PregnancyNCT06917703
Effectiveness of a Mobile Health Program in Pregnant Women
A study testing E-learning in people with Pregnancy and Gestational Age and Weight Conditions, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Gestational Age and Weight Conditions, Eating Behaviors
- What is being tested?
- E-learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Engaged in weight loss activities prior to pregnancy.
- Diagnosed with chronic illnesses that may affect weight changes (e.g., psychiatric disorders, thyroid diseases).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
365, Ming-Te Rd, Peitou District, Taipei 11219, Taiwan, ROC
Taipei, Taiwan, 11219
About this study
Official title: Effectiveness of a Mobile Health Program on Blood Glucose and Gestational Weight Gain in Pregnant Women: A Mixed-Methods Study
- To evaluate the usability and user experience of the i-PregMom mobile application and digital dietary image recording among pregnant women.
- 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.
Read the detailed description
- Sociodemographic variables: age, education level, marital status, occupation, and socioeconomic status.
- Obstetric variables: gravidity, history of miscarriage, pregnancy complications, and mode of delivery.
- Pre-pregnancy BMI.
- Dietary habits, perceived healthy eating behaviors, and dietary patterns.
- Psychological distress and depressive symptoms.
- Gestational blood glucose levels and GWG
- Being tested
- E-learning
- Keywords
- pregnancy, health literacy, E-learning, gestational weight gains, nutriention
- Medical subject headings
- Feeding Behavior, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learningOther
in experience group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start11 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Tzu-Ling Chen, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917703
- Sponsor's protocol ID
- (1154)114A-12
- Other IDs
- CHGH113-IU02
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be anonymized and used solely for analysis in preparation for publication; it will not be shared."
Publications
Chen TL, Liao LL, Weng CS, Wu CH, Wei MH. Effectiveness of the i-PregMom scenario-based nutrition literacy mobile app for pregnant women: A randomized controlled trial. Midwifery. 2026 Aug 27;163:104963. doi: 10.1016/j.midw.2026.104963. Online ahead of print.
PubMed 42679591
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Health Program on Blood Glucose and Gestational Weight Gain in Pregnant Women: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT06917703
- Acronym / sponsor ID
- (1154)114A-12
- Keywords
- pregnancy, health literacy, E-learning, gestational weight gains, nutriention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate the usability and user experience of the i-PregMom mobile application and digital dietary image recording among pregnant women.
- 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
- Sociodemographic variables: age, education level, marital status, occupation, and socioeconomic status.
- Obstetric variables: gravidity, history of miscarriage, pregnancy complications, and mode of delivery.
- Pre-pregnancy BMI.
- Dietary habits, perceived healthy eating behaviors, and dietary patterns.
- Psychological distress and depressive symptoms.
- Gestational blood glucose levels and GWG
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Program | Experimental | Other: E-learningThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Engaged in weight loss activities prior to pregnancy.
- Diagnosed with chronic illnesses that may affect weight changes (e.g., psychiatric disorders, thyroid diseases).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-learningin experience group | Other | Mobile Health Program |
Primary outcome
Gestational Weight Gain in Pregnant
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 42679591Chen TL, Liao LL, Weng CS, Wu CH, Wei MH. Effectiveness of the i-PregMom scenario-based nutrition literacy mobile app for pregnant women: A randomized controlled trial. Midwifery. 2026 Aug 27;163:104963. doi: 10.1016/j.midw.2026.104963. Online ahead of print.
- Individual participant dataSharing planned: No. The data will be anonymized and used solely for analysis in preparation for publication; it will not be shared."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning in people with Pregnancy and Gestational Age and Weight Conditions, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Weight Gain in Pregnant (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.