Back to resultsConstruct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy
Primary Purpose
Gestational Weight Gain, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
experimental group
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Weight Gain focused on measuring overweight, obese, pregnant women
Eligibility Criteria
Inclusion Criteria:
women--who have had, for 8-12 weeks, a pre-pregnancy body mass index of more than 25 kg/m2
Exclusion Criteria:
-
Sites / Locations
- Department of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experiemental group
control group
Arm Description
Experimental group was the mHealth app to improved their gestational weight gain and physical activity during pregnancy.
standard prenatal care and without mHealth app
Outcomes
Primary Outcome Measures
Manage gestational weight gain
control excessive gestational weight gain
Secondary Outcome Measures
Increase physical activity level
increase the scores of pregnancy of physical activity questionnaire
Full Information
NCT ID
NCT04553718
First Posted
September 11, 2020
Last Updated
September 9, 2023
Sponsor
Mackay Medical College
1. Study Identification
Unique Protocol Identification Number
NCT04553718
Brief Title
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy
Official Title
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women --Develop Applications With Wearable Devices
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain, Physical Activity
Keywords
overweight, obese, pregnant women
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experiemental group
Arm Type
Experimental
Arm Description
Experimental group was the mHealth app to improved their gestational weight gain and physical activity during pregnancy.
Arm Title
control group
Arm Type
No Intervention
Arm Description
standard prenatal care and without mHealth app
Intervention Type
Other
Intervention Name(s)
experimental group
Intervention Description
provide mHealth program, which has pregnant women using wearable device and app
Primary Outcome Measure Information:
Title
Manage gestational weight gain
Description
control excessive gestational weight gain
Time Frame
4-6 week
Secondary Outcome Measure Information:
Title
Increase physical activity level
Description
increase the scores of pregnancy of physical activity questionnaire
Time Frame
4-6 week
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching Fang Lee, PhD
Organizational Affiliation
Mackay Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nursing
City
New Taipei City
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy
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