ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03706872
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Elena Gonzalez-Plaza, Hospital Clinic of Barcelona

Brief Summary:

Efficacy of an App for monitoring physical activity and weight of obese pregnant women.

Obese women will be randomized in prenatal control of pregnancy in the second trimester into an App for monitoring their physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone, with respect to pregnant women who follow usual prenatal care.


Condition or disease Intervention/treatment Phase
Obese Pregnant Women Other: App and virtual advices through messages with mobile phone Not Applicable

Detailed Description:

Randomized controlled trial among obese women. These women will be randomized in order to evaluate an improvement in several outcomes thanks to different strategies : an App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages/ midwife feedback with mobile phone/ , with respect to pregnant women who follow usual prenatal care.

Main hypothesis: An intervention in the prenatal control through an App for monitoring physical activity and weight and the administration of virtual advices in pregnant women with obesity:

  • It will increase the proportion of pregnant women who obtain a weight gain adjusted to the preconceptional BMI with respect to the pregnant women of the control group.
  • Decrease the incidence of maternal complications in pregnancy, childbirth, postpartum and perinatal, with respect to pregnant women in the control group.

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
Active Comparator: App and virtual advices
Use an App for monitoring physical activity and weight with a smart watch Administration of virtual advices through messages with mobile phone
Other: App and virtual advices through messages with mobile phone
Use an App for monitoring physical activity and weight with a smart watch Administration of virtual advices through messages with mobile phone
Other Name: smart watch

No Intervention: Normal prenatal care
Normal prenatal care No intervention strategy



Primary Outcome Measures :
  1. Gestational weight gain [ Time Frame: 24 weeks ]
    Compare gestational weight gain in both groups.


Secondary Outcome Measures :
  1. Gestational complications [ Time Frame: 24 weeks ]
    Compare prevalence of hypertensive disorders, preeclampsia, thromboembolic disease, gestational diabetes.

  2. Intrapartum complications [ Time Frame: 3 days ]
    Compare prevalence of inductions, instrumented delivery, cesarean section, shoulder dystocia.

  3. Postpartum complications [ Time Frame: 2weeks ]
    Compare prevalence of uterine atony, retention of membranes, endometritis

  4. perinatal complications [ Time Frame: 25 weeks ]
    Compare prevalence of prematurity, presence of malformations, perinatal loss, fetal growth restriction, macrosomia and admission to the Care Unit Neonatal Intensive in both groups ( experimental and control).


Other Outcome Measures:
  1. App usability [ Time Frame: 24 weeks ]
    To describe App usability using System Usability Scale in pregnant women of the experimental group

  2. Physical activity [ Time Frame: 24 weeks ]
    Compare physical activity in both groups with IPAQuestionnaire

  3. Eating habits [ Time Frame: 24 weeks ]
    Compare eating habits in both groups with Food habits questionnaire for patients with overweight and obesity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 932275400 ext 7294 eplaza@clinic.cat

Locations
Spain
Elena González Plaza Recruiting
Barcelona, Spain, 08038
Contact: Elena González Plaza, Midwife    93227554 ext 7294    eplaza@clinic.cat   
Contact: Angela Arranz         
Sub-Investigator: Gloria Seguranyes, Midwife         
Sub-Investigator: Jordi Bellart Alfonso, Obstetrician         
Principal Investigator: Elena González Plaza, Midwife         
Sponsors and Collaborators
Hospital Clinic 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: October 16, 2018
Last Verified: October 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:
obese pregnant women
app mobile phone
gestational weight gain