Gestational Diabetes Mellitus (GDM)NCT07067411
Gamified Education for Diabetes Self-Management in GDM
A study testing Education Program Using Gamification on GDM in people with Gestational Diabetes Mellitus (GDM), run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
Gestational diabetes mellitus (GDM) is a serious public health problem characterized by hyperglycemia that develops during pregnancy and causes significant short- and long-term health risks for both the mother and the fetus. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Education Program Using Gamification on GDM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 1 Jul 2027
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Those who speak Turkish,
- Literate,
- Between the ages of 18 and 40,
- Those diagnosed with Gestational Diabetes Mellitus (based on a single-stage and/or two-stage oral glucose tolerance test between the 24th and 28th weeks),
- Those with a singleton pregnancy,
- Pregnant women who have not been previously diagnosed with diabetes,
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- Those who do not have a chronic disease diagnosed by a doctor (hypertension, cardiovascular diseases, kidney diseases, anemia, thyroid and autoimmune diseases),
- Those who do not have any other pregnancy-related problems (gestational hypertension, preeclampsia, gestational thyroiditis, etc.),
- Those who do not have a physical disability,
- Pregnant women who have access to the internet via phone or computer will be included in the sample.
Who cannot join
- Those who cannot read or write,
- Those with threatened premature labor (PTD), premature membrane rupture (PROM), preeclampsia; risky pregnancy conditions,
- Intrauterine mortal fetus,
- Those who have experienced significant losses in the last 3 months (divorce, death of a loved one, etc.),
- Those with moderate to severe (over 14 points) depressive symptoms as a result of the Patient Health Questionnaire-8 (PHQ-8) will be considered as a risk group and will not be included in the sample.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children Diseases Traning and Research Hospital
Istanbul, Uskudar, 34668
About this study
Official title: The Effect of an Education Program Given to Patients With Gestational Diabetes Mellitus Using a Gamification Technique on Diabetes Self-Management
Gestational diabetes mellitus (GDM) is a serious public health problem characterized by hyperglycemia that develops during pregnancy and causes significant short- and long-term health risks for both the mother and the fetus. Lifestyle changes, especially appropriate diet and exercise practices and glycemic control are among the basic approaches in GDM management. However, the individual's adoption and sustainability of these approaches are often insufficient, and the individual's participation in treatment and motivation levels may be limited.
When the literature is examined, it has been proven that gamification-based interventions, especially in individuals with type 2 diabetes, have positive effects such as increasing the level of knowledge, encouraging physical activity and improving glycemic control. However, the lack of gamification-based nursing interventions specific to women with GDM is striking. The fact that there is no standardized nursing protocol specific to GDM management in our country makes the literature gap in this area even more evident.
Read more
This study aims to develop health behaviors in individuals with GDM through a gamified training program to be developed based on the Information-Motivation-Behavioral Skills (IMB) model. Thanks to the innovative structure of gamification, it is aimed not only to increase the knowledge level of individuals, but also to increase their motivation and make behavioral changes permanent. Thus, the active participation of the individual in the treatment process will be encouraged and the self- management skills will be strengthened.
This research will be an important step in terms of the integration of digitalization and patient-centered approaches in nursing practices, as well as indirectly contributing to the protection and development of public health. While the training program has the potential to increase the quality of life at the individual level, it will also allow the development of an original and structured nursing care intervention that can be used in GDM management.
