Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders (ePerinatal-RCT)
25. května 2026 aktualizováno: Emma Motrico, University of Seville
Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial
This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial.
The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders.
Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
This clinical trial evaluates the effectiveness and implementation of the e-Perinatal intervention, a personalized mobile health (mHealth) psychological program designed for the universal prevention of maternal perinatal depression and anxiety disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 effectiveness-implementation trial in routine maternal care settings within primary healthcare centers.
Primary healthcare centers will be randomized to either the intervention or control arm. Participants will include pregnant women and their partners.
The primary objective is to evaluate the effectiveness of the e-Perinatal intervention in reducing the cumulative incidence of maternal perinatal depression and anxiety disorders, assessed via structured diagnostic interviews. Secondary objectives include assessing maternal and paternal mental health outcomes, child development outcomes, and identifying moderators and mediators of intervention effectiveness.
In addition, the study will evaluate implementation outcomes, including acceptability, feasibility, adoption, fidelity, and barriers and facilitators to implementation in real-world healthcare settings.
Participants in the intervention group will receive access to the e-Perinatal app alongside usual maternal care. The e-Perinatal app includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. Participants in the control group will receive usual maternal care.
Typ studie
Intervenční
Zápis (Odhadovaný)
3000
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Emma Motrico, PhD Psychology
- Telefonní číslo: 0034636995778
- E-mail: eperinatal@us.es
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- Inclusion Criteria (Women)
Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
Must be pregnant for at least 11 weeks at the time of enrollment
Must be at least 18 years old
Must have access to a mobile phone and internet connection
Must be able to read, write, and understand Spanish
Must have a personal email account
No diagnosis of depression or anxiety disorder at baseline Forma
- Inclusion Criteria (Partners or significant others)
Must receive an invitation to participate from a woman already enrolled in the study
Must be at least 18 years old
Must have access to a mobile phone and internet connection
Must be able to read, write, and understand Spanish
Must have a personal email account
Exclusion Criteria:
- Exclusion Criteria (Women)
Current diagnosis of depression or anxiety disorder
Receiving psychological or pharmacological treatment for mental health or substance use conditions
- Exclusion criteria for partners (or significant others):
There are no exclusion criteria for partners
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Zásahová skupina
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The e-Perinatal intervention is a personalized mobile health (mHealth) program that includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. The intervention is delivered through a mobile application and is integrated into routine maternal care. Participants will use the app from recruitment (pregnancy) until 12 months of postpartum. |
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Aktivní komparátor: Kontrolní skupina
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Participants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cumulative incidence of maternal perinatal depression and anxiety disorders
Časové okno: Baseline and 12 months postpartum
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Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria
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Baseline and 12 months postpartum
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maternal depressive symptoms (mothers)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Changes in depressive symptoms.
Assessment method: The Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure.
Each item is scored from 0 to 3, with higher scores indicating more severe depressive symptoms.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Maternal anxiety symptoms (mothers)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Changes in anxiety symptoms.
Assessment method: The General Anxiety Questionnaire (GAD-7), a 7-item self-report measure.
Each item is scored from 0 to 3, with higher scores indicating more severe anxiety symptoms.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Paternal depressive symptoms (partner)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Changes in depressive symptoms.
Assessment method: The Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure.
Each item is scored from 0 to 3, with higher scores indicating more severe depressive symptoms.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Paternal anxiety symptoms (partner)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Changes in anxiety symptoms.
Assessment method: The General Anxiety Questionnaire (GAD-7), a 7-item self-report measure.
Each item is scored from 0 to 3, with higher scores indicating more severe anxiety symptoms.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Psychological well-being (mothers, partners)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Changes in subjective well-being.
Assessment method: The Well-Being Index (WHO-5), a 5-item self-report measure.
Each item is scored from 0 to 5, with higher scores indicating better subjective well-being.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Organizační připravenost na zavádění změn
Časové okno: Měřeno před náborem
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Připravenost organizace na zavádění změn v běžné péči.
Metoda hodnocení: The Organizational Readiness Implementing Change (ORIC), 12-položkové self-reportové opatření.
Každá položka je bodována od 1 do 5, přičemž vyšší skóre znamená větší připravenost na implementaci změny.
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Měřeno před náborem
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Vlastnosti PHC
Časové okno: Měřeno před náborem
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Velikost populace, kde se primární zdravotní péče nachází, a počet odborníků na primární zdravotní péči.
