Evaluation of Healthy Lifestyle Behaviors in Pregnant Women Diagnosed With Gestational Diabetes Mellitus

NCT ID: NCT07060963

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-12-01

Brief Summary

The aim was to evaluate the effect of a nursing education intervention based on Pender's SGM on gestational diabetes management and healthy lifestyle behaviors for pregnant women diagnosed with gestational diabetes. The main questions it aims to answer are:

1. Is there a difference between the total mean scores of the Healthy Lifestyle Behaviors Scale of the pregnant women in the intervention and control groups?

2. Is there a difference between the total mean scores of the Self-Efficacy in Gestational Diabetes Scale of the pregnant women in the intervention and control groups?

3. Is there a difference between the total mean scores of the Health Belief Model Scale in Diabetic Patients of the pregnant women in the intervention and control groups?

4. Is there a difference between the total mean scores of the Multidimensional Perceived Social Support Scale of the pregnant women in the intervention and control groups?

5. Is there a difference between the development of maternal complications (at least one complication) of the pregnant women in the intervention and control groups?

6. Is there a difference in the development of fetal complications (at least one complication) between the pregnant women in the intervention and control groups?

Detailed Description

It was conducted in the Department of Obstetrics and Gynecology (GHD) of the Cebeci Application and Research Hospital (AÜTFCH) of Ankara University Faculty of Medicine. This study was conducted with pregnant women who were diagnosed with OGTT test at 24-28 weeks of pregnancy and applied to the AÜTFCH GHD pregnancy clinic.

The study was conducted in two stages: the first stage was the preparation of research materials and determination of study groups, and the second stage was the implementation of the diabetes self-management program based on the Penderin health promotion model.

In the first stage of the study, women diagnosed with gestational diabetes mellitus (GDM) who constituted the intervention and control groups were divided into groups using the simple randomization method. Patients diagnosed according to the oral glucose tolerance test (OGTT) results are started to be followed up in the perinatology clinic. Pregnant women are routinely referred to a dietician in the perinatology clinic. In order to prevent bias, support was received from a dietician independent of the study to create an intervention and control group. Randomization was used to prevent distribution bias. Patients who applied to the dietician were grouped according to their application days. Patients formed the intervention group on the 1st, 3rd and 5th days of the first week, while the control group formed the 2nd and 4th days. The control group formed the 1st, 3rd and 5th days of the second week, while the intervention group formed the 2nd and 4th days. The education groups were divided into groups of at least 10 people by taking into account their gestational weeks. The second phase of the study included the application of the Diabetes Self-Management Program Based on Pender's Health Promotion Model to the pregnant women in the intervention group. Face-to-face interviews were conducted with pregnant women in the intervention group who were diagnosed with gestational diabetes and were between 24-28 weeks of pregnancy. Pregnant women who agreed to participate in the study were informed about how the study would proceed and their written consent was obtained. The pregnant women in the intervention group were asked to fill out the personal information form and the pre-test (Health Belief Model Scale in Diabetic Patients (DHSMÖ), Gestational Diabetes Self-Efficacy Scale (GDSES), Healthy Lifestyle Behaviors-II Scale (HLBS-II), Multidimensional Perceived Social Support Scale (MSPSS)]. Their contact information was obtained to facilitate the follow-up process of the pregnant women and to organize the training program. The researcher determined the day and time of the training according to the availability of the pregnant women to provide the Diabetes Self-Management Group training based on Pender's Health Promotion Model. The group was formed with at least 10 people. The first group completed the training with 16 people, the second group with 11 people, and the third group with 14 people. The training was completed face-to-face and practically, in 4 sessions of 1 day (160 minutes), each session being 40 minutes. In order to support the training program, the "Training for Patients with Gestational Diabetes Booklet", and to ensure follow-up and continuity, the "Lifestyle Behavior Change Follow-up Booklet" was given to the pregnant women and its use was explained. They were asked to bring the follow-up booklet to each interview, and the researcher determined the motivational interview topics according to the DHSMÖ sub-dimension scores and the booklet. In line with the interviews, motivational interviews were conducted within the scope of the health development-based diabetes self-management program by the researcher who has a certificate in diabetes life coaching, holistic medicine eating and drinking disorders and motivational interview. The first motivational interview was conducted between the 32nd and 34th weeks of pregnancy for each pregnant woman in the intervention group according to their DHSMÖ and HLBS-II scale sub-dimension scores. Before each interview, the pregnant women were called by phone to remind them of the interview. A follow-up file was created for each pregnant woman. The follow-up file includes OGTT test results, lifestyle behavior change booklet, DHSMÖ sub-dimension scores, motivational interview schedules, pre-test and post-test forms.

