Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women (Pas&Pes) (Pas&Pes)
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|ClinicalTrials.gov Identifier: NCT03706872|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : November 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Obese Pregnant Women||Other: Intervention group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial with 2 arms of intervention|
|Masking:||Single (Care Provider)|
|Masking Description:||Care provider will not know the arm of randomization|
|Official Title:||Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Intervention group
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
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
No Intervention: Control Group
Provision of usual prenatal care
- Gestational weight gain [ Time Frame: 36 weeks ]Compare gestational weight gain dring pregnancy in both groups.
- Physical activity [ Time Frame: 36 weeks ]METS/minutes/week by the "IPAQ Scale" short version
- Gestational complications [ Time Frame: 36 weeks ]Prevalence of preeclampsia, gestational diabetes.
- Intrapartum complications [ Time Frame: Labor ]Labor inductions and type of labor
- perinatal complications [ Time Frame: birth ]Prevalence of prematurity, macrosomia
- App usability [ Time Frame: 36 weeks ]To describe the App usability using "System Usability Scale" in pregnant women of the experimental group
- Eating habits [ Time Frame: 36 weeks ]Compare eating habits in both groups with "dietary habits questionaire for the overweight and obese"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706872
|Contact: Elena Gonzalez-Plaza, Midwife||+34 932275400 ext email@example.com|
|Contact: Gloria Seguranyes, PhDfirstname.lastname@example.org|
|Barcelona, Spain, 08038|
|Contact: Elena González-Plaza, Midwife +34 93227554 ext 7294 email@example.com|
|Contact: Angela Arranz, PhD|
|Principal Investigator: Elena González-Plaza, MsC|
|Sub-Investigator: Gloria Seguranyes, PhD|
|Sub-Investigator: Jordi Bellart, PhD|
|Principal Investigator:||Elena González-Plaza, Midwife||Clinic Hospital of Barcelona|
|Study Director:||Gloria Seguranyes, PhD||University of Barcelona|
|Study Director:||Jordi Bellart, PhD||Clinic Hospital of Barcelona|