Evaluatıon Of The Effectıveness Of A Dıabetes Self-Management Program Based On Pender's Health Promotıon Model In Pregnant Women Dıagnosed Wıth Gestatıonal Dıabetes Mellıtus
Phase: NA
Conditions: Self-Efficacy for Decision Making, Apgar Score, Behavior Change, Maternal and Neonatal Outcomes, Models, Theoretical
Sponsor: Ankara Yildirim Beyazıt University

OFFİCİAL TİTLE:
Evaluation of the Effectiveness of a Diabetes Self-Management Program Based on 
Pender’s Health Promotion Model in Pregnant Women Diagnosed with Gestational 
Diabetes Mellitus
NCT NUMBER:
NCT07060963
DOCUMENT DATE:
15.01.2025

STUDY PROTOCOL
Official Study Title:
Evaluation of the Effectiveness of a Diabetes Self-Management Program Based on Pender’s 
Health Promotion Model in Pregnant Women Diagnosed with Gestational Diabetes Mellitus
ClinicalTrials NCT Number:
NCT07060963
Study Type:
Interventional Study (Clinical Trial)
Study Design:
Parallel-group clinical trial
Research Center / Institution:
Ankara Yıldırım Beyazıt University Graduate School of Health Sciences 
Principal Investigator:
Esra ALTUN
Ethics Approval:
 Approved by the Ethics Committee of Ankara Yıldırım Beyazıt University, Graduate School 
of Health Sciences.  NO: 06/791
Document Type:
Study Protocol
Version Number:
Version 1.0
Country:
Türkiye

1. Title
Evaluatıon of the effectıveness of a dıabetes self-management program based on pender's 
health promotıon model ın pregnant women dıagnosed wıth gestatıonal dıabetes mellıtus
2. Study Summary
This randomized controlled trial aimed to evaluate the effectiveness of a self-management 
program based on Pender’s Health Promotion Model (HPM) in pregnant women diagnosed 
with  gestational  diabetes  mellitus  (GDM).  Participants  were  randomly  assigned  to 
intervention  and  control  groups,  which  were  similar  in  demographic  and  obstetric 
characteristics  (p>0.05).  Following  the  intervention,  meal  frequency  and  water  intake 
significantly  increased,  while  physical  activity  and  sleep  duration  improved  in  the 
intervention group (p<0.05). Fasting and postprandial blood glucose levels were significantly 
lower in the intervention group during pregnancy and postpartum, and maternal blood glucose 
at delivery was reduced compared to controls (p<0.05). HbA1c levels remained similar 
between groups (p>0.05). Significant improvements were observed in health beliefs, self-
efficacy,  and  healthy  lifestyle  behaviors  in  the  intervention  group,  particularly  in  diet, 
physical activity, stress management, and spiritual development domains (η² =0.029–0.218). 
Regarding birth outcomes, the intervention group showed lower rates of preterm birth (2.7% 
vs 23.5%, p=0.012), shorter hospital stays, and reduced macrosomia risk (p<0.05). APGAR 
scores and delivery mode did not significantly differ between groups. These findings suggest 
that a Pender HPM-based self-management program may improve metabolic control, healthy 
lifestyle behaviors, and certain perinatal outcomes in women with GDM.
3. Introduction & Objectives
Background: Gestational diabetes mellitus (GDM) is a common metabolic disorder during 
pregnancy, associated with maternal and neonatal complications, including hyperglycemia, 
hypoglycemia,  hypertension,  polyhydramnios,  infection,  dystocia,  cesarean  delivery, 
macrosomia,  and  neonatal  metabolic  issues.  Despite  existing  management  strategies, 
optimizing self-management and promoting healthy lifestyle behaviors remain challenging. 
Pender’s Health Promotion Model (HPM) provides a framework to enhance health behaviors 
and self-efficacy in individuals with chronic conditions, including GDM.

Study Aim: The aim of this study is to evaluate the effectiveness of a self-management 
program based on Pender’s HPM in pregnant women diagnosed with GDM.
Research Hypotheses:

H01: No difference in mean  Health Belief Model Scale for Patients with Diabetes 
scores between groups.

H02: No difference in mean Gestational Diabetes Self-Efficacy Scale scores between 
groups.

H03: No difference in mean Multidimensional Perceived Social Support Scale scores 
between groups.

H04: No difference in mean  Health-Promoting Lifestyle Profile II scores between 
groups.

H05: No difference in incidence of at least one maternal complication between groups.

H06: No difference in fasting and postprandial blood glucose levels at 24–28, 28–32, 
32–38 weeks, delivery, and first 24 hours postpartum between groups.

H07: No difference in HbA1c levels in the first and third trimesters between groups.

H08: No difference in neonatal complications frequency between groups.

H09: No difference in neonatal blood glucose levels at 3, 6, and 9 hours postpartum 
between groups.
4. Study Population and Sample Size
Population: Pregnant women attending antenatal clinics at a university hospital in Ankara, 
diagnosed with GDM at 24–28 weeks gestation via OGTT (ICD-10 O24.4).
Sample Size: Using G*Power (v3.1.9.6) with α=0.05, power=80%, and effect size=0.20, 
minimum  26  participants  per  group  were  required.  To  account  for  20%  dropout,  36 
participants per group (total 64) were enrolled (Intervention: n=32; Control: n=32).
5. Eligibility Criteria and Randomization
Inclusion  Criteria: Communication  in  Turkish,  no  mental/visual/hearing  impairments, 
≥secondary education, singleton pregnancy at 24–28 weeks, no prior GDM, not high-risk 
pregnancy, no contraindications for exercise, no special diet requirements, no psychiatric or 
endocrine disorders affecting glucose.

Exclusion Criteria: Withdrawal at any stage, missing program sessions, developing high-risk 
pregnancy during study, incomplete data collection forms.
Randomization: Simple  randomization  with  day-based  rotation  was  performed  by  an 
independent dietitian to avoid bias. Groups were balanced with at least 10 participants per 
educational subgroup.
6. Study Procedures
Enrollment and Group Assignment: Eligible participants were screened, consented, and 
systematically assigned to intervention or control groups using day-based rotation.
Intervention:

Intervention group received a structured diabetes self-management program based on 
Pender’s HPM.

Four face-to-face sessions (40 min each, total 160 min) delivered to groups of 10–15 
participants.

Provided with Gestational Diabetes Patient Education Booklet and Lifestyle Behavior 
Change Tracking Booklet.

Individual motivational interviews conducted at 28–32 weeks and 32–36 weeks, with 
phone reminders and follow-up.

Group  engagement  encouraged  through  sharing  exercise  photos/videos;  positive 
behaviors reinforced via telephone counseling.
Postpartum Assessment:

Intervention group: Maternal and neonatal outcomes collected from hospital records 
using a Postpartum Follow-up Form.

Control  group:  Received  routine  care  with  dietitian  referral,  glucose  monitoring 
instructions,  and  pre/post-test  data  collection  using  KBF,  DHSİMÖ,  GDÖYÖ, 
SYBDÖ-II, ÇBASDÖ; postpartum outcomes recorded 24–48 hours after delivery.
7. Outcome Measures
Primary Outcomes:


Maternal fasting and postprandial blood glucose levels, HbA1c, health beliefs, self-
efficacy, healthy lifestyle behaviors.
Secondary Outcomes:

Maternal  complications  (hyper/hypoglycemia,  hypertension,  polyhydramnios, 
cesarean delivery, dystocia, infection).

Neonatal outcomes (birth weight, APGAR scores, neonatal complications, NICU 
admission).

Postpartum maternal and neonatal glucose levels.