Clinical trial NCT06917703: Effectiveness of a Mobile Health Program in Pregnant Women
Official title: Effectiveness of a Mobile Health Program on Blood Glucose and Gestational Weight Gain in Pregnant Women: A Mixed-Methods Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy
Gestational Age and Weight Conditions
Eating Behaviors
Literacy
E-learning
Keywords: pregnancy
health literacy
E-learning
gestational weight gains
nutriention
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: 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).

Primary outcomes:
measure: Gestational Weight Gain in Pregnant
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: 365, Ming-Te Rd, Peitou District, Taipei 11219, Taiwan, ROC
Study officials:
References: