NCT04553718

Brief Summary

This study was to construct and develop an application (APP) based on social-cognitive theory for overweight and obese women during pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

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

August 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
11 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
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 11, 2020

Last Update Submit

September 9, 2023

Conditions

Gestational Weight GainPhysical Activity

Keywords

overweightobesepregnant women

Outcome Measures

Primary Outcomes (1)

  • Manage gestational weight gain

    control excessive gestational weight gain

    4-6 week

Secondary Outcomes (1)

  • Increase physical activity level

    4-6 week

Study Arms (2)

experiemental group

EXPERIMENTAL

Experimental group was the mHealth app to improved their gestational weight gain and physical activity during pregnancy.

Other: experimental group

control group

NO INTERVENTION

standard prenatal care and without mHealth app

Interventions

experimental groupOTHER

provide mHealth program, which has pregnant women using wearable device and app

experiemental group

Eligibility Criteria

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

You may qualify if:

  • pregnant women--who have had, for 8-12 weeks, a pre-pregnancy body mass index of more than 25 kg/m2

You may not qualify if:

  • high risk pregnancy, such as pre-clampsia, pregnancy induced hypertension, preterm contraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Gestational Weight GainMotor ActivityOverweightObesity

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorOvernutritionNutrition DisordersNutritional and Metabolic Diseases

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: randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of administration

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 17, 2020

Study Start

August 1, 2018

Primary Completion

August 1, 2019

Study Completion

October 31, 2019

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)