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

Obese Pregnant Women Clinical Trial

— Pas&Pes  

Official title:

Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03706872
• Other study ID #: HCB2017/0756
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2020
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: April 1, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obese Pregnant Women
• Obesity

Intervention

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

Locations

Country	Name	City	State
Spain	Elena González-Plaza	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	App usability	To describe the App usability using "System Usability Scale" in pregnant women of the experimental group	36 weeks
Other	Eating habits	Compare eating habits in both groups with "dietary habits questionaire for the overweight and obese"	36 weeks
Primary	Gestational weight gain	Compare gestational weight gain dring pregnancy in both groups.	36 weeks
Primary	Physical activity	METS/minutes/week by the "IPAQ Scale" short version	36 weeks
Secondary	Gestational complications	Prevalence of preeclampsia, gestational diabetes.	36 weeks
Secondary	Intrapartum complications	Labor inductions and type of labor	Labor
Secondary	perinatal complications	Prevalence of prematurity, macrosomia	birth