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Clinical Trials/NCT04553731
NCT04553731CompletedNot Applicable

The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy

Mackay Medical College1 site in 1 country92 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
92
Locations
1
Primary Endpoint
Change in body weight and gestational weight gain from pregnancy to 6 months postpartum

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •pregnant women--who have had, 8-12 weeks
  • •pre-pregnancy body mass index > 25 kg/m2

Exclusion Criteria

  • Not provided

Arms & Interventions

The standard antenatal treatments with no mHealth-based elements

No Intervention

controls received standard antenatal treatments with no mHealth-based elements

The mHealth-based program

Experimental

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

Intervention: empowerment program with mHealth (Behavioral)

Outcomes

Primary Outcomes

Change in body weight and gestational weight gain from pregnancy to 6 months postpartum

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

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 Outcomes

  • control infant birthweight(The data were collected at childbirth)
  • Change in physical activity before intervention to childbirth(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.)
  • self-efficacy related weight gain(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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chin-Tsung Shen

the Office of Research and Development

Mackay Medical College

Study Sites (1)

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