Effectiveness of a Pender's Health Promotion Model-Based Diabetes Self-Management Program in Gestational Diabetes: A Clinical Trial

NCT07060963 | Completed Results

• 1 other identifier: E-84892257-300-292369
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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. 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. 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?

Conditions

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

Keywords

Gestational diabetes; nursing; motivational interviewing,; diabetes management; health promotion theory

Outcome Measures

Primary Outcomes (3)

• Health Belief Model Scale for Diabetes Patients

  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).

  At 36-38 weeks of gestation

• Gestational Diabetes Self-Efficacy Scale

  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.

  At 36-38 weeks of gestation

• Multidimensional Scale of Perceived Social Support

  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.

  At 36-38 weeks of gestation

Secondary Outcomes (7)

• Healthy Lifestyle Behaviors Scale - II

  At 36-38 weeks of gestation

• Maternal Fastıng Blood Sugar Values

  Within the first 24 hours postpartum

• Maternal Postprandial Blood Sugar Values

  Within the first 24 hours postpartum

• Percentage of Participants With Preterm Labor

  At the time of delivery

• Neonatal Fasting Blood Glucose Measurements

  Within the first 24 hours after birth

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

Routine maintenance standard

NO INTERVENTION

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

Interventions

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

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

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt Üniversitesi, Sağlık Bilimleri Fakültesi

Ankara, Çubuk, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This study has several limitations. First, the sample size was relatively small (71 participants), which may limit the statistical power, especially for subgroup analyses or rare outcomes. Second, the study was conducted at a single university hospital in Ankara, which may restrict the generalizability of the findings to other populations or settings. Third, postpartum and neonatal measurements were limited to the first 24-48 hours, preventing assessment of long-term maternal and neonatal outcom

Results Point of Contact

• Title: ESRA ALTUN
• Organization: Ankara Yildirim Beyazit University

arse25400@hotmail.com

05537946177

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NURSE

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: January 15, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)