Construct and Evaluate the Effectiveness of a Theory-base... | NCT04553718

Studies
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy

NCT04553718

Sponsor

Mackay Medical College

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

82Actual

Phase

Not Applicable

Conditions

Gestational Weight Gain
Physical Activity

Interventions

experimental group

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Oct 31, 2019Actual

First Submitted Date

Sep 11, 2020

First Submission Date that Met QC Criteria

Sep 11, 2020

First Posted Date

Sep 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Our program used and evaluated the mHealth program, which has pregnant women using APP and wearable devices to help prevent excessive gestational weight gain, and it continued to promote physical activity for overweight and obese pregnant women.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
experimental group	Other	provide mHealth program, which has pregnant women using wearable device and app	experiemental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Manage gestational weight gain	control excessive gestational weight gain	4-6 week

Secondary Outcomes

Measure	Description	Time Frame
Increase physical activity level	increase the scores of pregnancy of physical activity questionnaire	4-6 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ching Fang Lee, PhD	Mackay Medical College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nursing		New Taipei City			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000078064	Gestational Weight Gain
D009043	Motor Activity
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D015430	Weight Gain
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided