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

evaluate the health empowerment program with mHealth to promote physical activity for overweight and obese pregnant women.

Study Overview

• Status: Completed
• Conditions: Overweight and Obese Pregnant Women
• Intervention / Treatment: Behavioral: empowerment program with mHealth

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The mHealth-based program; 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	Behavioral: empowerment program with mHealth; empowerment program with mHealth
No Intervention: The standard antenatal treatments with no mHealth-based elements; controls received standard antenatal treatments with no mHealth-based elements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity before intervention to childbirth	pregnancy physical activity questionnaire (PPAQ) was used to measure women's physical activity during pregnancy.	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	self-efficacy in exercise and diet was used to measure	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.
control infant birthweight	measure infant birthweight	The data were collected at childbirth

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): July 31, 2021

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): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight
• Other Study ID Numbers: LCF-MOST107

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