Effectiveness of Mobile Application-Supported Education and Counseling in Pregnant Women With Gestational Diabetes

NCT07318740 | Active Not Recruiting DMC

• 1 other identifier: Gulhane Faculty of Nursing
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the impact of mobile application-supported education and counseling on the intention, attitude, behavior, and self-efficacy of pregnant women diagnosed with gestational diabetes. The study will be conducted at Ankara Bilkent City Hospital, with participants assigned to intervention and control groups. The intervention group will receive planned education and counseling via a mobile application, while the control group will receive standard hospital education. Data will be collected at predetermined intervals, and outcomes will be compared between the groups. The study seeks to determine the effectiveness of a mobile application-supported approach in the management of gestational diabetes.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational Diabetes; Nursing; Mobile Application; Motivation; Self-Efficacy

Outcome Measures

Primary Outcomes (1)

• Change in Gestational Diabetes Intention, Attitude, and Behavior Scale (GDNTD-Ö) Scores

  This measure uses the validated Turkish adaptation of the Diabetes Intention, Attitude, and Behavior Scale. The instrument contains 14 items across 5 subdimensions. Total scores are transformed to a 0-100 scale, with higher scores indicating stronger intention, attitude, and behavior for self-management in gestational diabetes. There is no defined cut-off value. Measurement will be based on the self-administered GDNTD-Ö questionnaire.

  Baseline (before education), 3 weeks after completion of the 2-week education program (first follow-up), and 2 weeks after this first follow-up (second follow-up).

Secondary Outcomes (1)

• Change in Gestational Diabetes Self-Efficacy Scale (GESGD) Scores

  Baseline (before education), 3 weeks after completion of the 2-week education program (first follow-up), and 2 weeks after this first follow-up (second follow-up).

Other Outcomes (1)

• Mobile Health Applications Adoption Scale Score (Intervention Group Only)

  Second (final) follow-up, conducted 2 weeks after the first follow-up.

Study Arms (2)

Mobile Application-Based Education and Counseling

EXPERIMENTAL

Participants will receive a two-week structured education and counseling program via the SugarMoms mobile application for gestational diabetes management. The program, delivered by a certified diabetes nurse educator, covers topics including gestational diabetes management, blood glucose monitoring, insulin therapy, management of hypoglycemia and hyperglycemia, nutrition, physical activity, and pregnancy health recommendations. Each module includes audio support, a question-and-answer component, and daily motivational notifications (e.g., exercise, diet, hydration). Participants will record their daily blood glucose, dietary intake, and physical activity in the app. After completing the two-week program, participants will continue daily use of the app during the study. Follow-up assessments and questionnaires will also be administered through the app. Progress, logs, and module completion will be monitored via the administrator panel.

Behavioral: Mobile Application-Based Education and Counseling Program

Standard Face-to-Face Gestational Diabetes Education

ACTIVE COMPARATOR

Participants will receive a two-week standard face-to-face gestational diabetes education program provided by a certified diabetes nurse educator in accordance with the hospital protocol. The content will parallel the topics included in the intervention group's mobile application program. Blood glucose monitoring will be recorded using paper-based forms.

Behavioral: Standard Face-to-Face Gestational Diabetes Education

Interventions

Mobile Application-Based Education and Counseling Program BEHAVIORAL

A two-week structured education and counseling program delivered via the SugarMoms mobile application for gestational diabetes management. Education is provided by a certified diabetes nurse educator and includes topics such as gestational diabetes management, blood glucose monitoring, insulin therapy, management of hypo/hyperglycemia, healthy nutrition, physical activity, and pregnancy health recommendations. Each module includes audio support, a question-and-answer component, and daily motivational notifications. Participants will log daily blood glucose, dietary intake, and physical activity in the app and continue app use throughout the study. Follow-up assessments and questionnaires are delivered through the app, and progress is monitored via the administrator panel.

Mobile Application-Based Education and Counseling

Standard Face-to-Face Gestational Diabetes Education BEHAVIORAL

A two-week standard face-to-face gestational diabetes education program provided by a certified diabetes nurse educator in accordance with hospital protocol. The program covers the same topics as the intervention group's app-based program. Blood glucose monitoring is recorded using paper-based forms.

Standard Face-to-Face Gestational Diabetes Education

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged ≥18 years.
• Minimum education level: primary school graduate.
• Singleton pregnancy.
• No prior diagnosis of gestational diabetes mellitus (GDM).
• Newly diagnosed with GDM based on oral glucose tolerance test (OGTT) results.
• Currently receiving insulin treatment as part of the clinical management plan.
• Absence of comorbid conditions such as hypertension, preeclampsia, or other chronic diseases.
• Ability to read and understand Turkish.
• Ownership of a smartphone (iOS/Android) with internet access.
• Willingness to participate and provide written informed consent.

You may not qualify if:

• Development of pregnancy-related complications during the follow-up period.
• Incomplete or missing data in the study forms.
• Non-compliance with study protocol.
• Withdrawal from the study at the participant's request.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06170, 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

Study Officials

• Gönül Kurt, Assoc. Prof. Dr.

  University of Health Sciences, Gülhane Faculty of Nursing, Department of Obstetrics and Gynecology Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: January 6, 2026
• Study Start: August 18, 2025
• Primary Completion: November 30, 2025
• Study Completion: February 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after publication
• Access Criteria: De-identified IPD will be available upon reasonable request to the Principal Investigator, conditional on signing a data sharing agreement.

Locations

TU (1)