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NCT Number: NCT04874922

Gestational Diabetes Management Based on Planned Behavior Theory

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.

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Key information

Conditions

Diabetes Mellitus, Gestational Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafiye EROĞLU

Istanbul, 34520, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gestational Diabetes Training Intervention based on Planned Behavior Theory

Behavioral

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.

Gestational Diabetes Training Intervention based on standart

Behavioral

Standard training for gestational diabetes will be given once at 28 weeks of gestation.

Primary outcomes

  1. metabolic control variables evaluation form (first)

    Time frame: 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.

  2. metabolic control variables evaluation form (second)

    Time frame: 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.

  3. metabolic control variables evaluation form (third)

    Time frame: 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.

  4. metabolic control variables evaluation form (fourth)

    Time frame: 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.

Secondary outcomes

  1. Pregnancy Outcomes Evaluation Form for Mother and Baby

    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.

    This form evaluates the birth information of the mother and the baby, their health conditions and birth complications.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

The Effect Birth Outcome and Diabetes Management of Planned Behavior Theory Based Education Model in Women With Gestational Diabetes

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 6, 2021
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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