NCT04553731

Brief Summary

evaluate the health empowerment program with mHealth 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
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

September 11, 2020

Last Update Submit

July 15, 2023

Conditions

Overweight and Obese Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • Change in body weight and gestational weight gain from pregnancy to 6 months postpartum

    measure body weight and calculated according to the IOM guidelines to know their the total and weekly values of excess or achieve the IOM's guidelines.

    The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks), 6 months postpartum

Secondary Outcomes (3)

  • Change in physical activity before intervention to childbirth

    The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks); The highest total scores was depend the participants' activities of METs.

  • self-efficacy related weight gain

    The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks); The highest total scores was 125.

  • control infant birthweight

    The data were collected at childbirth

Study Arms (2)

The mHealth-based program

EXPERIMENTAL

The experimental group used the mHealth app and Mi Smart Band 5 on managing and preventing excessive GWG among overweight and obese women during pregnancy

Behavioral: empowerment program with mHealth

The standard antenatal treatments with no mHealth-based elements

NO INTERVENTION

controls received standard antenatal treatments with no mHealth-based elements

Interventions

empowerment program with mHealthBEHAVIORAL

empowerment program with mHealth

The mHealth-based program

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women--who have had, 8-12 weeks
  • pre-pregnancy body mass index \> 25 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, Taiwan

Location

Related Publications (2)

  • Chen HH, Hsiung Y, Lee CF, Huang JP, Chi LK, Weng SS. Effects of an mHealth intervention on maternal and infant outcomes from pregnancy to early postpartum for women with overweight or obesity: A randomized controlled trial. Midwifery. 2024 Nov;138:104143. doi: 10.1016/j.midw.2024.104143. Epub 2024 Aug 11.

    PMID: 39154597DERIVED

  • Chen HH, Lee CF, Huang JP, Hsiung Y, Chi LK. Effectiveness of a nurse-led mHealth app to prevent excessive gestational weight gain among overweight and obese women: A randomized controlled trial. J Nurs Scholarsh. 2023 Jan;55(1):304-318. doi: 10.1111/jnu.12813. Epub 2022 Sep 19.

    PMID: 36121127DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the Office of Research and Development

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 17, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

July 31, 2021

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)