Promoting Healthy Brain Development: Wellness for 2 Study

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 15, 2019

Primary Completion Date

July 28, 2024

Study Completion Date

July 31, 2024

Conditions
Prenatal Stress
Interventions
BEHAVIORAL

Mothers and Babies (MB) Course

The Mothers and Babies course (MB) is a 12-session manualized stress-reduction intervention that will be delivered to participants, prenatally, with an integrated technology suite designed for timely detection and response to maternal stress.

BEHAVIORAL

Just in Time Intervention (JITI) Content

"Participants will also receive additional MB intervention content in the form of just-in-time text messages, which will be sent to participants' smartphones every other day for up to 12 weeks. During the current trial, participants will receive text message prompts with links to additional stress reduction content based on a combination of their objective (sensor) and subjective (EMA) stress responses from the previous day."

DEVICE

Biostamp nPoint Device

During the intervention period, participants will be asked to wear the BioStamp nPoint sensor, daily, while engaging in their usual activities (e.g., sleep, showering, exercise). The BioStamp Sensor is a thin, wearable patch, equipped with wireless high-range 6-axis gyroscope + accelerometer, and sEMG and ECG sensors, that adheres to the skin using a disposable medical-grade adhesive sticker (with adhesive similar to Band-Aid).

Trial Locations (2)

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

Northwestern University (Feinberg School of Medicine), Chicago

All Listed Sponsors
collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

lead

Northwestern University

OTHER

NCT05052281 - Promoting Healthy Brain Development: Wellness for 2 Study | Biotech Hunter | Biotech Hunter