A second motivational interview was planned between the 32nd and 36th weeks of pregnancy according to the determined need situation and the pregnant women were asked to repeat the relevant DHSMÖ sub-dimension. were provided. Each interview lasted approximately 40 minutes. During the study, group dynamics were maintained by having the pregnant women post walking videos and photos of their meals. In order to ensure continuity for the pregnant women who achieved positive behavioral outcomes, reinforcement was provided by phone calls and the counseling process was completed.

Conditions

Self-Efficacy for Decision Making; Apgar Score; Behavior Change; Maternal and Neonatal Outcomes; Models, Theoretical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Motivational interviewing within the context of a health promotion-based diabetes mellitüs

The group that received the diabetes self-management program based on the Pender's health promotion model

Group Type: ACTIVE_COMPARATOR

Motivational interviews within the context of a health promotion-based diabetes self-management program

Intervention Type: BEHAVIORAL

The researcher provided counseling services to pregnant women to provide Diabetes Self-Management Group training based on Pender's Health Promotion Model. A group was formed consisting of at least 10 people. The training was completed face-to-face and practically, in 1 day (160 minutes), in 4 sessions, each session being 40 minutes. Motivational interviews were conducted by the researcher within the scope of the health promotion-based diabetes self-management program. A second motivational interview was planned according to the determined need and the interviews were provided. Each interview lasted approximately 40 minutes. In order to ensure continuity for the pregnant women who obtained positive behavioral outcomes, reinforcement was provided by telephone interviews and the counseling process was completed.

Routine maintenance standard

The group that did not receive the diabetes self-management program based on Pender's health promotion model

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational interviews within the context of a health promotion-based diabetes self-management program

The researcher provided counseling services to pregnant women to provide Diabetes Self-Management Group training based on Pender's Health Promotion Model. A group was formed consisting of at least 10 people. The training was completed face-to-face and practically, in 1 day (160 minutes), in 4 sessions, each session being 40 minutes. Motivational interviews were conducted by the researcher within the scope of the health promotion-based diabetes self-management program. A second motivational interview was planned according to the determined need and the interviews were provided. Each interview lasted approximately 40 minutes. In order to ensure continuity for the pregnant women who obtained positive behavioral outcomes, reinforcement was provided by telephone interviews and the counseling process was completed.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Able to communicate in Turkish,
• Not having conditions that would create communication problems (mental, visual, hearing impairment),
• Graduated from at least secondary school,
• Having a singleton pregnancy between the 24th and 28th weeks of pregnancy,
• Not having been diagnosed with GDM in a previous pregnancy,
• Not having been diagnosed with a risky pregnancy (adolescent pregnancy, preeclampsia, eclampsia, hypertension),
• Not having a health problem that would prevent exercise (heart disease, respiratory diseases, risk of abortion, orthopedic problems),
• Not having to follow a special diet program (Celiac disease, kidney disease, heart disease).
• Not having a psychiatric diagnosis (psychosomatic disorders),
• Having an endocrine disease known to affect blood glucose levels (hyperthyroidism, hypothyroidism).

Exclusion Criteria

• Wanting to leave at any stage of the study,
• Not participating in the program at least once after joining the study (Signature chart follow-up, detection of non-continuation of daily follow-up),
• Being diagnosed with a risky pregnancy at any stage of the study (preeclampsia, eclampsia, premature membrane rupture, systemic disease)
• Incompletely filling in the data collection forms applied during the program.

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Esra Altun

NURSE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Yıldırım Beyazıt Üniversitesi, Sağlık Bilimleri Fakültesi

Ankara, Çubuk, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

E-84892257-300-292369

Identifier Type: -

Identifier Source: org_study_id