Effectiveness of a Mobile Health Program in Pregnant Women

NCT06917703 | Enrolling By Invitation DMC

• 2 other identifiers: (1154)114A-12CHGH113-IU02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the usability and user experience of the i-PregMom mobile application and digital dietary image recording among pregnant women.
2. 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.

Conditions

Pregnancy; Literacy; Gestational Age and Weight Conditions; Eating Behaviors; E-learning

Keywords

pregnancy; health literacy; E-learning; gestational weight gains; nutriention

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Mobile Health Program

EXPERIMENTAL

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

rountine care

NO INTERVENTION

The control group will receive only face-to-face nutrition education (15-30 min/session) based on standard pregnancy dietary guidelines.

Interventions

E-learning OTHER

in experience group

Mobile Health Program

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Engaged in weight loss activities prior to pregnancy.
• Diagnosed with chronic illnesses that may affect weight changes (e.g., psychiatric disorders, thyroid diseases).

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

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

Taipei, Taiwan, 11219, Taiwan

Location

MeSH Terms

Conditions

Feeding Behavior; Literacy

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Communication

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: To assess the effectiveness of the i-PregMom mobile application and digital dietary image recording on blood glucose control and gestational weight gain, a randomized controlled design with a double repeated measures approach will be conducted (Intervention group: n=80; Control group: n=80). Data will be collected at three time points: * Baseline (10-14 weeks of gestation) * Two weeks post-intervention (12-16 weeks of gestation) * Three months post-intervention (24-28 weeks of gestation) 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. The control group will receive only face-to-face nutrition education (15-30 min/session) based on standard pregnancy dietary guidelines.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)