Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women (Pas&Pes)

Study Overview
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Brief Summary
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This study evaluate the efficacy of an App for monitoring the physical activity and weight with a smart watch and the provision of virtual advice through messages with a mobile phone in obese pregnant women in the second trimester. Half of the women will be randomized at the intervention group (App + smart watch) and the other half, to the control group who will receive the usual prenatal care.

Detailed Description
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Randomized controlled trial among obese women. These women will be randomized in two groups in order to evaluate an improvement in several outcomes thanks to different strategies: Intervention group (IG). An App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care. Control group. Pregnant women will receive the usual prenatal care. Main hypothesis: In the intervention group pregnant women will improve the weight gain adjusted to the preconception BMI, during pregnanacy, with respect to the pregnant women of the control group. Secondary hypothesis. In the intervention group pregnant women will improve the physical activity.

Official Title
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Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women

Conditions
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Obese Pregnant Women

Intervention / Treatment
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* Other: Intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with BMI ≥ 30 Kg / m2 preconceptional Speak Spanish fluently Viable singleton non-malformed fetus 12-18 weeks of gestation Users of Android or Iphone smart mobile phone with internet connection Exclusion Criteria: Pregnant women users of a physical activity and weight monitoring App Pregnant women with Type I or II Diabetes Mellitus Pregnant Women with psychiatric disorders Pregnant women with thyroid disorders Women with chronic hypertension Pregnant women who for some reason have contraindicated the performance of exercise or mobility problems that make it impossible to walk in a moderate way. Pregnant women who do not accept to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with 2 arms of intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The provision of an App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care. | Other: Intervention group<br>* The provision of an App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care<br>|
| No Intervention: Control Group<br>Provision of usual prenatal care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Compare gestational weight gain dring pregnancy in both groups. | 36 weeks | 
| Physical activity | METS/minutes/week by the IPAQ Scale short version | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational complications | Prevalence of preeclampsia, gestational diabetes. | 36 weeks | 
| Intrapartum complications | Labor inductions and type of labor | Labor | 
| perinatal complications | Prevalence of prematurity, macrosomia | birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnant women, obesity, Mobile Applications, weight gain, physical activity