Pregnancy ComplicationsNCT06740695
Health Belief Model Based Education for Pregnant Women With Gestational Diabetes
A study testing Education group in people with Pregnancy Complications, run by Burdur Mehmet Akif Ersoy University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Education group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jul 2025
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-35,
- In the second trimester,
- Primiparous,
- Have adequate communication skills,
- Literate,
- Can read and understand Turkish,
Show all 10Show fewer
- Recently diagnosed with GDM,
- Have a singleton pregnancy,
- Pregnant women who agree to participate in the study will be included.
- Continuing pregnancy school
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Health Belief Model-Based Education Given to Pregnant Women Via WhatsApp on Self-Efficacy and Risk Perception in Pregnancy in Gestational Diabetes
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,
Read the detailed description
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
- Pregnancy Complications
- Being tested
- Education group
- Keywords
- Health Belief Model Gestational Diabetes Self-efficacy risk perception
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Education group | Active comparator | Not described Receives: Behavioral: Education group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Risk Perception Scale (GRP)
The scale was developed by Heaman and Gupton (2009) to assess the risk perception of pregnant women. The Turkish validity and reliability study of the scale was conducted by Evcili and Dağlar (2019) . The risk perception scale consists of 9 items and 2 sub-dimensions. The scale is a visual analog measurement tool. The scale consists of 9 items and 2 factors. There is a 0-100 mm linear line immediately below each item in the scale, indicating "no risk" and "extremely high risk". The total score of the scale is found by adding the scores for each of the nine items and dividing the obtained score by 9. A score can also be made for the factors of the scale: The score for the "Risk perception of the pregnant woman towards her baby" factor is found by adding the scores for each of the 5 items under this factor and dividing the obtained score by 5. The score for the "Risk perception of the pregnant woman towards herself" factor is obtained by add
Measured: 1 HOUR
Self-Efficacy Scale in Gestational Diabetes (GESGD):
Developed by Polat and Avdal (2020), the Self-Efficacy Scale in Gestational Diabetes is a five-point Likert-type scale consisting of 23 items and four sub-dimensions. The total Cronbach alpha value of the scale was determined as 0.654. Its sub-dimensions are Diet and Weight Management, Complication Precautions, Nutrition Education Compliance and Medical Treatment Applications. It has been emphasized that as the score to be obtained from the scale increases as a result of the coding of the positive and negative expressions in the scale, the individual's self-efficacy will increase and that he/she will be able to effectively perform his/her own care as a result of the training he/she receives.
Measured: 1 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740695
- Sponsor's protocol ID
- 2024/12 GO 2024/800
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 18 Dec 2024
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Education Given to Pregnant Women Via WhatsApp on Self-Efficacy and Risk Perception in Pregnancy in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06740695
- Acronym / sponsor ID
- 2024/12 GO 2024/800
- Conditions
- Pregnancy Complications
- Keywords
- Health Belief Model Gestational Diabetes Self-efficacy risk perception
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 18 Dec 2024 (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 (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
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,
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Education group | Active comparator | Behavioral: Education group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Between the ages of 18-35,
Key exclusion criteria (6 listed)
- Pregnant women with risky pregnancies,
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 groupThe 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 | Behavioural | Education group |
Primary outcome
Pregnancy Risk Perception Scale (GRP)
Time frame: 1 HOUR
The scale was developed by Heaman and Gupton (2009) to assess the risk perception of pregnant women. The Turkish validity and reliability study of the scale was conducted by Evcili and Dağlar (2019) . The risk perception scale consists of 9 items and 2 sub-dimensions. The scale is a visual analog measurement tool. The scale consists of 9 items and 2 factors. There is a 0-100 mm linear line immediately below each item in the scale, indicating "no risk" and "extremely high risk". The total score of the scale is found by adding the scores for each of the nine items and dividing the obtained score by 9. A score can also be made for the factors of the scale: The score for the "Risk perception of the pregnant woman towards her baby" factor is found by adding the scores for each of the 5 items under this factor and dividing the obtained score by 5. The score for the "Risk perception of the pregnant woman towards herself" factor is obtained by add
Self-Efficacy Scale in Gestational Diabetes (GESGD):
Time frame: 1 HOUR
Developed by Polat and Avdal (2020), the Self-Efficacy Scale in Gestational Diabetes is a five-point Likert-type scale consisting of 23 items and four sub-dimensions. The total Cronbach alpha value of the scale was determined as 0.654. Its sub-dimensions are Diet and Weight Management, Complication Precautions, Nutrition Education Compliance and Medical Treatment Applications. It has been emphasized that as the score to be obtained from the scale increases as a result of the coding of the positive and negative expressions in the scale, the individual's self-efficacy will increase and that he/she will be able to effectively perform his/her own care as a result of the training 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 18 Dec 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Education group in people with Pregnancy Complications, run by Burdur Mehmet Akif Ersoy University.
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 6 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 MİNE GÖKDUMAN (248 213 82 50, minegokdumankeles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Risk Perception Scale (GRP) (time frame: 1 HOUR). The study lists 2 primary outcomes in all. 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 18 Dec 2024.