Gestational Diabetes Mellitus (GDM)NCT07318740
Effectiveness of Mobile Application-Supported Education and Counseling in Pregnant Women With Gestational Diabetes
A study testing Mobile Application-Based Education and Counseling Program and Standard Face-to-Face Gestational Diabetes Education in people with Gestational Diabetes Mellitus (GDM), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the impact of mobile application-supported education and counseling on the intention, attitude, behavior, and self-efficacy of pregnant women diagnosed with gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Mobile Application-Based Education and Counseling Program and Standard Face-to-Face Gestational Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged ≥18 years.
- Minimum education level: primary school graduate.
- Singleton pregnancy.
- No prior diagnosis of gestational diabetes mellitus (GDM).
- Newly diagnosed with GDM based on oral glucose tolerance test (OGTT) results.
- Currently receiving insulin treatment as part of the clinical management plan.
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- Absence of comorbid conditions such as hypertension, preeclampsia, or other chronic diseases.
- Ability to read and understand Turkish.
- Ownership of a smartphone (iOS/Android) with internet access.
- Willingness to participate and provide written informed consent.
Who cannot join
- Development of pregnancy-related complications during the follow-up period.
- Incomplete or missing data in the study forms.
- Non-compliance with study protocol.
- Withdrawal from the study at the participant's request.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile Application Supported Education and Counselling on Intention, Attitude, Behaviour and Self-Efficacy of Pregnant Women With Gestational Diabetes
This randomized controlled trial aims to evaluate the impact of mobile application-supported education and counseling on the intention, attitude, behavior, and self-efficacy of pregnant women diagnosed with gestational diabetes. The study will be conducted at Ankara Bilkent City Hospital, with participants assigned to intervention and control groups. The intervention group will receive planned education and counseling via a mobile application, while the control group will receive standard hospital education. Data will be collected at predetermined intervals, and outcomes will be compared between the groups. The study seeks to determine the effectiveness of a mobile application-supported approach in the management of gestational diabetes.
Read the detailed description
Gestational Diabetes Mellitus (GDM) is a carbohydrate intolerance disorder that develops during pregnancy or is first diagnosed during this period. If not properly managed, it can lead to serious complications for both the mother and the fetus. Current guidelines recommend healthy nutrition, regular physical activity, self-monitoring of blood glucose, and support from healthcare professionals for the management of GDM. In recent years, mobile health applications have emerged as valuable tools for providing pregnant women with rapid access to information, personalized counseling, and behavioural change support. However, studies evaluating the effects of mobile application-supported interventions in pregnant women with GDM who have initiated insulin therapy remain limited.
This randomized controlled trial aims to evaluate the effect of mobile application-supported education and counseling on the intention, attitude, behaviour, and self-efficacy levels of pregnant women with GDM who have initiated insulin therapy. The study will be conducted at the Internal Medicine Outpatient Clinic of the Obstetrics and Gynecology Hospital, Ankara Bilkent City Hospital. Pregnant women meeting the inclusion criteria will be randomly assigned to either the intervention or control group using a simple randomization method. A total of 94 participants (47 in the intervention group and 47 in the control group) will be included in the study.
In the intervention group, the developed mobile application will be installed on participants' smartphones, and a structured two-week education and counseling program will be implemented. The educational content will comprise seven modules: Essential Knowledge on Gestational Diabetes, Blood Glucose Monitoring in Pregnancy, Fundamental Information on Insulin Therapy in Pregnancy, Management of hypoglycemia and Hyperglycemia in Gestational Diabetes, Healthy Nutrition in Gestational Diabetes, Physical Activity and Exercise in Gestational Diabetes, and General Health Recommendations for a Healthy Life in Gestational Diabetes. Each educational module will be supported with audio recordings and followed by a question-and-answer session to enhance motivation. Daily motivational notifications (e.g., exercise reminders, healthy eating recommendations, water intake reminders) will be sent via the application, and participants' blood glucose records and module completion status will be monitored by the researcher through the administrator panel.
The control group will receive standard face-to-face diabetes education, in line with hospital protocols, for two weeks. This education will cover content comparable to that provided to the intervention group. Assessments will be conducted at three stages for both groups:
- Baseline assessment (before the start of education): Participant Identification Form, Gestational Diabetes Intention, Attitude, and Behaviour Scale, and Gestational Diabetes Self-Efficacy Scale.