Způsob hodnocení: Dotazník vypracovaný výzkumným týmem
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Měřeno před náborem
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App quality (mothers, partners)
Časové okno: 12 months postpartum
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Objective and subjective quality, and the perceived impact of the application.
Assessment method: The User Version of the Mobile Application Rating Scale (u-MARS), a 26-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating better app quality.
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12 months postpartum
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Implementation process
Časové okno: 12 months postpartum
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App implementation process from the perspective of healthcare professionals involved in implementing complex interventions.
Assessment method: The Normalization Measure Development Questionnaire (NoMAD), a 20-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating more effective implementation processes.
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12 months postpartum
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Barriers and facilitators
Časové okno: 12 months postpartum
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Identifies barriers and facilitators impacting the integration of the intervention into routine healthcare, drawing from the experiences of users and healthcare professionals.
Assessment method: Semi-structured interviews following the Normalization Process Theory (NPT) framework
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12 months postpartum
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Reasons for dropout (mothers, partners)
Časové okno: 12 months postpartum
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Number and reasons (e.g., experienced miscarriage or stillbirth, lack of engagement with the app) for dropout among women and their partners.
Assessment method: Records and semi structured interviews.
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12 months postpartum
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Antenatal and postnatal risks (mothers, partners)
Časové okno: Baseline, 6 weeks postpartum
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Measures both antenatal and postnatal risk factors.
Assessment method: The Antenatal Risk Questionnaire (ANRQ-R), a 11-item self-report measure.
Some items are scored from 1 to 5 and others are scored on categorical scale, with higher scores indicating greater risk.
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Baseline, 6 weeks postpartum
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Basic psychological needs (mothers, partners)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measures the satisfaction and frustration of basic psychological needs.
Assessment method: The Basic Psychological Need Satisfaction and Frustration Scale - Short Form (BPNSFS), a 12-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating a higher need satisfaction (i.e., need satisfaction subscale) or a higher need frustration (i.e., need frustration subscale).
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Maternal post-traumatic stress symptoms (mothers)
Časové okno: 6 weeks postpartum
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Presence of post-traumatic stress symptoms after childbirth.
Assessment method: City Birth Trauma Scale (City-BiTS), a 5-item self-report measure.
A total of 4 items are scored from 0 to 3 and one item is scored from 0 to 1, with higher scores indicating greater severity of postnatal post-traumatic stress.
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6 weeks postpartum
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Maternal perceptions of childbirth (mothers)
Časové okno: 6 weeks postpartum
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Measure of the perceived quality of the childbirth experience.
Assessment method: Childbirth Experience Questionnaire (CEQ-E), a 22-items self-report scale.
A total of 19 items range from 1 to 4. A total of 2 items range from 0 to 10. Higher scores indicate a more positive experience of childbirth.
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6 weeks postpartum
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Maternal breastfeeding experience (mothers)
Časové okno: 6 weeks postpartum; 6 months postpartum
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Assessment method: Ad hoc instrument.
The instrument assesses infant feeding practices (2 items) and maternal satisfaction with breastfeeding (1 item), yielding a score ranging from 0 to 100.
Higher scores indicate greater satisfaction with breastfeeding.
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6 weeks postpartum; 6 months postpartum
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Maternal antenatal attachment (mothers)
Časové okno: 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measures the level of maternal antenatal attachment to the baby.
Assessment method: The Maternal Antenatal Attachment Scale (MAAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger maternal antenatal attachment.
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34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Paternal antenatal attachment (partners)
Časové okno: 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measures the level of paternal antenatal attachment to the baby.
Assessment method: The Paternal Antenatal Attachment Scale (PAAS), a 16-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger paternal antenatal attachment.
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34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Maternal postnatal attachment (mothers)
Časové okno: 6 weeks postpartum
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Measures the level of maternal postnatal attachment to the baby.
Assessment method: The Maternal Postnatal Attachment Scale (MPAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger maternal postnatal attachment.
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6 weeks postpartum
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Paternal postnatal attachment (fathers)
Časové okno: 6 weeks postpartum
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Measures the level of postnatal attachment to the baby in both mothers and fathers.
Assessment method: The Paternal Postnatal Attachment Scale (PPAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger paternal postnatal attachment.
