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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obese Pregnant Women
• Intervention / Treatment: Other: Intervention group

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08038
    • Elena González-Plaza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
No Intervention: Control Group; Provision of usual prenatal care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational complications	Prevalence of preeclampsia, gestational diabetes.	36 weeks
Intrapartum complications	Labor inductions and type of labor	Labor
perinatal complications	Prevalence of prematurity, macrosomia	birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
App usability	To describe the App usability using "System Usability Scale" in pregnant women of the experimental group	36 weeks
Eating habits	Compare eating habits in both groups with "dietary habits questionaire for the overweight and obese"	36 weeks

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Elena González-Plaza, Midwife, Clinic Hospital of Barcelona; Study Director: Gloria Seguranyes, PhD, University of Barcelona; Study Director: Jordi Bellart, PhD, Clinic Hospital of Barcelona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; obesity; pregnant women; weight gain; Mobile Applications
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: HCB2017/0756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No