Determining the Effectiveness of an Educational Program Based on Health Action process Approach on Lifestyle of Women with history of Gestational Diabetes
The effect of educational intervention based on health action process approach on lifestyle of women with gestational diabetes
Design
This study is a randomized controlled clinical trial, and 70 women with history of gestational diabetes will be randomly assigned into two intervention and control groups.
Settings and conduct
In this study, 70 women referred to Tonekabon health centers who had a history of gestational diabetes in their recent pregnancy were randomly divided into intervention and control groups after obtaining informed consent.in Intervention group will present 3 sessions Training Program based on Health Action Approach to Prevent Type 2 Diabetes. The control group will not receive any training.
Participants/Inclusion and exclusion criteria
All women with a history of gestational diabetes in their recent pregnancy that they have Iranian nationality who are able to read and write in Persian can participate in this study if they have given birth at least 6 months up to two years ago. But if they have type one or two diabetes, chronic diseases such as heart disease, hypertension, thyroid disease and ... mental illness and cancer as well as having a physical disability that impedes physical activity and also pregnancy or pregnancy planning In the next 6 months, smoking, drinking and drug use will not be eligible.
Intervention groups
In the intervention group, the training program will be conducted in 3 sessions of 90 minutes in lecture, group discussion, question and answer and slide show at the health center.The content of the curriculum is designed based on the results of a cross-sectional study, a literature review and the opinion of nutritionists, physical education and health educators and based on a health action process approach theory.The control group will receive routine care.
Main outcome variables
Physical Activity Score and Food Group Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200108046051N1
Registration date:2020-01-16, 1398/10/26
Registration timing:prospective
Last update:2020-01-16, 1398/10/26
Update count:0
Registration date
2020-01-16, 1398/10/26
Registrant information
Name
Banafshe Mohamadi zeidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
mohamadi23@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the Effectiveness of an Educational Program Based on Health Action process Approach on Lifestyle of Women with history of Gestational Diabetes
Public title
Determining the Effectiveness of an Educational Program on Lifestyle of Women with history of Gestational Diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
They have a history of gestational diabetes in their recent pregnancy.
Passing at least 6 months to a maximum of 2 years after delivery.
Able to read and write Persian.
Exclusion criteria:
She has type one or two diabetes.
Chronic diseases such as heart and respiratory diseases.
She has mental illness.
She has Cancer.
Any physical disability that impedes physical activity.
Is pregnant or planning to become pregnant in the next six months.
Consume cigarettes, alcohol and other drugs.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by using random numbers in Excel software (Rand function)
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-01-08, 1397/10/18
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.831
Health conditions studied
1
Description of health condition studied
lifestyle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physical activity score
Timepoint
Food subgroups score
Method of measurement
International Physical Activity Questionnaire (IPAQ)
2
Description
Food subgroups score
Timepoint
Food subgroups score
Method of measurement
Food Frequency Questionnaire (FFQ)
Secondary outcomes
1
Description
weight
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
balance scale
Intervention groups
1
Description
The intervention group will receive 3 sessions of counseling and education based on a health action process approach theory in the areas of nutrition and physical activity to prevent type 2 diabetes. The first session will cover the long-term consequences of gestational diabetes and type 2 diabetes, groups at risk for type 2 diabetes, and ways to prevent or delay type 2 diabetes. These are ways to lose weight, reduce calories, reduce harmful fats, increase fiber and increase physical activity. The positive consequences of healthy eating and physical activity will also be discussed. The interval time of each session with the next session will be a week, each session will take 90 minutes that includes fifteen minutes for a review of past session content, forty-five minute for presentation and individual counseling as required references will be thirty minutes and also a booklet about nutrition and physical activity will given to them. This booklet develop based on review of document and comment of expert.
Category
Lifestyle
2
Description
The control group will receive the routine cares.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Urban Health Care Centres
Full name of responsible person
Banafshe Mohamadi Zeidi
Street address
Urban Health Care Centres., Tonekabom., Mazandaran.,
City
Tonekabon
Province
Mazandaran
Postal code
-
Phone
+98 11 5438 2186
Email
Mohamadi23@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Ziaei
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak.,
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9781
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Banafshe Mohamadi Zeidi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niayesh intersection, Vali-e-Asr street,.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
Mohamadi23@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Noroussadat Kariman
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niayesh intersection., Vali-e-Asr street.,
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
n_kariman@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Banafshe Mohamadi Zeidi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niayesh intersection., Vali-e-Asr street.,
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
Mohamadi23@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
We can share information about the main outcome. The data will spread unknown.
When the data will become available and for how long
The data will be an accessible 6-12 month after publishing the results.
To whom data/document is available
Researchers in academic institutes were allowed to access data.
Under which criteria data/document could be used
With stating the reference.
From where data/document is obtainable
Sending email to corresponding author through: n_kariman@yahoo.com
What processes are involved for a request to access data/document
An application letter must include the name of the applicant, used item, the scientific title of the research project or article.