Apgar Score, Behavior Change, Maternal and Neonatal Outcomes, Models, Theoretical, Self-Efficacy for Decision Making
Conditions
Keywords
Gestational diabetes, nursing, motivational interviewing,, diabetes management, health promotion theory
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.
Interventions
BEHAVIORALMotivational 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.
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Belief Model Scale for Diabetes Patients | At 36-38 weeks of gestation | Health Belief Model Scale for Diabetes Patients (HBM) consists of 33 items and five subscales: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, and recommended health activities. Items are rated on a 5-point Likert scale (1-5), and negative items are reverse-coded. The total score is calculated as the mean of all items, with a possible score range of 1-5. Higher scores indicate stronger health beliefs. The scale was administered to participants before the intervention (24-28 gestational weeks) and after completion of the intervention (36-38 gestational weeks). |
| Gestational Diabetes Self-Efficacy Scale | At 36-38 weeks of gestation | The Diabetes Self-Efficacy Scale for Gestational Diabetes consists of 23 items across four subscales: Diet-Weight Management, Complication Prevention, Adherence to Nutrition Education, and Medical Treatment Practices. Each item is rated on a 5-point Likert scale (1 = not confident at all, 5 = completely confident). Higher scores indicate greater self-efficacy. The scale was administered to participants at baseline (24-28 gestational weeks) and after completion of the intervention (36-38 gestational weeks). The reported outcome represents the post-intervention score for each participant, calculated as the mean of all item scores (range 1-5). Data were not normally distributed, so medians and interquartile ranges were used to summarize. Results were analyzed using Robust ANOVA based on medians. |
| Multidimensional Scale of Perceived Social Support | At 36-38 weeks of gestation | The Multidimensional Scale of Perceived Social Support consists of 12 items and three subscales: Family, Friends, and Significant Other, each containing four items. Items are rated on a 7-point Likert scale. Subscale scores are calculated by summing the four items within each subscale (range 4-28), and the total score is obtained by summing all subscale scores (range 12-84). Higher scores indicate greater perceived social support. In this study, a total score of 42 and above was considered indicative of positive social support. The unit of measure is scale points. The scale was administered to participants before (24-28 gestational weeks) and after (36-38 gestational weeks) the intervention. The scale was administered before and after the intervention. Pre-test and post-test scores were analyzed in a single analysis using Robust ANOVA (medians) to evaluate the effectiveness of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthy Lifestyle Behaviors Scale - II | At 36-38 weeks of gestation | The Healthy Lifestyle Behaviors Scale-II (HLBS-II) is a 52-item scale consisting of six subscales: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. Each item is rated on a 4-point Likert scale (1 = never, 4 = routinely). Subscale scores are calculated by summing the items within each subscale. The total scale score ranges from 52 to 208, with higher scores indicating better healthy lifestyle behaviors. The scale was administered to participants before the education program (24-28 gestational weeks) and after completion of the intervention (36-38 gestational weeks). The reported outcome represents the post-intervention total score for each participant. Data were summarized using medians because scores were not normally distributed. Results were analyzed using Generalized Linear Models based on medians to evaluate the effectiveness of the intervention. |
| Maternal Fastıng Blood Sugar Values | Within the first 24 hours postpartum | Maternal fasting blood glucose (mg/dL): A single outcome value for each participant was calculated as the mean of all measurements obtained at predefined follow-up time points during pregnancy (24-28, 28-32, and 32-36 gestational weeks) and within the first 24 hours postpartum. Unit of measure: mg/dL Statistical analysis: Robust ANOVA medians were used for comparison. |
| Maternal Postprandial Blood Sugar Values | Within the first 24 hours postpartum | Maternal postprandial blood glucose (mg/dL): A single outcome value for each participant was calculated as the mean of all measurements obtained at predefined follow-up time points during pregnancy (24-28, 28-32, and 32-36 gestational weeks) and within the first 24 hours postpartum. Unit of measure: mg/dL Statistical analysis: Robust ANOVA medians were used for comparison. |
| Percentage of Participants With Preterm Labor | At the time of delivery | Preterm labor was defined as delivery before 37 completed weeks of gestation. Results are presented as the percentage of participants experiencing preterm labor in each study group. |
| Neonatal Fasting Blood Glucose Measurements | Within the first 24 hours after birth | Neonatal fasting blood glucose levels were measured from venous or capillary blood samples within the first 24 hours after birth to assess early neonatal glycemic status. |
| Neonatal Postprandial Blood Glucose Measurements | Within the first 24 hours after birth | Postprandial blood glucose levels measured in neonates born to study participants. Measurements were obtained after feeding within the first 24 hours following birth to assess neonatal glycemic response. |
| Number and Percentage of Participants With Macrosomia (Birth Weight ≥ 4000 Grams) | At the time of delivery | Neonatal birth weight was measured immediately after delivery. Macrosomia was defined as a birth weight of 4000 grams or greater. The outcome was recorded as presence or absence of macrosomia for each study group. Results are reported as both the number and percentage of participants. The unit of measure is number of participants and percentage of participants. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants were recruited between January and July 2025 from the Department of Obstetrics and Gynecology of a university hospital in Ankara. Recruitment was carried out during routine antenatal outpatient clinic visits. Pregnant women between 24 and 28 weeks of gestation were identified through antenatal follow-up records and screened for eligibility according to the predefined inclusion and exclusion criteria.
Pre-assignment details
Before group allocation, eligible participants were informed about the study and provided written informed consent. Baseline assessments, including sociodemographic data, obstetric history, maternal blood glucose measurements, and scale-based evaluations, were completed prior to randomization using standardized procedures. Only participants who completed baseline assessments were randomized, and no intervention was initiated before group assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Age, Continuous | 32.76 YEARS STANDARD_DEVIATION 5.19 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Turkey | 71 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed