Clinical trial NCT04874922: Gestational Diabetes Management Based on Planned Behavior Theory
Official title: The Effect Birth Outcome and Diabetes Management of Planned Behavior Theory Based Education Model in Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Gestational
Keywords: Education, Nursing
Pregnancy Complications
Complications, Labor
Diabetes, Pregnancy-Induced
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women diagnosed with gestational diabetes will be assigned to the case and control groups in a randomized controlled manner (with simple random numbers table). Matching will be made between groups according to age and education level.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our study was planned as a randomized controlled trial in order to determine the effect of Planned Behavior Theory based training model on diabetes management and pregnancy outcomes in women with Gestational Diabetes Mellitus.

Detailed description: The trial will be conducted to evaluate the effectiveness of the model and to determine the impact of the Planned Behavior Theory based educational intervention on diabetes management and pregnancy outcomes.The research will be conducted in Women's Training and Research Hospitals in Istanbul. The sample group will be 70 subjects calculated by power analysis. Case and control groups will be determined by simple randomization. Sampling selection criteria; 24-28. they are pregnant women who are diagnosed with GDM between the weeks of gestation, can communicate in Turkish, are literate, have no GDM in their previous pregnancies, have a personal contact number and e-mail address, and plan to give birth at the hospital where the study will be conducted. Research data will be collected by the researcher between the 28th week of gestation and the 12th week of postpartum through the Diabetes Intention, Attitude and Behavior Questionnaire, Personal Data Collection Form, Metabolic Control Variables Form, Maternal and Infant Pregnancy Results Form. Case group; In addition to the training given in the hospital, the Training for Gestational Diabetes Based on Planned Behavior Theory will be given in three stages. Figures, percentage distributions, chi-square test, student t-test and analysis of variance will be used in the analysis of the data. As a result of the intervention made to the case group; It is expected to decrease complications due to diabetes in mothers, babies and newborns, to provide maternal metabolic control, to control the mother's weight and to shorten the duration of hospital stay.

Eligibility criteria: Inclusion Criteria:

* Sample selection criteria describe pregnant women with personal contact information available who are diagnosed to have GDM between the weeks of 24-28 of their pregnancy, literate and capable of communicating in Turkish, not diagnosed to have GDM in their previous pregnancies, planning to deliver the child in the hospital where the research is to be conducted.

Exclusion Criteria:

* Not having had a cesarean delivery before.

Primary outcomes:
measure: metabolic control variables evaluation form (first)
timeFrame: The data of metabolic control variables of each pregnant woman at 28th gestational week will be evaluated.
measure: metabolic control variables evaluation form (second)
timeFrame: The data of metabolic control variables of each pregnant woman at 32nd gestational week will be evaluated.
measure: metabolic control variables evaluation form (third)
timeFrame: The data of metabolic control variables of each pregnant woman at her 36th gestational week will be evaluated.
measure: metabolic control variables evaluation form (fourth)
timeFrame: The data of metabolic control variables of each pregnant woman at her 40th gestational week will be evaluated.
Secondary outcomes:
measure: Pregnancy Outcomes Evaluation Form for Mother and Baby
timeFrame: Data of each pregnant woman will be evaluated with Pregnancy Outcome Form for Mother and Baby in the postnatal period of 12 weeks.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kafiye EROĞLU
Study officials:
affiliation: Koç University
name: Kafiye EROĞLU, Prof.
role: STUDY_DIRECTOR
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