Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Ahvaz.
The purpose of this study is to investigate the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant women
Design
Samples were randomly divided into intervention and control groups.Each group has 40 people.
Settings and conduct
This is a semi-experimental interventional study that will be carried out among pregnant women covered by Ahvaz health care centers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 12 to 16 weeks pregnancy, single-crowned pregnancy, having BMI greater than 25 or overweight BMI greater than 30, age over 25 years, having a family history of type 2 diabetes in first-degree relatives, having a history of gestational diabetes or glucose intolerance in the previous pregnancy, having a baby weighing more than 4000 grams, having a premature baby, or losing a baby during the previous pregnancy, and exit criteria: having type 2 diabetes, thyroid disease, cardiovascular disease, respiratory disease, history of taking medications that affect The level of blood sugar like corticosteroids
Intervention groups
Training on pregnant women in the intervention group is based on the glycemic index of food items and their glycemic load and their effect on the blood sugar of the pregnant mother. Pregnant women in the control group receive routine pregnancy training and care. The duration of the intervention is three months.
Main outcome variables
At the beginning and the end of the study will be measured fasting blood glucose, blood glucose 1h ppt and 2h ppt after giving 75 grams of oral glucose, Fasting insulin, hs CRP, total cholesterol, LDL and HDL cholesterol, triglycerides, and the variables of the health belief model.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190227042858N1
Registration date:2019-07-18, 1398/04/27
Registration timing:prospective
Last update:2019-07-18, 1398/04/27
Update count:1
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
Shirin Alipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 6756
Email address
alipour.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Ahvaz.
Public title
The effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Interested in participating in the study
Gestational age 12-16 weeks
Having reading and writing skills
Single pregnancy
Having weight gain, BMI> 25 or obesity, BMI> 30
Age over 25 years
Having a family history of type 2 diabetes in first-degree relatives
Having a history of gestational diabetes or glucose intolerance in previous pregnancies
Having a baby weighing> 4000 grams
Having a baby prematurely or losing a baby during the previous pregnancy
Exclusion criteria:
Having Type 2 Diabetes / Thyroid Disease / Cardiovascular Disease / Respiratory Disease
Having a history of taking drugs that affect blood sugar level, such as corticosteroid medications
Absence of active participation in class / training sessions
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In a randomized simple way, two groups of intervention and control (using random numbers 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 Ahvaz University of Medical Sciences
Street address
Golestan Highway, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.AJUMS.REC.1397.600
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Blood tests and fasting blood glucose measurements
2
Description
Blood Glucose Level One hour, two hours after giving 75 grams of glucose
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Using OGTT
3
Description
Fasting Insulin serum
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Blood test and INS measurement
4
Description
hs CRP measurement
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Blood test and hs CRP measurement
5
Description
Health belief model variables (awareness, sensitivity, severity, perceived benefits and barriers and self-efficacy)
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Health Belief Model Questionnaire
Secondary outcomes
1
Description
Body Mass Index (BMI) measurements
Timepoint
Before intervention and three months after the intervention
Method of measurement
Weight ratio (kg) divided by height (m) to power two
2
Description
Measuring maternal weight gain
Timepoint
Before intervention and three months after the intervention
Method of measurement
digital scale
3
Description
Measure physical activity
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Physical activity questionnaire
4
Description
Measurement of triglyceride levels
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Blood test and TG measurement
5
Description
Total cholesterol level measurements
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Perform blood tests and measure TC
6
Description
Measuring LDL and HDL cholesterol
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Blood test and LDL and HDL measurements
Intervention groups
1
Description
Intervention group: A general questionnaire and a physical activity questionnaire, a three-day dietary questionnaire for food intake and a researcher-made questionnaire based on the HBM model that included awareness, autoimmunity, sensitivity and severity, and the perceived benefits and barriers in choosing action. Nutritional behaviors preventing gestational diabetes mellitus from the population studied before the start of the training session. The training is based on the glycemic index of food items and their glycemic load and its effect on the pregnant mother's blood glucose, the prevalence of gestational diabetes mellitus and its complications for mother and fetus, and the importance of preventing gestational diabetes. At the end of the three-month intervention period, a face-to-face session for the post-test, the Health Belief Model (HBM) questionnaire and the three-day food registration form will be re-launched.
Category
Prevention
2
Description
Control group: Pregnant women in the control group receive routine pregnancy training and care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Services Centers
Full name of responsible person
Shirin alipour
Street address
Health Services Centers
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
alipour.sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Golestan Highway, Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
alipour.sh@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shirin Alipour
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, Faculty of Paramedicine, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 613738319
Email
alipour.sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Borazjani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, Faculty of Paramedicine ، Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 613738319
Email
borazjani-f@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shirin Alipour
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, Faculty of Paramedicine, Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 613738319
Email
alipour.sh@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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