Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03615261
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2018-07-23
Brief Title:
Wellness For 2 A Feasibility and Acceptability Pilot
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Promoting Healthy Brain Development Via Prenatal Stress Reduction An Innovative Precision Medicine Approach An Intervention Feasibility and Acceptability Pilot
Status:
COMPLETED
Status Verified Date:
2021-10
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:
We2-P
Brief Summary:
The investigators are studying strategies and tools that women can use to manage stress and wellness during pregnancy The purpose of this project is to test a technology-enhanced version of a wellness intervention for women during their pregnancy the Mothers and Babies course MB The technology that the investigators will test includes wearable heart rate sensors smartphone text message surveys and intervention materials delivered through text message
Detailed Description:
Perinatal early life stress ELS has significant consequences for mothers and their infants1-3 Prolonged prenatal stress places pregnant women at increased risk for depression health risk behaviors and poor overall health and quality of life Likewise fetal exposure to stress places infants at greater risk of neurodevelopmental disruptions45
Prior clinical trials led by co-PI Darius Tandon have demonstrated that pregnant women particularly those in low income environments demonstrate positive health and parenting benefits as a result of receiving prenatal stress reduction interventions6-8 The stress-reduction intervention proposed in the overarching Promoting Healthy Brains Project PHBP the Mothers and Babies course MB is a scalable manualized evidence-based cognitive-behavioral intervention that can be adapted to meet client needs eg setting dose timing modality without compromising fidelity However as there is substantial heterogeneity in maternal responsiveness to prenatal stress-reduction interventions MB in its current form may be too low-intensity to improve fetal outcomes Although a few studies have examined impact of interventions like MB on developmental outcomes the extant evidence base does not provide strong support for intervention effects Further state-of-the-art neurodevelopmental methods have not been employed to detect how manipulation of early exposure to stress may effect brainbehavior patterns in early life Advancing this is the overarching goal of the PHBP
A crucial component of the proposed work involves an enhanced version of the 12-session one-on-one version of MB with 1 mindfulness training content 2 inter-session text messages prompting skills reinforcement self-monitoring and homework reminders 3 adaptive real-time stress monitoring that will optimize the intervention by identifying the key point at which to deliver just-in-time stress intervention content to individual participants
The investigators will ask pregnant women to wear a long-wearing unobtrusive wireless ECG sensor BioStamp Research Connect BioStamp BioStamp sensor data will be used to detect physiological responses to stress ie heart rate variability HRV to build a system that can be used to trigger real-time stress reduction intervention BioStamp a lightweight rechargeable and easy to use wearable device is equipped to passively and continuously measure HRV and motion Unlike traditional wired ECG monitors BioStamp can be worn under typical daily-living conditions eg sleeping showering physical activity with only minimal obtrusion in daily life eg re-charging re-applying adhesive
Led by PI Laurie Wakschlag the overarching PBHP will harness multidisciplinary expertise from Northwesterns Institute for Innovations in Developmental Sciences DevSci Lurie Childrens Hospital Center for Community Health McCormick School of Engineering and Feinberg School of Medicine Northwestern Medicine ObGyn Preventive Medicine Medical Social Sciences and Pediatrics to 1 adapt and pilot MB enhanced with mindfulness training content and just-in-time feedback to participants regarding their in-the-moment stress responses and 2 experimentally test the effects of the optimized intervention on maternal wellbeing pre- and postnatally and postnatal neurodevelopmental health trajectories
Prior clinical trials led by co-PI Darius Tandon have demonstrated that pregnant women particularly those in low income environments demonstrate positive health and parenting benefits as a result of receiving prenatal stress reduction interventions6-8 The stress-reduction intervention proposed in the overarching Promoting Healthy Brains Project PHBP the Mothers and Babies course MB is a scalable manualized evidence-based cognitive-behavioral intervention that can be adapted to meet client needs eg setting dose timing modality without compromising fidelity However as there is substantial heterogeneity in maternal responsiveness to prenatal stress-reduction interventions MB in its current form may be too low-intensity to improve fetal outcomes Although a few studies have examined impact of interventions like MB on developmental outcomes the extant evidence base does not provide strong support for intervention effects Further state-of-the-art neurodevelopmental methods have not been employed to detect how manipulation of early exposure to stress may effect brainbehavior patterns in early life Advancing this is the overarching goal of the PHBP
A crucial component of the proposed work involves an enhanced version of the 12-session one-on-one version of MB with 1 mindfulness training content 2 inter-session text messages prompting skills reinforcement self-monitoring and homework reminders 3 adaptive real-time stress monitoring that will optimize the intervention by identifying the key point at which to deliver just-in-time stress intervention content to individual participants
The investigators will ask pregnant women to wear a long-wearing unobtrusive wireless ECG sensor BioStamp Research Connect BioStamp BioStamp sensor data will be used to detect physiological responses to stress ie heart rate variability HRV to build a system that can be used to trigger real-time stress reduction intervention BioStamp a lightweight rechargeable and easy to use wearable device is equipped to passively and continuously measure HRV and motion Unlike traditional wired ECG monitors BioStamp can be worn under typical daily-living conditions eg sleeping showering physical activity with only minimal obtrusion in daily life eg re-charging re-applying adhesive
Led by PI Laurie Wakschlag the overarching PBHP will harness multidisciplinary expertise from Northwesterns Institute for Innovations in Developmental Sciences DevSci Lurie Childrens Hospital Center for Community Health McCormick School of Engineering and Feinberg School of Medicine Northwestern Medicine ObGyn Preventive Medicine Medical Social Sciences and Pediatrics to 1 adapt and pilot MB enhanced with mindfulness training content and just-in-time feedback to participants regarding their in-the-moment stress responses and 2 experimentally test the effects of the optimized intervention on maternal wellbeing pre- and postnatally and postnatal neurodevelopmental health trajectories
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None