Clinical trial NCT03706872: Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women (Pas&Pes)
Official title: Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obese Pregnant Women
Keywords: pregnant women
obesity
Mobile Applications
weight gain
physical activity
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 2 arms of intervention
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gestational weight gain
timeFrame: 36 weeks
measure: Physical activity
timeFrame: 36 weeks
Secondary outcomes:
measure: Gestational complications
timeFrame: 36 weeks
measure: Intrapartum complications
timeFrame: Labor
measure: perinatal complications
timeFrame: birth
Other outcomes:
measure: App usability
timeFrame: 36 weeks
measure: Eating habits
timeFrame: 36 weeks
Locations:
city: Barcelona
country: Spain
facility: Elena González-Plaza
Study officials:
affiliation: Clinic Hospital of Barcelona
name: Elena González-Plaza, Midwife
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Gloria Seguranyes, PhD
role: STUDY_DIRECTOR
affiliation: Clinic Hospital of Barcelona
name: Jordi Bellart, PhD
role: STUDY_DIRECTOR
References:
citation: 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.