PregnancyNCT07814885
Development of a Pregnancy Weight Management Service Model
A study testing Pregnancy Weight Management Counseling in people with Pregnancy and Weight Gain, run by Mackay Medical College at 1 site in Taiwan.
Trial summary
To develop a pregnancy weight management application and service model for pregnant women, and to evaluate its feasibility and effects on gestational weight management and health behaviors during pregnancy. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Weight Gain
- What is being tested?
- Pregnancy Weight Management Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2025to Dec 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women older than 20 years.
- Pregnant women with pregnancy confirmed by an obstetrician.
- Singleton pregnancy.
- Planning to deliver at the participating hospital.
- Able to communicate in Mandarin Chinese or Taiwanese.
- Have access to a smartphone, computer, or tablet.
Who cannot join
- No access to a smartphone, computer, or tablet.
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, 1 recruiting
- Recruiting
Mackay Memorial Hospital
Taipei, 104
Ching Fang Lee, PhD, +886 26360323 ext. 1323, chingfang@mmu.edu.tw
About this study
Official title: Development and Construction of a Service Model for a Pregnancy Weight Management Application
To develop a pregnancy weight management application and service model for pregnant women, and to evaluate its feasibility and effects on gestational weight management and health behaviors during pregnancy.
Read the detailed description
This study will develop and evaluate a pregnancy weight management application and service model for pregnant women. Pregnant women will receive an app-based weight management intervention and related professional health services. The feasibility, user experience, and effects of the service model on gestational weight management and health behaviors will be evaluated.
- Conditions
- Pregnancy, Weight Gain
- Being tested
- Pregnancy Weight Management Counseling
- Keywords
- Prenatal Counseling, mHealth, Pregnant Women
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy Weight Management CounselingBehavioural
Participants will receive in-person pregnancy weight management counseling provided by healthcare professionals. The counseling will provide individualized guidance on pregnancy weight management and related health behaviors according to participants' needs.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy Weight Management Counseling | Experimental | Participants will receive in-person pregnancy weight management counseling provided by healthcare professionals. Individualized counseling will be provided according to participants' needs to support weight management during pregnancy. Receives: Behavioral: Pregnancy Weight Management Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Body weight will be measured in kilograms before and after the pregnancy weight management intervention.
Measured: Baseline and after 8-12 weeks of intervention
Change in technology acceptance
Technology acceptance will be assessed using the 23-item Technology Acceptance Model questionnaire. Each item is rated from 0 (strongly disagree) to 4 (strongly agree). Higher scores indicate greater acceptance of the pregnancy weight management application.
Measured: Baseline and after 8-12 weeks of intervention
Secondary outcomes (2)
Change in exercise self-efficacy
Exercise self-efficacy will be assessed using the exercise-related items of the Diet and Exercise Daily Life Self-Efficacy Scale. Each item is rated from 0 to 4, with higher scores indicating greater exercise self-efficacy.
Measured: Baseline and after 8-12 weeks of intervention
Change in dietary self-efficacy
Dietary self-efficacy will be assessed using the dietary-related items of the Diet and Exercise Daily Life Self-Efficacy Scale. Each item is rated from 0 to 4, with higher scores indicating greater dietary self-efficacy.
Measured: Baseline and after 8-12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Ching Fang Lee, PhD, Principal investigator, Mackay Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814885
- Sponsor's protocol ID
- NSTC 114-2637-H-715-002
- Other IDs
- NSTC 114-2637-H-715-002
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Construction of a Service Model for a Pregnancy Weight Management Application
- ClinicalTrials.gov ID
- NCT07814885
- Acronym / sponsor ID
- NSTC 114-2637-H-715-002
- Conditions
- Pregnancy, Weight Gain
- Keywords
- Prenatal Counseling, mHealth, Pregnant Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Sep 2026 (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 develop a pregnancy weight management application and service model for pregnant women, and to evaluate its feasibility and effects on gestational weight management and health behaviors during pregnancy.
Detailed description
This study will develop and evaluate a pregnancy weight management application and service model for pregnant women. Pregnant women will receive an app-based weight management intervention and related professional health services. The feasibility, user experience, and effects of the service model on gestational weight management and health behaviors will be evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy Weight Management Counseling | Experimental | Behavioral: Pregnancy Weight Management CounselingParticipants will receive in-person pregnancy weight management counseling provided by healthcare professionals. Individualized counseling will be provided according to participants' needs to support weight management during pregnancy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women older than 20 years.
- Pregnant women with pregnancy confirmed by an obstetrician.
- Singleton pregnancy.
- Planning to deliver at the participating hospital.
- Able to communicate in Mandarin Chinese or Taiwanese.
Key exclusion criteria (1 listed)
- No access to a smartphone, computer, or tablet.
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 |
|---|---|---|
| Pregnancy Weight Management CounselingParticipants will receive in-person pregnancy weight management counseling provided by healthcare professionals. The counseling will provide individualized guidance on pregnancy weight management and related health behaviors according to participants' needs. | Behavioural | Pregnancy Weight Management Counseling |
Primary outcome
Change in body weight
Time frame: Baseline and after 8-12 weeks of intervention
Body weight will be measured in kilograms before and after the pregnancy weight management intervention.
Change in technology acceptance
Time frame: Baseline and after 8-12 weeks of intervention
Technology acceptance will be assessed using the 23-item Technology Acceptance Model questionnaire. Each item is rated from 0 (strongly disagree) to 4 (strongly agree). Higher scores indicate greater acceptance of the pregnancy weight management application.
2 secondary outcomes
Change in exercise self-efficacy
Time frame: Baseline and after 8-12 weeks of intervention
Change in dietary self-efficacy
Time frame: Baseline and after 8-12 weeks of 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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ching Fang Lee, PhD principal investigator
Mackay Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnancy Weight Management Counseling in people with Pregnancy and Weight Gain, run by Mackay Medical College 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 1 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: looking for participants now, as of the sponsor's last update on 11 Sep 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?
Contact Ching Fang Lee, PhD (+886 26360323 ext. 1323, chingfang@mmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline and after 8-12 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.