Pregnancy ComplicationsGDMNCT05141929
Effect of Web-Based Education on Gestational Diabetes Mellitus and Health Management Self Efficacy
A study testing web based education in people with Pregnancy Complications and Efficacy, Self, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Complications, Efficacy, Self
- What is being tested?
- web based education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Web-Based Education Related to Gestational Diabetes Mellitus on Women Health Management Self Efficacy and Maternal-Fetal-Neonatal Results
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.
Read the 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).
- Conditions
- Pregnancy Complications, Efficacy, Self
- Being tested
- web based education
- Keywords
- Gestational Diabetes Mellitus, self efficacy, web based education
- Medical subject headings
- Pregnancy Complications, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web based educationBehavioural
Also called only routine clinical procedure
In addition to routine care, web-based education was offered to pregnant women with Gestational Diabetes Mellitus.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | web based education and routine clinical procedure Receives: Behavioral: web based education |
| control group | No intervention | only routine clinical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Change in rate of maternal, fetal and neonatal complications up to postpartum 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Jun 2020
- Primary completion1 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control study
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuran Nur Aypar Akbağ, Dokuz Eylul University
- Investigators
- Nuran N Aypar Akbağ, Dr, Study director, Karamanoğlu Mehmetbey UniversityMerlinda Aluş Tokat, Dr, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141929
- Sponsor's protocol ID
- 2908-GOA-2019/01-25
- Acronym
- GDM
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) is planned to be shared after the publication of the article.
Publications
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. 2026;47(2):111-132. doi: 10.1080/07399332.2025.2597240. Epub 2025 Dec 18.
PubMed 41412825
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Web-Based Education Related to Gestational Diabetes Mellitus on Women Health Management Self Efficacy and Maternal-Fetal-Neonatal Results
- ClinicalTrials.gov ID
- NCT05141929
- Acronym / sponsor ID
- GDM / 2908-GOA-2019/01-25
- Conditions
- Pregnancy Complications, Efficacy, Self
- Keywords
- Gestational Diabetes Mellitus, self efficacy, web based education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized control study
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: web based educationweb based education and routine clinical procedure |
| control group | No intervention | –only routine clinical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web based educationAlso: only routine clinical procedureIn addition to routine care, web-based education was offered to pregnant women with Gestational Diabetes Mellitus. | Behavioural | intervention group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 41412825Akbag 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. 2026;47(2):111-132. doi: 10.1080/07399332.2025.2597240. Epub 2025 Dec 18.
- Individual participant dataSharing planned: No. Individual participant data (IPD) is planned to be shared after the publication of the article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuran N Aypar Akbağ, Dr study director
Karamanoğlu Mehmetbey University
Merlinda Aluş Tokat, Dr study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web based education in people with Pregnancy Complications and Efficacy, Self, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05141929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.