- Second follow-up (three weeks after completion of the two-week education program): The same scales will be administered again.
- Third follow-up (two weeks after the second follow-up assessment): The Gestational Diabetes Intention, Attitude, and Behaviour Scale and the Gestational Diabetes Self-Efficacy Scale will be administered again. Additionally, the Mobile Health Applications Adoption Scale will be applied to the intervention group.
Throughout the study, all participants will be asked to regularly complete the Self-Monitoring of Blood Glucose (SMBG) log, whereas the intervention group will additionally record their blood glucose measurements via the mobile application. This study aims to generate robust evidence on the effectiveness of mobile health applications in managing GDM and to contribute to the wider adoption of digital health solutions during pregnancy.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Mobile Application-Based Education and Counseling Program, Standard Face-to-Face Gestational Diabetes Education
- Keywords
- Gestational Diabetes, Nursing, Mobile Application, Motivation, Self-Efficacy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application-Based Education and Counseling ProgramBehavioural
A two-week structured education and counseling program delivered via the SugarMoms mobile application for gestational diabetes management. Education is provided by a certified diabetes nurse educator and includes topics such as gestational diabetes management, blood glucose monitoring, insulin therapy, management of hypo/hyperglycemia, healthy nutrition, physical activity, and pregnancy health recommendations. Each module includes audio support, a question-and-answer component, and daily motivational notifications. Participants will log daily blood glucose, dietary intake, and physical activity in the app and continue app use throughout the study. Follow-up assessments and questionnaires are delivered through the app, and progress is monitored via the administrator panel.
Standard Face-to-Face Gestational Diabetes EducationBehavioural
A two-week standard face-to-face gestational diabetes education program provided by a certified diabetes nurse educator in accordance with hospital protocol. The program covers the same topics as the intervention group's app-based program. Blood glucose monitoring is recorded using paper-based forms.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application-Based Education and Counseling | Experimental | Participants will receive a two-week structured education and counseling program via the SugarMoms mobile application for gestational diabetes management. The program, delivered by a certified diabetes nurse educator, covers topics including gestational diabetes management, blood glucose monitoring, insulin therapy, management of hypoglycemia and hyperglycemia, nutrition, physical activity, and pregnancy health recommendations. Each module includes audio support, a question-and-answer component, and daily motivational notifications (e.g., exercise, diet, hydration). Participants will record their daily blood glucose, dietary intake, and physical activity in the app. After completing the two-week program, participants will continue daily use of the app during the study. Follow-up assessments and questionnaires will also be administered through the app. Progress, logs, and module completion will be monitored via the administrator panel. Receives: Behavioral: Mobile Application-Based Education and Counseling Program |
| Standard Face-to-Face Gestational Diabetes Education | Active comparator | Participants will receive a two-week standard face-to-face gestational diabetes education program provided by a certified diabetes nurse educator in accordance with the hospital protocol. The content will parallel the topics included in the intervention group's mobile application program. Blood glucose monitoring will be recorded using paper-based forms. Receives: Behavioral: Standard Face-to-Face Gestational Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gestational Diabetes Intention, Attitude, and Behavior Scale (GDNTD-Ö) Scores
This measure uses the validated Turkish adaptation of the Diabetes Intention, Attitude, and Behavior Scale. The instrument contains 14 items across 5 subdimensions. Total scores are transformed to a 0-100 scale, with higher scores indicating stronger intention, attitude, and behavior for self-management in gestational diabetes. There is no defined cut-off value. Measurement will be based on the self-administered GDNTD-Ö questionnaire.
Measured: Baseline (before education), 3 weeks after completion of the 2-week education program (first follow-up), and 2 weeks after this first follow-up (second follow-up).
Secondary outcomes (1)
Change in Gestational Diabetes Self-Efficacy Scale (GESGD) Scores
This measure consists of 23 items and 4 subdimensions (diet-weight management, complication prevention, adherence to nutrition education, and medical treatment practices). Higher scores indicate greater self-efficacy. There is no defined cut-off value. Measurement will be based on a self-administered questionnaire.
