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

Not Applicable

Terminated

• Conditions: Obese Pregnant Women
• Interventions: Other: Intervention group

• Registration Number: NCT03706872
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-16
• Primary Completion: 2020-03-10
• Study Completion: 2020-04-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	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.

Primary Outcome Measures

Name	Time	Method
Physical activity	36 weeks	METS/minutes/week by the "IPAQ Scale" short version
Gestational weight gain	36 weeks	Compare gestational weight gain dring pregnancy in both groups.

Secondary Outcome Measures

Name	Time	Method
Intrapartum complications	Labor	Labor inductions and type of labor
perinatal complications	birth	Prevalence of prematurity, macrosomia
Gestational complications	36 weeks	Prevalence of preeclampsia, gestational diabetes.

Trial Locations

Locations (1)

Elena González-Plaza; 🇪🇸 Barcelona, Spain