Effect of Web-Based Education on Gestational Diabetes Mellitus and Health Management Self Efficacy (GDM)
Primary Purpose
Pregnancy Complications, Efficacy, Self
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
web based education
Sponsored by
About this trial
This is an interventional supportive care trial for Pregnancy Complications focused on measuring Gestational Diabetes Mellitus, self efficacy, web based education
Eligibility Criteria
Inclusion Criteria:
- Being 18 years or older
- Being primigravida or multigravida
- Getting a diagnosis of Gestational Diabetes Mellitus
- Having a gestational week between 24-28
- Having a single fetus
- Ability to use the Internet (Computer, tablet, smart phone, etc.)
- Voluntary participation in the research
Exclusion Criteria:
- Having a diagnosis of Type 1 and Type 2 Diabetes Mellitus
- Having another chronic disease
- Having a visual or hearing impairment
- Having a psychiatric medical diagnosis
- Having a diagnosis of risky pregnancy not related to GDM
Sites / Locations
- Dokuz Eylul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
web based education and routine clinical procedure
only routine clinical procedure
Outcomes
Primary Outcome Measures
Change from Self Rated Abilities for Health Practices levels in pregnant women with GDM
Self Rated Abilities for Health Practices Scale: Self Rated Abilities for Health Practices Scale: The 5-point Likert scale was adapted for Turkish version by Aypar Akbağ and Aluş Tokat (Aypar Akbağ and Aluş Tokat, 2021). The scale consists of 4 sub-dimensions: "Exercise"," Responsible Health Practices", "Psychological Well Being" and "Nutrition". (from 0 (not at all) to 4 (completely). The scale total-score ranged between 0 and 112, while subscale total-scores ranging from 0 to 28 points. The higher scores from the scale indicate higher self-efficacy levels for the health applications.
Secondary Outcome Measures
Rate of maternal-fetal-neonatal complications in pregnant women with GDM
The chart was used to evaluate the maternal (ketoacidosis, preeclampsia, polyhydramnios, preterm labor, vaginal or urinary infection), fetal (macrosomia, Intrauterine Growth Retardation) and neonatal (neonatal hypoglycemia, polycythemia and neonatal hyperbilirubinemia, duration of treatment for hyperbilirubinemia, Respiratory Distress Syndrome (RDS), hypothermia, dehydration) complications of Gestational Diabetes Mellitus. Complications during pregnancy and postpartum period were followed up. Complication follow-up was done by contacting the intervention group via the website. In the control group, complication follow-up was obtained by phone calls.
Full Information
NCT ID
NCT05141929
First Posted
October 25, 2021
Last Updated
December 2, 2021
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT05141929
Brief Title
Effect of Web-Based Education on Gestational Diabetes Mellitus and Health Management Self Efficacy
Acronym
GDM
Official Title
Effect of Web-Based Education Related to Gestational Diabetes Mellitus on Women Health Management Self Efficacy and Maternal-Fetal-Neonatal Results
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized controlled study aimed to examine the effect of web-based education related to Gestational Diabetes Mellitus on women health management self-efficacy and maternal-fetal-neonatal results.
Detailed Description
Objective: To examine the effect of web-based education related to Gestational Diabetes Mellitus on women health management self-efficacy and maternal-fetal-neonatal results.
Design: Randomized controlled study. Patients: Thirty one pregnant women were included in the intervention group and thirty four pregnant women in the control group.
Interventions: For 8 weeks, web-based education for Gestational Diabetes Mellitus was offered to pregnant women who diagnosed with Gestational Diabetes Mellitus for the first time. The data were collected before web-based education, after web-based education and postpartum between 4-12 weeks at three different times. Control group was offered routine clinical procedure.
Main Outcome Measures: health management self efficacy (primary outcomes), maternal-fetal-neonatal results (secondary outcome).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Efficacy, Self
Keywords
Gestational Diabetes Mellitus, self efficacy, web based education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized control study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
web based education and routine clinical procedure
Arm Title
control group
Arm Type
No Intervention
Arm Description
only routine clinical procedure
Intervention Type
Behavioral
Intervention Name(s)
web based education
Other Intervention Name(s)
only routine clinical procedure
Intervention Description
In addition to routine care, web-based education was offered to pregnant women with Gestational Diabetes Mellitus.
Primary Outcome Measure Information:
Title
Change from Self Rated Abilities for Health Practices levels in pregnant women with GDM
Description
Self Rated Abilities for Health Practices Scale: Self Rated Abilities for Health Practices Scale: The 5-point Likert scale was adapted for Turkish version by Aypar Akbağ and Aluş Tokat (Aypar Akbağ and Aluş Tokat, 2021). The scale consists of 4 sub-dimensions: "Exercise"," Responsible Health Practices", "Psychological Well Being" and "Nutrition". (from 0 (not at all) to 4 (completely). The scale total-score ranged between 0 and 112, while subscale total-scores ranging from 0 to 28 points. The higher scores from the scale indicate higher self-efficacy levels for the health applications.
Time Frame
Change in Self Rated Abilities for Health Practices levels up to postpartum 12th week
Secondary Outcome Measure Information:
Title
Rate of maternal-fetal-neonatal complications in pregnant women with GDM
Description
The chart was used to evaluate the maternal (ketoacidosis, preeclampsia, polyhydramnios, preterm labor, vaginal or urinary infection), fetal (macrosomia, Intrauterine Growth Retardation) and neonatal (neonatal hypoglycemia, polycythemia and neonatal hyperbilirubinemia, duration of treatment for hyperbilirubinemia, Respiratory Distress Syndrome (RDS), hypothermia, dehydration) complications of Gestational Diabetes Mellitus. Complications during pregnancy and postpartum period were followed up. Complication follow-up was done by contacting the intervention group via the website. In the control group, complication follow-up was obtained by phone calls.
Time Frame
Change in rate of maternal, fetal and neonatal complications up to postpartum 12th week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being 18 years or older
Being primigravida or multigravida
Getting a diagnosis of Gestational Diabetes Mellitus
Having a gestational week between 24-28
Having a single fetus
Ability to use the Internet (Computer, tablet, smart phone, etc.)
Voluntary participation in the research
Exclusion Criteria:
Having a diagnosis of Type 1 and Type 2 Diabetes Mellitus
Having another chronic disease
Having a visual or hearing impairment
Having a psychiatric medical diagnosis
Having a diagnosis of risky pregnancy not related to GDM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuran N Aypar Akbağ, Dr
Organizational Affiliation
Karamanoğlu Mehmetbey University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Merlinda Aluş Tokat, Dr
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) is planned to be shared after the publication of the article.
Learn more about this trial
Effect of Web-Based Education on Gestational Diabetes Mellitus and Health Management Self Efficacy
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