NCT06349070

RESTORE - Phase II

Bridging Maternal Lifestyle Education, and Counseling With Community Health Workers and Health Equity - Phase II

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,050 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Maternal Health

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-26
• Primary completion: 2027-01-30
• Completion: 2027-03-30
• First posted: 2024-04-05
• Last updated: 2026-02-19

Locations

2 sites across 1 country: United States