Health Belief Model Based Education for Pregnant Women With Gestational Diabetes

NCT ID: NCT06740695

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Gestational diabetes (GDM) is a type of diabetes that occurs as a result of intolerance of carbohydrate metabolism during pregnancy in an individual whose blood glucose concentration is within normal limits before pregnancy. GDM is an important condition that should be handled carefully. Because it is one of the most common metabolic diseases during pregnancy and poses risks to the health of the mother, fetus and newborn. Increasing Self-Efficacy in Gestational Diabetes with education based on the Health Belief Model,

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Gestational diabetes (GDM) is a type of diabetes that occurs as a result of intolerance of carbohydrate metabolism during pregnancy in an individual whose blood glucose concentration is within normal limits before pregnancy. GDM is an important condition that should be addressed carefully. Because it is one of the most common metabolic diseases during pregnancy and brings risks to the health of the mother, fetus and newborn. The prevalence of GDM is 1-14% without considering geographical changes, and the incidence of Type 2 diabetes diagnosed at the end of pregnancy increases with the increase in the rate of occurrence in fertile obese women. Similar to Type 2 diabetes, the main problem in gestational diabetes is that production is not sufficient for the need due to insulin resistance. In addition to the fact that consuming more calories than normal due to uncontrolled nutrition, increasing the fat rate in the body and exercise and lack of movement are important factors in the emergence of gestational diabetes, hormones such as cortisol, prolactin, human placental lactogen, progesterone, which have an adverse effect on insulin, and placental insulinase enzymes that accelerate insulin destruction also play a major role in the emergence of gestational diabetes. Regardless of the main problem or the type of diabetes, pregnancy complications are related to the degree to which blood glucose cannot be controlled. Pregnancy-related diabetes complications generally consist of two groups. The first group consists of congenital anomalies that occur due to metabolic conditions in the first trimester of pregnancy. A significant increase in blood glucose in the first trimester of pregnancy is one of the most important teratogenic factors. It is reported that approximately 27% of pregnant women with uncontrolled high glucose in the first trimester develop congenital anomalies. It is stated in the literature that providing effective education to individuals with gastrointestinal diabetes facilitates the control of complications that may occur due to diabetes. In addition, the absence of such a study in the literature suggests that our study will make a very good contribution to the literature.To increase self-efficacy in gestational diabetes through training based on the Health Belief Model,

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Complications

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Health Belief Model Gestational Diabetes Self-efficacy risk perception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Education group

Group Type ACTIVE_COMPARATOR

Education group

Intervention Type BEHAVIORAL

The training materials were prepared in line with the researchers and expert opinions were obtained. Trainings will be given for two weeks. After the trainings are completed, reminder information will be sent to the pregnant women via text messages every other day to inform them that the trainings are continuing. Reminder information prepared as text messages will be sent to the pregnant women's mobile phones. 4 weeks after the first training, the same training will be reminded again via WhatsApp as a summary training by emphasizing key points.

The trainings will be carried out by an expert researcher in the field. In the training content prepared in line with WhatsApp, the risks that may be seen during pregnancy and Gestational Diabetes Mellitus;

* Sensitivity perception and Seriousness perception, perceived risks that may be seen during pregnancy
* Health motivation perception, the pregnant woman's beliefs and practices regarding being healthy,
* Benefit perception, pregnancy follow

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education group

The training materials were prepared in line with the researchers and expert opinions were obtained. Trainings will be given for two weeks. After the trainings are completed, reminder information will be sent to the pregnant women via text messages every other day to inform them that the trainings are continuing. Reminder information prepared as text messages will be sent to the pregnant women's mobile phones. 4 weeks after the first training, the same training will be reminded again via WhatsApp as a summary training by emphasizing key points.

The trainings will be carried out by an expert researcher in the field. In the training content prepared in line with WhatsApp, the risks that may be seen during pregnancy and Gestational Diabetes Mellitus;

* Sensitivity perception and Seriousness perception, perceived risks that may be seen during pregnancy
* Health motivation perception, the pregnant woman's beliefs and practices regarding being healthy,
* Benefit perception, pregnancy follow

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between the ages of 18-35,

* In the second trimester,
* Primiparous,
* Have adequate communication skills,
* Literate,
* Can read and understand Turkish,
* Recently diagnosed with GDM,
* Have a singleton pregnancy,
* Pregnant women who agree to participate in the study will be included.
* Continuing pregnancy school

Exclusion Criteria

* Pregnant women with risky pregnancies,

* Multiple pregnancies were not included in the study.
* Pregnant women with previous type 1 or type 2 diabetes,
* Have a psychiatric diagnosis,
* Have a physical disability,
* Have communication problems will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mine Gokduman Keles

Burdur Mehmet Akif Ersoy University DOCTORATE LECTURER MIDWIFERİY

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

MİNE GÖKDUMAN

Role: CONTACT

Phone: 248 213 82 50

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024/12 GO 2024/800

Identifier Type: -

Identifier Source: org_study_id