Education of Pregnant Women at Risk of Gestational Diabetes

NCT ID: NCT05568277

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2023-10-31

Brief Summary

There are studies in the literature showing that there is a decrease in the number of pregnant women diagnosed with gestational diabetes and improvements in parameters related to maternal and infant health, with the education to be given to pregnant women at risk of gestational diabetes on preventive lifestyle practices such as healthy nutrition, physical exercise, and coping with stress. The aim of this study; For pregnant women at risk of gestational diabetes; education on preventive health behaviors; It is to determine the level of knowledge about GDM, risk perception and its effect on healthy living behaviors.

Detailed Description

Gestational diabetes mellitus (GDM) is carbohydrate intolerance of varying degrees that begins during pregnancy or is first diagnosed during pregnancy. 4% of pregnancies are complicated by GDM. History of diabetes in first-degree relatives, history of GDM in previous pregnancies, body mass index over 30 kg/m2, significant weight gain during pregnancy, and maternal age over 25 are among the primary risk factors for gestational diabetes in pregnant women. Gestational diabetes; It causes serious maternal and fetal complications such as the risk of developing Type 2 diabetes in the mother, traumatic birth, preeclampsia, cesarean delivery, macrosomic baby, and congenital malformations.

It is known that healthy lifestyle behaviors are as effective as genetic factors in the development of diabetes. Lifestyle behavior modification is an essential component of gestational diabetes management. Studies show that 70-85% of pregnant women can control diabetes only with lifestyle changes. Protective health behaviors such as being at an ideal weight, eating healthy, exercising regularly and not smoking prevent the development of gestational diabetes. As a result of the Finnish Gestational Diabetes Prevention Study (RADIEL), it was found that physical activity and dietary intervention decreased the incidence of GDM by 36% in high-risk women. It is important that these preventive health behaviors are adopted and maintained by the pregnant woman. For this purpose, it is necessary to determine the problems in the process of acquiring behaviors that protect and improve health and prevent negative behaviors. Self-efficacy level plays an important role in initiating and maintaining preventive health behaviors. Education on preventive health behaviors can improve and improve self-care behaviors by increasing the self-efficacy level of women at risk of gestational diabetes.

Conditions

Pregnant Women; Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Education

A minimum of 12-week training program and follow-up based on Pender's Health Promotion Model is planned until the 24th gestational week.

Group Type: EXPERIMENTAL

Education on preventive health behaviors based on Pender's Health Promotion Model

Intervention Type: BEHAVIORAL

Pregnant women included in the study will be given education on preventive health behaviors based on Pender's Health Promotion Model on the prevention of gestational diabetes over the web (ZOOM/Teams etc.) every two weeks. Pregnant women's questions will be answered. At the end of each training, data will be collected from pregnant women and follow-up charts will be filled. The education booklet prepared by the researcher will be given to the pregnant women after the first education and will be sent to their e-mail addresses.

Control

No intervention will be made by the researcher and they will receive routine antenatal care. After the post-test data are collected, the education booklet prepared by the researcher will be given to the pregnant women and sent to their e-mail addresses.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education on preventive health behaviors based on Pender's Health Promotion Model

Pregnant women included in the study will be given education on preventive health behaviors based on Pender's Health Promotion Model on the prevention of gestational diabetes over the web (ZOOM/Teams etc.) every two weeks. Pregnant women's questions will be answered. At the end of each training, data will be collected from pregnant women and follow-up charts will be filled. The education booklet prepared by the researcher will be given to the pregnant women after the first education and will be sent to their e-mail addresses.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Being between the 8th and 12th gestational weeks,
• Having risk factors for GDM (BMI of 30 kg/m2 and above, presence of diabetes in 1st degree relatives, diagnosis of GDM in previous pregnancy), being over 18 years old)
• Having a singleton pregnancy
• Ability to read and write Turkish
• Volunteering to participate in the study

Exclusion Criteria

• Being older than 12 weeks of pregnancy
• Not having risk factors for GDM (BMI of 30 kg/m2 and above, presence of diabetes in 1st degree relatives, diagnosis of GDM in previous pregnancy), being over 18 years old)
• Having a multiple pregnancy
• Inability to read and write Turkish
• Not volunteering to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Burçin Bektaş Pardes

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulten Guvenc

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi

Central Contacts

Burcin Bektas Pardes

Role: CONTACT

burcinbektas.pardes@sbu.edu.tr

5545680840

Gulten Guvenc

Role: CONTACT

gulten.guvenc@sbu.edu.tr

+905366700321

References

Rono K, Stach-Lempinen B, Eriksson JG, Poyhonen-Alho M, Klemetti MM, Roine RP, Huvinen E, Andersson S, Laivuori H, Valkama A, Meinila J, Kautiainen H, Tiitinen A, Koivusalo SB. Prevention of gestational diabetes with a prepregnancy lifestyle intervention - findings from a randomized controlled trial. Int J Womens Health. 2018 Aug 27;10:493-501. doi: 10.2147/IJWH.S162061. eCollection 2018.

Reference Type: RESULT

PMID: 30214318 (View on PubMed)

Koivusalo SB, Rono K, Klemetti MM, Roine RP, Lindstrom J, Erkkola M, Kaaja RJ, Poyhonen-Alho M, Tiitinen A, Huvinen E, Andersson S, Laivuori H, Valkama A, Meinila J, Kautiainen H, Eriksson JG, Stach-Lempinen B. Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial. Diabetes Care. 2016 Jan;39(1):24-30. doi: 10.2337/dc15-0511. Epub 2015 Jul 29.

Reference Type: RESULT

PMID: 26223239 (View on PubMed)

Chasan-Taber L. Lifestyle interventions to reduce risk of diabetes among women with prior gestational diabetes mellitus. Best Pract Res Clin Obstet Gynaecol. 2015 Jan;29(1):110-22. doi: 10.1016/j.bpobgyn.2014.04.019. Epub 2014 Aug 19.

Reference Type: RESULT

PMID: 25220104 (View on PubMed)

Other Identifiers

bpardes1

Identifier Type: -

Identifier Source: org_study_id