Measured: Baseline (before education), 3 weeks after completion of the 2-week education program (first follow-up), and 2 weeks after this first follow-up (second follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start18 Aug 2025
- Primary completion30 Nov 2025
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gönül Kurt, Assoc. Prof. Dr., Principal investigator, University of Health Sciences, Gülhane Faculty of Nursing, Department of Obstetrics and Gynecology Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318740
- Sponsor's protocol ID
- Gulhane Faculty of Nursing
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form may also be provided.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application Supported Education and Counselling on Intention, Attitude, Behaviour and Self-Efficacy of Pregnant Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT07318740
- Acronym / sponsor ID
- Gulhane Faculty of Nursing
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational Diabetes, Nursing, Mobile Application, Motivation, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 6 Jan 2026 (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 trial aims to evaluate the impact of mobile application-supported education and counseling on the intention, attitude, behavior, and self-efficacy of pregnant women diagnosed with gestational diabetes. The study will be conducted at Ankara Bilkent City Hospital, with participants assigned to intervention and control groups. The intervention group will receive planned education and counseling via a mobile application, while the control group will receive standard hospital education. Data will be collected at predetermined intervals, and outcomes will be compared between the groups. The study seeks to determine the effectiveness of a mobile application-supported approach in the management of gestational diabetes.
Detailed description
Gestational Diabetes Mellitus (GDM) is a carbohydrate intolerance disorder that develops during pregnancy or is first diagnosed during this period. If not properly managed, it can lead to serious complications for both the mother and the fetus. Current guidelines recommend healthy nutrition, regular physical activity, self-monitoring of blood glucose, and support from healthcare professionals for the management of GDM. In recent years, mobile health applications have emerged as valuable tools for providing pregnant women with rapid access to information, personalized counseling, and behavioural change support. However, studies evaluating the effects of mobile application-supported interventions in pregnant women with GDM who have initiated insulin therapy remain limited.
This randomized controlled trial aims to evaluate the effect of mobile application-supported education and counseling on the intention, attitude, behaviour, and self-efficacy levels of pregnant women with GDM who have initiated insulin therapy. The study will be conducted at the Internal Medicine Outpatient Clinic of the Obstetrics and Gynecology Hospital, Ankara Bilkent City Hospital. Pregnant women meeting the inclusion criteria will be randomly assigned to either the intervention or control group using a simple randomization method. A total of 94 participants (47 in the intervention group and 47 in the control group) will be included in the study.
In the intervention group, the developed mobile application will be installed on participants' smartphones, and a structured two-week education and counseling program will be implemented. The educational content will comprise seven modules: Essential Knowledge on Gestational Diabetes, Blood Glucose Monitoring in Pregnancy, Fundamental Information on Insulin Therapy in Pregnancy, Management of hypoglycemia and Hyperglycemia in Gestational Diabetes, Healthy Nutrition in Gestational Diabetes, Physical Activity and Exercise in Gestational Diabetes, and General Health Recommendations for a Healthy Life in Gestational Diabetes. Each educational module will be supported with audio recordings and followed by a question-and-answer session to enhance motivation. Daily motivational notifications (e.g., exercise reminders, healthy eating recommendations, water intake reminders) will be sent via the application, and participants' blood glucose records and module completion status will be monitored by the researcher through the administrator panel.
The control group will receive standard face-to-face diabetes education, in line with hospital protocols, for two weeks. This education will cover content comparable to that provided to the intervention group. Assessments will be conducted at three stages for both groups:
- Baseline assessment (before the start of education): Participant Identification Form, Gestational Diabetes Intention, Attitude, and Behaviour Scale, and Gestational Diabetes Self-Efficacy Scale.
- Second follow-up (three weeks after completion of the two-week education program): The same scales will be administered again.
- Third follow-up (two weeks after the second follow-up assessment): The Gestational Diabetes Intention, Attitude, and Behaviour Scale and the Gestational Diabetes Self-Efficacy Scale will be administered again. Additionally, the Mobile Health Applications Adoption Scale will be applied to the intervention group.
