NCT03706872

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

October 10, 2018

Last Update Submit

May 14, 2020

Conditions

Obese Pregnant Women

Keywords

pregnant womenobesityMobile Applicationsweight gainphysical activity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Gestational complications

    36 weeks

  • Intrapartum complications

    Labor

  • perinatal complications

    birth

Other Outcomes (2)

  • App usability

    36 weeks

  • Eating habits

    36 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Provision of usual prenatal care

Interventions

Intervention groupOTHER

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women with BMI ≥ 30 Kg / m2 preconceptional
  • Speak Spanish fluently
  • Viable singleton non-malformed fetus
  • weeks of gestation
  • Users of Android or Iphone smart mobile phone with internet connection

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elena González-Plaza

Barcelona, 08038, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35166684DERIVED

MeSH Terms

Conditions

ObesityWeight GainMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Elena González-Plaza, Midwife

    Clinic Hospital of Barcelona

    PRINCIPAL INVESTIGATOR

  • Gloria Seguranyes, PhD

    University of Barcelona

    STUDY DIRECTOR

  • Jordi Bellart, PhD

    Clinic Hospital of Barcelona

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Care provider will not know the arm of randomization
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with 2 arms of intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 16, 2018

Study Start

July 1, 2018

Primary Completion

March 10, 2020

Study Completion

April 1, 2020

Last Updated

May 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)