Gamified Education for Diabetes Self-Management in GDM

NCT ID: NCT07067411

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-07-01

Brief 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. 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.

Conditions

Gestational Diabetes Mellitus (GDM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

The group participating in the Education Program Given with Gamification Technique

39 participants were assigned as a result of randomization. Participants receiving care through games.

Group Type: EXPERIMENTAL

Education Program Using Gamification on GDM

Intervention Type: BEHAVIORAL

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

Control

39 participants were assigned as a result of randomization. Receiving only routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education Program Using Gamification on GDM

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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,
• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yeditepe University

OTHER

Sponsor Role: lead

Responsible Party

Begum Kirik

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zeynep Kamil Women and Children Diseases Traning and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Begüm Kırık

Role: CONTACT

begum.kirik@yeditepe.edu.tr

+905454369290

Other Identifiers

YU-HEM-BK-01

Identifier Type: -

Identifier Source: org_study_id