NCT05141929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

October 25, 2021

Last Update Submit

December 2, 2021

Conditions

Keywords

Gestational Diabetes Mellitusself efficacyweb based education

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

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

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

Study Arms (2)

intervention group

EXPERIMENTAL

web based education and routine clinical procedure

Behavioral: web based education

control group

NO INTERVENTION

only routine clinical procedure

Interventions

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

Also known as: only routine clinical procedure
intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

  • Akbag NNA, Tokat MA. Effects of web-based gestational diabetes mellitus education on health management self-efficacy, treatment modality, and maternal-fetal-neonatal outcomes: A randomized controlled trial. Health Care Women Int. 2025 Dec 18:1-22. doi: 10.1080/07399332.2025.2597240. Online ahead of print.

MeSH Terms

Conditions

Pregnancy ComplicationsDiabetes, Gestational

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nuran N Aypar Akbağ, Dr

    Karamanoğlu Mehmetbey University

    STUDY DIRECTOR
  • Merlinda Aluş Tokat, Dr

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 25, 2021

First Posted

December 2, 2021

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

August 30, 2021

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) is planned to be shared after the publication of the article.

Locations