Baby2Home (B2H) Mobile Health Application

NCT05595486 | Completed DMC

• 2 other identifiers: STU002166591R01HD105499-01
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 2

Brief Summary

The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life. This randomized controlled trial will evaluate whether, compared to usual care, Baby2Home 1) improves maternal, paternal, and infant health service utilization outcomes over the first year postpartum, 2) improves maternal and paternal patient reported outcomes, and 3) reduces racial/ethnic and income-based disparities in preventive health services utilization and parental patient reported outcomes.

Conditions

COVID-19 Pandemic; Perinatal Depression; Mental Health Wellness; Health Knowledge, Attitudes, Practice; Post Partum Depression

Outcome Measures

Primary Outcomes (1)

• Completion of preventive health services utilization for all family members (birthing, non-birthing, and infant)

  The primary outcome defined as positive if all of the items below are met for all family members: 1. optimal maternal preventive health services utilization over the 1st year postpartum (including attendance at the comprehensive postpartum visit, receives chosen contraceptive method, and undergoes postpartum depression screening) 2. optimal paternal/co-parental preventive health services utilization over the 1st year postpartum (including receiving recommended vaccinations for new parents, if desires a male-driven contraceptive option, receives chosen method, and undergoes screening for depression) 3. optimal infant preventive health services utilization over the 1st year postpartum (including attending all AAP recommended wellness visits, receiving all AAP recommended vaccines, and receiving breast milk for 6 months of life)

  Baseline through 1 year postpartum

Secondary Outcomes (17)

• Number of participants who attend comprehensive postpartum visit (birthing parent)

  At least once between 4 and 12 weeks postpartum

• Completion of postpartum depression screening (birthing parent)

  Through study completion, up to 12 months

• Number of participants who received contraception (birthing and non-birthing parent)

  Through study completion, up to 12 months

• Number of participants who received the recommended vaccinations (non-birthing parent)

  Through study completion, up to 12 months

• Completion of postnatal depression screening for non-birthing parent

  Through study completion, up to 12 months

Study Arms (2)

Usual Care

NO INTERVENTION

As a pragmatic trial, usual care will be defined by contemporary clinical standards. For maternal care, this includes a comprehensive medical visit between 4-12 weeks postpartum. This visit includes utilization of a validated screen for postpartum depression and, if that screen is positive, a clinical assessment and initiation of treatment (e.g. pharmacotherapy or referral for psychotherapy). In addition, this visit includes a discussion of contraception as well as supportive education on breastfeeding. For paternal care, clinical standards are gleaned from the AAP, ACOG, and USPSTF reports outlining mental health screening, reproductive health, and vaccine uptake. For infant care, standard pediatric care from the AAP and Bright Futures periodicity timeline and guidelines will be used. In addition, assignment in this arm will be given surveys at baseline, 1M, 2M, 4M, 6M, and 12M.

Baby2Home Intervention

EXPERIMENTAL

Families randomized to the intervention arm will receive the B2H services. B2H is a novel digitized CC-based intervention delivered via a smartphone app available on iOS or Android phones, built by combining two successful programs: NICU2Home+ app and CC services. Using the UCD methodologies, AI-based communication within the app will include education for mothers and fathers on the standard of care regarding self-care and newborn care after hospital discharge as well as education, reminders and scheduling for recommended preventative healthcare services for themselves and their new infant.

Other: Baby2Home Mobile Application

Interventions

Baby2Home Mobile Application OTHER

Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life.

Baby2Home Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Delivery at Prentice Women's Hospital or Women and Infants Hospital of Rhode Island
• Viable term infant (≥ 37 weeks)
• First live born child
• English speaking
• Age 18 years old or greater
• Access to a smartphone
• Access to a working email address

You may not qualify if:

• No smartphone access
• Infant death
• Infant requires NICU admission
• Known severe mental illness of either parent (e.g., bipolar disorder, schizophrenia)
• SARS-CoV-2 infection without clinical clearance
• History of IPV (intimate partner violence) with current partner (would exclude partner)
• Concurrent enrollment in studies that may affect the outcome of the trial (or vice versa)

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Northwestern University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Women and Infant's Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• Chang E, Lewkowitz AK, Unger JA, Garfield CF, Miller ES. Smartphone Applications to Support Perinatal Mental Health. Obstet Gynecol. 2026 Feb 1;147(2):229-238. doi: 10.1097/AOG.0000000000006139. Epub 2025 Dec 18.

  PMID: 41411652 DERIVED

MeSH Terms

Conditions

COVID-19; Behavior; Depression, Postpartum

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Craig Craig, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research team abstracting the data and performing the analyses will be masked to the randomization arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Families will be randomized into either the control or intervention group.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: October 27, 2022
• Study Start: November 9, 2022
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)