RESTORE - Phase II

NAEnrolling by invitationINTERVENTIONAL
Enrollment

1,050

Participants

Timeline

Start Date

January 26, 2024

Primary Completion Date

January 30, 2027

Study Completion Date

March 30, 2027

Conditions
Maternal Health
Interventions
BEHAVIORAL

Low Touch - Text Messaging Implementation Strategy

The low touch strategy is designed as a tool to distill and organize the most important information from the Starting Early Program (StEP) original evidenced-based intervention curriculum. Video links are sent to pregnant subjects via automated SMS messaging. Subjects will receive videos (20 videos total) at least weekly lasting 17 to 31 weeks and the duration is based upon the gestational age at enrollment into the study. Subjects will also receive SMS messages in between videos at least weekly to keep them engaged and reinforce the video content delivered. The StEP curriculum is guideline concordant and includes sessions delivered during pregnancy coordinated with prenatal visits. The sessions delivered during pregnancy aim to improve diet, physical activity and stress management, enhance prenatal breastfeeding support, and build social support. The StEP curriculum was adapted into brief videos (\<5 minutes), and an additional module on Sleep Health was added.

BEHAVIORAL

High Touch - Community Health Worker (CHW) Implementation Strategy

The curriculum will be delivered by CHWs. Each subject will be asked to participate in 1-hour live sessions with a CHW. During the sessions, videos are interspersed with open-ended questions and pauses to discuss these open-ended questions. This results in an interactive session that employs principles of active learning. The curriculum includes sessions delivered during pregnancy coordinated with prenatal visits. The sessions delivered during pregnancy aim to improve diet, physical activity and stress management during pregnancy, enhance prenatal breastfeeding support, and build social support and are anchored by the same brief videos developed for the low touch strategy.

Trial Locations (2)

10016

NYC Health + Hospitals/Bellevue, New York

NYU Langone Health, New York

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

NYU Langone Health

OTHER