The effect of intervention based on health belief model on dietary behavior promotion among pregnant women with iron deficiency anemia attending to health center
This study aimed to determine the effect of intervention based on health belief model on nutritional behaviors anemic pregnant women that referred to health centers in Orumieh, 1395. The statistical population were 90 pregnant women with iron deficiency anemia diagnosed based on having HB<11 mg/dl in the first pregnancy care (6-10 gestational weeks). In this study, six health centers were selected based on the three level division (level 1, 2 and 3) of the Deputy of Health and in each level, 30 available people attended two centers in that level were randomly selected according to inclusion and exclusion criteria. In each level, people were randomly assigned to the intervention and control groups using sealed envelopes. After completing a researcher-made questionnaire based on the Health Belief Model by the intervention group on anemia and nutrition during pregnancy, the educational and counseling sessions for the intervention group were held through 4 sessions of 60-90 minutes (one session every week) and the control group will receive routine care. Inclusion criteria included age between 18-35 years; nonspecific underlying disease; iron deficiency anemia; normal BMI. Exclusion criteria included high risk pregnancy. Two months after the ending of intervention in both groups, questionnaires will be completed in the presence of researcher and changes of hemoglobin, knowledge, nutritional behavior and structures pattern will be analyzed between and within the two intervention and control groups before and after consultation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121824340N10
Registration date:2017-08-25, 1396/06/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-25, 1396/06/03
Registrant information
Name
Hamideh Mohaddesi
Name of organization / entity
Urmia University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4963
Email address
mohaddesi.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Orumieh University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention based on health belief model on dietary behavior promotion among pregnant women with iron deficiency anemia attending to health center
Public title
The impact of counseling on dietary behaviors among anemic pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : aged between 35-18 years; no specific underlying disease :chronic renal failure and infection of HI, parasitic infections, malaria, schistosomiasis and hookworm infections; iron deficiency anemia :Hemoglobin less than 11 mg per deciliter and willingness to enter the study; ability to read and write; experiencing last pregnancy less than last three years.
Exclusion criteria: Pre-eclampsia and eclampsia; gestational diabetes; preterm delivery; hyperemesis gravidarom; high and low BMI below 18.5 and over 25.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After selecting the people of each center based on the criteria of entry and exit , randomly using a packet in a blind and blind envelope, the control group will be 30 and the intervention group will be 30 people.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
(postal code:571478334), Urmia University of Medical Sciences, Orghance Street, Resalat blvd, Urmia
City
Urmia
Postal code
5714783734
Approval date
2016-08-19, 1395/05/29
Ethics committee reference number
IR.UMSU.REC.13950218
Health conditions studied
1
Description of health condition studied
anemia
ICD-10 code
Nutritiona
ICD-10 code description
D50.9 Iron deficiency anaemia, unspecified
Primary outcomes
1
Description
Dietary behavior
Timepoint
Pretest (Before intervention) and post test (Two months after intervention)
Method of measurement
Questionnaire created based on Health Belief Model
2
Description
Knowledge
Timepoint
Pretest (Before intervention) and post test (Two months after intervention)
Method of measurement
Questionnaire created based on Health Belief Model
3
Description
Perceived susceptibility
Timepoint
Pretest (Before intervention) and post test (Two months after intervention)
Method of measurement
Questionnaire created based on Health Belief Model
4
Description
Perceived severity
Timepoint
Pretest (Before intervention) and post test (Two months after intervention)
Method of measurement
Questionnaire created based on Health Belief Model
5
Description
Perceived benefits
Timepoint
Pretest (Before intervention) and post test (Two months after intervention)
Method of measurement
Questionnaire created based on Health Belief Model
6
Description
Perceived barriers
Timepoint
Pretest (Before intervention) and post test (Two months after intervention)
Method of measurement
Questionnaire created based on Health Belief Model
7
Description
Cues to action
Timepoint
Pretest (Before intervention) and post test (Two months after intervention)
Method of measurement
Questionnaire created based on Health Belief Model
8
Description
Self efficacy
Timepoint
Pretest (Before intervention) and post test (Two months after intervention)
Method of measurement
Questionnaire created based on Health Belief Model
Secondary outcomes
1
Description
Hemoglobin
Timepoint
One month after iron therapy and 26th-30th week of pregnancy
Method of measurement
Health records
Intervention groups
1
Description
Intervention group: After completing a researcher-made questionnaire based on the Health Belief Model by the intervention group on anemia and nutrition during pregnancy, the educational and counseling sessions for the intervention group were held through 4 sessions of 60-90 minutes (one session every week) and these educational contents were given to the patients via lecture, Group discussion, question and answer as well as individual nutrition counseling according to the health belief model and according to the country's guidelines.
Category
Prevention
2
Description
Control group: After completing a researcher-made questionnaire based on the health belief model, the control group did not undergo any educational interventions on anemia and nutrition during pregnancy. The control group received only routine health care from their care providers.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz Health Center
Full name of responsible person
Hamideh Mohaddesi
Street address
Alborz street, Urmia
City
Urmia
2
Recruitment center
Name of recruitment center
Behdari Health Center
Full name of responsible person
Hamideh Mohaddesi
Street address
Behdari street, Urmia
City
Urmia
3
Recruitment center
Name of recruitment center
Dizaje siavash Health Center
Full name of responsible person
Hamideh Mohaddesi
Street address
Marefat alley,Shora street, Urmia
City
Urmia
4
Recruitment center
Name of recruitment center
17 Shahrivar Health Center
Full name of responsible person
Hamideh Mohaddesi
Street address
Shahid Ebrahimi alley, 17 Shahrivar street, Urmia
City
Urmia
5
Recruitment center
Name of recruitment center
SHohada Health Center
Full name of responsible person
Hamideh Mohaddesi
Street address
Babasaei street, Urmia
City
Urmia
6
Recruitment center
Name of recruitment center
Nikkhah Health Center
Full name of responsible person
Hamideh Mohaddesi
Street address
Rajaii street, Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences ,Orjhans Street ,Resalat Boulevard
City
Urmia
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 of Urmia 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
Urmia University Of Medical Sciences
Full name of responsible person
Hamideh Mohaddesi
Position
Assistant Professor, Nursing and Midwifery Department
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty Urmia
City
Urmia
Postal code
5714783734
Phone
+98 44 3327 5496
Fax
Email
hmohaddesi.han@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University Of Medical Sciences
Full name of responsible person
Hamideh Mohaddesi
Position
Assistance professor, Nursing and Midwifery department
Other areas of specialty/work
Street address
Urmia University Of Medical Science, Nursing and Midwifery Faculty Urmia
City
Urmia
Postal code
5714783734
Phone
+98 44332754963
Fax
Email
hmohaddesi.han@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University Of Medical Sciences
Full name of responsible person
Hamideh Mohaddesi
Position
Assistant Professor, Nursing and Midwifery Department
Other areas of specialty/work
Street address
Urmia University Of Medical Sciences
City
Urmia
Postal code
5715171534
Phone
+98 44 3368 6419
Fax
Email
hmohaddesi.han@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)