The effect of nutrition-based educational intervention based on Health Action Process Approach (HAPA) on pregnancy outcomes of pregnant mothers covered by nutritional support program
Determining the effect of nutrition-based educational intervention based on HAPA educational model on pregnancy outcomes of pregnant mothers covered by support program
Design
Randomized trial with control group, with parallel groups, without blinding, randomized by simple randomized method using randomizer website, phase 3 on 210 participants.
Settings and conduct
This study will be performed in comprehensive health centers of Qazvin province. Pregnant women covered by the nutritional support program are randomly selected and assigned to intervention or control groups. Due to the nature of the study, blinding is not performed. The intervention group will receive nutrition process training based on health practice.
Participants/Inclusion and exclusion criteria
Inclusion criteria: mother's unfavorable economic status; BMI < 18.5 at the beginning of pregnancy; weight < 45 kg before pregnancy; Hemoglobin < 11 gr/dl; multi fetal gestation; unfavorable weight gain during pregnancy based on the table of weight gain in terms of BMI.
Exclusion criteria: lack of regular visits to receive prenatal care; reluctance to participate in the study.
Intervention groups
Intervention group: receiving nutrition-based educational intervention based on HAPA educational model.
Control group: no intervention only routine care.
Main outcome variables
Health action process approach constructs; consequences of pregnancy include type of delivery, gestational anemia, gestational diabetes, hypertension in pregnancy, optimal gestational weight gain, birth weight, neonatal hypothyroidism, weight for child age.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038789N5
Registration date:2020-12-24, 1399/10/04
Registration timing:prospective
Last update:2020-12-24, 1399/10/04
Update count:0
Registration date
2020-12-24, 1399/10/04
Registrant information
Name
Zainab Alimoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6003
Email address
z.alimoradi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nutrition-based educational intervention based on Health Action Process Approach (HAPA) on pregnancy outcomes of pregnant mothers covered by nutritional support program
Public title
Nutrition-based educational intervention based on Health Action Process Approach (HAPA) on pregnancy outcomes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inadequate economic status of the mother
BMI <18.5 before pregnancy
weight <45 kg before pregnancy
hemoglobin < 11 gr/dl
multi fetal gestation
Unfavorable weight gain during pregnancy based on the table of weight gain in terms of BMI
Exclusion criteria:
Irregular visits for prenatal care
Reluctance to participate in the study
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method was used to assign individuals in study groups. Assignment sequences were generated using the randomizer website. To hide the allocation sequence, 240 matte envelopes were prepared. The type of intervention was written based on the allocation sequence and was placed inside a matte envelope and closed.
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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.QUMS.REC.1398.209
Health conditions studied
1
Description of health condition studied
Gestational outcomes
ICD-10 code
O99
ICD-10 code description
Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
The constructs of the health action process approach include behavioral intent, outcome expectations, perceived risk, action planning, self-planning, self-efficacy, self-efficacy improvement
Timepoint
Before and 3 months after the intervention
Method of measurement
Questionnaire
2
Description
Consequences of pregnancy include type of delivery, gestational anemia, gestational diabetes, hypertension in pregnancy, optimal gestational weight, birth weight, neonatal hypothyroidism, weight for child age
Timepoint
3 months after the intervention
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receive nutrition training based on the structures of the health action process approach model in 3 sessions of 45 to 60 minutes, which will be presented by a nutrition expert in the form of a lecture, group discussion with an educational pamphlet. Training will be designed based on the structures of the health action process approach model, including self-efficacy, behavioral intent, outcome expectations, perceived risk, action control, action planning, and nutrition planning related to pregnancy.
Category
Prevention
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health clinics affiliated to Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6005
Email
zainabalimoradi.sbmu.ac.ir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr MohammadMahdi EmamJomeh
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 7006
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6003
Fax
Email
z.alimoradi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
ُQazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6003
Fax
Email
z.alimoradi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6003
Fax
Email
z.alimoradi@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' individual data after unidentifiable
When the data will become available and for how long
Start the access period at the same time as printing the results
To whom data/document is available
There are no restrictions on access
Under which criteria data/document could be used
For secondary analysis and by sending an email request
From where data/document is obtainable
Email to the responsible author
What processes are involved for a request to access data/document