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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706872
Recruitment Status : Terminated (Women's confinement for COVID-19 pandemic and changes on prenatal care.)
First Posted : October 16, 2018
Last Update Posted : May 18, 2020
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 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
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : April 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"



Information from the National Library of Medicine

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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


Locations
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Spain
Elena González-Plaza
Barcelona, Spain, 08038
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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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
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Responsible Party: Elena Gonzalez-Plaza, Midwife, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03706872    
Other Study ID Numbers: HCB2017/0756
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight