The present study was conducted to design and explore the effectiveness of an educational intervention based on some constructs of the Health Belief Model (HBM) in preventing excessive gestational weight gain (GWG) among pregnant women in Isfahan, Iran.
Design
This study is a single blind, randomized controlled clinical trial with parallel group design
Settings and conduct
This survey was done in Isfahan health care centers. 100 pregnant women were randomly selected and allocated to intervention and control groups with the use of random number table. Then, intervention group members have participated in four educational sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Consent for participation in the study;The pregnant women aged 18-35 years old referred to Isfahan health care centers; Pre- pregnancy BMI between 18.5 and higher; Gestational age of 15 weeks; Singleton pregnancy.
Exclusion criteria:
Diagnosed mental health problems such as anxiety, depression and Obsessive-Compulsive Disorder (OCD); BMI higher than 30 kg/m².
Intervention groups
Intervention group: four educational sessions were designed and conducted for intervention group members based on Health Belief Model Constructs.
Control group: There was not any educational session for the control group and they have received only the routine cares from health care centers.
Main outcome variables
Gestational Obesity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180703040325N1
Registration date:2018-08-20, 1397/05/29
Registration timing:retrospective
Last update:2018-08-20, 1397/05/29
Update count:0
Registration date
2018-08-20, 1397/05/29
Registrant information
Name
Hossein Shahnazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3243
Email address
h-shahnazi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2016-09-10, 1395/06/20
Trial completion date
empty
Scientific title
Designing and Implementing an Educational Intervention for Preventing Gestational Obesity : The Application of the Health Belief Model
Public title
The effect of educational intervention based on Health Belief Model on Gestational Obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Consent for participation in the study
The pregnant women at the age of 18-35 years old referred to Isfahan health care centers
Pre- pregnancy BMI between 18.5 and higher
Gestational age 15 weeks
Singleton pregnancy
Exclusion criteria:
Diagnosed mental health problem such as anxiety, depression, and Obsessive-Compulsive Disorder (OCD)
BMI higher than 30 kg/m²
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:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants were selected by multi-stage sampling. At first, all districts in Isfahan were categorized into five sections, namely north, south, west, east, and central. Two health centers were selected randomly from each district to organize the intervention and control groups. Next, medical records of 100 pregnant women were randomly selected and allocated to intervention and control groups using random number table.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
IR.MUI.REC.1394.3.350
Health conditions studied
1
Description of health condition studied
Excessive Gestational Weight Gain
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS
Primary outcomes
1
Description
The mean score of Health Belief Model constructs
Timepoint
Before intervention, Two and four months after intervention
Method of measurement
The questionnaire of Health Belief Model
2
Description
Excessive Gestational Weight Gain
Timepoint
Two and four months after intervention
Method of measurement
Balance (Seca) scale (precision = 0.1 kg)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The subjects of the intervention group were assigned to four 10- to 15-member groups and attended the training sessions once a week for four weeks. An outlook of educational sessions are:Increasing knowledge about the usefulness of healthy diet and physical activity, severity and duration of physical activity, to become familiar with the changes of nutritional needs and advised weight gain in pregnancy. Perceived susceptibility: Referring to the statistics of overweight problems during pregnancy for the mother and the fetus using the figure and related images. Self-efficacy: Breaking down the overall goals into smaller goals for making implementation easier and using a role model and verbal encouragement to promote the self-confidence of pregnant women. Perceived barriers: Discussion of possible solutions to solving negative attitudes to improve nutritional status and physical activity in them. Cues to action: Getting help from other family members to improve the healthy lifestyle of pregnant women.
Category
Prevention
2
Description
Control group: The control group has received only the routine education from health care centers.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dastgerd health center
Full name of responsible person
Hossein Shahnazi
Street address
Ghaemieh Ave, Zoobahan Highway, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8177916841
Phone
+98 31 3780 8847
Email
h_shahnazi@yahoo.com
2
Recruitment center
Name of recruitment center
َAmirhamzeh health center
Full name of responsible person
Hossein Shahnazi
Street address
Fourth Ave, Amirhamzeh Town, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8198374454
Phone
+98 31 3775 1889
Email
h_shahnazi@yahoo.com
3
Recruitment center
Name of recruitment center
Rehnan health center
Full name of responsible person
Hossein Shahnazi
Street address
Hasheminejad Ave, Rehnan BLvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8136643981
Phone
+98 31 3331 7091
Email
h_shahnazi@yahoo.com
4
Recruitment center
Name of recruitment center
Sajad health center
Full name of responsible person
Hossein shahnazi
Street address
Azadegan Cross, Golestan Ave, Khaneh Isfahan
City
Isfahan
Province
Isfehan
Postal code
8149716581
Phone
+98 31 3420 5052
Email
h_shahnazi@yahoo.com
5
Recruitment center
Name of recruitment center
Azadegan health center
Full name of responsible person
Hossein Shahnazi
Street address
Shojaei Alley, Olfat Cross, Hojatieh Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8177759161
Phone
+98 31 3662 0522
Email
h_shahnazi@yahoo.com
6
Recruitment center
Name of recruitment center
Shahid keshavari health center
Full name of responsible person
Hossein Shahnazi
Street address
Golestan Ave, Shahid Keshvari Town, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8185874885
Phone
+98 31 3633 0400
Email
h_shahnazi@yahoo.com
7
Recruitment center
Name of recruitment center
Enghelab health center
Full name of responsible person
Hossein Shahnazi
Street address
Fateh Street, Hezarjerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8197618661
Phone
+98 31 3668 7303
Email
h_shahnazi@yahoo.com
8
Recruitment center
Name of recruitment center
Baharestan health center
Full name of responsible person
Hossein Shahnazi
Street address
North Valiasr Blvd, Baharestan Town, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8148657113
Phone
+98 31 3685 0220
Email
h_shahnazi@yahoo.com
9
Recruitment center
Name of recruitment center
Golzar health center
Full name of responsible person
Hossein Shahnazi
Street address
Basij Alley, Shafagh Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8139614416
Phone
+98 31 3788 8349
Email
h_shahnazi@yahoo.com
10
Recruitment center
Name of recruitment center
Vahid health center
Full name of responsible person
Hossein Shahnazi
Street address
Shabbidar Alley, Vahid Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8179916787
Phone
+98 31 3775 6531
Email
h_shahnazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD