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RESTORE - Phase II

Recruiting
18 - 89 years of age
Female
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria (Implementation Group (Low Touch and High Touch)):

  • Confirmed pregnant and <20 weeks 0 days gestational age
  • receiving care at one of the 10 clinics
  • ≥18 years old
  • able to speak and read English or Spanish
  • Has a smartphone or mobile device with a data plan to accept text messages and internet connection to watch videos

Inclusion Criteria (Follow-up Group):

  • Enrolled as a subject in the Implementation Group (Low Touch or High Touch) within the first trimester (before the end of the 13th week (13w6d))
  • willing and able to provide consent for baseline and follow up surveys

Exclusion Criteria:

  • Significant psychiatric or developmental disability as noted in the medical record.

Study details

Maternal Health

NCT06349070

NYU Langone Health

3 April 2025

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