NCT06740695

Brief 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. 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,

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 9, 2024

Last Update Submit

December 14, 2024

Conditions

Keywords

Health Belief Model Gestational Diabetes Self-efficacy risk perception

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    1 HOUR

Study Arms (2)

Control Group

NO INTERVENTION

Education group

ACTIVE COMPARATOR
Behavioral: Education group

Interventions

Education groupBEHAVIORAL

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

Education group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Burdur Mehmet Akif Ersoy University DOCTORATE LECTURER MIDWIFERİY

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 18, 2024

Study Start

January 1, 2025

Primary Completion

May 30, 2025

Study Completion

July 30, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share