The effects of web-based program training compared to face-to-face training on nutritional literacy and physical activity of Tehrani women with gestational diabetes: a randomized controlled clinical trial
Determining the effect of web-based program training compared to face-to-face training on nutritional literacy and physical activity of women with gestational diabetes in Tehran
Design
A clinical trial with a control group, with parallel groups, on 160 pregnant women from Tehran with gestational diabetes.
Settings and conduct
This study will be conducted as a parallel clinical trial on pregnant women with gestational diabetes from Tehran. Sampling will be done in health centers in Tehran in 2024. After explaining the objectives of the study and its implementation method, informed written consent is obtained from the participants, then they will be randomly assigned to one of the two intervention groups based on the permuted block randomization method in the form of online or face-to-face training. The study period will be 2 months. At the beginning and end of the study, information related to food intake, nutritional literacy, physical activity, and anthropometric evaluations are collected.
Participants/Inclusion and exclusion criteria
Adult pregnant woman over 18 years old, suffering from gestational diabetes, pre-pregnancy body mass index between 18.5-35 kg/m2, singleton pregnancy between 12 and 28 weeks of pregnancy, literate to read and write, use the internet regularly Daily and willing to cooperate.
Intervention groups
Intervention group: Tehrani pregnant women with gestational diabetes will receive nutrition and physical activity training online for 2 months.
Control group: Tehrani pregnant women with gestational diabetes will receive face-to-face nutrition and physical activity training for 2 months.
Main outcome variables
nutritional literacy;
The amount of physical activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230217057441N2
Registration date:2024-02-02, 1402/11/13
Registration timing:prospective
Last update:2024-02-02, 1402/11/13
Update count:0
Registration date
2024-02-02, 1402/11/13
Registrant information
Name
mahsa ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4223 9415
Email address
mahsa.rnjb99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of web-based program training compared to face-to-face training on nutritional literacy and physical activity of Tehrani women with gestational diabetes: a randomized controlled clinical trial
Public title
Evaluation of online training compared to face-to-face training on nutritional literacy and physical activity of Tehrani women with gestational diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult pregnant women over 18 years of age referring to health care centers under the supervision of Tehran University of Medical Sciences for prenatal care in Tehran,
Suffering from gestational diabetes,
Body mass index before pregnancy between 18.5-35 kg/m2,
Singleton pregnancy in the 12th to 28th weeks of pregnancy,
Literate to read and write,
Use the Internet on a daily basis,
Willingness to cooperate.
Exclusion criteria:
Having a history of malabsorption diseases, eating disorders, HIV infection, diabetes, high blood pressure
Current smoking
Lack of literacy
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the permuted block technique using 2 blocks will be based on the BMI variable and will be assigned to one of the two intervention groups with web-based program training or the face-to-face training control group.
Participants will be randomised using stratified permuted blocks. A block size of 2 will be used, and stratification factors are the participant's BMI. People will be allocated to one of the two groups of intervention and control. Random allocation will be based on a random number list, the letters A, and B will be assigned to an equal number of random number lists.
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 in Research Institute of Neuroscience "Neurological Rehabilitation" - Tehran Univer
Street address
Keshavarz street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۳۹
Approval date
2023-09-27, 1402/07/05
Ethics committee reference number
IR.TUMS.NI.REC.1402.024
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus
Primary outcomes
1
Description
Nutritional literacy
Timepoint
Evaluation of nutritional literacy at the beginning of the study (before the start of the intervention) and 2 months after the start of the nutrition education of Tehrani women with gestational diabetes.
Method of measurement
Nutrition literacy questionnaire of pregnant women with gestational diabetes
2
Description
Physical activity
Timepoint
Examination of physical activity at the beginning of the study (before the start of the intervention) and 2 months after the start of nutrition education of Tehrani women with gestational diabetes
Method of measurement
Physical activity questionnaire
Secondary outcomes
1
Description
Gaining weight during pregnancy
Timepoint
Examining the mother's weight at the beginning of the study (before the intervention) and 2 months after the start of nutrition education for Tehrani women with gestational diabetes
Method of measurement
Scale
Intervention groups
1
Description
Intervention group: Tehrani pregnant women with gestational diabetes will receive nutrition and physical activity training online for 2 months.
Category
Lifestyle
2
Description
Control group: Tehrani pregnant women suffering from gestational diabetes will receive face-to-face nutrition and physical activity training for 2 months.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute of Neurosciences "Neural Rehabilitation"
Full name of responsible person
Kurosh Djafarian
Street address
Keshavarz Blvd.Tehran,
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 66 5815 6061
Email
tini@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Futohi
Street address
Tehran Province, Tehran,Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Research assistant of Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kurosh Djafarian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran Province, Tehran, Hojjatdoust St
City
tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5975
Email
info_snsd@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kurosh Djafarian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran Province, Tehran, Hojjatdoust St
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5975
Email
info_snsd@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kurosh Djafarian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran Province, Tehran, Hojjatdoust St
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5975
Email
info_snsd@tums.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