This study aims to fill an important gap in the literature, to disseminate innovative practices in the field of nursing, and to support healthy pregnancy outcomes at the social level. For this reason, the purpose of the research was planned to examine the effect of the training program applied to women with gestational diabetes with the gamification technique based on the information-motivation-behavior (IMB) model on diabetes self-management.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Education Program Using Gamification on GDM
- Keywords
- gestational diabetes, self-management, gamification, nursing
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Program Using Gamification on GDMBehavioural
The five games planned to be used in the study are; "What is Gestational Diabetes?", "Nutrition Education", "Complication Precautions", "Medical Treatment Applications" and "Physical Activity". The creation and implementation of these games will be done through the "Genially" platform. The Genially platform is an easy-to-use and free web tool used to create interactive visual content. The platform includes features such as sharing or downloading via website, social media or e-mail by adding animations, effects, sounds and interactive elements. In addition, the performances of the people who share the created content can be tracked and feedback can be obtained. At the beginning of the games planned to be used in the study, an informative video of not more than five minutes on the subject created by the researcher will be shared. National and international guidelines will be taken into consideration in the creation of these videos. One day after the informative video is
| Study group | Role | What they receive |
|---|---|---|
| The group participating in the Education Program Given with Gamification Technique | Experimental | 39 participants were assigned as a result of randomization. Participants receiving care through games. Receives: Behavioral: Education Program Using Gamification on GDM |
| Control | No intervention | 39 participants were assigned as a result of randomization. Receiving only routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy Scale in Gestational Diabetes
The validity and reliability of the "Self-Efficacy Scale in Gestational Diabetes" was determined by Polat and Ünsal Avdal and it was concluded that it is a valid and reliable measurement tool. The Self-Efficacy Scale in Gestational Diabetes (SESGD) is a five-point Likert-type scale consisting of four sub-dimensions. The sub-dimensions of the scale are; ''Diet-Weight Management'', ''Complication Precautions'', ''Adherence to Nutrition Education'' and ''Medical Treatment Applications''. The total Cronbach alpha value of the scale was determined as 0.654. The scale includes positive and negative statements. Reverse and forward coding is done during the analysis. It can be thought that as the score to be obtained from the scale increases as a result of the coding of positive and negative statements in the scale, the individual's self-efficacy will increase and that he/she will be able to effectively take care of himself/herself as a result of the education he/she receives.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (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.
- 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
- The participants in the intervention group will be shared with an information video link created by the researcher, no longer than five minutes, one day before each game. The participants in the intervention group will be given the game link after watching the information video. The order of the five games planned to be included in the research is; "What is Gestational Diabetes?", "Nutrition Education", "Complication Precautions", "Medical Treatment Applications" and "Physical Activity".
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begum Kirik, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067411
- Sponsor's protocol ID
- YU-HEM-BK-01
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Education Program Given to Patients With Gestational Diabetes Mellitus Using a Gamification Technique on Diabetes Self-Management
- ClinicalTrials.gov ID
- NCT07067411
- Acronym / sponsor ID
- YU-HEM-BK-01
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- gestational diabetes, self-management, gamification, nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Jul 2025 (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.
Gestational diabetes mellitus (GDM) is a serious public health problem characterized by hyperglycemia that develops during pregnancy and causes significant short- and long-term health risks for both the mother and the fetus. Lifestyle changes, especially appropriate diet and exercise practices and glycemic control are among the basic approaches in GDM management. However, the individual's adoption and sustainability of these approaches are often insufficient, and the individual's participation in treatment and motivation levels may be limited.
When the literature is examined, it has been proven that gamification-based interventions, especially in individuals with type 2 diabetes, have positive effects such as increasing the level of knowledge, encouraging physical activity and improving glycemic control. However, the lack of gamification-based nursing interventions specific to women with GDM is striking. The fact that there is no standardized nursing protocol specific to GDM management in our country makes the literature gap in this area even more evident.
This study aims to develop health behaviors in individuals with GDM through a gamified training program to be developed based on the Information-Motivation-Behavioral Skills (IMB) model. Thanks to the innovative structure of gamification, it is aimed not only to increase the knowledge level of individuals, but also to increase their motivation and make behavioral changes permanent. Thus, the active participation of the individual in the treatment process will be encouraged and the self- management skills will be strengthened.
This research will be an important step in terms of the integration of digitalization and patient-centered approaches in nursing practices, as well as indirectly contributing to the protection and development of public health. While the training program has the potential to increase the quality of life at the individual level, it will also allow the development of an original and structured nursing care intervention that can be used in GDM management.
