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The study stopped because of delays in the development of the smartphone app intervention
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| Name | Class |
|---|---|
| Grand Challenges Canada | OTHER |
| Fundação Maria Cecilia Souto Vidigal | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Educational App (Active Control) | Active Comparator | An app with educational content about gestation, maternal health and mental health, child development, etc. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motherly App | Behavioral | The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of sleep: Bergen Insomnia Scale | Quality of sleep measured by the Bergen Insomnia Scale | Monthly up to 3 months of the child's age |
| Quality of maternal diet: questionnaire | Quality of maternal diet measured by a 14-item questionnaire developed for the present study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniel Fatori | São Paulo | Brazil |
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| Educational App (Active Control) | Behavioral | An app with educational content about gestation, maternal health and mental health, child development, etc. |
|
| Monthly up to 3 months of the child's age |
| Physical activity | Physical activity measured by accelerator data from the smartphone. | Monthly up to 3 months of the child's age |
| Psychological well-being | Psychological well-being measured by the Ryff's Psychological well-being scales | Monthly up to 3 months of the child's age |
| General well-being | WHO-5 Well-Being Index | 3 months of the child's age |
| Maternal anxiety | Maternal anxiety measured by the General Anxiety Disorder 7 scale | 3 months of the child's age |
| Maternal self-efficacy: General Self-efficacy Scale | Maternal self-efficacy measured by the General Self-efficacy Scale | 3 months of the child's age |
| Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment | Quality of stimulation and support available to the child in the home environment measured by the Home Observation for Measurement of the Environment | 3 months of the child's age |
| Maternal parenting stress | Maternal parenting stress measured by the Parenting Stress Index (PSI) | 3 months of the child's age |
| Child development | Child developmental milestones measured by in-app questions | After child birth up to 3 months of the child's age |
| Child developmental milestones | Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC) | 3 months of the child's age |