NCT06053151

Brief Summary

To construct the platform for exercise counseling for pregnant women, and evaluate the effects of that telecare platform integration model for exercise consultation on exercise behaviors and prenatal health outcomes among pregnant women during pregnancy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Status
unknown

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

First Submitted

Initial submission to the registry

September 9, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 9, 2023

Last Update Submit

September 19, 2023

Conditions

Keywords

exercise counsellingpregnancywomenplatformphysical activity

Outcome Measures

Primary Outcomes (3)

  • increase physiacl activity

    measure by pregnancy physical activity questionnaire

    The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)

  • decrese symptom distress

    pregnancy related symptom distress scale

    The data were collectedbefore the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)

  • decrease pregnancy related complications

    such as gestational diabetes, pregancy related hypertension, preclampsia, preterm labor.

    The data were collectedbefore the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)

Secondary Outcomes (1)

  • construct exercise counseling model

    The data will be collected from pregnant women and experts perspectives; From date of first participant attend the focus group until the date of the last experts meeting , assessed up to 12 months

Study Arms (2)

experiemental group

EXPERIMENTAL

The experimental group will receive the cloud platform integration model for exercise consultation intervention for two phases continue 24 weeks to promote exercise behavior during pregnancy.

Behavioral: exercise counselling

control group

NO INTERVENTION

The control group will receive standard antenatal treatments without intervention.

Interventions

. The experimental group will receive the cloud platform integration model for exercise consultation intervention for two phases continue 24 weeks to promote exercise behavior during pregnancy. The goal of the first phase was to start regular exercise, and the goal of the second phase was to continue regular exercise.

experiemental group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women who less than 17 gestation and able to understand basic technologies such as smartphone and computer

You may not qualify if:

  • women who had a diagnosis of pregnancy related compliactions and absolute limited exercise, such as preterm contraction, ruputer of menbrance, evidence of intrauterus growth retardation, heart and lung disease, cervical incompetence and/or medical conditions that influence exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of administion

Study Record Dates

First Submitted

September 9, 2023

First Posted

September 25, 2023

Study Start

December 15, 2023

Primary Completion

May 31, 2024

Study Completion

July 31, 2025

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share