- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07814885
Development of a Pregnancy Weight Management Service Model
September 6, 2026 updated by: Chin-Tsung Shen, Mackay Medical College
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ching Fang Lee, PhD
- Phone Number: 1323 +886 26360323
- Email: chingfang@mmu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 104
- Recruiting
- Mackay Memorial Hospital
-
Contact:
- Ching Fang Lee, PhD
- Phone Number: 1323 +886 26360323
- Email: chingfang@mmu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- No access to a smartphone, computer, or tablet.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pregnancy Weight Management Counseling
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and after 8-12 weeks of 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.
|
Baseline and after 8-12 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in exercise self-efficacy
Time Frame: Baseline and after 8-12 weeks of intervention
|
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.
|
Baseline and after 8-12 weeks of intervention
|
|
Change in dietary self-efficacy
Time Frame: Baseline and after 8-12 weeks of intervention
|
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.
|
Baseline and after 8-12 weeks of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ching Fang Lee, PhD, Mackay Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
August 13, 2026
First Submitted That Met QC Criteria
September 6, 2026
First Posted (Actual)
September 11, 2026
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 6, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSTC 114-2637-H-715-002 (Other Grant/Funding Number: National Science and Technology Council)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.