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出境医 / 临床实验 / Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Maternal Depression Behavioral: Motherly App Behavioral: Educational App (Active Control) Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health
Estimated Study Start Date : September 25, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Behavioral: Motherly App
The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.
Active Comparator: Educational App (Active Control)
An app with educational content about gestation, maternal health and mental health, child development, etc.
 Behavioral: Educational App (Active Control)
An app with educational content about gestation, maternal health and mental health, child development, etc.
Outcome Measures
Primary Outcome Measures :
  1. Maternal depression [ Time Frame: At 3 months of the child's age ]
    Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale


Secondary Outcome Measures :
  1. Quality of sleep: Bergen Insomnia Scale [ Time Frame: Monthly up to 3 months of the child's age ]
    Quality of sleep measured by the Bergen Insomnia Scale

  2. Quality of maternal diet: questionnaire [ Time Frame: Monthly up to 3 months of the child's age ]
    Quality of maternal diet measured by a 14-item questionnaire developed for the present study.

  3. Physical activity [ Time Frame: Monthly up to 3 months of the child's age ]
    Physical activity measured by accelerator data from the smartphone.

  4. Psychological well-being [ Time Frame: Monthly up to 3 months of the child's age ]
    Psychological well-being measured by the Ryff's Psychological well-being scales

  5. General well-being [ Time Frame: 3 months of the child's age ]
    WHO-5 Well-Being Index

  6. Maternal anxiety [ Time Frame: 3 months of the child's age ]
    Maternal anxiety measured by the General Anxiety Disorder 7 scale

  7. Maternal self-efficacy: General Self-efficacy Scale [ Time Frame: 3 months of the child's age ]
    Maternal self-efficacy measured by the General Self-efficacy Scale

  8. Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment [ Time Frame: 3 months of the child's age ]
    Quality of stimulation and support available to the child in the home environment measured by the Home Observation for Measurement of the Environment

  9. Maternal parenting stress [ Time Frame: 3 months of the child's age ]
    Maternal parenting stress measured by the Parenting Stress Index (PSI)

  10. Child development [ Time Frame: After child birth up to 3 months of the child's age ]
    Child developmental milestones measured by in-app questions

  11. Child developmental milestones [ Time Frame: 3 months of the child's age ]
    Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Brazil
Daniel Fatori
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Grand Challenges Canada
Fundação Maria Cecilia Souto Vidigal
Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date July 22, 2020
Estimated Study Start Date  ICMJE September 25, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		Maternal depression [ Time Frame: At 3 months of the child's age ]
Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Quality of sleep: Bergen Insomnia Scale [ Time Frame: Monthly up to 3 months of the child's age ]
    Quality of sleep measured by the Bergen Insomnia Scale
  • Quality of maternal diet: questionnaire [ Time Frame: Monthly up to 3 months of the child's age ]
    Quality of maternal diet measured by a 14-item questionnaire developed for the present study.
  • Physical activity [ Time Frame: Monthly up to 3 months of the child's age ]
    Physical activity measured by accelerator data from the smartphone.
  • Psychological well-being [ Time Frame: Monthly up to 3 months of the child's age ]
    Psychological well-being measured by the Ryff's Psychological well-being scales
  • General well-being [ Time Frame: 3 months of the child's age ]
    WHO-5 Well-Being Index
  • Maternal anxiety [ Time Frame: 3 months of the child's age ]
    Maternal anxiety measured by the General Anxiety Disorder 7 scale
  • Maternal self-efficacy: General Self-efficacy Scale [ Time Frame: 3 months of the child's age ]
    Maternal self-efficacy measured by the General Self-efficacy Scale
  • Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment [ Time Frame: 3 months of the child's age ]
    Quality of stimulation and support available to the child in the home environment measured by the Home Observation for Measurement of the Environment
  • Maternal parenting stress [ Time Frame: 3 months of the child's age ]
    Maternal parenting stress measured by the Parenting Stress Index (PSI)
  • Child development [ Time Frame: After child birth up to 3 months of the child's age ]
    Child developmental milestones measured by in-app questions
  • Child developmental milestones [ Time Frame: 3 months of the child's age ]
    Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health
Official Title  ICMJE Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Maternal Depression
Intervention  ICMJE
  • Behavioral: Motherly App
    The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.
  • Behavioral: Educational App (Active Control)
    An app with educational content about gestation, maternal health and mental health, child development, etc.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Motherly App
  • Active Comparator: Educational App (Active Control)
    An app with educational content about gestation, maternal health and mental health, child development, etc.
    Intervention: Behavioral: Educational App (Active Control)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 19, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2019) 		1004
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03955718
Other Study ID Numbers  ICMJE SB-POC-1810-20573
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Guilherme Vanoni Polanczyk, MD PhD, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE
  • Grand Challenges Canada
  • Fundação Maria Cecilia Souto Vidigal
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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