On the day of discharge from the hospital, face to face education and an educational booklet about postpartum lifestyle will be provided to intervention group. Telephone counseling will be provided for at least 10 minutes at the end of second week of postpartum for intervention group. Every 5 days until 6 weeks, a message about health and nutrition will be sent to the mobile phone of mothers and their husbands appropriate to spent days of birth.
Main outcome measures: Physical activity and food subgroups scores will be respectively assessed by IPAQ and FFQ questionnaires at the end of 6 weeks after birth, also the health-related behaviors will be evaluated at the end of 2 and 6 weeks after birth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042110324N13
Registration date:2013-05-26, 1392/03/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-26, 1392/03/05
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-06-10, 1392/03/20
Expected recruitment end date
2013-12-11, 1392/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education on postpartum lifestyle in primiparous mothers: a randomized controlled trial
Public title
Effect of education on postpartum lifestyle in primiparous mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: delivered nulliparous women during the last 12 hours; Vaginal or cesarean delivery; Singleton birth; having a healthy and full-term newborn; Desire to breastfeed; Living in Tabriz and suburb; Having low-risk pregnancy; 18 years old and older; Being able to speaking and understanding the Persian language; Willingness to participate in the study; Willingness to come back to the hospital at the end of the 6-week postpartum for visiting and completing of questionnaires; Having a home phone; Having a mobile phone (both parturient woman and her husband).
Exclusion Criteria: Diagnosed physical and mental illnesses in the mother; Following specific diet; History of hospitalization of the mother or baby in hospital during postpartum period; Change in location during the study; Divorce.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
220
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
Approval date
2013-04-29, 1392/02/09
Ethics committee reference number
9218
Health conditions studied
1
Description of health condition studied
Postpartum lifestyle
ICD-10 code
Z39.0
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
Physical activity score
Timepoint
6 weeks after intervention
Method of measurement
International Physical Activity Questionnaire (IPAQ)
2
Description
Food subgroups score
Timepoint
6 weeks after intervention
Method of measurement
Food Frequency Questionnaire (FFQ)
3
Description
Health-related behaviors status
Timepoint
2 and 6 weeks after intervention
Method of measurement
Health-related behaviors questionnaire
Secondary outcomes
1
Description
Frequency of maternal health problems
Timepoint
2 and 6 weeks after intervention
Method of measurement
Maternal health problems checklist
2
Description
Knowledge score about nutrition and health
Timepoint
Before and 6 weeks after intervention
Method of measurement
Knowledge questionnaire about nutrition and health
3
Description
Health belief score
Timepoint
Before and 6 weeks after intervention
Method of measurement
Health belief questionnaire
Intervention groups
1
Description
Intervention group: Mothers in the intervention group will receive face to face counseling and education about postpartum lifestyle and booklet, also messages about health and nutrition will be sent to the mobile phone of mothers and their husbands.
Category
Lifestyle
2
Description
Control group: The control group will not receive the intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farzane Khodabande
Street address
South Shariati Street, Nursing & Midwifery Faculty
City
Tabriz
2
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Farzane Khodabande
Street address
South Shariati Street, Nursing & Midwifery Faculty.
City
Tabriz
3
Recruitment center
Name of recruitment center
Private hospital
Full name of responsible person
Farzane khodabande
Street address
South Shariati Street, Nursing & Midwifery Faculty
City
Tabriz
4
Recruitment center
Name of recruitment center
Private hospital 2
Full name of responsible person
Farzane Khodabande
Street address
South Shariati Street, Nursing & Midwifery Faculty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Shakouri Seyyed Kazem
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
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 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
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Farzane Khodabande
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
South Shariati Street, Nursing & Midwifery Faculty