NCT07814885

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
2mo left

Started Dec 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

August 13, 2026

Last Update Submit

September 6, 2026

Conditions

Keywords

Prenatal CounselingmHealthPregnant Women

Outcome Measures

Primary Outcomes (2)

  • Change in body weight

    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

    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 Outcomes (2)

  • Change in exercise self-efficacy

    Baseline and after 8-12 weeks of intervention

  • Change in dietary self-efficacy

    Baseline and after 8-12 weeks of intervention

Study Arms (1)

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.

Behavioral: Pregnancy Weight Management Counseling

Interventions

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.

Pregnancy Weight Management Counseling

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • No access to a smartphone, computer, or tablet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, 104, Taiwan

RECRUITING

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ching Fang Lee, PhD

    Mackay Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching Fang Lee, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of administion

Study Record Dates

First Submitted

August 13, 2026

First Posted

September 11, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations