Back to resultsThe Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
Primary Purpose
Overweight and Obese Pregnant Women
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
empowerment program with mHealth
Sponsored by
About this trial
This is an interventional supportive care trial for Overweight and Obese Pregnant Women
Eligibility Criteria
Inclusion Criteria:
- pregnant women--who have had, 8-12 weeks
- pre-pregnancy body mass index > 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
The mHealth-based program
The standard antenatal treatments with no mHealth-based elements
Arm Description
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
controls received standard antenatal treatments with no mHealth-based elements
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in physical activity before intervention to childbirth
pregnancy physical activity questionnaire (PPAQ) was used to measure women's physical activity during pregnancy.
self-efficacy related weight gain
self-efficacy in exercise and diet was used to measure
control infant birthweight
measure infant birthweight
Full Information
NCT ID
NCT04553731
First Posted
September 11, 2020
Last Updated
July 15, 2023
Sponsor
Mackay Medical College
1. Study Identification
Unique Protocol Identification Number
NCT04553731
Brief Title
The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
Official Title
The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
July 31, 2021 (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
evaluate the health empowerment program with mHealth to promote physical activity for overweight and obese pregnant women.
Detailed Description
This two-phase study develops an mhealth application (app) based on social-cognitive theory (SCT) and evaluates its effectiveness for overweight and obese women, which can help to prevent excessive GWG by enhancing optimal weight and healthy behavior during pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obese Pregnant Women
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The mHealth-based program
Arm Type
Experimental
Arm Description
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
Arm Title
The standard antenatal treatments with no mHealth-based elements
Arm Type
No Intervention
Arm Description
controls received standard antenatal treatments with no mHealth-based elements
Intervention Type
Behavioral
Intervention Name(s)
empowerment program with mHealth
Intervention Description
empowerment program with mHealth
Primary Outcome Measure Information:
Title
Change in body weight and gestational weight gain from pregnancy to 6 months postpartum
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change in physical activity before intervention to childbirth
Description
pregnancy physical activity questionnaire (PPAQ) was used to measure women's physical activity during pregnancy.
Time Frame
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.
Title
self-efficacy related weight gain
Description
self-efficacy in exercise and diet was used to measure
Time Frame
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.
Title
control infant birthweight
Description
measure infant birthweight
Time Frame
The data were collected at childbirth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women--who have had, 8-12 weeks
pre-pregnancy body mass index > 25 kg/m2
Exclusion Criteria:
-
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
The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
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