Effect of Web-Based Education on Gestational Diabetes Mellitus and Health Management Self Efficacy

Pregnancy Complications Clinical Trial

— GDM  

Official title:

Effect of Web-Based Education Related to Gestational Diabetes Mellitus on Women Health Management Self Efficacy and Maternal-Fetal-Neonatal Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141929
• Other study ID #: 2908-GOA-2019/01-25
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: December 2021
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 30, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Efficacy, Self
• Pregnancy Complications

Intervention

Behavioral:
• web based education
In addition to routine care, web-based education was offered to pregnant women with Gestational Diabetes Mellitus.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Akbag and Alus Tokat (Aypar Akbag and Alus 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.	Change in Self Rated Abilities for Health Practices levels up to postpartum 12th week
Secondary	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.	Change in rate of maternal, fetal and neonatal complications up to postpartum 12th week