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

Not Applicable

Completed

• Conditions: Overweight and Obese Pregnant Women
• Interventions: Behavioral: empowerment program with mHealth

• Registration Number: NCT04553731
• Lead Sponsor: Mackay Medical College

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-15
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The mHealth-based program	empowerment program with mHealth	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

Primary Outcome Measures

Name	Time	Method
Change in body weight and gestational weight gain from pregnancy to 6 months postpartum	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 Outcome Measures

Name	Time	Method
control infant birthweight	The data were collected at childbirth	measure infant birthweight
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.	pregnancy physical activity questionnaire (PPAQ) was used to measure women's physical activity during pregnancy.
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.	self-efficacy in exercise and diet was used to measure

Trial Locations

Locations (1)

Department of Nursing; 🇨🇳 New Taipei City, Taiwan