Evaluation of the effect of education intervention based on health belief model on knowledge ,belief and performance of weight management of women with high body mass index in the before pregnancy period in patients referred to comprehensive health centers in Bokan
Determining the effect of educational intervention based on health belief model on knowledge ,belief and performance of weight management of women with high body mass index in the before pregnancy period in Bukan city
Design
The clinical trial has an experimental group and a control group that will be performed with the participation of 68 people by random sampling. Randomization will be based on even and odd numbers.
Settings and conduct
The study will be conducted at Bukan Comprehensive Health Service Centers.
Participants in this study are women of Reproductive age who want to become pregnant.
First, Bukan city in terms of socio-economic status will be divided into three parts : upper, middle and lower. Then, in each level, two centers will randomly selec (even number for the experimental group and odd for the control group).
Participants/Inclusion and exclusion criteria
*Inclusion criteria:
Indigenous regional
Having written consent
Have a fifth grade and higher
literacy Having a smartphone and whats app messenger
Body mass index above 25
No chronic diseases
No stressful events in the last six months in the individual or family
*No entry conditions:
Pregnancy
Illiteracy
Over 50 years old
Having physical activity related diseases such as cardiovascular disease
Having weight management activities
Intervention groups
Holding 4 training classes on pre-pregnancy weight management based on the Health Belief Model via WhatsApp Messenger in the intervention group
Delivery of the training booklet to the control group after the end of the intervention
Main outcome variables
BMI
Awareness
Attitude
Function
Health Belief Model Structures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210824052278N1
Registration date:2021-10-23, 1400/08/01
Registration timing:registered_while_recruiting
Last update:2021-10-23, 1400/08/01
Update count:0
Registration date
2021-10-23, 1400/08/01
Registrant information
Name
Zhila Rashidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3623 3327
Email address
rashidi.zhila81@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-24, 1400/06/02
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
2021-09-10, 1400/06/19
Actual recruitment end date
2022-09-10, 1401/06/19
Trial completion date
2022-09-10, 1401/06/19
Scientific title
Evaluation of the effect of education intervention based on health belief model on knowledge ,belief and performance of weight management of women with high body mass index in the before pregnancy period in patients referred to comprehensive health centers in Bokan
Public title
The effect of education based on health belief model on knowledge ,belief and performance of weight management of women with high body mass index in the before pregnancy period .
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Indigenous
Having written consent
Have a fifth grade and higher literacy
Having a smartphone and whats app messenger
Body mass index above 25 kg per cubic meter
No chronic diseases
No stressful events in the last six months in the individual or family
Exclusion criteria:
Pregnancy
Illiteracy
Over 50 years old
Having physical activity related diseases such as cardiovascular disease
Having weight management activities
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Before sampling, comprehensive urban health service centers will be classified into three levels: high, medium and low based on social and economic status.
The sampling method will be multi-step.
First, based on socio-economic levels, two health centers will be selected from each level. One center for the experimental group and one center for the control group will be randomly selected.
Randomization is based on even and odd numbers and through lotteries. The even number is considered for the experimental group and the odd number is considered for the control group.
We will have a total of 6 centers. Then, in each of the centers, 11 women who refer to the Comprehensive Health Service Center, who are in the pre-pregnancy stage and have the criteria to enter the intervention, will be available. 12 people will be selected in two centers.
A total of 68 people (34 in the control group and 34 in the experimental group) will be included in the study based on the inclusion criteria.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, the control group was kept blind from receiving educational intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of urmia university of Medical sciences
Street address
no.36,Shafaet Alley ,Shohada street
City
saqqez
Province
Kurdistan
Postal code
6681718568
Approval date
2021-08-25, 1400/06/03
Ethics committee reference number
IR.UMSU.REC.1400.199
Health conditions studied
1
Description of health condition studied
Obesity and overweight in women in the before pregnancy stage
ICD-10 code
E66.8
ICD-10 code description
Other obesity
Primary outcomes
1
Description
Weight management in women with higher-than-normal pre-pregnancy body mass index
Timepoint
One month and three months after the intervention
Method of measurement
Using a researcher-made questionnaire based on health belief model and three-factor eating questionnaire and short form physical activity questionnaire
Secondary outcomes
1
Description
Weight Loss
Timepoint
Three months after the intervention
Method of measurement
Weight measurement with accurate and controlled scales with control weights
Intervention groups
1
Description
In the intervention group, 4 training sessions will be held in groups of 6-7 people once a week. The duration of the sessions will be 90-60 minutes. Educational content will be prepared based on credible sources based on needs assessment of the subjects.The trainings will be provided online once a week at a pre-determined time in the form of chat, voice, video and video, and questions and answers. People in the control group will receive only routine pre-pregnancy care. The first session, introduction to the definition of obesity and overweight, explaining some of the major causes of weight gain and obesity. Session 2, Familiarity with the effects of obesity and overweight for the mother, fetus and pregnancy consequences. Session 3, Familiarity with the benefits of weight control in reducing the complications of obesity and weight gain; Obstacles to weight control and solutions to overcome these obstacles. The fourth session, the existing recommendations to change the diet and increase physical activity will be presented according to the National Curriculum Guide to Nutritional Care before Pregnancy of the Ministry of Health.
Category
Behavior
2
Description
Control group: Receive routine care in comprehensive health service centers
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Bukan Comprehensive Health Service Centers
Full name of responsible person
Zhila Rashidi
Street address
Bukan Comprehensive Health Service Centers
City
Bukan
Province
West Azarbaijan
Postal code
6681718568
Phone
+98 87 3623 3327
Email
farokhi.behdad89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia, Resalat Blvd., Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Zilla Rashidi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bukan Comprehensive Health Service Centers
City
Bokan
Province
West Azarbaijan
Postal code
6681718568
Phone
+98 87 3623 3327
Email
rashidi.zhila81@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zhila Rashidi
Position
Bukan Comprehensive Health Service Centers Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bukan Comprehensive Health Service Centers
City
Bukan
Province
West Azarbaijan
Postal code
6681718568
Phone
+98 87 3623 3327
Email
rashidi.zhila81@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zhila Rashidi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bukan city Comprehensive Health Service Centers
City
Bukan
Province
West Azarbaijan
Postal code
6681718568
Phone
009887362367
Email
rashidi.zhila81@gmail.com
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
Extract the results related to the main outcome and compile the final design report and write the article
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If you need a questionnaire or an educational intervention file, provided you refer to the article
From where data/document is obtainable
Author of the article or final report, Jila Rashidi,
rashidi.zhila81@gmail.com
What processes are involved for a request to access data/document
After receiving the email stating that the data has been sent and coordinating with the research team, the data will be sent for at least one month.