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Completed

NCT Number: NCT05141929

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

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.

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Key information

Conditions

Pregnancy Complications Diabetes Mellitus Diabetes, Gestational Efficacy, Self Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

web based education

Behavioral

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

Other names: only routine clinical procedure

Primary outcomes

  1. Change from Self Rated Abilities for Health Practices levels in pregnant women with GDM

    Time frame: Change in Self Rated Abilities for Health Practices levels up to postpartum 12th week

    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 outcomes

  1. Rate of maternal-fetal-neonatal complications in pregnant women with GDM

    Time frame: Change in rate of maternal, fetal and neonatal complications up to postpartum 12th week

    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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Acronym: GDM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2021
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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