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6 weeks postpartum
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Psychological flexibility (mothers, partner)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measure of psychological flexibility.
Assessment method: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT), a 10-item self-report scale.
Each item is scored from 1 to 7, with higher scores indicating greater psychological flexibilityTime
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Partnership quality (mothers, partners)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measures the quality of the marital or partnership relationship.
Assessment method: The Quality of Marriage Index (QMI), a 6-item self-report measure.
Some items are scored from 1 to 7 and others from 1 to 10, with higher scores indicating better relationship quality.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Parental role perception (mothers)
Časové okno: 6 months postpartum
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Measures parents' perception of their competence in the parental role.
Assessment method: The Parental Sense of Competence scale (PSOC), a 21-item self-report measure.
Each item is scored from 1 to 6, with higher scores indicating a stronger sense of parental competence.
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6 months postpartum
|
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Coparenting dynamics (mothers, partners)
Časové okno: 6 months postpartum
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Measures the dynamics of coparenting relationships.
Assessment method: The Coparenting Relationship Scale (CRS), a 14-item self-report measure.
Each item is scored from 0 to 6, with higher scores indicating more positive coparenting dynamics.
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6 months postpartum
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Mediterranean diet adherence (mothers, partners)
Časové okno: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Measure of adherence to the mediterranean diet.
Assessment method: Mediterranean Diet Adherence Screener (MEDAS), a 14-items self-report instrument.
Each item score from 0 to 1. Higher scores indicate greater adherence to the mediterranean diet.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
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Maternal physical activity levels (mothers)
Časové okno: Baseline, 6 months postpartum
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Measures physical activity levels in pregnant women and mothers.
Assessment method: The Pregnancy Physical Activity Questionnaire (PPAQ), a 33-item self-report measure.
Each item is scored from 0 to 5, with higher scores indicating higher levels of physical activity.
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Baseline, 6 months postpartum
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Physical condition (mothers)
Časové okno: Baseline, 6 months postpartum
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Measures overall physical condition and the main components (i.e., cardiorespiratory fitness, muscular strength, speed-agility, and flexibility) in pregnant women and mothers.
Assessment method: The International FItness Scale (IFIS), a 5-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating better physical condition.
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Baseline, 6 months postpartum
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Child temperament (mothers)
Časové okno: 6 months postpartum
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Measures various aspect of infant temperament.
Assessment method: The Infant Behavior Questionnaire-Revised Short Form (IBQ-R SF), a 37-item self-report measure.
Each item is scored from 1 to 7, with higher scores indicating a higher frequency of the specified temperament behavior.
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6 months postpartum
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Child development (mothers)
Časové okno: 6 months postpartum
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Measures of various domains of infant development. Assessment method: Ages & Stages Questionnaires (ASQ-3), a self-report measure. Each milestone question is answered using one of three frequency options, which are converted into point values:
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6 months postpartum
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Life quality (mothers, partners)
Časové okno: 12 months postpartum
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Measures the overall quality of life.
Assessment method: The European Quality of Life-5 Dimensions-5 Levels (EuroQol-5D-5L), a 5-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating worse quality of life
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12 months postpartum
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Identity (mothers, partners)
Časové okno: Baseline, 6 months postpartum
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Measure of various domains of identity development.
Assessment method: Dimensions of Identity Development Scale (DIDS)., a 25-items self-report measure.
Each item is scored from 1 to 5, with higher scores indicating greater endorsement of the corresponding identity development dimension.
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Baseline, 6 months postpartum
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Economic data
Časové okno: 12 months postpartum
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Measures healthcare service utilization and sick leave days over the previous year among participating women.
Assessment method: a post hoc semi-structured interview that collects information on emergency visits, hospital admissions, primary care visits (e.g., nurse, midwife, social worker), secondary care visits, and consultations with specialists.
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12 months postpartum
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Emma Motrico, PhD, University of Seville
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
30. května 2026
Primární dokončení (Odhadovaný)
30. prosince 2027
Dokončení studie (Odhadovaný)
30. března 2028
Termíny zápisu do studia
První předloženo
6. května 2026
První předloženo, které splnilo kritéria kontroly kvality
25. května 2026
První zveřejněno (Aktuální)
29. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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- EP-WP3-2025
- 101042139 (Jiný identifikátor: European Research Council (ERC))
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