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Women's confinement for COVID-19 pandemic and changes on prenatal care.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control Group | No Intervention | Provision of usual prenatal care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Other | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational complications | Prevalence of preeclampsia, gestational diabetes. | 36 weeks |
| Intrapartum complications | Labor inductions and type of labor |
| Measure | Description | Time Frame |
|---|---|---|
| App usability | To describe the App usability using "System Usability Scale" in pregnant women of the experimental group | 36 weeks |
| Eating habits | Compare eating habits in both groups with "dietary habits questionaire for the overweight and obese" |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena González-Plaza, Midwife | Clinic Hospital of Barcelona | Principal Investigator |
| Gloria Seguranyes, PhD | University of Barcelona | Study Director |
| Jordi Bellart, PhD | Clinic Hospital of Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elena González-Plaza | Barcelona | 08038 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35166684 | Derived | Gonzalez-Plaza E, Bellart J, Arranz A, Lujan-Barroso L, Crespo Mirasol E, Seguranyes G. Effectiveness of a Step Counter Smartband and Midwife Counseling Intervention on Gestational Weight Gain and Physical Activity in Pregnant Women With Obesity (Pas and Pes Study): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Feb 15;10(2):e28886. doi: 10.2196/28886. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015430 | Weight Gain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized controlled trial with 2 arms of intervention
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Care provider will not know the arm of randomization
| Labor |
| perinatal complications | Prevalence of prematurity, macrosomia | birth |
| 36 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |