Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05052281
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2019-08-30
Brief Title:
Promoting Healthy Brain Development Wellness for 2 Study
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Promoting Healthy Brain Development Via Prenatal Stress Reduction An Innovative Precision Medicine Approach
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Promoting Healthy Brain Project PHBP is part of the Lurie Childrens Hospital Strategic Research Initiative on Perinatal Origins of Childhood Disease Research Prevention at the Maternal-Fetal Interface The overall purpose of the PHBP is to test whether reducing maternal stress during pregnancy is associated with improved neurodevelopment in the first year of life This will be tested via a randomized controlled trial n 100 of a technology and mindfulness enhanced prenatal stress-reduction intervention Mothers and Babies MB
Detailed Description:
The Promoting Healthy Brain Project PHBP aims to improve infant neurodevelopmental trajectories by intervening on the fetal environment The PHBP will experimentally test whether reducing prenatal maternal stress is associated with improved neurodevelopment in the first year of life A randomized controlled trial RCT of a technology and mindfulness-enhanced prenatal maternal stress-reduction intervention The Mothers and Babies Course MB compared to usual prenatal care Prospective evaluation of infant neurodevelopmental outcomes will take place through infant age 24 months Participants assigned to the intervention group will be offered the 12-session MB intervention a well-studied intervention that will include new mindfulness practice enhancements designed to promote practice of awareness and attention to the present moment MB visits will be delivered 1-on-1 by a trained facilitator in an open and nonjudgmental way and will be offered in-person over the phone andor by video chat Throughout the intervention all participants intervention group and control group will also wear a wireless smart health sensing device BioStamp Sensor - nPoint Device that will measure heart rate and motion Mothers heart rate variability and self-reported stress and emotion will be monitored using the BioStamp Sensor and brief smartphone surveys For mothers in the intervention group patterns of prolonged stress will trigger a just-in-time adapted intervention JITAI that will be delivered to mothers smartphones The booster intervention will include activities that will enhance skills learned in the MB course All participants will complete self-report measures of prenatal maternal stress emotion depression and skills related to the intervention eg mindfulness Infant neurodevelopmental health will be measured via brain and behavioral indicators of self-regulation including performance-based indicators of executive function and corollary prefrontal cortex maturation and dimensional phenotypes of disruptive behavior particularly irritability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None