This study aims to fill an important gap in the literature, to disseminate innovative practices in the field of nursing, and to support healthy pregnancy outcomes at the social level. For this reason, the purpose of the research was planned to examine the effect of the training program applied to women with gestational diabetes with the gamification technique based on the information-motivation-behavior (IMB) model on diabetes self-management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The participants in the intervention group will be shared with an information video link created by the researcher, no longer than five minutes, one day before each game. The participants in the intervention group will be given the game link after watching the information video. The order of the five games planned to be included in the research is; "What is Gestational Diabetes?", "Nutrition Education", "Complication Precautions", "Medical Treatment Applications" and "Physical Activity".
| Arm | Type | Receives |
|---|---|---|
| The group participating in the Education Program Given with Gamification Technique | Experimental | Behavioral: Education Program Using Gamification on GDM39 participants were assigned as a result of randomization. Participants receiving care through games. |
| Control | No intervention | –39 participants were assigned as a result of randomization. Receiving only routine care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Those who speak Turkish,
- Literate,
- Between the ages of 18 and 40,
- Those diagnosed with Gestational Diabetes Mellitus (based on a single-stage and/or two-stage oral glucose tolerance test between the 24th and 28th weeks),
- Those with a singleton pregnancy,
Key exclusion criteria (5 listed)
- Those who cannot read or write,
- Those with threatened premature labor (PTD), premature membrane rupture (PROM), preeclampsia; risky pregnancy conditions,
- Intrauterine mortal fetus,
- Those who have experienced significant losses in the last 3 months (divorce, death of a loved one, etc.),
- Those with moderate to severe (over 14 points) depressive symptoms as a result of the Patient Health Questionnaire-8 (PHQ-8) will be considered as a risk group and will not be included in the sample.
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 |
|---|---|---|
| Education Program Using Gamification on GDMThe five games planned to be used in the study are; "What is Gestational Diabetes?", "Nutrition Education", "Complication Precautions", "Medical Treatment Applications" and "Physical Activity". The creation and implementation of these games will be done through the "Genially" platform. The Genially platform is an easy-to-use and free web tool used to create interactive visual content. The platform includes features such as sharing or downloading via website, social media or e-mail by adding animations, effects, sounds and interactive elements. In addition, the performances of the people who share the created content can be tracked and feedback can be obtained. At the beginning of the games planned to be used in the study, an informative video of not more than five minutes on the subject created by the researcher will be shared. National and international guidelines will be taken into consideration in the creation of these videos. One day after the informative video is | Behavioural | The group participating in the Education Program Given with Gamification Technique |
Primary outcome
Self-Efficacy Scale in Gestational Diabetes
Time frame: through study completion, an average of 1 year
The validity and reliability of the "Self-Efficacy Scale in Gestational Diabetes" was determined by Polat and Ünsal Avdal and it was concluded that it is a valid and reliable measurement tool. The Self-Efficacy Scale in Gestational Diabetes (SESGD) is a five-point Likert-type scale consisting of four sub-dimensions. The sub-dimensions of the scale are; ''Diet-Weight Management'', ''Complication Precautions'', ''Adherence to Nutrition Education'' and ''Medical Treatment Applications''. The total Cronbach alpha value of the scale was determined as 0.654. The scale includes positive and negative statements. Reverse and forward coding is done during the analysis. It can be thought that as the score to be obtained from the scale increases as a result of the coding of positive and negative statements in the scale, the individual's self-efficacy will increase and that he/she will be able to effectively take care of himself/herself as a result of the education he/she receives.
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 16 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Program Using Gamification on GDM in people with Gestational Diabetes Mellitus (GDM), run by Yeditepe 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 10 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: opening soon, as of the sponsor's last update on 16 Jul 2025. 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?
Contact Begüm Kırık (+905454369290, begum.kirik@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy Scale in Gestational Diabetes (time frame: through study completion, an average of 1 year). 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 16 Jul 2025.