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

Primary Purpose

Obese Pregnant Women

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention group
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obese Pregnant Women focused on measuring pregnant women, obesity, Mobile Applications, weight gain, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Elena González-Plaza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control Group

Arm 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.

Provision of usual prenatal care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gestational complications
Prevalence of preeclampsia, gestational diabetes.
Intrapartum complications
Labor inductions and type of labor
perinatal complications
Prevalence of prematurity, macrosomia

Full Information

First Posted
October 10, 2018
Last Updated
May 14, 2020
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT03706872
Brief Title
Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women (Pas&Pes)
Acronym
Pas&Pes
Official Title
Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Women's confinement for COVID-19 pandemic and changes on prenatal care.
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese Pregnant Women
Keywords
pregnant women, obesity, Mobile Applications, weight gain, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with 2 arms of intervention
Masking
Care Provider
Masking Description
Care provider will not know the arm of randomization
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Provision of usual prenatal care
Intervention Type
Other
Intervention Name(s)
Intervention group
Intervention 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
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
Compare gestational weight gain dring pregnancy in both groups.
Time Frame
36 weeks
Title
Physical activity
Description
METS/minutes/week by the "IPAQ Scale" short version
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Gestational complications
Description
Prevalence of preeclampsia, gestational diabetes.
Time Frame
36 weeks
Title
Intrapartum complications
Description
Labor inductions and type of labor
Time Frame
Labor
Title
perinatal complications
Description
Prevalence of prematurity, macrosomia
Time Frame
birth
Other Pre-specified Outcome Measures:
Title
App usability
Description
To describe the App usability using "System Usability Scale" in pregnant women of the experimental group
Time Frame
36 weeks
Title
Eating habits
Description
Compare eating habits in both groups with "dietary habits questionaire for the overweight and obese"
Time Frame
36 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena González-Plaza, Midwife
Organizational Affiliation
Clinic Hospital of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria Seguranyes, PhD
Organizational Affiliation
University of Barcelona
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jordi Bellart, PhD
Organizational Affiliation
Clinic Hospital of Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Elena González-Plaza
City
Barcelona
ZIP/Postal Code
08038
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35166684
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.
Results Reference
derived

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

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