Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349070
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-04-01
Brief Title:
RESTORE - Phase II
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Bridging Maternal Lifestyle Education and Counseling With Community Health Workers and Health Equity - Phase II
Status:
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 study will apply the principles of Community Based Participatory Research to evaluate implementation strategies designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants The primary strategies include a technology supported strategy low touch in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous group and individual strategy high touch Prior to implementation one-time interview and focus groups will be conducted with clinic providers and staff In addition a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum The aims of the study are 1 to evaluate and compare adoption of the program delivery with text technology messaging vs delivery by Community Health Workers CHW 2 to examine implementation fidelity 3 to evaluate and compare the impact of the strategies on key clinical outcomes 4 to examine sustainability continued adoption following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies
Detailed Description:
None
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