Effectiveness of a Mobile Health Program in Pregnant Women (Effectiveness)

Effectiveness of a Mobile Health Program on Blood Glucose and Gestational Weight Gain in Pregnant Women: A Mixed-Methods Study

1. To evaluate the usability and user experience of the i-PregMom mobile application and digital dietary image recording among pregnant women.
2. To examine the effectiveness of digital mobile health interventions on blood glucose levels and gestational weight gain among pregnant women from 10-14 weeks to 24-28 weeks of gestation.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy; Gestational Age and Weight Conditions; Literacy; Eating Behaviors; E-learning
• Intervention / Treatment: Other: E-learning

Detailed Description

1. Sociodemographic variables: age, education level, marital status, occupation, and socioeconomic status.
2. Obstetric variables: gravidity, history of miscarriage, pregnancy complications, and mode of delivery.
3. Pre-pregnancy BMI.
4. Dietary habits, perceived healthy eating behaviors, and dietary patterns.
5. Psychological distress and depressive symptoms.
6. Gestational blood glucose levels and GWG

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 11219
      • 365, Ming-Te Rd, Peitou District, Taipei 11219, Taiwan, ROC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Primiparous women aged ≥18 years.

Singleton pregnancy.

Pregnant women between 10 and 14 weeks of gestation, with gestational age calculated based on the first day of the last menstrual period.

Able to listen, speak, read, and write in Chinese.

Willing to provide prenatal weight and blood glucose data.

Possess a mobile communication device (such as a smartphone or social media account) and be able to receive emails.

Exclusion Criteria:

• Engaged in weight loss activities prior to pregnancy.

Diagnosed with chronic illnesses that may affect weight changes (e.g., psychiatric disorders, thyroid diseases).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Health Program; The intervention group will receive face-to-face nutrition education (15-30 min/session) based on the Health Promotion Administration's pregnancy dietary guidelines and access to the i-PregMom mobile application for continuous dietary management.	Other: E-learning; in experience group
No Intervention: rountine care; The control group will receive only face-to-face nutrition education (15-30 min/session) based on standard pregnancy dietary guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational Weight Gain in Pregnant	Gestational Weight Gain (GWG) will be recorded three times (10-14, 12-16, and 24-28 weeks of gestation) based on maternity health records to analyze trends in weight changes and the impact of the mobile health intervention.	o Gestational Weight Gain (GWG) will be recorded three times (10-14, 12-16, and 24-28 weeks of gestation) based on maternity health records to analyze trends in weight changes and the impact of the mobile health intervention.

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Collaborators: Ministry of Science and Technology, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; health literacy; E-learning; gestational weight gains; nutriention
• Additional Relevant MeSH Terms: Behavior; Behavior, Animal; Communication; Feeding Behavior; Literacy
• Other Study ID Numbers: (1154)114A-12; CHGH113-IU02 (Registry Identifier: Effectiveness)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be anonymized and used solely for analysis in preparation for publication; it will not be shared."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No