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Gestational Diabetes Management Based on Planned Behavior Theory

Primary Purpose

Diabetes Mellitus, Gestational

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gestational Diabetes Training Intervention based on Planned Behavior Theory
Gestational Diabetes Training Intervention based on standart
Sponsored by
Koç University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Gestational focused on measuring Education, Nursing, Pregnancy Complications, Complications, Labor, Diabetes, Pregnancy-Induced

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Kafiye EROĞLU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Case group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

metabolic control variables evaluation form (first)
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)
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 (third)
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)
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.

Secondary Outcome Measures

Pregnancy Outcomes Evaluation Form for Mother and Baby
This form evaluates the birth information of the mother and the baby, their health conditions and birth complications.

Full Information

First Posted
April 27, 2021
Last Updated
January 19, 2022
Sponsor
Koç University
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1. Study Identification

Unique Protocol Identification Number
NCT04874922
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
October 17, 2021 (Actual)
Study Completion Date
November 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koç University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Gestational
Keywords
Education, Nursing, Pregnancy Complications, Complications, Labor, Diabetes, Pregnancy-Induced

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gestational Diabetes Training Intervention based on Planned Behavior Theory
Intervention Description
On the basis of Planned Behavior Theory, an training intervention is planned in three stages for medical nutrition, physical activity and gestational diabetes follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Gestational Diabetes Training Intervention based on standart
Intervention Description
Standard training for gestational diabetes will be given once at 28 weeks of gestation.
Primary Outcome Measure Information:
Title
metabolic control variables evaluation form (first)
Description
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
Time Frame
The data of metabolic control variables of each pregnant woman at 28th gestational week will be evaluated.
Title
metabolic control variables evaluation form (second)
Description
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
Time Frame
The data of metabolic control variables of each pregnant woman at 32nd gestational week will be evaluated.
Title
metabolic control variables evaluation form (third)
Description
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
Time Frame
The data of metabolic control variables of each pregnant woman at her 36th gestational week will be evaluated.
Title
metabolic control variables evaluation form (fourth)
Description
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
Time Frame
The data of metabolic control variables of each pregnant woman at her 40th gestational week will be evaluated.
Secondary Outcome Measure Information:
Title
Pregnancy Outcomes Evaluation Form for Mother and Baby
Description
This form evaluates the birth information of the mother and the baby, their health conditions and birth complications.
Time Frame
Data of each pregnant woman will be evaluated with Pregnancy Outcome Form for Mother and Baby in the postnatal period of 12 weeks.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
As the study was about pregnancy, only women were included.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kafiye EROĞLU, Prof.
Organizational Affiliation
Koç University
Official's Role
Study Director
Facility Information:
Facility Name
Kafiye EROĞLU
City
İstanbul
ZIP/Postal Code
34520
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://khgmsaglikhizmetleridb.saglik.gov.tr/TR,42839/dogum-oncesi-bakim-yonetim-rehberi.html
Description
Republic of Turkey Ministry of Health antenatal care and management guide
URL
https://khgmsaglikhizmetleridb.saglik.gov.tr/TR,42842/riskli-gebelik-yonetim-rehberi.html
Description
Republic of Turkey Ministry of Health-risk pregnancy care and management guide

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Gestational Diabetes Management Based on Planned Behavior Theory

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