A Home Visiting Program for Pregnant Youth to Promote Early Brain Development

NCT ID: NCT02807818

Last Updated: 2018-10-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-12-31

Brief Summary

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Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 20 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6 and 12 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6 and 12 months.

Detailed Description

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Conditions

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Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nurse home visits

Nurse biweekly home visit.

Group Type EXPERIMENTAL

Home visiting Program for Young Pregnant Women

Intervention Type BEHAVIORAL

Usual care

Usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home visiting Program for Young Pregnant Women

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Low socioeconomic status
* Mother's age between 14-19
* Mother being a primapara
* Gestation between the 8th and 16th week

Exclusion Criteria

* High-risk gestation
* Mother's Intellectual, visual or auditory disability
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Guilherme Vanoni Polanczyk

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculdade de Medicina da Universidade de São Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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da Silva LA, Siqueira LD, Oliveira LGF, Miguel Filho EC, Polanczyk GV, Fracolli LA. The impact of a home visiting program on the care environment of Brazilian adolescent mothers - an descriptive exploratory study. Front Glob Womens Health. 2025 Apr 25;6:1530351. doi: 10.3389/fgwh.2025.1530351. eCollection 2025.

Reference Type DERIVED
PMID: 40351759 (View on PubMed)

Euclydes VLV, Gastaldi VD, Feltrin AS, Hoffman DJ, Gouveia G, Cogo H, Felipe-Silva A, Vieira RP, Miguel EC, Polanczyk GV, Chiesa A, Fracolli L, Matijasevich A, Ferraro A, Argeu A, Maschietto M, Brentani HP. DNA methylation mediates a randomized controlled trial home-visiting intervention during pregnancy and the Bayley infant's cognitive scores at 12 months of age. J Dev Orig Health Dis. 2022 Oct;13(5):556-565. doi: 10.1017/S2040174421000738. Epub 2022 Mar 8.

Reference Type DERIVED
PMID: 35256034 (View on PubMed)

Fatori D, Fonseca Zuccolo P, Shephard E, Brentani H, Matijasevich A, Archanjo Ferraro A, Aparecida Fracolli L, Chiesa AM, Leckman J, Constantino Miguel E, V Polanczyk G. A randomized controlled trial testing the efficacy of a Nurse Home Visiting Program for Pregnant Adolescents. Sci Rep. 2021 Jul 13;11(1):14432. doi: 10.1038/s41598-021-93938-7.

Reference Type DERIVED
PMID: 34257407 (View on PubMed)

Alarcao FSP, Shephard E, Fatori D, Amavel R, Chiesa A, Fracolli L, Matijasevich A, Brentani H, Nelson CA, Leckman J, Miguel EC, Polanczyk GV. Promoting mother-infant relationships and underlying neural correlates: Results from a randomized controlled trial of a home-visiting program for adolescent mothers in Brazil. Dev Sci. 2021 Nov;24(6):e13113. doi: 10.1111/desc.13113. Epub 2021 Apr 12.

Reference Type DERIVED
PMID: 33844435 (View on PubMed)

Fatori D, Argeu A, Brentani H, Chiesa A, Fracolli L, Matijasevich A, Miguel EC, Polanczyk G. Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of Sao Paulo, Brazil: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 28;8(7):e13686. doi: 10.2196/13686.

Reference Type DERIVED
PMID: 32720906 (View on PubMed)

Other Identifiers

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0722-03

Identifier Type: -

Identifier Source: org_study_id

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