NCT05022680

Brief Summary

This study will apply the peer-led walking intervention with mHealth technology to maintain physical activity and promote prenatal health. Moreover, the participants of the trained peer mentors support women walking with mHealth technology, which has pregnant women using the APP to set goals, self-monitor, and self-manage, and it will continue to promote physical activity for overweight and obese pregnant women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

July 25, 2021

Last Update Submit

July 15, 2023

Conditions

mHealth Intervention

Outcome Measures

Primary Outcomes (1)

  • physical activity

    physical activity (pregnancy physical activity questionnaire)

    throughout childbirth, average of 20-30 weeks

Study Arms (2)

Participants were used app to record their diet and steps every day

EXPERIMENTAL

Experimental group was the mHealth with peer led to improved their physical activity during pregnancy. Participants received app to record and monitor their physical activity every days and using it until childbirth.

Behavioral: mhealth

non-mhealth

NO INTERVENTION

control group was the traditional prenatal care during pregnancy.

Interventions

mhealthBEHAVIORAL

the peer-led intervention with mHealth technology (an application (APP) and Sports bracelet)

Participants were used app to record their diet and steps every day

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women who had a pre-pregnancy body mass index of more than 25 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, Taiwan

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ching-Fang Lee, PhD

    Mackay Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomize control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
head of administration

Study Record Dates

First Submitted

July 25, 2021

First Posted

August 26, 2021

Study Start

May 1, 2021

Primary Completion

August 1, 2022

Study Completion

December 31, 2022

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)