Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health

NCT ID: NCT03955718

Last Updated: 2020-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2020-06-01

Brief Summary

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The investigators plan to develop and test Motherly, a smartphone app to promote maternal mental health and child development. The Motherly app is visually appealing aimed at engaging the user with a minimalistic layout. The app will offer a gamified experience ideal for engaging youth in behaviors that can promote mental health, such as stimulating pleasure, productivity, and physical activities, connecting with peers, and eating healthy food. Pregnant women aged 16-34 living in Brazil will participate in the clinical trial to test the efficacy of the intervention.

Detailed Description

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Conditions

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Maternal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Motherly App

A smartphone app with an automated intervention that provides strategies to prevent maternal depression and to promote child development: (1) behavioral activation, (2) sleep hygiene, (3) physical activity, (4) social support, (5) nutrition, (6) prenatal care schedule, and (7) educational content.

Group Type EXPERIMENTAL

Motherly App

Intervention Type BEHAVIORAL

The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.

Educational App (Active Control)

An app with educational content about gestation, maternal health and mental health, child development, etc.

Group Type ACTIVE_COMPARATOR

Educational App (Active Control)

Intervention Type BEHAVIORAL

An app with educational content about gestation, maternal health and mental health, child development, etc.

Interventions

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Motherly App

The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.

Intervention Type BEHAVIORAL

Educational App (Active Control)

An app with educational content about gestation, maternal health and mental health, child development, etc.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Literate women in the first or second trimester of pregnancy
* Living in Brazil
* Owning a functional smartphone for personal use with Android or iOS operational system

Exclusion Criteria

* High-risk pregnancy
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Grand Challenges Canada

OTHER

Sponsor Role collaborator

Fundação Maria Cecilia Souto Vidigal

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Guilherme Vanoni Polanczyk, MD PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Daniel Fatori

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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SB-POC-1810-20573

Identifier Type: -

Identifier Source: org_study_id

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