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

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ClinicalTrials.gov Identifier: NCT03706872
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Elena Gonzalez-Plaza, 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.


Condition or disease Intervention/treatment Phase
Obese Pregnant Women Other: Intervention group Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with 2 arms of intervention
Masking: Single (Care Provider)
Masking Description: Care provider will not know the arm of randomization
Primary Purpose: Prevention
Official Title: Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Gestational weight gain [ Time Frame: 36 weeks ]
    Compare gestational weight gain dring pregnancy in both groups.

  2. Physical activity [ Time Frame: 36 weeks ]
    METS/minutes/week by the "IPAQ Scale" short version


Secondary Outcome Measures :
  1. Gestational complications [ Time Frame: 36 weeks ]
    Prevalence of preeclampsia, gestational diabetes.

  2. Intrapartum complications [ Time Frame: Labor ]
    Labor inductions and type of labor

  3. perinatal complications [ Time Frame: birth ]
    Prevalence of prematurity, macrosomia


Other Outcome Measures:
  1. App usability [ Time Frame: 36 weeks ]
    To describe the App usability using "System Usability Scale" in pregnant women of the experimental group

  2. Eating habits [ Time Frame: 36 weeks ]
    Compare eating habits in both groups with "dietary habits questionaire for the overweight and obese"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706872


Contacts
Contact: Elena Gonzalez-Plaza, Midwife +34 932275400 ext 7294 eplaza@clinic.cat
Contact: Gloria Seguranyes, PhD gseguranyes@ub.edu

Locations
Spain
Elena González-Plaza Recruiting
Barcelona, Spain, 08038
Contact: Elena González-Plaza, Midwife    +34 93227554 ext 7294    eplaza@clinic.cat   
Contact: Angela Arranz, PhD         
Principal Investigator: Elena González-Plaza, MsC         
Sub-Investigator: Gloria Seguranyes, PhD         
Sub-Investigator: Jordi Bellart, PhD         
Sponsors and Collaborators
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

Responsible Party: Elena Gonzalez-Plaza, Midwife, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03706872     History of Changes
Other Study ID Numbers: HCB2017/0756
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elena Gonzalez-Plaza, Hospital Clinic of Barcelona:
pregnant women
obesity
Mobile Applications
weight gain
physical activity