N/A N=71 Randomized Single-blind Supportive Care

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

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

Bottom Line

View on ClinicalTrials.gov: NCT07060963 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Mar 2026

Primary outcome: Primary: Health Belief Model Scale for Diabetes Patients — 3.45; 3.42 Score — p=0.015

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Motivational interviews within the context of a health promotion-based diabetes self-management program (Behavioral)
Age: Adult, Older Adult · 19+ yrs
Sex: Female
Sponsor: Ankara Yildirim Beyazıt University
Primary completion: Jun 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Health Belief Model Scale for Diabetes Patients	3.45; 3.42	0.015 sig
PRIMARY Gestational Diabetes Self-Efficacy Scale	4.09; 3.74	<0.001 sig
PRIMARY Multidimensional Scale of Perceived Social Support	78; 75	0.243
SECONDARY Healthy Lifestyle Behaviors Scale - II	151.36; 137.63	<0.001 sig
SECONDARY Maternal Fastıng Blood Sugar Values	95; 106	0.047 sig
SECONDARY Maternal Postprandial Blood Sugar Values	113; 128	0.025 sig
SECONDARY Percentage of Participants With Preterm Labor	1; 8	—
SECONDARY Neonatal Fasting Blood Glucose Measurements	63; 61	—
SECONDARY Neonatal Postprandial Blood Glucose Measurements	71; 70	—
SECONDARY Number and Percentage of Participants With Macrosomia (Birth Weight ≥ 4000 Grams)	6; 0	—

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?

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07060963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.