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

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

Detailed Description
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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.

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

Conditions
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Overweight and Obese Pregnant Women

Intervention / Treatment
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* Behavioral: empowerment program with mHealth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women--who have had, 8-12 weeks pre-pregnancy body mass index > 25 kg/m2 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The mHealth-based program<br>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<br>* empowerment program with mHealth<br>|
| No Intervention: The standard antenatal treatments with no mHealth-based elements<br>controls received standard antenatal treatments with no mHealth-based elements | |

What is the study measuring?
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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 |