Trial Outcomes & Findings for Effectiveness of a Pender's Health Promotion Model-Based Diabetes Self-Management Program in Gestational Diabetes: A Clinical Trial (NCT NCT07060963)

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.

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.

Age of participants at baseline, reported as mean and standard deviation in years.

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).

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.

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.

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 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 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.

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 levels were measured from venous or capillary blood samples within the first 24 hours after birth to assess early neonatal glycemic status.

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.

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.