Gestational Diabetes Management Based on Planned Behavior Theory

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Gestational
• Interventions: Behavioral: Gestational Diabetes Training Intervention based on Planned Behavior Theory; Behavioral: Gestational Diabetes Training Intervention based on standart

• Registration Number: NCT04874922
• Lead Sponsor: Koç University

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-06
• Study Start: 2021-05-15
• Status Verified: 2021-06
• Primary Completion: 2021-10-17
• Study Completion: 2021-11-27
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case group	Gestational Diabetes Training Intervention based on Planned Behavior Theory	The case group will first receive standard diabetes training from the hospital. After 28-30. Diabetes training based on Planned Behavior Theory will be given three times between gestational weeks. Each training will take an average of 45 minutes. After that, the data evaluation phase will be started.
Control Group	Gestational Diabetes Training Intervention based on standart	The control group will only receive standart diabetes training from the hospital. Then, only follow-up will be done and the data will be evaluated.

Primary Outcome Measures

Name	Time	Method
metabolic control variables evaluation form (third)	The data of metabolic control variables of each pregnant woman at her 36th gestational week will be evaluated.	It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
metabolic control variables evaluation form (fourth)	The data of metabolic control variables of each pregnant woman at her 40th gestational week will be evaluated.	It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
metabolic control variables evaluation form (second)	The data of metabolic control variables of each pregnant woman at 32nd gestational week will be evaluated.	It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
metabolic control variables evaluation form (first)	The data of metabolic control variables of each pregnant woman at 28th gestational week will be evaluated.	It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.

Secondary Outcome Measures

Name	Time	Method
Pregnancy Outcomes Evaluation Form for Mother and Baby	Data of each pregnant woman will be evaluated with Pregnancy Outcome Form for Mother and Baby in the postnatal period of 12 weeks.	This form evaluates the birth information of the mother and the baby, their health conditions and birth complications.

Trial Locations

Locations (1)

Kafiye EROĞLU; 🇹🇷 İstanbul, Turkey