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

NCT03955718 | Withdrawn DMC

• 1 other identifier: SB-POC-1810-20573
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal Depression

Outcome Measures

Primary Outcomes (1)

• Maternal depression

  Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale

  At 3 months of the child's age

Secondary Outcomes (11)

• Quality of sleep: Bergen Insomnia Scale

  Monthly up to 3 months of the child's age

• Quality of maternal diet: questionnaire

  Monthly up to 3 months of the child's age

• Physical activity

  Monthly up to 3 months of the child's age

• Psychological well-being

  Monthly up to 3 months of the child's age

• General well-being

  3 months of the child's age

Study Arms (2)

Motherly App

EXPERIMENTAL

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.

Behavioral: Motherly App

Educational App (Active Control)

ACTIVE COMPARATOR

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

Behavioral: Educational App (Active Control)

Interventions

Motherly App BEHAVIORAL

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

Motherly App

Educational App (Active Control) BEHAVIORAL

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

Educational App (Active Control)

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• High-risk pregnancy

Sponsors & Collaborators

• University of Sao Paulo: lead
• Grand Challenges Canada: collaborator
• Fundação Maria Cecilia Souto Vidigal: collaborator

Study Sites (1)

Daniel Fatori

São Paulo, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: May 20, 2019
• Study Start: September 25, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)