Throughout the study, all participants will be asked to regularly complete the Self-Monitoring of Blood Glucose (SMBG) log, whereas the intervention group will additionally record their blood glucose measurements via the mobile application. This study aims to generate robust evidence on the effectiveness of mobile health applications in managing GDM and to contribute to the wider adoption of digital health solutions during pregnancy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application-Based Education and Counseling | Experimental | Behavioral: Mobile Application-Based Education and Counseling ProgramParticipants will receive a two-week structured education and counseling program via the SugarMoms mobile application for gestational diabetes management. The program, delivered by a certified diabetes nurse educator, covers topics including gestational diabetes management, blood glucose monitoring, insulin therapy, management of hypoglycemia and hyperglycemia, nutrition, physical activity, and pregnancy health recommendations. Each module includes audio support, a question-and-answer component, and daily motivational notifications (e.g., exercise, diet, hydration). Participants will record their daily blood glucose, dietary intake, and physical activity in the app. After completing the two-week program, participants will continue daily use of the app during the study. Follow-up assessments and questionnaires will also be administered through the app. Progress, logs, and module completion will be monitored via the administrator panel. |
| Standard Face-to-Face Gestational Diabetes Education | Active comparator | Behavioral: Standard Face-to-Face Gestational Diabetes EducationParticipants will receive a two-week standard face-to-face gestational diabetes education program provided by a certified diabetes nurse educator in accordance with the hospital protocol. The content will parallel the topics included in the intervention group's mobile application program. Blood glucose monitoring will be recorded using paper-based forms. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Pregnant women aged ≥18 years.
- Minimum education level: primary school graduate.
- Singleton pregnancy.
- No prior diagnosis of gestational diabetes mellitus (GDM).
- Newly diagnosed with GDM based on oral glucose tolerance test (OGTT) results.
Key exclusion criteria (4 listed)
- Development of pregnancy-related complications during the follow-up period.
- Incomplete or missing data in the study forms.
- Non-compliance with study protocol.
- Withdrawal from the study at the participant's request.
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 |
|---|---|---|
| Mobile Application-Based Education and Counseling ProgramA two-week structured education and counseling program delivered via the SugarMoms mobile application for gestational diabetes management. Education is provided by a certified diabetes nurse educator and includes topics such as gestational diabetes management, blood glucose monitoring, insulin therapy, management of hypo/hyperglycemia, healthy nutrition, physical activity, and pregnancy health recommendations. Each module includes audio support, a question-and-answer component, and daily motivational notifications. Participants will log daily blood glucose, dietary intake, and physical activity in the app and continue app use throughout the study. Follow-up assessments and questionnaires are delivered through the app, and progress is monitored via the administrator panel. | Behavioural | Mobile Application-Based Education and Counseling |
| Standard Face-to-Face Gestational Diabetes EducationA two-week standard face-to-face gestational diabetes education program provided by a certified diabetes nurse educator in accordance with hospital protocol. The program covers the same topics as the intervention group's app-based program. Blood glucose monitoring is recorded using paper-based forms. | Behavioural | Standard Face-to-Face Gestational Diabetes Education |
Primary outcome
Change in Gestational Diabetes Intention, Attitude, and Behavior Scale (GDNTD-Ö) Scores
Time frame: Baseline (before education), 3 weeks after completion of the 2-week education program (first follow-up), and 2 weeks after this first follow-up (second follow-up).
This measure uses the validated Turkish adaptation of the Diabetes Intention, Attitude, and Behavior Scale. The instrument contains 14 items across 5 subdimensions. Total scores are transformed to a 0-100 scale, with higher scores indicating stronger intention, attitude, and behavior for self-management in gestational diabetes. There is no defined cut-off value. Measurement will be based on the self-administered GDNTD-Ö questionnaire.
1 secondary outcome
Change in Gestational Diabetes Self-Efficacy Scale (GESGD) Scores
Time frame: Baseline (before education), 3 weeks after completion of the 2-week education program (first follow-up), and 2 weeks after this first follow-up (second follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form may also be provided.
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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.
Gönül Kurt, Assoc. Prof. Dr. principal investigator
University of Health Sciences, Gülhane Faculty of Nursing, Department of Obstetrics and Gynecology Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application-Based Education and Counseling Program and Standard Face-to-Face Gestational Diabetes Education in people with Gestational Diabetes Mellitus (GDM), run by Saglik Bilimleri Universitesi 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 in Gestational Diabetes Intention, Attitude, and Behavior Scale (GDNTD-Ö) Scores (time frame: Baseline (before education), 3 weeks after completion of the 2-week education program (first follow-up), and 2 weeks after this first follow-up (second follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.