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

September 9, 2023 updated by: Chin-Tsung Shen, Mackay Medical College

Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women --Develop Applications With Wearable Devices

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Department of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experiemental group
Experimental group was the mHealth app to improved their gestational weight gain and physical activity during pregnancy.
Other: experimental group
provide mHealth program, which has pregnant women using wearable device and app
No Intervention: control group
standard prenatal care and without mHealth app

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Medical College

Investigators

  • Principal Investigator: Ching Fang Lee, PhD, Mackay Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 9, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MackayMedical

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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