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

Hospital Clinic of Barcelona

Status: Terminated

Conditions: Obese Pregnant Women

Treatments: Other: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT03706872

HCB2017/0756

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

123 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Intervention group

Control Group

No Intervention group

Description:

Provision of usual prenatal care