Obese Pregnant Women
Conditions
Keywords
pregnant women, obesity, Mobile Applications, weight gain, physical activity
Brief summary
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
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.
Interventions
OTHERIntervention 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
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
Care provider will not know the arm of randomization
Intervention model description
Randomized controlled trial with 2 arms of intervention
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational weight gain | 36 weeks | Compare gestational weight gain dring pregnancy in both groups. |
| Physical activity | 36 weeks | METS/minutes/week by the IPAQ Scale short version |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intrapartum complications | Labor | Labor inductions and type of labor |
| Gestational complications | 36 weeks | Prevalence of preeclampsia, gestational diabetes. |
| perinatal complications | birth | Prevalence of prematurity, macrosomia |
Other
| Measure | Time frame | Description |
|---|---|---|
| App usability | 36 weeks | To describe the App usability using System Usability Scale in pregnant women of the experimental group |
| Eating habits | 36 weeks | Compare eating habits in both groups with dietary habits questionaire for the overweight and obese |
Countries
Spain
Outcome results
None listed